Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 500 mg
Sandoz Pty Ltd
Metformin hydrochloride
Tablet, film coated
Excipient Ingredients: magnesium stearate; macrogol 6000; purified talc; colloidal anhydrous silica; povidone; titanium dioxide; sodium starch glycollate; propylene glycol; hypromellose; maize starch
Oral
100 tablets
(S4) Prescription Only Medicine
Treatment of type 2 diabetes mellitus in adults, particularly in over weight patients, when dietary management and exercise alone, does not result in adequate glycaemic control. Metformin may be used as initial treatment, or in sulphonylurea failures, either alone or in combination with a sulphonylurea and other oral agents or as adjuvant therapy in insulin dependent diabetes.
Visual Identification: White, biconvex capsule shaped tablet with central breakline on one side and "500' embossed on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2006-09-11
METFORMIN SANDOZ ® 1 METFORMIN SANDOZ ® _metformin hydrochloride tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Metformin Sandoz. 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 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, PHARMACIST OR DIABETES EDUCATOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT METFORMIN SANDOZ IS USED FOR This medicine is used to control blood sugar (glucose) in patients with diabetes mellitus. Metformin Sandoz is used to treat Type 2 diabetes when it cannot be properly controlled by diet and exercise. It can also be used in patients with Type 1 diabetes mellitus where insulin alone is not enough to control your blood glucose levels. Metformin Sandoz can be used alone, or in combination with other medicines for treating diabetes. _HOW METFORMIN SANDOZ _ _WORKS _ It contains the active ingredient metformin hydrochloride. Metformin belongs to a group of medicines called oral hypoglycaemics. It works to reduce high levels of blood glucose by helping your body to make better use of the insulin produced by your pancreas. Diabetes mellitus is a condition in which the blood glucose levels are not adequately controlled. People with type 2 diabetes are not able to make enough insulin or do not respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including heart disease, kidney damage, poor blood circulation, gangrene, amputation and blindness. If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). _HYPOGLYCAEMIA: _ Hypoglycaemia (low blood glucose) can occ Przeczytaj cały dokument
210421-Metformin Sandoz-pi Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION METFORMIN SANDOZ ® (METFORMIN HYDROCHLORIDE) 1. NAME OF THE MEDICINE Metformin hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 500 mg film coated tablet contains 500 mg of metformin hydrochloride. Each 850 mg film coated tablet contains 850 mg of metformin hydrochloride. Each 1000 mg film coated tablet contains 1000 mg of metformin hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Metformin Sandoz film coated tablets 500 mg: white, film coated, biconvex capsule shaped tablet with central breakline on one side and 500 embossed on the other side. Metformin Sandoz film coated tablets 850 mg: white, film coated, round, biconvex tablet plain on one side and ‘850’ embossed on the other side. Metformin Sandoz film coated tablets 1000 mg: white, film coated, capsule-shaped, biconvex tablet plain on one side and central breakline on the other side. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC 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 initial treatment, or in sulphonylurea failures, either alone or in combination with a sulphonylurea and other oral agents or as adjuvant therapy in insulin dependent type 2 diabetes. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE Life-threatening lactic acidosis can occur due to accumulation of metformin. Risk factors include renal impairment, old age and high doses of metformin above 2 g/day. Initially 500 mg should be taken once or twice a day with breakfast and evening meal. If necessary the dose may be increased over a few weeks up to 1 g three times per day. The dose should be titrated with gradual dose increments until the desired effect is obtained. 500 mg three times a day is often sufficient to obtain a diabetic control. If necessary, the dose can be increased to 1 g thre Przeczytaj cały dokument