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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.
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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
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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).
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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)
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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)
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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.
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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: 2225d1b960f790ec8efe81c61c431a54ed96d2d0b827a0a75c0088c24774bfaf
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