Diapro 60 MR

Gliclazide 60 mg Modified Release

What Diapro® 60 MR is and what it is used for?
Diapro® 60 MR is a preparation of Gliclazide which is a second generation sulphonylurea used as a Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed.

Before you take Diapro® 60 MR
Do not take the medicine and talk to your doctor if
Hypoglycemia (overdose effect), gastrointestinal disturbances and dermatological reactions occur.

Take special care with
All sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycemia.
Early symptoms of hypoglycemia such as tremor, sweating and tachycardia may be masked by beta-adrenoreceptor blocking drugs, such as propranolol allowing severe hypoglycemic episodes without preceding warning symptoms.

Diapro® 60 MR is contraindicated in patients with definite hepatic disease. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when the serum creatinine starts to rise.

Tell your doctor if you are taking other medicines
Drug interactions occur with rifampicin, barbiturates, phenytoin, and alcohol, or drugs that inhibit release of insulin like thiazide diuretics, dioxides, glucocorticoids, estrogens or sympathomimetic drugs.

Pregnancy and breast-feeding
Diapro® 60 MR should not be used in nursing mothers. It is contraindicated in children and pregnant women.

How to take Diapro® 60 MR?
Dosage and Administrations
Initially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily.
Switching from Gliclazide 80 mg tablets to Gliclazide 30 mg & 60 mg modified release tablets:
1 tablet of Gliclazide 80 mg is comparable to 1 tablet of Gliclazide 30 mg modified release tablet. Consequently the switch can be performed provided a careful blood monitoring.
One Gliclazide 60 mg modified release tablet is equivalent to two Gliclazide 30 mg modified release tablets. Gliclazide 60 mg modified release tablets can be used to replace other oral antidiabetic agents.

Possible side effects
Potentially life-threatening effects - All hypoglycemic agents have the potential to cause severe hypoglycemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than glyburide to cause hypoglycemia. Hypoglycemia may be favored by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency.

Severe or irreversible adverse effects - Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycemia (overdose effect), gastrointestinal disturbances and dermatological reactions.

Symptomatic adverse effects - Side effects of Gliclazide treatment are similar to those of other sulfonylureas. Headache, gastrointestinal upsets, nausea and dizziness have been reported and skin reactions, including rash, pruritus, erythema and bullous eruptions may occur. Abnormalities of liver function are not uncommon.

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

How to store Diapro® 60 MR?
Keep in a cool & dry place. Protect from light. Keep out of the reach of children.
Do not store above 25°C (room temperature). Do not freeze.

Diapro® 60 MR Prescribing Information