Pflanzenwissen.
Mit Herkunft.

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 2,3
 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.
                                                                Vitis vinifera L., folium, (grapevine leaf) 5
 Vitis vinifera L., folium, (grapevine leaf) 4
                                                                i) Herbal substance
 i) Herbal substance
                                                                Not applicable
 Not applicable
                                                                ii) Herbal preparation
 ii) Herbal preparation
                                                                a) Comminuted herbal substance
 Dry extract (DER 4-6:1); extraction solvent
                                                                b) Powdered herbal substance
 water
                                                                c) Soft extract (DER 2.5-4:1); extraction solvent
                                                                   water



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.

                                                                Herbal preparation in solid dosage forms for oral
                                                                use.

                                                                Herbal preparation in semi-solid dosage forms
                                                                for cutaneous use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.




2 Detailed specifications for the herbal substance shall be given by references to bibliographic sources in absence of a
monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a
Member State.
3 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
4 and 5 The material complies with the monograph of the Pharmacopée Française X., 1996



European Union herbal monograph on Vitis vinifera L., folium
EMA/HMPC/464684/2016                                                                                                 Page 2/7
4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                          Traditional use

 Herbal medicinal product for treatment of chronic             Indication 1)
 venous insufficiency, which is characterised by
                                                               Traditional herbal medicinal product to relieve
 swollen legs, varicose veins, a feeling of
                                                               symptoms of discomfort and heaviness of legs
 heaviness, pain, tiredness, itching, tension and
                                                               related to minor venous circulatory
 cramps in the calves.
                                                               disturbances.

                                                               Indication 2)

                                                               Traditional herbal medicinal product for
                                                               symptomatic relief of itching and burning
                                                               associated with haemorrhoids after serious
                                                               conditions have been excluded by a medical
                                                               doctor.

                                                               Indication 3)

                                                               Traditional herbal medicinal product for
                                                               symptomatic treatment of cutaneous capillary
                                                               fragility.

                                                               The product is a traditional herbal medicinal
                                                               product for use in specified indications
                                                               exclusively based upon long-standing use.


                                                                         6
4.2. Posology and method of administration

 Well-established use                                          Traditional use

 Posology                                                      Posology

 Adults and elderly                                            Indication 1)

 Dry extract (DER 4-6:1; water)                                Adults and elderly
 Single dose: 360-720 mg
                                                               Oral use
 Daily dose: 360-720 mg
                                                               a) Comminuted herbal substance as herbal tea
 Use in children and adolescents
                                                               Herbal tea: 5-10 g of dried leaves in 250 ml of
 The use in children and adolescents under
                                                               boiling water as herbal infusion, 2 times daily.
 18 years of age is not recommended (see section
 4.4 ‘Special warnings and precautions for use’).              b) Powdered herbal substance

 Duration of use                                               270-350 mg, 3-5 times daily

 The recommended duration of use is 12 weeks.                  Cutaneous use
 Two to three weeks of treatment may be
                                                               c) Soft extract (DER 2.5-4:1; water) in a cream

6
  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 Vitis vinifera L., folium
EMA/HMPC/464684/2016                                                                                             Page 3/7
 required before beneficial effects are observed.                 base (10 g contain 282 mg soft extract).

 Long term use is possible in consultation with a              Apply a thin layer on the affected area 1-3
 doctor.                                                       times daily.

 Method of administration                                      Indication 2) and 3)

 Oral use                                                      Adults and elderly

                                                               Oral use

                                                               a) Comminuted herbal substance as herbal tea

                                                                Herbal tea: 5-10 g of dried leaves in 250 ml of
                                                                boiling water as herbal infusion, 2 times daily.

                                                               b) Powdered herbal substance

                                                               270-350 mg, 3-5 times daily

                                                               Duration of use

                                                               Indication 1)

                                                               The recommended duration of use is 4 weeks.
                                                               If the symptoms persist for more 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 for more than 1 week
                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               The use in children and adolescents under
                                                               18 years of age is not recommended (see section
                                                               4.4 ‘Special warnings and precautions for use’).

                                                               Method of administration

                                                               Indication 1), 2) and 3)

                                                               Oral use

                                                               Indication 1)

                                                               Cutaneous use.

Contraindications

4.3. Contraindications

 Well-established use                                          Traditional use

 Hypersensitivity to the active substance.                     Hypersensitivity to the active substance.




European Union herbal monograph on Vitis vinifera L., folium
EMA/HMPC/464684/2016                                                                                          Page 4/7

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                          Traditional use

 If there is inflammation of the skin,                         Indication 1)
 thrombophlebitis or subcutaneous induration,
                                                               If there is inflammation of the skin,
 severe pain, ulcers, sudden swelling of one or
                                                               thrombophlebitis or subcutaneous induration,
 both legs, cardiac or renal insufficiency, a doctor
                                                               severe pain, ulcers, sudden swelling of one or
 should be consulted.
                                                               both legs, cardiac or renal insufficiency, a doctor
 In the event of inadequate or unsatisfactory                  should be consulted.
 symptomatic response within 2 weeks, a doctor
                                                               Cutaneous use: The product should not be used
 should be consulted as oedema may have
                                                               on broken skin, around the eyes or on mucous
 alternative causes.
                                                               membranes.
 In the absence of sufficient safety data, the use
                                                               Oral use: In the event of inadequate or
 in children and adolescents below 18 years of
                                                               unsatisfactory symptomatic response within 2
 age is not recommended.
                                                               weeks, a doctor should be consulted as oedema
 If the symptoms worsen during the use of the                  may have alternative causes.
 medicinal product, a doctor or a pharmacist
                                                               Indication 2)
 should be consulted.
                                                               If rectal bleeding occurs during the treatment of
                                                               haemorrhoids a doctor or a qualified health care
                                                               practitioner should be consulted.

                                                               In the event of inadequate or unsatisfactory
                                                               symptomatic response within 1 week, a doctor
                                                               should be consulted.

                                                               Indication 3)

                                                               In the event of inadequate or unsatisfactory
                                                               symptomatic response within 1 week, a doctor
                                                               should be consulted as oedema may have
                                                               alternative causes.

                                                               Indication 1), 2) and 3)

                                                               In the absence of sufficient safety data, the use
                                                               in children and adolescents below 18 years of
                                                               age is not recommended.

                                                               If the symptoms worsen during the use of the
                                                               medicinal product, a doctor or a pharmacist
                                                               should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                          Traditional use

 Not known                                                     Not known




European Union herbal monograph on Vitis vinifera L., folium
EMA/HMPC/464684/2016                                                                                        Page 5/7

Undesirable effects

4.8. Undesirable effects

 Well-established use                                          Traditional use

 Hypersensitivity reactions of the skin (itching and           Contact allergy and/or hypersensitivity reactions
 erythema, urticaria) have been reported. The                  of the skin (itching and erythema, urticaria)
 frequency is not known.                                       have been reported. The frequency is not
                                                               known.
 Nausea, gastrointestinal complaints and
 headache may occur. The frequency is not                      Oral use: Nausea, gastrointestinal complaints
 known.                                                        and headache may occur. The frequency is not
                                                               known.
 If other adverse reactions not mentioned above
 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.