Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE PH. EUR.
A. Menarini Pharmaceuticals Ireland Ltd
A10BA; A10BA02
METFORMIN HYDROCHLORIDE PH. EUR.
750 milligram(s)
Prolonged-release tablet
Biguanides; metformin
Not marketed
2019-05-03
PACKAGE LEAFLET: INFORMATION FOR THE USER SIOFOR SR 500 MG PROLONGED-RELEASE TABLETS SIOFOR SR 750 MG PROLONGED-RELEASE TABLETS SIOFOR SR 1000 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 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 Siofor SR is and what it is used for 2. What you need to know before you take Siofor SR 3. How to take Siofor SR 4. Possible side effects 5. How to store Siofor SR 6. Contents of the pack and other information 1. WHAT SIOFOR SR IS AND WHAT IT IS USED FOR Siofor SR contains the active ingredient metformin hydrochloride and belongs to a group of medicines called biguanides, used in the treatment of diabetes. Siofor 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. Siofor SR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose. Siofor SR is associated with either a stable body weight or modest weight loss. Les hele dokumentet
Health Products Regulatory Authority 09 May 2019 CRN008K4Z Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Siofor SR 750 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 750 mg metformin hydrochloride corresponding to 585 mg metformin base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White to off-white, capsule shaped tablet, debossed on one side with 'SR 750' and plain on the other side. Tablet dimensions: length 19.60 mm, breadth 9.30 mm, thickness 6.90 mm. 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. Siofor 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 IN TYPE 2 DIABETES MELLITUS AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS: -Siofor SR 750 mg is intended for patients who are already treated with metformin tablets (prolonged or immediate release). -The dose of Siofor 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 Siofor SR 750 mg is adequate on the basis of blood glucose measurements. -In the event of transfer from another oral antidiabetic agent, titration should begin with Siofor SR 500 mg before switching to Siofor SR 750 mg. COMBINATION WITH INSULIN Metformin hydrochloride and insulin may be used in combination therapy to achieve better blood glucose control. For patients already treated with metformin and insulin in combination therapy, the dose of Siofor SR 750 mg should be equivalent to the daily dose of metformin tablets, Les hele dokumentet