Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
gliclazide, Quantity: 60 mg
Pharmacor Pty Ltd
Tablet, modified release
Excipient Ingredients: hypromellose; lactose monohydrate; sodium acetate; mannitol; magnesium stearate; silicon dioxide
Oral
60's, 100's
(S4) Prescription Only Medicine
Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.,During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.
Visual Identification: White to off-white, oblong shaped tablets, scored with a break bar on both sides, engraved with G L on one face and plain on the other face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-04-29
PHARMACOR GLICLAZIDE MR Ver 01 Page 1 of 9 PHARMACOR GLICLAZIDE MR TABLETS 30 MG & 60 MG GLICLAZIDE CONSUMER MEDICINE INFORMATION(CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PHARMACOR GLICLAZIDE MR. It does not contain all the available information Reading this leaflet 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 PHARMACOR GLICLAZIDE MR 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 PHARMACOR GLICLAZIDE MR IS The name of your medicine is PHARMACOR GLICLAZIDE MR. PHARMACOR GLICLAZIDE MR contains the active ingredient 'gliclazide'. Gliclazide belongs to a group of medicines called sulphonylureas. The medicine releases the active ingredient gliclazide progressively over 24 hours. WHAT PHARMACOR GLICLAZIDE MR IS USED FOR PHARMACOR GLICLAZIDE MR is used to control blood glucose (sugar) in patients with Type II diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes (NIDDM), or maturity-onset diabetes). WHY PHARMACOR GLICLAZIDE MR IS USED FOR TYPE II DIABETES MELLITUS _ _ PHARMACOR GLICLAZIDE MR is used when diet and exercise are not enough to control your blood glucose. PHARMACOR GLICLAZIDE MR can be used alone or together with insulin or other medicines for treating diabetes. HOW IT WORKS Glucose is used by the body as fuel, and all people have glucose circulating in their blood. In diabetes,levels of blood glucose are higher than is needed, which is also known as hyperglycaemia. If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). High blood glucose can lead to serious problems with our heart, circulation and/or kidneys. It is very important to control hig Prečítajte si celý dokument
PHARMACOR GLICLAZIDE MR Ver 03 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION PHARMACOR GLICLAZIDE MR TABLETS (GLICLAZIDE) 1. NAME OF THE MEDICINE Gliclazide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACOR GLICLAZIDE MR 30 mg: Each modified release tablet contain 30 mg Gliclazide._ _ Excipient with known effect: Lactose Monohydrate 39 mg PHARMACOR GLICLAZIDE MR 60 mg: Each modified release tablet contain 60 mg Gliclazide._ _ Excipient with known effect: Lactose Monohydrate 78 mg For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablet, Modified Release PHARMACOR GLICLAZIDE MR 30 mg: White to off-white, round tablets, engraved with “G3” on one face and plain on the other face. PHARMACOR GLICLAZIDE MR 60 mg: White to off-white, oblong shaped tablets, scored with a break bar on both sides, engraved with “G L” on one face and plain on the other face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose. During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE For adult use only. PHARMACOR GLICLAZIDE MR Ver 03 Page 2 of 14 PHARMACOR GLICLAZIDE MR 60 mg have a break bar and may be administered as whole or as half tablets (see section 5.2 Pharmacokinetic properties). PHARMACOR GLICLAZIDE MR are modified release tablets; tablets should not be chewed or crushed to maintain the modified release properties of the product. A single daily dose provides an effective blood glucose control. The daily dose may vary from 30 mg to 120 mg taken orally. The initial recommended dose is 30 mg, even in elderly patients (≥ 65 years). The daily dose should not exceed 120 mg. As with all hypoglycaemic agents, the dose Prečítajte si celý dokument