Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
Wockhardt UK Limited
A10BA; A10BA02
METFORMIN HYDROCHLORIDE
500 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Biguanides; metformin
Not marketed
2016-04-08
PACKAGE LEAFLET: INFORMATION FOR THE USER YALTORMIN SR 500MG PROLONGED RELEASE TABLETS YALTORMIN SR 750MG PROLONGED RELEASE TABLETS YALTORMIN SR 1000MG PROLONGED RELEASE TABLETS METFORMIN HYDROCHLORIDE This medicine is intended for ADULT patients only. 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 Yaltormin SR is and what it is used for 2. What you need to know before you take Yaltormin SR 3. How to take Yaltormin SR 4. Possible side effects 5. How to store Yaltormin SR 6. Contents of the pack and other information 1. WHAT YALTORMIN SR IS AND WHAT IT IS USED FOR Yaltormin SR prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes. Yaltormin SR is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus 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. Yaltormin SR makes the body more sensitive to insulin and helps return to normal the way your b Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Yaltormin SR 500mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged release tablet contains 500mg metformin hydrochloride corresponding to 390 mg metformin base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged Release Tablets White to off-white, capsule shaped tablet debossed with ‘SR 500’ on one side and plain on other side. The tablets are approximately 16.5 mm in length and 8.2 mm in breadth. 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. Yaltormin 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 90mL/min) _Monotherapy in Type 2 diabetes mellitus and combination with other oral antidiabetic agents:_ • The usual starting dose is one tablet of Yaltormin SR 500mg once daily. • After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastro-intestinal tolerability. The maximum recommended dose is 4 tablets daily. • Dosage increases should be made in increments of 500 mg every 10-15 days, up to a maximum of 2000 mg once daily with the evening meal. If glycaemic control is not achieved on Yaltormin SR 2000 mg once daily, Yaltormin SR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily. • In patients already treated with metformin tablets, the starting dose of Yaltormin SR should be equivalent to the daily dose of metformin immediate release tablets. In patients treated with metformin at a dose above 2000 mg daily, switching t Read the complete document