Consumer medicine information

1. Why am I using APX-GLICLAZIDE?

APX-GLICLAZIDE contains the active ingredient gliclazide. APX-GLICLAZIDE is used to control blood glucose in people with Type 2 diabetes mellitus when diet and exercise are not enough to control your blood glucose.
For more information, see Section 1. Why am I using APX-GLICLAZIDE? in the full CMI.

2. What should I know before I use APX-GLICLAZIDE?

Do not use if you have ever had an allergic reaction to gliclazide, or other sulphonylurea, sulfonamide (sulfur) antibiotics, certain types of fluid tablets (thiazide diuretics), 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 APX-GLICLAZIDE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APX-GLICLAZIDE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use APX-GLICLAZIDE?

Swallow the tablets with a glass of water at about the same time each day, usually with breakfast.
More instructions can be found in Section 4. How do I use APX-GLICLAZIDE? in the full CMI.

5. What should I know while using APX-GLICLAZIDE?

6. Are there any side effects?

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: Skin rash, redness itching and/or hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty), and rash progressing to widespread blistering or peeling of the skin and may be the first sign of rare life-threatening conditions. The common side effects are Hypoglycaemia, hyperglycaemia (for more information, see section on recognising and treating hypoglycaemia and hyperglycaemia), runny or blocked nose, sneezing, facial pressure or pain, bronchitis, sore throat and discomfort when swallowing, upper respiratory infection, coughing, back pain, arthralgia, arthrosis, high blood pressure, chest pain, headache, unusual weakness, viral infection, urinary tract infection, dizziness, stomach upset with symptoms like feeling sick, stomach pain, vomiting, diarrhoea, or constipation.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Gliclazide.

2 Qualitative and Quantitative Composition

APX-Gliclazide tablets contain 80 mg of gliclazide.
Excipients with known effect. Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Uncoated tablets.
A white to off white round, bevel-edged, uncoated tablet with cross score (+) on one face and plain on the other.

4 Clinical Particulars

4.9 Overdose

Overdose of sulphonylureas may cause hypoglycaemia.
Moderate symptoms of hypoglycaemia (without loss of consciousness or neurological signs), should be corrected by carbohydrate intake, dose adjustment and/or modification of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.
Severe hypoglycaemic reactions are possible (with coma, convulsions or other neurological disorders) and must be treated as a medical emergency, requiring immediate hospitalisation.
If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate necessary to maintain blood glucose levels above 5 mmol/L. It is recommended that patients should be monitored closely for a 48 hour period at least.
Plasma clearance of gliclazide may be prolonged in patients with hepatic disease. However, due to the strong binding of gliclazide to proteins, dialysis is not effective in these patients.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In animal studies embryotoxicity and/or birth defects have been demonstrated.
Carcinogenicity. No animal studies have been performed that investigate the carcinogenic potential of gliclazide.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Gliclazide is a white or almost white powder, practically insoluble in water, freely soluble in dichloromethane, sparingly soluble in acetone and slightly soluble in ethanol 96%.
Chemical structure. Gliclazide. The chemical name for gliclazide is 1-(3-azabicyclo[3.3.0] oct- 3-yl)-3-para- tolylsulfonylurea. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGLICLA.gif C₁₅H₂₁N₃O₃S. Molecular weight: 323.4.
CAS number. 21187-98-4.

7 Medicine Schedule (Poisons Standard)

Prescription medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APXGLIST.gif