País: Malta
Idioma: inglés
Fuente: Medicines Authority
ETAMSYLATE
OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal
B02BX01
ETAMSYLATE 500 mg
TABLET
ETAMSYLATE 500 mg
POM
ANTIHEMORRHAGICS
Withdrawn
2006-11-20
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER DICYNONE ® 500 Etamsylate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness symptoms are the same as yours - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dicynone ® 500 is and what it is used for 2. What you need to know before you take Dicynone ® 500 3. How to take Dicynone ® 500 4. Possible side effects 5. How to store Dicynone ® 500 6. Contents of the pack and other information 1. WHAT DICYNONE ® 500 IS AND WHAT IT IS USED FOR Each tablet contains 500 mg etamsylate which is the active ingredient. Etamsylate is a synthetic antihaemorrhagic and angioprotective drug acting on the first step of haemostasis (endothelium - platelet interaction). By improving platelet adhesiveness and restoring capillary resistance, it reduces bleeding time and blood losses. Etamsylate has no vasoconstrictor action, it does not influence fibrinolysis nor modify the plasma coagulation factors. PHARMACOTHERAPEUTIC CLASS Antihaemorrhagic THERAPEUTIC INDICATIONS _In surgery:_ Prevention and treatment of pre- or postsurgical capillary haemorrhages in all delicate operations and in those affecting highly vascularised tissues E.N.T, gy Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DICYNONE ® 500 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg etamsylate as the active ingredient. Excipient with known effect: sodium sulfite (E 221) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DICYNONE 500 is indicated in adults. _In surgery : _ Prevention and treatment of pre- or postsurgical capillary haemorrhages in all delicate operations and in those affecting highly vascularised tissues : E.N.T., gynecology, obstetrics, urology, odontostomatology, ophthalmology, plastic and reconstructive surgery. _In internal medicine : _ Prevention and treatment of capillary haemorrhages of whatever origin or localisation : haematuria, haematemesis, melaena, epistaxis, gingivorrhagia. _In gynecology : _ Metrorrhagia, primary or IUD-related menorrhagia in the absence of organic pathology. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS _ _Presurgical : _1 tablet (500 mg) 1 hour before surgery. _Postsurgical : _1 tablet (500 mg) every 4 - 6 hours as long as the risk of bleeding persists. _Internal medicine : g_enerally 1 tablet 2 - 3 times a day (1000 - 1500 mg) to be taken with meals with a little water; treatment duration depends on the results obtained. _Gynecology, meno-metrorrhagia :_ 1 tablet 3 times a day (1500 mg) to be taken with meals with a little water. Treatment lasts 10 days and starts 5 days before the expected onset of menses. _CHILDREN _ Because of its high concentration of active principle, DICYNONE 500 is not appropriate Leer el documento completo