Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride
Apotex Pty Ltd
Metformin hydrochloride
Registered
METFORMIN XR APOTEX _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 hyperg Lue koko asiakirja
1 AUSTRALIAN PRODUCT INFORMATION METFORMIN XR APOTEX (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 Each modified release tablet contains either 500 mg or 1000 mg metformin hydrochloride (HCl). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. METFORMIN XR 500 APOTEX METFORMIN XR 1000 APOTEX 3 PHARMACEUTICAL FORM METFORMIN XR 500 APOTEX Modified release tablet. White to off-white capsule-shaped, unscored tablet; engraved “APO” on one side and “XR500” on the other side. METFORMIN XR 1000 APOTEX Modified release tablet. White to off-white capsule-shaped biconvex tablet; engraved “MXR 1000” on 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. 2 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). 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 divide Lue koko asiakirja