Therapeutic Indication

Treatment of type 2 diabetes in adults

When dietary management and exercise do not result in adequate glycemic control.
When dietary management, exercise and monotherapy with metformin or sulfonylurea do not result in adequate glycemic control.
As replacement for previous combination therapy with metformin and a sulfonylurea in patients whose glycaemia is stable and well-controlled.

Pharmaceutical Form

Apperance

Glucovance 500 mg /2.5 mg tablets are orange capsule-shaped, biconvex, film-coated tablets with "2.5" engraved on one side.
Glucovance 500 mg /5 mg tablets are yellow capsule-shaped, biconvex, film-coated tablets with "5" engraved on one side.

Health Insurance Code

Glucovance tablets 500 mg/5 mg BC24006100

License

衛署藥輸字第024006號 (500毫克/5毫克)

Qualitative and Quantitative Composition

Each film-coated tablet of Glucovance 500 mg/2.5mg contains 500 mg metformin hydrochloride, equivalent to 390 mg of metformin, and 2.5 mg of glibenclamide.

Each film-coated tablet of Glucovance 500 mg /5 mg contains 500 mg metformin hydrochloride, equivalent to 390 mg of metformin, and 5 mg of glibenclamide.

Dose and Administration

Oral route. For use in adults only

As for all hypoglycaemic agents, the dosage should be adapted according to the individual metabolic response (glycaemia, HbAlc).

Initiation of treatment

When dietary management and exercise do not result in adequate glycemic control: The usual initial dosage is 1 tablet of GLUCOVANCE 250 mg/1.25 mg daily.
In the event of monotherapy failure with metformin or a sulfonylurea: The usual initial dosage is 1 tablet of GLUCOVANCE 500 mg/2.5 mg daily.
As substitution for combination therapy with metformin and glibenclamide: Patients previously treated with a free combination of metformin and glibenclamide may be switched to GLUCOVANCE at equal doses.
As substitution for combination therapy with metformin and sulfonylurea: Patients previously treated with a free combination of metformin hand sulfonylurea may be switched to 1 tablet of GLUCOVANCE 500mg/2.5mg daily.

Dose titration

The dosage should be adjusted every 2 weeks or longer, by increments of 1 tablet, depending on glycaemia results. A gradual increase in the dosage may aid gastrointestinal tolerance and prevent the onset of hypoglycaemia.
Patients not adequately controlled on GLUCOVANCE 500mg/2.5 mg may be switched to GLUCOVANCE 500mg/5mg.

Maximum daily recommended dose

The maximum recommended dose is 6 tablets of GLUCOVANCE 500 mg/2.5 mg per day may be recommended.
In exceptional cases, an increase up to 4 tablets of GLUCOVANCE 500 mg/5 mg per day may be recommended.

Dosage regimen

The dosage regimen depends on the individual posology:

Once a day, in the morning at breakfast, for a dosage of 1 tablet/day,
Twice a day, morning and evening, for a dosage of 2 or 4 tablets/day,
Three times a day, morning, noon and evening, for a dosage of 3, 5 or 6 tablets/day.

The tablets should be taken with meals. The dosage regimen should be adjusted according to the individual eating habits.
However, any intake must be followed by a meal with a sufficiently high carbohydrate content to prevent the onset of hypoglycaemic episodes.

Combination with insulin therapy

No clinical data are available on the concomitant use of this product with insulin therapy.

Elderly

In the elderly, the dosage of GLUCOVANCE should be adjusted depending on renal function parameters (start with 1 tablet of GLUCOVANCE 250mg/1.25mg daily); regular checks on the renal function are necessary.

Children

Since insufficient data are available, GLUCOVANCE should not be administered in children.

CONTRAINDICATIONS

This medicinal product must never be used in case of: hypersensitivity to metformin hydrochloride, glibenclamide or other suIphonyIurea(s) and suIphonamide(s) sr to any of the excipients; type 1 diabetes (insulin-dependent diabetes), ketoacidosis, diabetic pre-coma; renal failure or renal dysfunction (e.g., creatinine clearance 60 ml/min); acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast materials; acute or chronic disease, which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock; major surgery; hepatic insufficiency, acute alcohol intoxication, alcoholism; porphyria; lactation; in association with miconazole.