Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 500 mg
Alphapharm Pty Ltd
Metformin hydrochloride
Tablet, modified release
Excipient Ingredients: hypromellose; microcrystalline cellulose; magnesium stearate; carmellose sodium
Oral
90 Tablets, 60 Tablets, 100 Tablets, 120 Tablets, 30 Tablets, 10 Tablets (Starter Pack)
(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. Diaformin XR 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
Licence status A
2005-10-18
DIAFORMIN ® XR AND DIAFORMIN ® XR 1000 D I A F O R M I N ® X R a n d D I A F O R M I N ® X R 1 0 0 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING DIAFORMIN XR OR DIAFORMIN XR 1000? DIAFORMIN XR and DIAFORMIN XR 1000 contains the active ingredient metformin hydrochloride. DIAFORMIN XR and DIAFORMIN XR 1000 are used to control blood glucose (sugar) in people with Type 2 diabetes mellitus. For more information, see Section 1. Why am I using DIAFORMIN XR or DIAFORMIN XR 1000? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DIAFORMIN XR OR DIAFORMIN XR 1000? Do not use if you have ever had an allergic reaction to DIAFORMIN XR or DIAFORMIN XR 1000 or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use DIAFORMIN XR or DIAFORMIN XR 1000? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DIAFORMIN XR and DIAFORMIN XR 1000 and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE DIAFORMIN XR OR DIAFORMIN XR 1000? • The usual starting dose is 500 mg once daily with the evening meal. Your doctor may increase the dose slowly, depending on your blood glucose levels. More instructions can be found in Section 4. How do I use DIAFORMIN XR or DIAFORMIN XR 1000? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DIAFORMIN XR OR DIAFORMIN XR 1000? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using DIAFORMIN XR or DIAFORMIN XR 1000. • Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them. THINGS YOU S Soma hati kamili
AUSTRALIAN PRODUCT INFORMATION DIAFORMIN ® XR _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 Diaformin XR extended release tablet contains 500 mg of metformin hydrochloride. Diaformin XR 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. Diaformin XR 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. Diaformin XR 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 DIAFORMIN XR 500 MG For patients new to metformin, the usual starting dose of Diaformin XR is one tablet (500 mg) 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 every 10-15 days, up to a maximum of 2000 mg once daily with the evening meal. DIAFORMIN XR– AUSTRALIAN PRODUCT INFORMATION 2 COMBINING Soma hati kamili