(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., FOLIUMScientific name of the plantVitis vinifera L.Botanical familyVitaceaeHerbal substanceGrapevine leafnoteCommon name of herbal substance in all EU official languages
Herbal preparation(s)Soft extract (2.5-4:1; extraction solvent water)European Pharmacopoeia monograph referenceNot applicableIndication(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 traditionEuropeanSpecified strengthPlease see “Specified posology”.Specified posologyAdults and elderlySoft 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 administrationCutaneous use.Duration of use or any restrictions on the duration of useAdults and elderlyThe 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 useContraindicationsHypersensitivity to the active substance.Special warnings and precautions for useIf 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 interactionNone reported.Pregnancy and lactationSafety 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 machinesNo studies on the effect on the ability to drive and use machines have been performed.Undesirable effectsContact 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.OverdoseNo 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.