Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Metformin Hydrochloride
Pinewood Laboratories Ltd
A10BA02
Metformin Hydrochloride
500 milligram(s)
Film-coated tablet
metformin
Marketed
2019-07-19
PACKAGE LEAFLET: INFORMATION FOR THE USER METFORMIN PINEWOOD 500 MG FILM-COATED TABLETS METFORMIN PINEWOOD 850 MG FILM-COATED TABLETS METFORMIN PINEWOOD 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. Do not pass it on to others. It may harm them, even if their symptoms 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 Pinewood tablets are and what they are used for 2. What you need to know before you take Metformin Pinewood tablets 3. How to take Metformin Pinewood tablets 4. Possible side effects 5. How to store Metformin Pinewood tablets 6. Contents of the pack and other information 1. WHAT METFORMIN PINEWOOD TABLETS ARE AND WHAT THEY ARE USED FOR Metformin Pinewood tablets contain 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. Metformin Pinewood tablets help to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metformin Pinewood tablets over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin Pinewood tablets are associated with either a stable body weight or modest weight loss. Metformin Pinewood tablets are used to treat patients with type 2 diabetes ( Read the complete document
Health Products Regulatory Authority 25 September 2023 CRN00DQF8 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metformin Pinewood 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains metformin hydrochloride 500 mg corresponding to metformin base 390 mg. For the full list of excipients, see section6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off white round, biconvex, film-coated tablets which are plain on both sides 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 Pinewood 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 Pinewood 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 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. Metfo Read the complete document