Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 1000 mg
Pharmacor Pty Ltd
Tablet, modified release
Excipient Ingredients: microcrystalline cellulose; povidone; hypromellose; carmellose sodium; copovidone; magnesium stearate
Oral
120's, 60's, 90's, 100's, 10's, 30's
(S4) Prescription Only Medicine
Metformin is indicated in the 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 HCl Extended Release Tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin
Visual Identification: White to off white, oval shaped uncoated tablets, debossed with PR on one side and 1000 on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-10-16
DIAXEMET XR Ver: 01 1 DIAXEMET XR 500 DIAXEMET XR 750 DIAXEMET XR 1000 _metformin hydrochloride _ DIAXEMET XR 500 metformin hydrochloride 500 mg extended release tablets DIAXEMET XR 750 metformin hydrochloride 750 mg extended release tablets DIAXEMET XR 1000 metformin hydrochloride 1000 mg extended release tablets CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DIAXEMET XR. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. All medicines have benefits and risks. Your doctor has weighed the risks of you taking DIAXEMET XR against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR, PHARMACIST OR DIABETES EDUCATOR. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT DIAXEMET XR IS USED FOR DIAXEMET 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. DIAXEMET XR can be used alone, or in combination with other medicines for treating diabetes. 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 hyperglycaemia may include: • tiredness or lack of energy • headache • thirst • passing large amounts of urine • blurred vision _HOW DIAXEMET XR _ _WORKS _ DIAXEMET X Přečtěte si celý dokument
DIAXEMET XR Ver: 01 1 AUSTRALIAN PRODUCT INFORMATION DIAXEMET XR 500, DIAXEMET XR 750 AND DIAXEMET XR 1000 (METFORMIN HYDROCHLORIDE) EXTENDED 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. 1. NAME OF THE MEDICINE Metformin hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DIAXEMET XR 500, DIAXEMET XR 750 or DIAXEMET XR 1000 extended release tablets are available in three strengths. DIAXEMET XR 500 extended release tablets 500 mg Each extended release tablet contains 500 mg metformin hydrochloride. DIAXEMET XR 750 extended release tablets 750 mg Each extended release tablet contains 750 mg metformin hydrochloride. DIAXEMET XR 1000 extended release tablets 1000 mg Each extended release tablet contains 1000 mg metformin hydrochloride. For the full list of excipients, see section 6.1 List of Excipients. DIAXEMET XR Ver: 01 2 3. PHARMACEUTICAL FORM Extended release tablets. DIAXEMET XR 500 extended release tablets 500 mg White to off white, oval shaped, biconvex, tablets with ‘MX’ debossed on one side and ‘500’ on other. DIAXEMET XR 750 extended release tablets 750 mg White to off white, capsule shaped tablets with ‘MX’ debossed on one side and ‘750’ on other side. DIAXEMET XR 1000 extended release tablets 1000 mg White to off white, oval shaped uncoated tablet with 'PR' debossed on one side and '1000' on other side. All three tablet strengths are gluten free. The tablet shells may be present in the faeces. Patients should be advised that this is normal. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metformin is indicated in the 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. DIAXEMET XR 500, DIAXEMET XR 750 or DIAXEMET XR 1000 may be used as monotherapy or in combination with other oral antidiabetic ag Přečtěte si celý dokument