מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Metformin Hydrochloride
Juta Pharma GmbH
A10BA02
Metformin Hydrochloride
1000 milligram(s)
Film-coated tablet
metformin
2019-07-19
190 mm Print Free Area Size : 190 mm x 729 mm (L x H) (Front & Back) 729 mm FRONT 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 or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours. • If you get any of the side effects, talk to your doctor or pharmacist or nurse. This includes any 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 the active ingredient metformin hydrochloride. Metformin hydrochloride belongs to a group of medicines called biguanides used for the treatment of non-insulin-dependent diabetes mellitus (type 2 diabetes) in adults and children from 10 years of age. 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 helps 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 קרא את המסמך השלם
Health Products Regulatory Authority 16 October 2019 CRN0098WV Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metformin Pinewood 1000 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains metformin hydrochloride 1000 mg corresponding to metformin base 780 mg. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off white oval shaped, biconvex, film-coated tablets, with a deep breakline on one side and breakline on other side. The tablet can be divided into equal halves. 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. In patients receiving a high metformin dose (2 to 3 grams per day), it is possi קרא את המסמך השלם