País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Metformin Hydrochloride
Consilient Health Limited
A10BA; A10BA02
Metformin Hydrochloride
750 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Biguanides; metformin
Not marketed
2014-10-24
PACKAGE LEAFLET INFORMATION FOR THE USER LUCOMET ® SR 750 MG PROLONGED-RELEASE 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 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 LUCOMET SR IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LUCOMET SR 3. HOW TO TAKE LUCOMET SR 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LUCOMET SR 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT LUCOMET SR IS AND WHAT IT IS USED FOR Lucomet SR prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of Type 2 (non- insulin dependant diabetes mellitus. Lucomet SR is used for the treatment of Type 2 diabetes when diet and exercise changes alone have not been enough to control blood glucose (sugar). Insulin is a hormone that enables body tissues to take glucose from the blood and to use it for energy or for storage for future use. People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms. Lucomet SR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose. Lucomet SR is associated with either a stable body weight or modest weight loss. Lucomet SR Prolonged Release Tablets are specially Leer el documento completo
Health Products Regulatory Authority 14 July 2020 CRN009TPR Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lucomet SR 750 mg prolonged release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 750 mg metformin hydrochloride (equivalent to 585 mg metformin). Excipients For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet White tablet, shallow convex, dimension 20 x 9 mm, with marking "SR1" on one side and without marking on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Lucomet SR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (GFR≥ 90 mL/min)_ _Monotherapy and combination with other oralantidiabetic agents:_ Lucomet SR 750 mg is intended for patients who are already treated with metformin tablets (prolonged or immediate release). The dose of Lucomet SR 750 mg should be equivalent to the daily dose of metformin tablets (prolonged or immediate release), up to a maximum dose of 1500 mg given with the evening meal. After 10 to 15 days, it is recommended to check that the dose of Lucomet SR 750 mg is adequate on the basis of blood glucose measurements. _Combination withinsulin:_ For patients already treated with metformin and insulin in combination therapy, the dose of Lucomet SR 750 mg should be equivalent to the daily dose of metformin tablets, up to a maximum of 1500 mg given with the evening meal, while insulin dosage is adjusted on the basis of blood glucose measurements. _Elderly:_ Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see se Leer el documento completo