देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
gliclazide, Quantity: 30 mg
Arrotex Pharmaceuticals Pty Ltd
Gliclazide
Tablet, modified release
Excipient Ingredients: hypromellose; stearic acid; colloidal anhydrous silica
Oral
100 (blister)
(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, Gliclazide MR 30 mg Tablets, 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, flat faced, radial edge capsule shaped tablet, engraved "APO 30" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2009-05-20
APO-GLICLAZIDE MR TABLETS _30 MG TABLETS_ _Modified Release tablets containing the active ingredient gliclazide_ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about gliclazide. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Gliclazide MR. It contains the active ingredient gliclazide. The tablets release the gliclazide gradually over 24 hours. The medicine is used to control, blood glucose in patients with Type II diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes. Gliclazide is used when diet and exercise are not enough to control your blood glucose. Gliclazide can be used alone, or together with other medicines for treating diabetes. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Gliclazide belongs to a group of medicines ca पूरा दस्तावेज़ पढ़ें
1 AUSTRALIAN PRODUCT INFORMATION – APO- GLICLAZIDE (GLICLAZIDE) MODIFIED RELEASE TABLETS 1 NAME OF THE MEDICINE Gliclazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gliclazide MR 30 mg tablets are intended for oral administration. Each tablet contains gliclazide 30 mg, as the active ingredient. For full list of excipients, see section 6.1 List of excipients 3 PHARMACEUTICAL FORM Modified release tablets: White to off-white, flat faced, radial edge, capsule shaped tablets, engraved “APO 30” on one side and plain on the other side. 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, 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 Gliclazide MR 30 mg Tablets are for adult use only. The daily dose may vary from 30 mg to 120 mg taken orally, once daily. Gliclazide MR 30 mg Tablets should be taken with food because there is an increased risk of hypoglycemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Gliclazide MR 30 mg Tablets are modified release tablets and therefore should be neither broken nor chewed. As with all hypoglycaemic agents, the dose should be titrated according to the individual patient's response. The initial recommended dose is 30 mg daily, even in elderly patients (≥ 65 years). Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. A single daily dose provides an effective blood glucose control. The single daily dose may b पूरा दस्तावेज़ पढ़ें