国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
MERCK SDN. BHD.
METFORMIN HYDROCHLORIDE
30tablet Tablets; 60tablet Tablets
MERCK SANTE S.A.S.
Consumer Medication Information Leaflet (RiMUP) GLUCOPHAGE XR TABLET Metformin Hydrochloride (500mg, 750mg & 1000mg) What is in this leaflet 1. What Glucophage XR is used for 2. How Glucophage XR works 3. Before you use Glucophage XR 4. How to take Glucophage XR 5. While you are using Glucophage XR 6. Side effects 7. Storage and disposal of Glucophage XR 8. Product description 9. Manufacturer and product registration holder 10. Date of revision What Glucophage XR is used for Glucophage XR prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes. Glucophage XR is used to delay the onset and treat Type 2 (non- insulin dependent) diabetes mellitus when diet and exercise changes alone have not been enough to control blood glucose (sugar). How Glucophage XR work 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 XR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose. Glucophage XR is associated with either a stable body weight or modest weight loss. Glucophage XR Prolonged Release Tablets are specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin. Before you take Glucophage XR When you must not take it Do not take Glucophage XR if: you are allergic to metformin or to any of the other ingredients which are listed later on in the leaflet. If you have lactic acidosis [too much lactic acid in the blood (see “Risk of lactic acidosis”)] or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead 完全なドキュメントを読む
1 1. NAME OF THE MEDICINAL PRODUCT GLUCOPHAGE XR 1000 mg Extended release tablet Metformin hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each extended release tablet of Glucophage XR 1000mg contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Extended release tablet. White to off-white, capsule shaped, biconvex tablet, debossed on one side with ‘1000’ and on the other side with ‘Merck’. Route of Administration Oral 4. CLINICAL PARTICULARS 4.1 Therapeutic indications • Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG*, and/or increased HbA1C who are: - at high risk for developing overt type 2 diabetes mellitus (see section Pharmacodynamic properties) and - still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months Treatment with Glucophage XR must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk (see section Pharmacodynamic properties). Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons. *IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose • Treatment of type 2 diabetes mellitus in adults, when dietary management and exercise alone does not result in adequate glycaemic control. Glucophage XR may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. 2 4.2 Posology and method of administration Posology Adults with normal renal function (GFR≥ 90 mL/min) Reduction in the risk or delay of the onset of type 2 diabetes • Metformin should only be considered where intensive lifestyle modifications for 3 to 6 months have not resulted in adequate glycaemic control. • The therapy should be initiated with one tablet Glucophage XR 500 mg once dail 完全なドキュメントを読む