Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
O, BETA, HYDROXYETHYL, RUTOSIDES
Novartis Consumer Health UK Limited Park View, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, United Kingdom
C05CA54
O-(BETA-HYDROXYETHYL)-RUTOSIDES 2 g
GEL
O-(BETA-HYDROXYETHYL)-RUTOSIDES 2 g
OTC
VASOPROTECTIVES
Withdrawn
2007-04-20
VENORUTON Gel ® DOSE/METHOD OF USE HOW SHOULD VENORUTON GEL BE USED? Apply the gel morning and evening to the areas to be treated. Rub gently to help the gel penetrate, until the skin is dry. If necessary, Venoruton gel many be applied under bandages or elastic stockings. Keep to the dose given in this leaflet or prescribed by your doctor. If you feel that the medicine is not effective enough, or indeed that it is too strong, see your doctor, pharmacist or chemist. _LOCAL TREATMENT FOR VENOUS_ _DISORDERS OR TRAUMA_ _ _ PROPERTIES/THERAPEUTIC USE WHAT IS VENORUTON GEL AND WHEN IS IT USED? Venoruton gel contains O-(ß-hydroxyethyl)-rutosides which helps to restore normal function to the smallest blood vessels, the capillaries. This reduces swelling of the ankles and other symptoms (pain, heaviness) related to varices or of traumatic origin (sprains and twists, bruised muscles). Venoruton gel is alcohol-free, odourless and non-greasy. It is very suitable for repeated application to the skin. It is pleasant to apply and feels fresh. UNDESIRABLE SIDE EFFECTS WHAT UNDESIRABLE SIDE EFFECTS CAN VENORUTON GEL HAVE? Medicines that are effective may cause certain side effects. Venoruton gel is generally well tolerated. Rare cases of sensitivity with skin reactions have been reported; these symptoms quickly disappear once you stop applying the gel. This medicinal product contains Benzalkonium chloride which is irritant and may cause skin irritation. SPECIAL COMMENTS WHAT ELSE SHOULD I KNOW ABOUT? Medicines should be kept out of the reach of children. The medicine should not be used after the date ‹EXP› printed on the pack. If you have any medicines which have passed their expiry date, take them back to your pharmacist or chemist. If you need any more information, see your doctor, pharmacist or chemist who have detailed information which is produced for people in the medical profession. Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Venoruton ® 2% gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100g Venoruton ® 2% gel contains 2 g O-( ß-hydroxyethyl)-rutosides (abbreviated to HR) British Approved Name : Oxerutins For excipients, see 6.1. 3. PHARMACEUTICAL FORM Topical gel 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Relief of oedema and related symptoms of Chronic Venous Insufficiency (CVI) such as pain and heavy legs, pain after sclerotherapy or during long flights. Relief of pain and oedema of traumatic origin such as sprain and muscular contusion. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION - 2 applications daily with gentle massage to penetrate until the skin is dry - If necessary Venoruton ® 2% gel may be applied under occlusive or elastic bandages 4.3. CONTRA-INDICATIONS Known hypersensitivity to any ingredient of the product 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE The gel should only be used on intact skin; do not use it on the mucosa. Do not rub it in if you have venous disorders that were caused by a blood clot (called thromboembolism). If your symptoms persist or become worse, see a doctor. Before using Venoruton gel, tell your doctor, your pharmacist or your chemist if - you have any other illness, - you are allergic, particularly to other medicines, - you are already taking or using other medicines (including self- medication!) Page 2 of 3 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No drug interactions have been reported. 4.6. PREGNANCY AND LACTATION No controlled studies have been performed in pregnant or breast-feeding women with topical forms of HR. Only studies with oral forms of HR are available. In consequence, according to generally accepted safety recommendation, Venoruton ® 2% gel is not be used during the 1 st three months of pregnancy unless, in the opinion of Leggi il documento completo