מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 1000 mg
Arrotex Pharmaceuticals Pty Ltd
Metformin hydrochloride
Tablet, modified release
Excipient Ingredients: povidone; colloidal anhydrous silica; hypromellose; magnesium stearate
Oral
60 tablets
(S4) Prescription Only Medicine
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. Metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
Visual Identification: White, capsule shaped uncoated tablet with XR 1000 on one side and a plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-01-04
APO-METFORMIN XR _Contains the active ingredient metformin hydrochloride_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Metformin XR is used to control blood glucose (sugar) in people with Type 2 diabetes mellitus, especially in those who are overweight. It is used when diet and exercise are not enough to control high levels of blood glucose. Metformin XR can be used alone, or in combination with other medicines for treating diabetes. Metformin belongs to a group of medicines called biguanides. It lowers high blood glucose levels by: • improving your body's sensitivity to insulin and restoring the way it normally uses glucose • reducing the amount of glucose your liver makes • delaying the amount of glucose your intestine absorbs. This medicine is available only with a doctor's prescription. _TYPE 2 DIABETES MELLITUS_ Type 2 diabetes mellitus is also called Non-Insulin Dependent Diabetes Mellitus (NIDDM) or Maturity Onset Diabetes. Insulin is a hormone that enables body tissues to take up glucose from the blood and to use it for energy or fat storage for future use. People with Type 2 diabetes are unable to make enough insulin or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood (hyperglycaemia), which can lead to serious medical problems. Long-term hyperglycaemia can lead to heart disease, blindness, kidney damage, poor blood circulation and gangrene. Signs of hyperglyc קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION APO-METFORMIN XR (500 & 1000) (METFORMIN HYDROCHLORIDE) MODIFIED RELEASE TABLETS LIFE-THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. THE MAIN RISK FACTOR IS RENAL IMPAIRMENT; OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH REDUCED RENAL FUNCTION AND HIGH DOSES OF METFORMIN HYDROCHLORIDE (≥ 2 G PER DAY). 1 NAME OF THE MEDICINE Metformin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO-METFORMIN XR 500 modified release tablets contain 500 mg metformin hydrochloride (HCl). APO-METFORMIN XR 1000 modified release tablets contain 1000 mg metformin hydrochloride (HCl). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Modified release tablet. APO-METFORMIN XR 500: White, capsule shaped uncoated tablet with XR 500 on one side and plain on the other side. APO-METFORMIN XR 1000: White, capsule shaped uncoated tablet with XR 1000 one side and plain 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. Metformin may be used as monotherapy or in combination with other oral hypoglycaemic agents, or with insulin. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Intended for oral administration. LIFE-THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. THE MAIN RISK FACTOR IS RENAL IMPAIRMENT; OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH REDUCED RENAL FUNCTION AND HIGH DOSES OF METFORMIN HCL (≥ 2 G PER DAY). 2 MONOTHERAPY AND COMBINATION WITH OTHER ORAL HYPOGLYCAEMIC AGENTS Initiating Therapy with Metformin XR For patients new to metformin, the usual starting dose is one Metformin XR 500 tablet, once daily, with the evening meal. If the starting dose requires 750 mg modified release metformin HCl, then alternative brands will be required, as Metformin XR 500 cannot be divided. After 10 to 15 days the dos קרא את המסמך השלם