Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
A10BA02
METFORMIN HYDROCHLORIDE
850 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
metformin
Not Marketed
2010-04-23
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METFORMIN MYLAN 500 MG FILM-COATED TABLETS METFORMIN MYLAN 850 MG FILM-COATED TABLETS METFORMIN MYLAN 1000 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 Metformin Mylan is and what it is used for. 2. What you need to know before you take Metformin Mylan. 3. How to take Metformin Mylan. 4. Possible side effects. 5. How to store Metformin Mylan. 6. Contents of the pack and other information. 1. WHAT METFORMIN MYLAN IS AND WHAT IT IS USED FOR WHAT METFORMIN MYLAN IS Metformin Mylan contains the active substance metformin hydrochloride, 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. Metformin Mylan helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metformin Mylan over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin Mylan is associated with either a stable body weight or modest weight loss. WHAT METFORMIN MYLAN IS USED FOR Metformin Mylan is used to treat patients with type 2 diabetes (also Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metformin Mylan 850 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 850 mg film-coated tablet contains 850 mg metformin hydrochloride equivalent to metformin base 662.9 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White round normal convex film-coated tablets plain on both sides. Diameter about 13.5mm 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 Mylan 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, Metformin Mylan 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 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 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. In patients receiving a high metformin dose (2 to 3 grams per day), it is possible to replace two Metformin Mylan 500 mg film-coated tablets with one Metformin Mylan 1000 mg film-coated tablet. 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 hydrochloride at the dose indicated above Läs hela dokumentet