מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
METFORMIN HYDROCHLORIDE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
A10BA02
METFORMIN HYDROCHLORIDE 500 mg
FILM-COATED TABLET
METFORMIN HYDROCHLORIDE 500 mg
POM
DRUGS USED IN DIABETES
Authorised
2007-02-15
mt-pl-glyformin-500mg-fc-tabs-a2 page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GLYFORMIN 500 MG FILM-COATED TABLETS 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 Glyformin is and what it is used for 2. What you need to know before you take Glyformin 3. How to take Glyformin 4. Possible side effects 5. How to store Glyformin 6. Contents of the pack and other information 1. WHAT GLYFORMIN IS AND WHAT IT IS USED FOR Glyformin contains 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. Glyformin helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Glyformin over a long period of time also helps to lower the risk of complications associated with diabetes. Glyformin is associated with either a stable body weight or modest weight loss. Glyformin is used to treat patients with type 2 diabetes (also called ‘non-insulin dependent siabetes’) when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients. Adults can take Glyformin on its קרא את המסמך השלם
mt-spc-glyformin-500mg-fc-tabs-v05-r00-a0 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glyformin 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ Film-coated tablet. White to off white, round, biconvex film-coated tablets, embossed with “MET 500” on one side and plain on the other side. 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, Glyformin 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, Glyformin 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 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 times daily given during or after meals. mt-spc-glyformin-500mg-fc-tabs-v05-r00-a0 2 of 12 After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above. COMBINATION WITH INSULIN Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual startin קרא את המסמך השלם