APO-GLICLAZIDE MR

4 Geriatrics). 2 CONTRAINDICATIONS APO-GLICLAZIDE MR is contraindicated in patients: • With known hypersensitivity or allergy to gliclazide, other sulfonylureas, sulfonamides, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see

1 Adverse Reaction Overview Gliclazide modified release tablets 30 mg has been evaluated for safety in controlled clinical trials in 955 patients, of which 728 were treated in long-term studies for up to 10 months, in comparison with gliclazide 80 mg tablets.

The most frequent adverse drug reactions are hypoglycaemia and gastrointestinal disturbances (including abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation). Serious adverse drug reactions that resulted in hospitalization during clinical trials were malaise, acute renal failure, and thrombophlebitis.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Hypoglycemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism) Severe hypoglycemia which mimics acute CNS disorders may occur.

Hepatic and/or renal impairment, malnutrition, debility, advanced age, alcoholism, adrenal or pituitary insufficiency may be predisposing factors. 1%). 8). 1). Other adverse events Adverse events reported during controlled clinical trials with gliclazide modified release tablets 30 mg were those expected in the population of interest, a population whose underlying disease is recognized atheromatous risk factor.

0% of diabetic patients in long-term controlled studies, whatever their relationship to treatment, are listed by body system in Table 2. The most frequent adverse events were unspecific of the disease as respiratory infections or back pain.

Table 2 – Adverse events reported in ≥1% of type 2 diabetic patients in long-term controlled studies with Gliclazide Modified Release Tablets 30 mg vs. 4 Analysis of adverse events in sub-populations led to similar pattern as in the whole population and showed that sex, age and renal insufficiency had no significant influence on the safety profile of 30 mg.

, Hepatic/Biliary/Pancreatic). • In the presence of severe renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Drug-Drug Interactions). 2 Breast-feeding). 1 Dosing Considerations Determination of the proper dosage for APO-GLICLAZIDE MR for each patient should be made APO-GLICLAZIDE MR (Gliclazide Modified Release Tablets) Page 5 of 46 on the basis of frequent determinations of blood glucose during dose titration and throughout maintenance.

, one half tablet to 2 tablets of APO-GLICLAZIDE MR 60 mg, or 1 to 4 tablets of APO-GLICLAZIDE MR 30 mg). e. one half tablet of APO-GLICLAZIDE MR 60 mg or one tablet of APO-GLICLAZIDE MR 30 mg, even in elderly patients (over 65 years old).

A single daily dose provides effective blood glucose control. The single daily dose may be between 30 mg and 120 mg. The daily dose should not exceed 120 mg. Dose adjustment should be carried out in steps of 30 mg, according to the blood glucose response.

Each step should last for at least two weeks. 4 Administration It is recommended that the medication be taken at breakfast time. The 30 mg tablets cannot be split in half and should be swallowed whole. The 60 mg tablets can be halved.

Both the 30 mg and 60 mg tablets must not be chewed or crushed. - Previously untreated patients should commence with a dose of 30 mg and will benefit from dose adjustment until the appropriate dose is reached. - One APO-GLICLAZIDE MR 60 mg tablet is equivalent to two APO-GLICLAZIDE MR 30 mg tablets.

The breakability of the APO-GLICLAZIDE MR 60 mg tablet allows the use of a dose of 30 mg as a half tablet and of 90 mg as one and a half tablets. - APO-GLICLAZIDE MR can replace an antidiabetic treatment without any transitional period.

e. chlorpropamide) he/she should be carefully monitored (for 1 to 2 weeks) in order to avoid hypoglycemia due to possible residual effects of the previous therapy. Pediatrics (< 18 years of age) Safety and effectiveness of gliclazide modified release tablets in pediatrics have not been established; therefore, Health Canada has not authorized an indication for pediatric use.

APO-GLICLAZIDE MR is contraindicated in patients: • With known hypersensitivity or allergy to gliclazide, other sulfonylureas, sulfonamides, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • With unstable and/or insulin-dependent (Type 1) diabetes mellitus, particularly juvenile diabetes, diabetic ketoacidosis, diabetic pre-coma and coma.

• During stress conditions such as serious infection, trauma or surgery. • In the presence of severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). • In the presence of severe renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal).

4 Drug-Drug Interactions). 2 Breast-feeding).