Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 1000 mg
Arrotex Pharmaceuticals Pty Ltd
Metformin hydrochloride
Tablet, modified release
Excipient Ingredients: hypromellose; povidone; magnesium stearate; colloidal anhydrous silica
Oral
30 tablets, 120 tablets, 60 tablets, 90 tablets, 100 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. Metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
Visual Identification: White, capsule shaped uncoated tablet with XR 1000 on one side and a plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-09-10
METEX XR CMI 1 METEX XR _contains the active ingredient metformin hydrochloride _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about METEX XR. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking METEX 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 METEX XR IS USED FOR METEX XR is used to control blood glucose (sugar) in patients 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. METEX 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 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 include: • tiredness or lack of energy • headache • thirst • passing large amounts of urine • blurred vision _HOW METEX XR WORKS _ METEX 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 glu Διαβάστε το πλήρες έγγραφο
1 AUSTRALIAN PRODUCT INFORMATION – METEX XR (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. 1 NAME OF THE MEDICINE Metformin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Metex XR, (500 mg) modified release tablet contains 500 mg of metformin hydrochloride. Each Metex XR, (750 mg) modified release tablet contains 750 mg of metformin hydrochloride. Each Metex XR, (1000 mg) modified release tablet contains 1000 mg of metformin hydrochloride. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM _METEX XR_ Metformin hydrochloride 500 mg modified release tablet; White, capsule shaped uncoated tablet with ‘XR 500’ on one side and a plain on the other side. _METEX XR_ Metformin hydrochloride 750 mg modified release tablet; White, capsule shaped uncoated tablet with ‘XR 750’ on one side and a plain on the other side. _METEX XR_ Metformin hydrochloride 1000 mg modified release tablet; White, capsule shaped uncoated tablet with ‘XR 1000’ on one side and a plain 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 modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. 2 4.2 D OSE 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 METFORMIN HYDROCHLORIDE MODIFIED RELEASE TABLETS For patients new to metformin, the usual starting dose is one tablet Διαβάστε το πλήρες έγγραφο