INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo GLUCOPHAGE 500 mg Tablets
GLUCOPHAGE 850 mg Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

GLUCOPHAGE 500 mg Tablets
GLUCOPHAGE 850 mg Tablets

COMPOSITION:
Each Glucophage 500 mg Tablet contains 500 mg
Metformin Hydrochloride.
Each Glucophage 850 mg Tablet contains 850 mg Metformin Hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 21.2 - Oral Hypoglycaemic.

PHARMACOLOGICAL ACTION:
Glucophage is a biguanide oral anti-hyperglycaemic agent. Its mode of action is thought to be multifactorial and includes delayed uptake of glucose from the gastrointestinal tract, increased peripheral glucose utilisation mediated by increased insulin sensitivity, and inhibition of increased hepatic and renal gluconeogenesis. No hypoglycaemia occurs when Glucophage is used alone but can occur when given concomitantly with a sulphonylurea, insulin or alcohol.

INDICATIONS:
Non-insulin dependent diabetes when diet has failed and especially if the patient is overweight. Glucophage can be given alone as initial therapy, or can be administered in combination with a sulphonylurea. In insulin-dependent diabetes, Glucophage may be given as an adjuvant to patients whose symptoms are poorly controlled.

CONTRA-INDICATIONS:
Sensitivity to metformin hydrochloride. 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 hypoxemia. Pancreatitis. The use of Glucophage during pregnancy is not advised. There is no information available concerning the safety of Glucophage during lactation.

WARNINGS:
Sensitivity to metformin hydrochloride. 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 hypoxemia. Pancreatitis. The use of Glucophage during pregnancy is not advised. There is no information available concerning the safety of Glucophage during lactation.

DOSAGE AND DIRECTIONS FOR USE:
It is important that Glucophage tablets be taken in divided doses with meals.
Adults:
Initially, one 850 mg tablet twice a day or one 500 mg tablet three times a day, with or after food. Good diabetic control may be achieved within a few days, but it is not usual for the full effect to be delayed for up to two weeks. If control is incomplete a cautious increase in dosage to a maximum of 3 g daily is justified. Once control has been obtained it may be possible to reduce the dosage of Glucophage.
Children:
Glucophage is not recommended for use.
Elderly:
Glucophage is indicated in the elderly, but not when renal function is impaired.
Combination therapy - see "Special Precautions"

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal adverse effects with anorexia, nausea and vomiting. Metallic taste. Lactic acidosis has been associated with Glucophage but, has occurred to a greater extent 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 Glucophage therapy stopped. Lactic acidosis is a medical emergency which must be treated in hospital.
Glucophage is excreted by the kidney and regular monitoring of renal function is advised in all diabetics. Glucophage therapy should be stopped 2-3 days before surgery and clinical investigations such as intravenous urography and intravenous angiography and reinstated only after control of renal function has been regained. The use of Glucophage is not advised in conditions which may cause dehydration or in patients suffering from serious infections, trauma or on low calorie intake.
Patients receiving continuous Glucophage therapy should have an annual estimation of Vitamin B
12 levels because of reports of decreased Vitamin B12 absorption.
During concomitant therapy with a sulphonylurea, blood glucose should be monitored because combined therapy may cause hypoglycaemia. Stabilisation of diabetic patients with Glucophage 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 Glucophage has been reported during cimetidine therapy, so a dose reduction should be considered. An interaction between Glucophage and anticoagulants is a possibility and dosage of the latter may need adjustment.
Contra-indications should be carefully observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypoglycaemia can occur when Glucophage is given concomitantly with a sulphonylurea, insulin or alcohol. In excessive dosage, and particularly if there is a possibility of accumulation, lactic acidosis may develop. Intense symptomatic and supportive therapy is recommended which should be particularly directed at correcting fluid loss and metabolic disturbance.

IDENTIFICATION:
Glucophage 500 mg Tablets - White, round, biconvex, film-coated tablets.
Glucophage 850 mg Tablets - White, round shallow, biconvex film-coated tablets.

PRESENTATION:
Glucophage 500 mg Tablets 500 mg - 100's and 500's
Glucophage 850 mg Tablets 850 mg - 60's and 300's

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
Keep out of reach of children.

REGISTRATION NUMBER:
Glucophage 500 mg Tablets G3244 (Act 101/1965)
Glucophage 850 mg Tablets F/21.2/145

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Limited
1 Friesland Drive
Longmeadow Business Estate
Modderfontein, 1645

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26.08.1974

        Highland Print         F70616 P10/03

Updated on this site: January 2005
Source: Community Pharmacy

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