البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Metformin Hydrochloride
Bluefish Pharmaceuticals AB
A10BA; A10BA02
Metformin Hydrochloride
850 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Biguanides; metformin
Marketed
2009-03-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER METFORMIN BLUEFISH 500 MG/ 850 MG/ 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 Bluefish is and what it is used for 2. What you need to know before you take Metformin Bluefish 3. How to take Metformin Bluefish 4. Possible side effects 5. How to store Metformin Bluefish 6. Contents of the pack and further information 1. WHAT METFORMIN BLUEFISH IS AND WHAT IT IS USED FOR Metformin Bluefish contains metformin , a medicine to treat diabetes. It belongs to a group of medicines called biguanides. Insulin is a hormone produced by the pancreasthat 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 Bluefish helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metformin Bluefish over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin Bluefish is associated with either a stable body weight or modest weight loss. Metformin Bluefish 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 particular اقرأ الوثيقة كاملة
Health Products Regulatory Authority 25 January 2024 CRN00DS9H Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metformin Bluefish 850 mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 850 mg metformin hydrochloride corresponding to 663 mg metformin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablets with dimensions of 12.70 x 12.70 mm, with ‘A’ debossed on one side and ‘61’ debossed 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, Metformin Bluefish 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 Bluefish 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 500mg or 850mg 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 hydrochloride dose (2 to 3 grams per day), it is possible to replace two Metformin HCl Bluefish 500 mg film-coated tablets with one Metformin HCl Bluefish 1000 mg film-coated tablet.The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. If tr اقرأ الوثيقة كاملة