Country: Իսրայել
language: անգլերեն
source: Ministry of Health
METFORMIN HYDROCHLORIDE
DEXCEL LTD, ISRAEL
A10BA02
CAPLETS
METFORMIN HYDROCHLORIDE 850 MG
PER OS
Required
DEXCEL LTD, ISRAEL
METFORMIN
METFORMIN
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, Glucomin 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, Glucomin 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.
2023-09-30
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold without a physician’s prescription GLUCOMIN® 850 MG, CAPLETS Each caplet contains 850 mg metformin hydrochloride. Inactive ingredients and allergens in the medicine - see section 6 "Additional information'. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet contains concise information about the medicine. 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 you think that their medical condition is the same as yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of type 2 diabetes mellitus, particularly in overweight patients, when change in diet and exercise alone are not sufficient to stabilize blood glucose levels. In adults, GLUCOMIN is indicated as monotherapy or in combination with other oral medicines for the treatment of diabetes or with insulin. In children from 10 years of age and adolescents, GLUCOMIN is indicated as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight adult patients with type 2 diabetes who were treated with metformin as first-line therapy after diet failure. THERAPEUTIC GROUP: Medicines to lower blood glucose levels. The active ingredient is part of the biguanide group. Insulin is a hormone produced by the pancreas, that causes the body to absorb glucose (sugar) from the blood. Your body uses glucose to create energy or stores it for future use. If you have diabetes, your pancreas does not produce enough insulin or your body is unable to properly use the insulin produced by it. This causes a high blood level of glucose. GLUCOMIN helps to reduce the blood level of glucose to as normal as possible. If you are an adult with excess weight, taking GLUCOMIN long term helps to reduce the risk of complications associated with diabetes read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glucomin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each caplet contains 850 mg metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Caplet. White caplets, scored on both sides. The caplet can be divided into equal doses. 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, Glucomin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin. • In children from 10 years of age and adolescents, Glucomin 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Glucomin can be halved. There is no information regarding crushing or chewing of the caplets. The caplets are coated to avoid the bitter taste of the medicine. In case of need, the medicine can be divided to halves (425 mg). A dose of 425 mg can be an alternative to a 500 _ _ mg dose. _ _ _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 2550 mg 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 bl read_full_document