Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 500 mg
Alphapharm Pty Ltd
Tablet, modified release
Excipient Ingredients: hypromellose; magnesium stearate; microcrystalline cellulose; carmellose sodium
Oral
90 Tablets, 10 Tablets (Starter Pack), 30 Tablets, 100 Tablets, 60 Tablets, 120 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. DIABEX XR 500 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
Visual Identification: White to off-white, capsule shaped, biconvex tablet, debossed with "500" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2005-02-24
DIABEX ® XR _metformin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Diabex 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 Diabex 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 DIABEX XR IS USED FOR Diabex 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. Diabex 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 DIABEX XR WORKS_ Diabex XR 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 abso Lue koko asiakirja
AUSTRALIAN PRODUCT INFORMATION DIABEX ® XR 500 _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 Each Diabex XR 500 extended release tablet contains 500 mg of metformin hydrochloride. Diabex XR 500 also contains trace amounts of sulfites. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Metformin hydrochloride 500 mg extended release tablets: white to off-white, capsule-shaped, biconvex tablet, debossed “500” on one side. DIABEX 500 is 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 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. Diabex XR 500 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. 4.2 DOSE AND METHOD OF 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. MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS INITIATING THERAPY WITH DIABEX XR For patients new to metformin, the usual starting dose of Diabex XR is one tablet of Diabex XR 500 or Diabex XR 750 once daily taken with the evening meal. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastro-intestinal tolerability. Dosage increases should be made in increments of 500 mg or 750 mg every 10-15 days. DIABEX ® XR 500 – AUSTRALIAN PRODUCT INFORMATION 2 COMBINING DIABEX XR DOSAGE STRENGTHS The Lue koko asiakirja