Glucophage XR 500 mg/750 mg/1000 mg Prolonged-Release Tablets

Glucophage XR is a prolonged release tablet that contains metformin hydrochloride. It is used for:

• Risk reduction or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with prediabetes (IGT* and/or IFG*, and/or increased HbA1c) and additional risk factors**, in whom lifestyle change has not resulted in adequate glycaemic control.
• Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.

Glucophage XR can be given alone as initial therapy or can be administered in combination with other oral antidiabetic agents or with insulin.

Warnings and precautions

Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication. Risk factors include poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, severe infection, hepatic insufficiency, and any condition associated with hypoxia (such as decompensated cardiac failure, acute myocardial infarction) or the concomitant use of medications which might cause lactic acidosis (such as NRTIs).

Children and adolescents

In the absence of available data, the Glucophage XR range should not be used in children.

Renal Impairment

A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.

Metformin should only be considered where intensive lifestyle modifications for 3 to 6 months have not resulted in adequate glycaemic control.

The therapy should be initiated with Glucophage XR 500 mg once daily with the evening meal. After 10 to 15 days, dose adjustment on the basis of blood glucose measurements is recommended. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose is 2000 mg of Glucophage XR once daily with the evening meal.

During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to gradually increase the dose of Glucophage XR to the desired dosage.

Adverse reactions reported are listed below by system organ class and by frequency:

• Very common: Gastrointestinal disorders such as nausea & vomiting, diarrhoea, abdominal pain and loss of appetite.
• Very rare: Decrease of vitamin B12 and folic acid absorption with decrease of serum levels during long-term use of metformin.

Store at or below 30 °C. Keep out of reach of children. Do not remove from carton until ready for use.