Specifications: In-house

Formula
Each tablet contains gliclazide 80 mg and excipients q.s. (lactose monohydrate, colloidal silicon dioxide, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate).

Dosage form
Tablets.

Presentation
Box of 3 blisters x 20 tablets.

Indications
- Diabetic patients who require oral antidiabetic treatment: non-ketotic and non-acidosic, non-insulin-dependent adult or elderly diabetic patients whose plasma glucose levels cannot be controlled by diet alone.
- Concomitant administration with insulin is recommended for insulin-dependent diabetic treatment. In this case patients must be strictly monitored.

Contra-indications
- Infantile-onset diabetes, juvenile-onset diabetes, acidosis, severe ketosis, diabetic precoma and coma, severe renal and hepatic impairment, known allergy to sulfonamides and association with miconazole.
- Pregnancy.

Precautions
- Using gliclazide in no case implies that a low calorie/carbohydrate diet becomes unnecessary.
- Potentiation of the hypoglycaemic effect of gliclazide by miconazole tablets, non-steroidal anti-inflammatory drugs (NSAIDs), especially aspirin, sulfonamide antibacterial agents, coumarin anticoagulants, MAOIs, Beta-blockers, diazepam, tetracyclines, perhexiline maleate, chloramphenicol, clofibrate. Ingestion of ethyl alcohol can also potentiate hypoglycaemic effects of gliclazide. In contrast, some drugs reduce the activity of gliclazide such as barbiturates, corticoids, thiazide diuretics and oral contraceptives.

Side effects
Mucocutaneous reactions, blood disturbances, mild gastrointestinal disturbances, hepatic function disturbances, hypoglycaemia caused by unappropriate use of the drug or over-dosage.
The physician should be informed any side effects during the treatment with ZIDENOL.

Interactions
Severe hypoglycaemia (coma) has been observed in cases in which certain hypoglycaemic sulfonylureas (glibenclamide, gliclazide) have been taken in conjunction with the oral form of miconazole. The association of Zidenol with this drug is contraindicated.

Hypoglycaemia has also been observed through: potentiation of the hypoglycaemic effect of gliclazide by non-steroidal anti-inflammatory agents (particularly salicylates), sulfonamide antibacterial agents, coumarin anticoagulants, MAOIs, Beta-blockers, diazepam, tetracyclines, perhexiline maleate, chloramphenicol, clofibrate. Ingestion of ethyl alcohol can also potentiate its hypoglycaemic effects

Occasional reduction in activity with barbiturates; some compounds (corticoids, thiazide diuretics, oral contraceptives) can alter glycaemic control and encourage hyperglycaemia.

Dosage and Administration
Usual dose: 1- 4 tablets, divided into 2 times daily.
ZIDENOL should be taken with food.

Shelf-life
24 months.

Storage
Store in a dry and cool place (below 30 C). Keep out of reach of children.

Read leaflet carefully before use.
For more information, consult your physician.