Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LOSARTAN KALIUM 12,5 mg/stuk
axcount Generika GmbH Max-Planck-Straße 36d D-61381 FRIEDRICHSDORF (DUITSLAND)
C09CA01
LOSARTAN KALIUM 12,5 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Losartan
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); TITAANDIOXIDE (E 171);
2008-04-21
1 V06 PACKAGE LEAFLET: INFORMATION FOR THE USER KALIUMLOSARTAN AXCOUNT 12,5 MG, FILMOMHULDE TABLETTEN KALIUMLOSARTAN AXCOUNT 25 MG, FILMOMHULDE TABLETTEN KALIUMLOSARTAN AXCOUNT 50 MG, FILMOMHULDE TABLETTEN KALIUMLOSARTAN AXCOUNT 100 MG, FILMOMHULDE TABLETTEN LOSARTAN POTASSIUM 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kaliumlosartan axcount is and what it is used for 2. What you need to know before you take Kaliumlosartan axcount 3. How to take Kaliumlosartan axcount 4. Possible side effects 5. How to store Kaliumlosartan axcount 6. Contents of the pack and other information 1. WHAT KALIUMLOSARTAN AXCOUNT IS AND WHAT IT IS USED FOR Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Kaliumlosartan axcount is used - to treat high blood pressure (hypertension) in adults and in children and adolescents 6 - 18 years of age - to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein) Прочетете целия документ
1 V04 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kaliumlosartan axcount 12,5 mg, filmomhulde tabletten Kaliumlosartan axcount 25 mg, filmomhulde tabletten Kaliumlosartan axcount 50 mg, filmomhulde tabletten Kaliumlosartan axcount 100 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Kaliumlosartan axcount 12.5 mg Tablet contains 12.5 mg of losartan potassium equivalent to 11.44 mg of losartan. Each Kaliumlosartan axcount 25 mg Tablet contains 25 mg of losartan potassium equivalent to 22.9 mg of losartan. Each Kaliumlosartan axcount 50 mg Tablet contains 50 mg of losartan potassium equivalent to 45.8 mg of losartan. Each Kaliumlosartan axcount 100 mg Tablet contains 100 mg of losartan potassium equivalent to 91.6 mg of losartan. Excipient with known effect: Kaliumlosartan axcount 12.5 mg tablets Each tablet contains 5.85 mg of lactose monohydrate/film-coated tablet. Kaliumlosartan axcount 25 mg tablets Each tablet contains 11.70 mg of lactose monohydrate/film-coated tablet. Kaliumlosartan axcount 50 mg tablets Each tablet contains 23.40 mg of lactose monohydrate/film-coated tablet. Kaliumlosartan axcount 100 mg tablets Each tablet contains 46.80 mg of lactose monohydrate/film-coated tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Kaliumlosartan axcount 12.5 mg tablet White, round, biconvex film-coated tablets with a diameter of 5.1 mm approximately. Kaliumlosartan axcount 25 mg tablet White, round, biconvex film-coated tablets with a diameter of 5.1 mm approximately. Kaliumlosartan axcount 50 mg tablet 2 V04 White, round, biconvex film-coated tablets with a diameter of 7.6 mm approximately, bearing a breakline on one side. The tablet can be divided into equal doses. Kaliumlosartan axcount 100 mg tablet White, round, biconvex film-coated tablets with a diameter of 9.1 mm approximately, bearing a breakline on one side. The tablet can be divided into equal doses._ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Прочетете целия документ