País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
EXTRACT (AS DRY EXTRACT) FROM FRESH HORSE CHESNUT SEEDS (AESCULUS HIPPOCASTANUM L. SEMEN)
Bioforce (UK) Ltd
EXTRACT (AS DRY EXTRACT) FROM FRESH HORSE CHESNUT SEEDS (AESCULUS HIPPOCASTANUM L. SEMEN)
157.5-225.0 Milligram
Tablets Gastro-Resistant
Product not subject to medical prescription
Authorised
2011-12-16
31450INX XXXXXXX/20170628 H O R S E C H E S T N U T S E E D _Please turn over..._ Information Do's and Don'ts Using Package Leaflet: Information for the user Venaforce ® 1. What Venaforce is and what it is used for Venaforce is a traditional herbal medicinal product containing the extract of fresh Horse Chestnut seeds. It is used for relieving the symptoms of varicose veins such as: Tired, heavy legs Aching legs This is exclusively based on long- standing use. Venaforce is for relieving the symptoms of varicose veins in adults. Varicose veins appear when veins lose their elasticity. Blood then gathers, causing swelling and discomfort 2. What you need to know before you take Venaforce Do not take Venaforce If you are allergic to: Horse Chestnut (_Aesculus _ _hippocastanum_) seed. This product contains Horse Chestnut seed. Any of the other ingredients of this product (listed in section 6). Warnings and precautions See your doctor as soon as possible if you have: Swelling, increased heat or redness of the skin around the affected vein A hard swelling in the affected vein Hardness under the skin around the affected vein Severe pain Sudden swelling of one or both legs A heart or kidney problem Leg ulcers or if you notice them developing, see your doctor. Varicose leg ulcers can arise on your lower legs as a result of varicose veins. See your doctor if your symptoms worsen or do not improve within 2 weeks. Children and adolescents Do not give this product to children or adolescents under 18 years of age. Other medicines and Venaforce You can take this product with other medicines. If you are speaking to your doctor, pharmacist or nurse always remember to tell them about any medicines you are taking, including herbal remedies such as Venaforce. Pregnancy and breast-feeding Do not take this product if you are pregnant or breast-feeding. Driving and using machines This product has no known effect on your ability to drive or use machines. Make sure you know how this product affects you before you drive or use machinery. V Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venaforce Varicose Veins gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 157.5 - 225.0 mg of extract (as dry extract) from fresh_ Aesculus hippocastanum_ L., semen (horse chestnut seed) corresponding to 50 mg triterpene glycosides, calculated as anhydrous -aescin. Extraction solvent: Ethanol 60 % m/m. Excipient with known effect: Each gastro-resistant tablet contains 12.5 mg of soya polysaccharide. For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet (tablet) It is a biconvex, oval-shaped, yellowish-beige coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product for relieving the symptoms of varicose veins such as tired, aching or heavy legs exclusively based on long standing use. This product is indicated for use in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and older people: one tablet twice daily taken immediately after food. Tablet should be swallowed whole. Do not exceed the recommended dose. This product should not be given to children and adolescents under the age of 18 years. If symptoms persist, worsen or do not improve after 2 weeks use of Venaforce a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. METHOD OF ADMINISTRATION For oral short-term use only. 4.3 CONTRAINDICATIONS This product should not be used by patients who have an allergy or are hypersensitive to horse chestnut seed or any of the other ingredients listed in section 6.1. Contains soya. If you are allergic to peanut or soya, do not use this medicinal product. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Llegiu el document complet