Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE
Wockhardt UK Limited
A10BA; A10BA02
METFORMIN HYDROCHLORIDE
1000 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 Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Yaltormin SR 1000mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged release tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged Release Tablets White to off-white, oval tablet debossed with ‘SR 1000’ on one side and plain on other side. The tablets are approximately 22 mm in length and 10.5 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_ _90 mL/min)_ _Monotherapy and combination with other oral antidiabetic agents:_ • Yaltormin SR 1000 mg should be taken once daily with the evening meal at a maximum recommended dose of 2 tablets per day. • Yaltormin SR 1000 mg is intended as a maintenance therapy for patients currently treated with either 1000 mg or 2000 mg of metformin hydrochloride. On switch, the daily dose of Yaltormin SR should be equivalent to the current daily dose of metformin hydrochloride. • In patients treated with metformin hydrochloride at a dose above 2000 mg daily, switching to Yaltormin SR is not recommended. • For patients new to metformin hydrochloride, the usual starting dose of Yaltormin SR is 500 mg once daily given with the evening meal. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increment in dose may improve gastro-intestinal tolerability. • If glycaemic control is not achieved on once daily dosing of Yaltormin SR at a maximum dose of 2000 mg a day, then a twice daily dosing schedule should be considered with both d Citiți documentul complet