Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
METFORMIN HYDROCHLORIDE PH. EUR.
A. Menarini Pharmaceuticals Ireland Ltd
A10BA; A10BA02
METFORMIN HYDROCHLORIDE PH. EUR.
1000 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. Belgenin tamamını okuyun
Health Products Regulatory Authority 09 May 2019 CRN008K4Z Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Siofor SR 1000 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 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 tablet. White to off-white, oval tablet, debossed on one side with 'SR 1000' and plain on the other side. Tablet dimensions: length 22.00 mm, breadth 10.50 mm, thickness 8.90 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 1000 mg should be taken once daily with the evening meal at a maximum recommended dose of 2 tablets per day. -Siofor 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 Siofor 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 Siofor SR is not recommended. -If glycaemic control is not achieved on once daily dosing of Siofor SR at a maximum dose of 2000 mg a day, then a twice daily dosing schedule should be considered with both doses being given with food, at the time of the morning and evening meals. If glycaemic control is still not achieved, patients may be switched to standard metformin hydrochloride tablets to a maximum dose of 3000 mg daily. -In t Belgenin tamamını okuyun