Meglu Tablet 500mg

Product Information

MEGLU

Meglu

Meglu®ER (Metformin Hydrochloride)

Presentation

Meglu-500 tablet: Blue, oblong shaped, scored tablet; each film coated tablet contains Metformin Hydrochloride BP 500 mg.

Meglu-850 tablet: Blue, oblong shaped tablet; each film coated tablet contains Metformin Hydrochloride BP 850 mg.

Meglu ER-500 tablet: Off-white, oblong shaped, scored tablet; each extended release tablet contains Metformin Hydrochloride BP 500

mg.

Meglu ER-750 tablet: Pink, oblong shaped, scored tablet; each extended release tablet contains Metformin Hydrochloride BP 750 mg.

Meglu ER-1000 tablet: Green, oblong shaped, scored tablet; each extended release tablet contains Metformin Hydrochloride BP 1000

mg.

Indication

Non-insulin dependant diabetes when diet has failed and especially if the patient is overweight. Metformin can be given alone as

initial therapy, or can be administered in combination with a sulphonylurea. In insulin-dependant diabetes, Metformin may be given

as an adjuvant to patients whose symptoms are poorly controlled.

Dosage and Administration

Adults: Initial dosage is 500 mg (one Meglu-500 tablet) two or three times daily or 850 mg (one Meglu-850 tablet) once or twice

daily with or after meals, gradually increased if necessary to 2 to 3 gm daily; dosage above 2 gm are associated with an increased

incidence of gastrointestinal adverse effects. The usual starting dose of Metformin Hydrochloride extended release tablet is 500

mg (one Meglu ER-500 tablet) once daily with the evening meal. Dosage increase should be made in increments of 500 mg weekly, up

to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Metformin hydrochloride extended

release 2000 mg once daily, a trial of Metformin hydrochloride extended release 1000 mg twice daily should be considered. Meglu ER

750 mg and Meglu ER 1000 mg are intended for patients who are already treated with Metformin tablets (prolonged or immediate

release). The dose of Meglu ER 750 mg or Meglu ER 1000 mg should be equivalent to the daily dose of Metformin tablets (prolonged

or immediate release), up to a maximum dose of 1500 mg or 2000 mg respectively, given with the evening meal.

Children: Not recommended for use.

Elderly: Indicated in the elderly, but not when renal function is impaired.

Contra-indications, warnings, etc.

Contra-indications: Hypersensitivity to the drug. Diabetic coma and ketoacidosis, impairment of renal function, chronic liver

disease, cardiac failure and recent myocardial infarction. History of, or states associated with lactic acidosis such as shock or

pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxaemia.

Precautions: Metformin Hydrochloride is excreted by the kidney and regular monitoring of renal function is advised in all

diabetics. Metformin Hydrochloride therapy should be stopped 2-3 days before surgery and clinical investigations such as

intravenous urography and intravenous angiography, and reinstated only after control or renal function has been regained. The use

of Metformin is not advised in conditions which may cause dehydration or in patients suffering from serious infections or trauma.

Patients receiving continuous Metformin therapy should have an annual estimation of Vitamin B-12 levels because of reports of

decreased Vitamin B-12 absorption. During concomitant therapy with a sulphonylurea, blood glucose should be monitored because

combined therapy may cause hypoglycaemia. Stabilization of diabetic patients with Metformin and insulin should be carried out in

hospital because of the possibility of hypoglycaemia until the correct ratio of the two drugs has been obtained. Reduced renal

clearance of Metformin Hydrochloride has been reported during cimetidine therapy, so a dose reduction should be considered. As

with a number of drugs, an interaction between Metformin Hydrochloride and anticoagulants is a possibility and dosage of the

latter may need adjustment.

Use in pregnancy and lactation: Pregnancy: The use of Metformin Hydrochloride is not advised. Lactation: No information is

available.

Side effects: Metformin Hydrochloride is normally well tolerated but gastro-intestinal disturbances sometimes occur. These are

usually minor and can often be avoided by taking Metformin Hydrochloride with or after food. Occasionally a temporary lowering of

the dose may be needed. It is important that Metformin Hydrochloride treatment is not abandoned at the first sign of intolerance,

since this has been found to resolve spontaneously. Lactic acidosis has been associated with Metformin Hydrochloride but, in the

few cases reported, has occurred in patients with contra-indications to therapy. In patients with a metabolic acidosis lacking

evidence of ketoacidosis (ketonuria and ketonaemia), lactic acidosis should be suspected and Metformin Hydrochloride therapy

stopped. Lactic acidosis is a medical emergency which must be treated in hospital.

Overdosage: Hypoglycaemia may occur when Metformin Hydrochloride is administered concomitantly with a sulphonylurea, insulin or

alcohol. In excessive dosage and particularly if there is a possibility of accumulation, lactic acidosis may develop.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Package quantities

Meglu-500 tablet: Carton containing 30 tablets in blister.

Meglu-850 tablet: Carton containing 30 tablets in blister.

Meglu ER-500 tablet: Carton containing 30 tablets in blister.

Meglu ER-750 tablet: Carton containing 30 tablets in blister.

Meglu ER-1000 tablet: Carton containing 30 tablets in blister.