Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE
Laurus Generics GmbH Van-der-Smissen-Strasse 1 22767 HAMBURG (DUITSLAND)
A10BA02
METFORMINEHYDROCHLORIDE COMPOSITION corresponding to ; METFORMIN
Filmomhulde tablet
HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Metformin
2019-06-26
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METFORMINE LAURUS 500 MG, FILMOMHULDE TABLETTEN METFORMINE LAURUS 1000 MG, FILMOMHULDE TABLETTEN Metformin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKINGTHIS 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. Whatis and what it is used for 2. What you need to know before you take Baca dokumen lengkapnya3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR film-coated tablets contain metformin, 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. helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking over a long period of time also helps to lower the risk of complications associated with diabetes. is associated with either a stable body weight or modest weight loss. 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 blood glucose levels.
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Metformine Laurus 500 mg, filmomhulde tabletten Metformine Laurus 1000 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION500 mg film-coated tablets One film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. The dimension of the film-coated tablet is 11.0 mm to 11.40 mm. Baca dokumen lengkapnya1000 mg film-coated tablets One film-coated tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. The dimension of the film-coated tablet is 19.0 -19.4 mm x 10.5 - 10.9 mm. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 500 mg film-coated tablets White to off white, round, biconvex, film-coated tablets with ‘LA15” debossed on one side and plain on the other side. 1000 mg film-coated tablets White to off white, oval, biconvex, film-coated tablets, bisected on both sides, with ‘LA’ and ‘07’ debossed on either side of bisect line on one side. The tablet can be divided into equal doses. 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, metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin. In children from 10 years of age and adolescents, metformin 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). 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (GFR _ _ 90 mL/min) _ _ _ MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3