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.
PDF abgerufen: 25.10.2026 · 8 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 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.Kontext im Original-PDF öffnen ↗4.3 · Gegenanzeigen
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
Original-PDF · Seite 5 ↗4.4 · Warnhinweise und Vorsichtsmaßnahmen
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.Original-PDF · Seite 6 ↗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
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
Original-PDF · Seite 6 ↗4.8 · Nebenwirkungen
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.Original-PDF · Seite 7 ↗Dokumentfassung nachweisen
SHA-256: 94ada55995ff00b41baaffa6ca89f365508d2e2e93a6ef5dd1cf4e5530b09f8c
Der Hash kennzeichnet die abgerufene Datei. Die Dokumentfassung und der Bearbeitungsstatus des Pflanzenprofils sind getrennte Angaben.
