País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
gliclazide, Quantity: 60 mg
Pharmacor Pty Ltd
Tablet, modified release
Excipient Ingredients: magnesium stearate; silicon dioxide; lactose monohydrate; sodium acetate; mannitol; hypromellose
Oral
100's, 30's, 10's, 20's, 60'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 GL on one face and plain on the other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-04-29
_PHARMACOR GLICLARON _ _Ver 00 _ _ 1 _ PHARMACOR GLICLARON TABLETS The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. PHARMACOR GLICLARON contains the active ingredient gliclazide. PHARMACOR GLICLARON is used so control blood glucose (sugar) in patients with Type II diabetes mellitus. For more information, see Section 1. Why am I using PHARMACOR GLICLARON? in the full CMI. Do not use if you have ever had an allergic reaction to PHARMACOR GLICLARON, macrolide antibiotics, 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 PHARMACOR GLICLARON ? in the full CMI. Some medicines may interfere with PHARMACOR GLICLARON and affect how it works. Tell your doctor, pharmacist or diabetes educator if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. See Section 3. What if I am taking other medicines? in the full CMI for information. Your doctor will tell you how many tablets to take each day. They may increase or decrease the dose, depending on your blood glucose levels. More instructions can be found in Section 4. How do I use PHARMACOR GLICLARON? in the full CMI. Tell all doctors, dentists, pharmacists and diabetes educators who are involved with your treatment that you are taking PHARMACOR GLICLARON. If you are about to start taking any new medicines, tell you doctor and pharmacist that you are taking. For more information, see Section 5. What should I know while using PHARMACOR GLICLARON? in the full CMI. There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). The serious side effects are: Back pain, ar Leia o documento completo
PHARMACOR GLICLARON Ver 03 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION PHARMACOR GLICLARON TABLETS (GLICLAZIDE) 1. NAME OF THE MEDICINE Gliclazide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACOR GLICLARON 30 mg: Each modified release tablet contain 30 mg Gliclazide._ _ Excipient with known effect: Lactose Monohydrate 39 mg PHARMACOR GLICLARON 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 GLICLARON 30 mg: White to off-white, round tablets, engraved with “G3” on one face and plain on the other face. PHARMACOR GLICLARON 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 GLICLARON Ver 03 Page 2 of 14 PHARMACOR GLICLARON 60 mg have a break bar and may be administered as whole or as half tablets (see section 5.2 Pharmacokinetic properties). PHARMACOR GLICLARON 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 should be titrated according to the Leia o documento completo