Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
Merck Serono Limited
A10BA02
METFORMIN HYDROCHLORIDE
500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Biguanides
Authorised
2010-06-04
MC-2076-2016 WHAT IS IN THIS LEAFLET 1. What Glucophage is and what it is used for 2. What you need to know before you take Glucophage 3. How to take Glucophage 4. Possible side effects 5. How to store Glucophage 6. Contents of the pack and other information 1. WHAT GLUCOPHAGE IS AND WHAT IT IS USED FOR Glucophage 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. Glucophage helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Glucophage over a long period of time also helps to lower the risk of complications associated with diabetes. Glucophage is associated with either a stable body weight or modest weight loss. Glucophage 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. It is used particularly in overweight patients. Adults can take Glucophage on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin). Children 10 years and over and adolescents can take Glucophage on its own or together with insulin. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUCOPHAGE DO NOT TAKE GLUCOPHAGE • if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see ‘What Glucophage contains’ in section 6) • if you have liver problems • if you have severely reduced kidney function • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Ris Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucophage 500 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, circular, convex film-coated tablets, 11 mm in diameter and 5.7 mm high, engraved with GL 500. 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, Glucophage 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, Glucophage 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. 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 starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glu Prečítajte si celý dokument