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GLUMERON 30 MR

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INFORMATION FOR MEDICAL STAFF

GLUMERON 30 MR

COMPOSITION:

Gliclazide ............................................................................ 30 mg

Excipients q.s .................................................................... 1 tablet

(Calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, colloidal silicon dioxide)

PHARMACEUTICAL FORM: Modified-release tablet.

PHARMACODYNAMIC PROPERTIES:

ATC code: A10BB09

Glumeron contains Gliclazide which is a sulfonylurea anti-diabetic agent. Gliclazide works by stimulating pancreatic beta cells to release insulin. Hence, the drug only gives its effects when patient's pancreas is still able to produce insulin. Besides, gliclazide reduces the hepatic insulin clearance, therefore increases the amount of serum hormone.

PHARMACOKINETIC PROPERTIES:

Gliclazide is readily absorbed from the gastrointestinal tract and the plasma peak concentration of gliclazide occurs between 2 and 4 hours after ingestion. It is extensively bound to plasma proteins. Gliclazide is extensively metabolized in the liver and excreted in the urine. The half-life is about 12 to 20 hours.

PRESENTATION: Box of 5 blisters x 20 tablets.

THERAPEUTIC INDICATIONS:

Non insulin-dependent diabetes (type 2) when dietary measures alone are not sufficient to control blood glucose.

Particularly, gliclazide should be used in the diabetic elderly.

DOSAGE & ADMINISTRATION:

Determination of the proper dosage for Glumeron 30 MR for each patient should be made on the basis of frequent determinations of blood glucose. It is recommended that the tablet(s) be swallowed whole without crushing or chewing.

The recommended starting dose is one tablet of Glumeron 30 MR daily, even in elderly patients (over 65 years old). Dose adjustment should be carried out in steps of 30 mg (one tablet of Glumeron 30 MR). The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.

A usual dose of Glumeron 30 MR may vary from 1 tablet to 4 tablets (The dose should not exceed 120 mg). It is recommended that it be taken at breakfast time. The dosage depends on therapeutic response.

CONTRAINDICATIONS:

Insulin-dependent diabetes mellitus (type 1). Diabetic coma or pre-coma. Severe renal or hepatic insufficiency. Hypersensitivity to sulfonamides and other sulfonylureas. Treatment with miconazole. Serious infection, trauma, surgery. 

PRECAUTIONS:

Use of Glumeron 30 MR must be considered as treatment in addition to proper dietary regimen. When used in combination with other drugs that increase or decrease the hypoglycemic effects, the dosage of gliclazide should be adjusted. In the case of kidney failure, liver failure, the dosage should be reduced.

Hypoglycaemia may occur in patients with malnutrition, irregular mealtimes, periods of fasting or dietary changes; imbalance between physical exercise and carbohydrate intake; use of alcohols (particularly enclosed with skipping meals), overdose of gliclazide; certain endocrine disorders (thyroid disorders, hypopituitarism and adrenal insufficiency); severe hepatic insufficiency or severe renal insufficiency.

Decreased hemoglobin level and red blood cell destruction have been reported in patients with a family history or known to G6PD-deficiency.

Pregnancy and lactation: The drug is contraindicated to pregnant women and breast-feeding mothers.

Effects on works: The drug is used with caution in drivers, machine operators, because of possibility of headache.

INTERACTIONS:

Hypoglycemic action may be potentiated when gliclazide is used concurrently with agents including nonsteroidal anti-inflammatory drugs (particularly aspirin), antibacterial sulfamides, coumarin, anticoagulants, MAOIs, beta-blockers, diazepam, tetracycline, perhexiline maleate, chloramphenicol, clofibrate, miconazole tablet. Hypoglycemia is more likely to occur following alcohol intake.

Certain drugs tend to induce hypoglycemia. These include barbituric, corticosteroids, sodium-eliminated diuretics, oral contraceptives.

UNDESIRABLE EFFECTS:

Common: CNS disorders: headache; Gastrointestinal disorders: nausea; Skin disorders: rash.

Uncommon: Blood disorders (general reversible): thrombocytopenia, agranulocytosis, neutropenia, anemia; Skin disorders: skin and mucosa reactions.

Rare: CNS disorders: drowsiness, sweating; Cardiovascular disorders: increased heart rate; Skin disorders: paleness; Gastrointestinal disorders: vomiting, ravenousness.

OVERDOSE:

Overdosage leads to manifestations of hypoglycemia including sweating, skin paleness, polycardia. For mild cases, the patient should be immediately taken a glass of syrup or fruit juice with 2 or 3 sugar coffee-spoons. For severe cases with vague symptoms, the patient should be given a rapid I.V. injection of glucose solution (10% or 30%) and hospitalized.

Read the directions carefully before use.

This drug is for prescription only.

STORAGE CONDITIONS:

Store in dry places, not exceeding 30oC, protect from light.

SHELF-LIFE: 24 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: April 16, 2018  

INFORMATION FOE THE USER

 

GLUMERIN 30 MR

Read all of this leaflet carefully before you start taking this medicine.

Keep out of reach of children

Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.

The drug is for prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Gliclazide ............................................................................. 30 mg

Excipients q.s ..................................................................... 1 tablet

(Calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, colloidal silicon dioxide)

PRODUCT DESCRIPTION: A white to off-white caplet, smooth on one side, a pattern      on the other, intact edges.

PRESENTATION: Box of 5 blisters x 20 modified-release tablets.

WHAT THE DRUG IS USED FOR:

Non insulin-dependent diabetes (type 2) when dietary measures alone are not sufficient to control blood glucose.

Particularly, gliclazide should be used in the diabetic elderly.

HOW TO TAKE THIS MEDICINE: Determination of the proper dosage for Glumeron 30 MR for each patient should be made on the basis of frequent determinations of blood glucose. It is recommended that the tablet(s) be swallowed whole without crushing or chewing.

The recommended starting dose is one tablet of Glumeron 30 MR daily, even in elderly patients (over 65 years old). Dose adjustment should be carried out in steps of 30 mg (one tablet of Glumeron 30 MR). The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.

A usual dose of Glumeron 30 MR may vary from 1 tablet to 4 tablets (The dose should not exceed 120 mg). It is recommended that it be taken at breakfast time. The dosage depends on therapeutic response.

Or as directed by the physician.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Insulin-dependent diabetes mellitus (type 1). Diabetic coma or pre-coma. Severe renal or hepatic insufficiency. Hypersensitivity to sulfonamides and other sulfonylureas. Treatment with miconazole. Serious infection, trauma, surgery. 

UNDESIRABLE EFFECTS:

Common: CNS disorders: headache; Gastrointestinal disorders: nausea; Skin disorders: rash.

Uncommon: Blood disorders (general reversible): thrombocytopenia, agranulocytosis, neutropenia, anemia; Skin disorders: skin and mucosa reactions.

Rare: CNS disorders: drowsiness, sweating; Cardiovascular disorders: increased heart rate; Skin disorders: paleness;

Gastrointestinal disorders: vomiting, ravenousness.

Inform your physician about any adverse effects occur during the treatment.

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:

Hypoglycemic action may be potentiated when gliclazide is used concurrently with agents including nonsteroidal anti-inflammatory drugs (particularly aspirin), antibacterial sulfamides, coumarin, anticoagulants, MAOIs, beta-blockers, diazepam, tetracycline, perhexiline maleate, chloramphenicol, clofibrate, miconazole tablet. Hypoglycemia is more likely to occur following alcohol intake.

Certain drugs tend to induce hypoglycemia. These include barbituric, corticosteroids, sodium-eliminated diuretics, oral contraceptives.

WHAT SHOULD YOU DO IF YOU MISS A DOSE:

The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.

HOW TO STORE THIS MEDICINE:

Store in dry places, not exceeding 30oC, protect from light.

SIGNS AND SYMPTOMS OF DRUG OVERDOSE:

Overdosage leads to manifestations of hypoglycemia including sweating, skin paleness, polycardia.

WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:

For mild cases, the patient should be immediately taken a glass of syrup or fruit juice with 2 or 3 sugar coffee-spoons. For severe cases with vague symptoms, the patient should be given a rapid I.V. injection of glucose solution (10% or 30%) and hospitalized.

WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE:

Use of Glumeron 30 MR must be considered as treatment in addition to proper dietary regimen. When used in combination with other drugs that increase or decrease the hypoglycemic effects, the dosage of gliclazide should be adjusted. In the case of kidney failure, liver failure, the dosage should be reduced.

Hypoglycaemia may occur in patients with malnutrition, irregular mealtimes, periods of fasting or dietary changes; imbalance between physical exercise and carbohydrate intake; use of alcohols (particularly enclosed with skipping meals), overdose of gliclazide; certain endocrine disorders (thyroid disorders, hypopituitarism and adrenal insufficiency); severe hepatic insufficiency or severe renal insufficiency.

Decreased hemoglobin level and red blood cell destruction have been reported in patients with a family history or known to G6PD-deficiency.

Pregnancy and lactation: The drug is contraindicated to pregnant women and breast-feeding mothers.

Effects on works: The drug is used with caution in drivers, machine operators, because of possibility of headache.

WHEN SHOULD YOU CONSULT YOUR DOCTOR, PHARMACIST:

If you need further information, please consult your doctor or pharmacist.

SHELF-LIFE: 24 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: April 16, 2018

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