Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE
Mylan Ireland Limited 35/36 Grange Parade, Baldoyle Industrial Estate DUBLIN 13 (IERLAND)
A10BA02
METFORMINEHYDROCHLORIDE COMPOSITION corresponding to ; METFORMIN
Filmomhulde tablet
HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 400 ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201),
Oraal gebruik
Metformin
Hulpstoffen: HYPROLOSE (E 463); HYPROMELLOSE (E 464); MACROGOL 400; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201);
2010-01-13
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METNOVA 500 MG, FILMOMHULDE TABLETTEN METNOVA 850 MG, FILMOMHULDE TABLETTEN METNOVA 1000 MG, FILMOMHULDE TABLETTEN metformin hydrochloride 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Metnova is and what it is used for. 2. What you need to know before you take Metnova. 3. How to take Metnova. 4. Possible side effects. 5. How to store Metnova. 6. Contents of the pack and other information. 1. WHAT METNOVA IS AND WHAT IT IS USED FOR WHAT METNOVA IS Metnova contains the active substance metformin hydrochoride , a medicine to treat diabetes. It belongs to a group of medicines called biguanides. _ _ Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use. If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metnova helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metnova over a long period of time also helps to lower the risk of complications associated with diabetes. Metnova is associated with either a stable body weight or modest weight loss. WHAT METNOVA IS USED FOR Metnovae is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your bl Přečtěte si celý dokument
PAGE 1 OF 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Metnova 500 mg, filmomhulde tabletten Metnova 850 mg, filmomhulde tabletten Metnova 1000 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 500 mg film-coated tablet contains 500 mg metformin hydrochloride equivalent to metformin base 390 mg. Each 850 mg film-coated tablet contains 850 mg metformin hydrochloride equivalent to metformin base 662.9 mg. Each 1000 mg film-coated tablet contains 1000 mg metformin hydrochloride equivalent to metformin base 780 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 500 mg: White, round, normal convex, film-coated tablets plain on both sides. Diameter about 12.0 mm. 850 mg: White, round, normal convex, film-coated tablets plain on both sides. Diameter about 13.5 mm. 1000 mg: White, oval, film coated tablet, debossed “MF” and “3” on either side of the breakline on one side and “G” on the other side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. • In adults, Metnova film-coated tablets may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. • In children from 10 years of age and adolescents, Metnova film-coated tablets may be used as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PAGE 2 OF 10 Posology ADULTS WITH NORMAL RENAL FUNCTION (GFR 90 ML/MIN): _Monotherapy and combination with other oral antidiabetic agents: _ • The usual starting dose is one tablet of 500 mg or 850 mg metformin 2 or 3 times daily given during or after meals. Af Přečtěte si celý dokument