(2)

in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.: ‘COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM Scientific name of the plant Vitis vinifera L. Botanical family Vitaceae Herbal substance Grapevine leaf (1) Common name of herbal substance in all EU official languages BG (bălgarski): лоза, лист CS (čeština): Červený list vinné révy DA (dansk): Vinblad DE (Deutsch): Rote Weinrebenblätter EL (elliniká): Φύλλο Αμπέλου EN (English): Grapevine leaf ES (español): Vid, hoja de ET (eesti keel): Viinapuu lehed FI (suomi): Aitoviiniköynnös, lehti FR (français): Feuille de vigne rouge HU (magyar): Bortermő szőlő levél IT (italiano): Vite, foglia LT (lietuvių kalba): Tikrųjų vynmedžių lapai LV (latviešu valoda): Īstā vīnkoka lapas MT (malti): Werqa tad-dielja NL (nederlands): Wijnstokblad PL (polski): Liść winorośli właściwej PT (português): Folha de videira RO (română): Frunze de viță-de-vie SK (slovenčina): List viniča SL (slovenščina): List vinske trte SV (svenska): Blad från vinranka IS (íslenska): Vínviðarlauf NO (norsk): Rød vinranke, blad Herbal preparation(s) Soft extract (2.5-4:1; extraction solvent water) European Pharmacopoeia monograph reference Not applicable Indication(s) Traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances. The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use. Type of tradition European Specified strength Please see “Specified posology”. Specified posology Adults and elderly Soft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract). Apply a thin layer on the affected area 1-3 times daily. The use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”). Route of administration Cutaneous use. Duration of use or any restrictions on the duration of use Adults and elderly The recommended duration of use is 4 weeks. 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. Any other information necessary for the safe use Contraindications Hypersensitivity to the active substance. Special warnings and precautions for use If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted. The product should not be used on broken skin, around the eyes or on mucous membranes. In the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended. Interactions with other medicinal products and other forms of interaction None reported. Pregnancy and lactation Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. Undesirable effects Contact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) have been reported. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. Overdose No case of overdose has been reported. Pharmaceutical particulars (if necessary) Not applicable. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) Not applicable.