St. John's Wort
Hyperici herba
Hypericum perforatumL.
HOS-215934hmpc:hyperici-herba-0
Botanische Abbildung
St. John's wort - flower and buds
Artbezogene Illustration. Sie zeigt nicht automatisch die im Profil genannte Arzneidroge oder Zubereitung und dient nicht zur sicheren Bestimmung einer Giftpflanze.
Didier Descouens · CC BY-SA 4.0 · Bildquelle ↗
Bildzuordnung & Herkunft
- Originalangabe im Profil
- Hypericum perforatumL.
- Taxonkennung
- Q158289 · Quellenrevision 2547636820
- Bearbeitung
- Auf maximal 1024 Pixel verkleinert, EXIF-Orientierung angewandt und als JPEG gespeichert; kein inhaltlicher Zuschnitt.
- Bildquelle abgerufen
- 25.10.2026
Bilddatei SHA-256: d116ce2a9ca7a9eb5f3954e5bf02c387493cf4ff7564d9a80dbef4fd7094135e
- Themengebiete laut EMA
- Skin disorders and minor wounds;Mental stress and mood disorders;Gastrointestinal disorders
- Ergebnis der Bewertung laut EMA
- European Union herbal monograph
- Kombination laut EMA
- Nein
Pflanzen–Arzneimittel-Beziehungen 8 belegte Zuordnungen
Explizite Einschränkungen aus der Monographie, verknüpft mit eindeutig bezeichneten Wirkstoffen. Die Aussage gilt im Zubereitungs- und Anwendungskontext der Quelle. Ein klinischer Schweregrad wird daraus nicht abgeleitet.
cyclosporine
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-084512RxNorm 3008
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
everolimus
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-086310RxNorm 141704
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
sirolimus
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-085172RxNorm 35302
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
tacrolimus
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-085202RxNorm 42316
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
fosamprenavir
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-086182RxNorm 358262
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
indinavir
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-084518RxNorm 114289
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
irinotecan
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-112102RxNorm 51499
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
imatinib
Laut Quelle kontraindiziertEtablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben
HOS-215934HOS-110212RxNorm 282388
glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
Zubereitungskontext & Beleg
Wortlaut der zugeordneten Einschränkung:
Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, irinotecan, imatinib and other cytostatic agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19 or transported by P-glycoprotein is contraindicated (see section 4.3. ‘Contraindications’).
1. Name of the medicinal product To be specified for the individual finished product. 2. Qualitative and quantitative composition 1,2 Well-established use Traditional use With regard to the marketing authorisation With regard to the registration application of application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC 2001/83/EC Hypericum perforatum L., herba (St. John’s wort) Hypericum perforatum L., herba (St. John’s wort) i) Herbal substance i) Herbal substance Not applicable. Not applicable. ii) Herbal preparations ii) Herbal preparations 3 a) Dry extract (DER 4-7:1), extraction solvent a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V methanol 80% V/V b) Liquid extract (DER 1:4-20), extraction solvent b) Dry extract (DER 3-6:1), extraction solvent vegetable oil ethanol 80% V/V c) Liquid extract (DER 1:13), extraction solvent c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil ethanol 50-68% V/V 4 d) Tincture (ratio herbal substance: extraction solvent 1:5), extraction solvent ethanol 50-70% V/V e) Tincture (ratio herbal substance: extraction solvent 1:10), extraction solvent ethanol 45-50% V/V f) Liquid extract (DER 1:2-7), extraction solvent ethanol 50% V/V4 g) Liquid extract from fresh herb (DER 1:1), extraction solvent ethanol 96% V/V h) Expressed juice from the fresh herb (DER 1:0.5-0.9) i) Stabilised expressed juice from fresh herb: The fresh herb is first stabilised over a boiling ethanol, then pressed and adjusted with water to a DER of 1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal quality guidance. 2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438) 3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874) 4 A narrow range of the DER to be specified for each individual medicinal product. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 3/14 Well-established use Traditional use 1:1. j) Comminuted herbal substance k) Powdered herbal substance 3. Pharmaceutical form Well-established use Traditional use Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for use. oral use. The pharmaceutical form should be described by Comminuted herbal substance for infusion the European Pharmacopoeia full standard term. preparation for cutaneous use. Herbal preparations a), k) in solid dosage forms for oral use. Herbal preparations b), c), d), e), f), g), h), i) in liquid dosage forms for oral use. Herbal preparations b), e), f) in liquid or semi- solid dosage forms for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. 4. Clinical particulars 4.1. Therapeutic indications Well-established use Traditional use Indication 1) Indication 1) Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k): Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief to moderate depressive episodes. of temporary mental exhaustion. Indication 2) Indication 2) Herbal preparation c): Herbal preparations b), d), e), j): Herbal medicinal product for the short-term Traditional herbal medicinal product for the treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of disorders. the skin (such as sunburn) and as an aid in healing of minor wounds. Indication 3) Herbal preparation i), j): Traditional herbal medicinal product for the European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 4/14 Well-established use Traditional use symptomatic relief of mild gastrointestinal discomfort. Indication 4) Herbal preparation j): Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. 4.2. Posology and method of administration 5 Well-established use Traditional use Posology Posology Adults and elderly Indication 1) Herbal preparation a): Adults and Elderly Single dose: 300-600 mg Herbal preparation a) Dosage frequency: 1-3 times daily Single dose: 60-180 mg Daily dose: 600-1800 mg Dosage frequency: 2-3 times daily Herbal preparation b): Daily dose: 180 - 360 mg Single dose: 900 mg Herbal preparation c) Dosage frequency: 1 single daily dose Single dose: 200 mg Daily dose: 900 mg Dosage frequency: 3 times daily Herbal preparation c): Daily dose: 600 mg Single dose: 600 mg or 612 mg Herbal preparation d) Dosage frequency: 1 single daily dose Single dose: 1-1.5 ml Daily dose: 600 mg or 612 mg Dosage frequency: 3 times daily or Daily dose: 3-4.5 ml Single dose: 250-600 mg Herbal preparation e) Dosage frequency: 2-3 times daily Single dose: 2-4 ml Daily dose: 500-1200 mg Dosage frequency: 3 times daily Children, adolescents Daily dose: 6-12 ml The use in children and adolescents under 18 Herbal preparation f) years of age is not recommended (see section 4.4 Single dose: 0.8-1.5 ml ‘Special warnings and precautions for use’). Dosage frequency: 3 times daily 5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1). European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 5/14 Well-established use Traditional use Duration of use Daily dose: 2.4-4.5 ml Indication 1) Herbal preparation g) The onset of the effect can be expected within 4 Single dose: 5ml weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily during the use of the medicinal product, a doctor Daily dose: 20 ml should be consulted. Herbal preparation h) Indication 2) Single dose: 10 – 20 ml Six weeks. Dosage frequency: 1-3 times daily Daily dose: 10-30 ml The onset of the effect can be expected within 4 weeks of treatment. If the symptoms persist Herbal preparation j) during the use of the medicinal product, a doctor Herbal tea: 1.5 - 2 g of the comminuted should be consulted. herbal substance in 150 ml of boiling water Method of administration as a herbal infusion, 2-3 times daily Daily dose: 3-6 g Oral use. Herbal preparation k) Single dose: 300 – 500 mg Dosage frequency: 2-3 times daily Daily dose: 900 – 1000 mg Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 2) Adolescents, adults, elderly Herbal preparation b), e), f): Cutaneous administration of the undiluted herbal preparation Herbal preparation j): Comminuted herbal preparation for infusion preparation for cutaneous use: 2 g of the comminuted herbal substance in 150 ml of water, several times daily as washing or impregnated dressing Children The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 3) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 6/14 Well-established use Traditional use Adults, elderly Herbal preparation i) Single dose: 2.5 ml Dosage frequency: 3 times daily Daily dose: 7.5 ml Herbal preparation j): Herbal tea: 2 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Indication 4) Adults, elderly Herbal preparation j): Herbal tea: 2-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 times daily Children, adolescents The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use Indications 1) and 4) If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indications 2) and 3) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Indications 1), 3) and 4) European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 7/14 Well-established use Traditional use Oral use. Indication 2) Cutaneous use. 4.5. Interactions with other medicinal products and other forms of interaction 6 Well-established use Traditional use Patients taking other medicines on prescription Patients taking other medicines on prescription are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist before taking Hypericum. before taking Hypericum. Pharmacokinetic interactions: Pharmacokinetic interactions: Hyperici herba preparations induce the activity of Indications 1), 3) and 4) CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- Daily dose of hyperforin ≤ 1 mg: glycoprotein. Concomitant use with coumarin-type anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9, agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P- CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with contraindicated (see section 4.3. drugs which are metabolised via other CYP- ‘Contraindications’). enzymes have not been investigated. Special care should be taken in case of Daily dose of hyperforin > 1 mg: concomitant use of all drug substances the Hyperici herba preparations induce the activity of metabolism of which is influenced by CYP3A4, CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P- CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein glycoprotein. Concomitant use with coumarin-type (e.g., amitriptyline, fexofenadine, alprazolam, anticoagulants, cyclosporine, everolimus, diazepam, midazolam, methadone, simvastatin, sirolimus, tacrolimus for systemic use, digoxin, finasteride), because a reduction of fosamprenavir, indinavir and other protease plasma concentrations is possible. inhibitors, nucleoside reverse transcriptase The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9, intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is 6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product information of individual products. European Union herbal monograph on Hypericum perforatum L., herba EMA/HMPC/7695/2021 Page 9/14 Well-established use Traditional use birth control. Women using hormonal contraindicated (see section 4.3. contraceptives should take additional ‘Contraindications’). contraceptive measures. Special care should be taken in case of Prior to elective surgery possible interactions with concomitant use of all drug substances the products used during general and regional metabolism of which is influenced by CYP3A4, anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam, diazepam, midazolam, methadone, simvastatin, The elevated enzyme activity returns within 1 digoxin, finasteride), because a reduction of week after cessation to normal level. plasma concentrations is possible. Pharmacodynamic interactions: The reduction of plasma concentrations of Hypericum dry extract may contribute to hormonal contraceptives may lead to increased serotonergic effects when combined with intermenstrual bleeding and reduced safety in antidepressants such as serotonin reuptake birth control. Women using hormonal inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional buspirone. Very rarely undesired effects contraceptive measures. (serotonin syndrome) with autonomic Prior to elective surgery possible interactions with dysfunctions (such as perspiration, tachycardia, products used during general and regional diarrhoea, fever), mental alterations (such as anaesthesia should be identified. If necessary, the agitation, disorientation), and motor alterations herbal medicinal product should be discontinued. (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1 other serotonergic active substances. week after cessation to normal level. Pharmacodynamic interactions: Hyperici herba preparations may contribute to serotonergic effects when combined with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and motor alterations (such as tremor or myoclonias) can occur in combination with serotonin-uptake inhibitors or other serotonergic active substances. Indication 2) None reportedPDF SHA-256:
2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfafDie Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.
Keine oder wenige Zuordnungen bedeuten nicht, dass keine Wechselwirkungen bestehen. Nicht eindeutig zuordenbare und verneinte Aussagen bleiben im Originalabschnitt nachlesbar.
Sicherheit aus der Monographie Originalabschnitte
Englische Originalabschnitte mit unveränderten Spalten für etablierte und traditionelle Anwendung. Aussagen gelten für die im Dokument genannten Zubereitungen und Anwendungsarten. Aus ihnen werden hier keine Interaktionspaare oder Schweregrade abgeleitet.
Final European Union herbal monograph on Hypericum perforatum L., herba - Revision 1 ↗
PDF abgerufen: 25.10.2026 · 14 Seiten · automatisch ausgelesen
Zubereitungs- und Anwendungskontext · Originaltext
Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition 1,2
Well-established use Traditional use
With regard to the marketing authorisation With regard to the registration application of
application of Article 10(a) of Directive Article 16d(1) of Directive 2001/83/EC
2001/83/EC
Hypericum perforatum L., herba (St. John’s wort)
Hypericum perforatum L., herba (St. John’s wort)
i) Herbal substance
i) Herbal substance
Not applicable.
Not applicable.
ii) Herbal preparations
ii) Herbal preparations 3
a) Dry extract (DER 4-7:1), extraction solvent
a) Dry extract (DER 3-7:1), extraction solvent ethanol 38% (m/m) = 45% V/V
methanol 80% V/V
b) Liquid extract (DER 1:4-20), extraction solvent
b) Dry extract (DER 3-6:1), extraction solvent vegetable oil
ethanol 80% V/V
c) Liquid extract (DER 1:13), extraction solvent
c) Dry extract (DER 2.5-8:1), extraction solvent maize oil or other suitable vegetable oil
ethanol 50-68% V/V 4
d) Tincture (ratio herbal substance: extraction
solvent 1:5), extraction solvent ethanol 50-70%
V/V
e) Tincture (ratio herbal substance: extraction
solvent 1:10), extraction solvent ethanol 45-50%
V/V
f) Liquid extract (DER 1:2-7), extraction solvent
ethanol 50% V/V4
g) Liquid extract from fresh herb (DER 1:1),
extraction solvent ethanol 96% V/V
h) Expressed juice from the fresh herb (DER
1:0.5-0.9)
i) Stabilised expressed juice from fresh herb: The
fresh herb is first stabilised over a boiling ethanol,
then pressed and adjusted with water to a DER of
1 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal
quality guidance.
2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438)
3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874)
4 A narrow range of the DER to be specified for each individual medicinal product.
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 3/14
Well-established use Traditional use
1:1.
j) Comminuted herbal substance
k) Powdered herbal substance
3. Pharmaceutical form
Well-established use Traditional use
Herbal preparation in solid dosage forms for oral Comminuted herbal substance as herbal tea for
use. oral use.
The pharmaceutical form should be described by Comminuted herbal substance for infusion
the European Pharmacopoeia full standard term. preparation for cutaneous use.
Herbal preparations a), k) in solid dosage forms
for oral use.
Herbal preparations b), c), d), e), f), g), h), i) in
liquid dosage forms for oral use.
Herbal preparations b), e), f) in liquid or semi-
solid dosage forms for cutaneous use.
The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.
4. Clinical particulars
4.1. Therapeutic indications
Well-established use Traditional use
Indication 1) Indication 1)
Herbal preparations a), b): Herbal preparations a), c), d), e), f), g), h), j), k):
Herbal medicinal product for the treatment of mild Traditional herbal medicinal product for the relief
to moderate depressive episodes. of temporary mental exhaustion.
Indication 2) Indication 2)
Herbal preparation c): Herbal preparations b), d), e), j):
Herbal medicinal product for the short-term Traditional herbal medicinal product for the
treatment of symptoms in mild depressive symptomatic treatment of minor inflammations of
disorders. the skin (such as sunburn) and as an aid in
healing of minor wounds.
Indication 3)
Herbal preparation i), j):
Traditional herbal medicinal product for the
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 4/14
Well-established use Traditional use
symptomatic relief of mild gastrointestinal
discomfort.
Indication 4)
Herbal preparation j):
Traditional herbal medicinal product for the
supportive treatment of nervous restlessness and
associated with difficulties in falling asleep.
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
4.2. Posology and method of administration 5
Well-established use Traditional use
Posology Posology
Adults and elderly Indication 1)
Herbal preparation a): Adults and Elderly
Single dose: 300-600 mg Herbal preparation a)
Dosage frequency: 1-3 times daily
Single dose: 60-180 mg
Daily dose: 600-1800 mg
Dosage frequency: 2-3 times daily
Herbal preparation b): Daily dose: 180 - 360 mg
Single dose: 900 mg Herbal preparation c)
Dosage frequency: 1 single daily dose
Single dose: 200 mg
Daily dose: 900 mg
Dosage frequency: 3 times daily
Herbal preparation c): Daily dose: 600 mg
Single dose: 600 mg or 612 mg Herbal preparation d)
Dosage frequency: 1 single daily dose
Single dose: 1-1.5 ml
Daily dose: 600 mg or 612 mg
Dosage frequency: 3 times daily
or Daily dose: 3-4.5 ml
Single dose: 250-600 mg Herbal preparation e)
Dosage frequency: 2-3 times daily
Single dose: 2-4 ml
Daily dose: 500-1200 mg
Dosage frequency: 3 times daily
Children, adolescents Daily dose: 6-12 ml
The use in children and adolescents under 18 Herbal preparation f)
years of age is not recommended (see section 4.4
Single dose: 0.8-1.5 ml
‘Special warnings and precautions for use’).
Dosage frequency: 3 times daily
5 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 5/14
Well-established use Traditional use
Duration of use Daily dose: 2.4-4.5 ml
Indication 1) Herbal preparation g)
The onset of the effect can be expected within 4 Single dose: 5ml
weeks of treatment. If the symptoms persist Dosage frequency: 4 times daily
during the use of the medicinal product, a doctor Daily dose: 20 ml
should be consulted.
Herbal preparation h)
Indication 2)
Single dose: 10 – 20 ml
Six weeks. Dosage frequency: 1-3 times daily
Daily dose: 10-30 ml
The onset of the effect can be expected within 4
weeks of treatment. If the symptoms persist Herbal preparation j)
during the use of the medicinal product, a doctor
Herbal tea: 1.5 - 2 g of the comminuted
should be consulted.
herbal substance in 150 ml of boiling water
Method of administration as a herbal infusion, 2-3 times daily
Daily dose: 3-6 g
Oral use.
Herbal preparation k)
Single dose: 300 – 500 mg
Dosage frequency: 2-3 times daily
Daily dose: 900 – 1000 mg
Children, adolescents
The use in children and adolescents under 18
years of age is not recommended (see section 4.4
‘Special warnings and precautions for use’).
Indication 2)
Adolescents, adults, elderly
Herbal preparation b), e), f):
Cutaneous administration of the undiluted herbal
preparation
Herbal preparation j):
Comminuted herbal preparation for infusion
preparation for cutaneous use: 2 g of the
comminuted herbal substance in 150 ml of water,
several times daily as washing or impregnated
dressing
Children
The use in children under 12 years of age is not
recommended (see section 4.4 ‘Special warnings
and precautions for use’).
Indication 3)
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 6/14
Well-established use Traditional use
Adults, elderly
Herbal preparation i)
Single dose: 2.5 ml
Dosage frequency: 3 times daily
Daily dose: 7.5 ml
Herbal preparation j):
Herbal tea: 2 g of the comminuted herbal
substance in 150 ml of boiling water as a
herbal infusion, 2 times daily
Children, adolescents
The use in children and adolescents under 18
years of age is not recommended (see section 4.4
‘Special warnings and precautions for use’).
Indication 4)
Adults, elderly
Herbal preparation j):
Herbal tea: 2-3 g of the comminuted herbal
substance in 150 ml of boiling water as a
herbal infusion, 2 times daily
Children, adolescents
The use in children and adolescents under 18
years of age is not recommended (see section 4.4
‘Special warnings and precautions for use’).
Duration of use
Indications 1) and 4)
If the symptoms persist longer than 2 weeks
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.
Indications 2) and 3)
If the symptoms persist longer than 1 week
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.
Method of administration
Indications 1), 3) and 4)
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 7/14
Well-established use Traditional use
Oral use.
Indication 2)
Cutaneous use.Kontext im Original-PDF öffnen ↗4.3 · Gegenanzeigen
Contraindications
4.3. Contraindications
Well-established use Traditional use
Hypersensitivity to the active substance. Daily dose of hyperforin ≤ 1 mg:
Concomitant use with coumarin-type Hypersensitivity to the active substance.
anticoagulants, cyclosporine, everolimus,
Daily dose of hyperforin > 1 mg:
sirolimus, tacrolimus for systemic use,
fosamprenavir, indinavir and other protease Hypersensitivity to the active substance.
inhibitors, nucleoside reverse transcriptase
Concomitant use with coumarin-type
inhibitors, irinotecan, imatinib and other cytostatic
anticoagulants, cyclosporine, everolimus,
agents metabolised by CYP3A4, CYP2B6, CYP2C9,
sirolimus, tacrolimus for systemic use,
CYP2C19 or transported by P-glycoprotein (see
fosamprenavir, indinavir and other protease
section 4.5 ‘Interactions with other medicinal
inhibitors, nucleoside reverse transcriptase
products and other forms of interaction’).
inhibitors, irinotecan, imatinib and other cytostatic
agents metabolised by CYP3A4, CYP2B6, CYP2C9,
CYP2C19 or transported by P-glycoprotein (see
section 4.5 ‘Interactions with other medicinal
products and other forms of interaction’).Original-PDF · Seite 8 ↗4.4 · Warnhinweise und Vorsichtsmaßnahmen
Special warnings and precautions for use
4.4. Special warnings and precautions for use
Well-established use Traditional use
Indications 1) and 2) Indications 1), 3) and 4)
During the treatment intense UV-exposure should During the treatment intense UV-exposure should
be avoided. be avoided.
Since no sufficient data are available, the use in Since no sufficient data are available the use in
children and adolescents under 18 years of age is children and adolescents under 18 years of age is
not recommended. not recommended.
Indication 2)
During the treatment intense UV-exposure of the
respective skin areas should be avoided.
Since no data on the safe use in children are
available, the use in children under 12 years of
age is not recommended.
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 8/14
Well-established use Traditional use
If signs of skin infections are observed, a doctor
or a qualified healthcare practitioner should be
consulted.
Indications 1) and 2)
For herbal preparations containing ethanol, the
appropriate labelling for ethanol, taken from the
‘Guideline on excipients in the label and package
leaflet of medicinal products for human use’, must
be included.Original-PDF · Seite 8–9 ↗4.5 · Wechselwirkungen
Interactions with other medicinal products and other forms of interaction
4.5. Interactions with other medicinal products and other forms of
interaction 6
Well-established use Traditional use
Patients taking other medicines on prescription Patients taking other medicines on prescription
are advised to consult a doctor or pharmacist are advised to consult a doctor or pharmacist
before taking Hypericum. before taking Hypericum.
Pharmacokinetic interactions: Pharmacokinetic interactions:
Hyperici herba preparations induce the activity of Indications 1), 3) and 4)
CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P-
Daily dose of hyperforin ≤ 1 mg:
glycoprotein. Concomitant use with coumarin-type
anticoagulants, cyclosporine, everolimus, As the daily intake of hyperforin is less than 1 mg
sirolimus, tacrolimus for systemic use, and of a duration of use not longer than 2 weeks
fosamprenavir, indinavir and other protease no clinically relevant interactions are reported for
inhibitors, nucleoside reverse transcriptase concomitantly administered drugs which are
inhibitors, irinotecan, imatinib and other cytostatic metabolised via CYP1A2, CYP2B6, CYP2C9,
agents metabolised by CYP3A4, CYP2B6, CYP2C9, CYP2C19, CYP3A4 or transported by P-
CYP2C19 or transported by P-glycoprotein is glycoprotein. Pharmacokinetic interactions with
contraindicated (see section 4.3. drugs which are metabolised via other CYP-
‘Contraindications’). enzymes have not been investigated.
Special care should be taken in case of Daily dose of hyperforin > 1 mg:
concomitant use of all drug substances the
Hyperici herba preparations induce the activity of
metabolism of which is influenced by CYP3A4,
CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P-
CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein
glycoprotein. Concomitant use with coumarin-type
(e.g., amitriptyline, fexofenadine, alprazolam,
anticoagulants, cyclosporine, everolimus,
diazepam, midazolam, methadone, simvastatin,
sirolimus, tacrolimus for systemic use,
digoxin, finasteride), because a reduction of
fosamprenavir, indinavir and other protease
plasma concentrations is possible.
inhibitors, nucleoside reverse transcriptase
The reduction of plasma concentrations of inhibitors, irinotecan, imatinib and other cytostatic
hormonal contraceptives may lead to increased agents metabolised by CYP3A4, CYP2B6, CYP2C9,
intermenstrual bleeding and reduced safety in CYP2C19 or transported by P-glycoprotein is
6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici
herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product
information of individual products.
European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021 Page 9/14
Well-established use Traditional use
birth control. Women using hormonal contraindicated (see section 4.3.
contraceptives should take additional ‘Contraindications’).
contraceptive measures.
Special care should be taken in case of
Prior to elective surgery possible interactions with concomitant use of all drug substances the
products used during general and regional metabolism of which is influenced by CYP3A4,
anaesthesia should be identified. If necessary, the CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein
herbal medicinal product should be discontinued. (e.g., amitriptyline, fexofenadine, alprazolam,
diazepam, midazolam, methadone, simvastatin,
The elevated enzyme activity returns within 1
digoxin, finasteride), because a reduction of
week after cessation to normal level.
plasma concentrations is possible.
Pharmacodynamic interactions:
The reduction of plasma concentrations of
Hypericum dry extract may contribute to hormonal contraceptives may lead to increased
serotonergic effects when combined with intermenstrual bleeding and reduced safety in
antidepressants such as serotonin reuptake birth control. Women using hormonal
inhibitors (e.g. sertraline, paroxetine) or contraceptives should take additional
buspirone. Very rarely undesired effects contraceptive measures.
(serotonin syndrome) with autonomic
Prior to elective surgery possible interactions with
dysfunctions (such as perspiration, tachycardia,
products used during general and regional
diarrhoea, fever), mental alterations (such as
anaesthesia should be identified. If necessary, the
agitation, disorientation), and motor alterations
herbal medicinal product should be discontinued.
(such as tremor or myoclonias) can occur in
combination with serotonin-uptake inhibitors or The elevated enzyme activity returns within 1
other serotonergic active substances. week after cessation to normal level.
Pharmacodynamic interactions:
Hyperici herba preparations may contribute to
serotonergic effects when combined with
antidepressants such as serotonin reuptake
inhibitors (e.g. sertraline, paroxetine) or
buspirone. Very rarely undesired effects
(serotonin syndrome) with autonomic
dysfunctions (such as perspiration, tachycardia,
diarrhoea, fever), mental alterations (such as
agitation, disorientation), and motor alterations
(such as tremor or myoclonias) can occur in
combination with serotonin-uptake inhibitors or
other serotonergic active substances.
Indication 2)
None reportedOriginal-PDF · Seite 9–10 ↗4.8 · Nebenwirkungen
Undesirable effects
4.8. Undesirable effects
Well-established use Traditional use
Gastrointestinal disorders (such as nausea, Indications 1), 3) and 4)
abdominal pain and diarrhoea), allergic skin
Gastrointestinal disorders (such as nausea,
reactions, fatigue and restlessness may occur.
abdominal pain and diarrhoea), allergic skin
The frequency is not known.
reactions, fatigue and restlessness may occur.
Fair-skinned individuals may react with The frequency is not known.
dysesthesia (e.g. tingling, sensitivity cold or pain,
Fair-skinned individuals may react with
burning sensation) and intensified sunburn-like
dysesthesia (e.g. tingling, sensitivity cold or pain,
symptoms under intense sunlight.
burning sensation) and intensified sunburn-like
If other adverse reactions not mentioned above symptoms under intense sunlight.
occur, a doctor or a pharmacist should be
If other adverse reactions not mentioned above
consulted.
occur, a doctor or a qualified health care
practitioner should be consulted.
Indication 2)
Skin reactions may occur. The frequency is not
known.
If other adverse reactions not mentioned above
occur, a doctor or a qualified health care
practitioner should be consulted.Original-PDF · Seite 11 ↗Dokumentfassung nachweisen
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Dokumente beim Herausgeber · 23
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- Call for scientific data for the systematic review of the monograph on Hypericum perforatum L., herba
- Overview of comments received on European Union herbal monograph on Hypericum perforatum L., herba (traditional use) (EMA/HMPC/45508/2017) - Revision 1
- Overview of comments received on European Union herbal monograph on Hypericum perforatum L., herba (well-established use and traditional use) (EMA/HMPC/7695/2021) - Revision 1
- Superseded overview of comments received on community herbal monograph on Hypericum perforatum L., herba
- Draft community herbal monograph on Hypericum perforatum L., herba - First version
- Draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1
- Final European Union herbal monograph on Hypericum perforatum L., herba - Revision 1
- Superseded community herbal monograph on Hypericum perforatum L., herba (traditional use)
- Superseded community herbal monograph on Hypericum perforatum L., herba (well-established medicinal use)
- Opinion of the HMPC on a European Union herbal monograph on Hypericum perforatum L., herba - Revision 1
- Second draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1
- Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hypericum perforatum L., herba (traditional use)
- Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hypericum perforatum L., herba (well-established medicinal use)
- Draft list of references for assessment of: Hyperici herba Hypericum perforatum L. (St. John´s wort) - First version
- Draft list of references supporting the assessment of Hypericum perforatum L., herba - Revision 1
- Final list of references supporting the assessment of Hypericum perforatum L., herba - Revision 1
- Second draft list of references supporting the assessment of Hypericum perforatum L., herba - Revision 1
- Superseded list of references supporting the assessment report on: Hyperici herba, Hypericum perforatum L., herba (St. John’s wort)
- Draft assessment report Hypericum perforatum L., herba - First version
- Draft assessment report on Hypericum perforatum L., herba - Revision 1
- Final assessment report on Hypericum perforatum L., herba - Revision 1
- Second draft assessment report on Hypericum perforatum L., herba - Revision 1
- Superseded assessment report on Hypericum perforatum L., herba
Dokumentenlinks geprüft: 25.10.2026
Quellenstand & Originalangaben
- Originalstatus
- F: Assessment finalised
- Zuletzt geändert laut EMA
- 22/02/2023
- Erstveröffentlichung laut EMA
- 31/12/2009
- Erfolgreicher Quellenabruf
- 25.10.2026