GLUCOPHAGE XR 500 MG EXTENDED RELEASE TABLET [SIN13249P]

Product Info

GLUCOPHAGE XR 500 MG EXTENDED RELEASE TABLET

[SIN13249P]

4.1 Therapeutic indications

• Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG* who are:

  • at high risk for developing overt type 2 diabetes mellitus (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and

  • not suitable for intensive lifestyle modifications.

  Treatment with Glucophage XR must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  *IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose

• 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 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

4.2 Posology and method of administration

Adults with normal renal function (GFR≥ 90 mL/min)

Reduction in the risk or delay of the onset of type 2 diabetes

• Metformin should only be considered where intensive lifestyle modifications are not feasible.

• The therapy should be initiated with one tablet 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 gastro-intestinal tolerability. The maximum recommended dose is 2000 mg once daily with the evening meal.

• It is recommended to regularly monitor (every 3–6 months) the glycaemic status (OGTT and/or FPG and/or HbA1c value) as well as the risk factors to evaluate whether treatment needs to be continued, modified or discontinued.

• A decision to re-evaluate therapy is also required if the patient subsequently implements improvements to diet and/or exercise, or if changes to the medical condition will allow increased lifestyle interventions to be possible.

Monotherapy and combination with other oral antidiabetic agents in Type 2 diabetes mellitus.

Glucophage XR 500 mg

• The usual starting dose of Glucophage XR 500 mg is one tablet once daily with the evening meal.

• Glucophage XR tablets must be swallowed whole and never crushed or chewed.

• After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements.

• To improve gastrointestinal tolerability, dosage increase is recommended in increments of 500 mg every 10 to15 days, up to 2000 mg once daily with the evening meal. If glycaemic control is not achieved on Glucophage XR 2000 mg once daily, Glucophage XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

• In patients already treated with metformin tablets, the starting dose of Glucophage XR should be equivalent to the daily dose of metformin immediate release tablets. In patients treated with metformin at a dose above 2000 mg daily, switching to Glucophage XR is not recommended.

Glucophage XR 750 mg

• Glucophage XR 750 mg is intended for patients who are already treated with metformin tablets (extended or immediate release). The dose of Glucophage XR 750 mg should be equivalent to the daily dose of metformin tablets (extended or immediate release), up to a maximum dose of 1500 mg given 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 recommended dose of Glucophage XR 750mg is 2 tablets once daily. If glycaemic control is not achieved on Glucophage XR 1500 mg once daily, the dose may be increased to a maximum dose of 2000 mg once daily. If glycaemic control is not achieved on Glucophage XR 2000 mg once daily, Glucophage XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

Glucophage XR 1000 mg

• Glucophage XR 1000 mg is intended as a maintenance therapy for patients treated with either 1000 mg or 2000 mg of metformin hydrochloride. On switch, the daily dose of Glucophage XR should be equivalent to the current daily dose of metformin hydrochloride.

• Glucophage XR 1000 mg should be taken once daily with the evening meal at a maximum recommended dose of 2 tablets per day. If glycaemic control is not achieved on Glucophage XR 2000 mg once daily, Glucophage XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

Combining Glucophage XR dosage strengths
The combined use of different strengths of Glucophage XR 500, Glucophage XR 750 or Glucophage XR 1000 is not recommended. Only one strength (Glucophage XR 500, Glucophage XR 750 or Glucophage XR 1000) should be used at a time in order to avoid accidentally exceeding the recommended upper daily dose limit of 2000mg.

Transfer from another oral antidiabetic agent
If transfer from another oral antidiabetic agent is intended, discontinue the other agent and initiate Glucophage XR 500 mg at the dose indicated above, before switching to Glucophage XR 750mg or Glucophage XR 1000 mg.

Combination with insulin
Metformin and insulin may be used in combination therapy to achieve better blood glucose control. The usual starting dose of Glucophage XR is 500mg once daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly
Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Benefit in the reduction of risk or delay of the onset of type 2 diabetes mellitus has not been established in patients 75 years and older (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and metformin initiation is therefore not recommended in these patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3–6 months.

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

4.3 Contra-indications

• Hypersensitivity to metformin hydrochloride or to any of the excipients.

• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).

• Diabetic pre-coma.

• Severe renal failure (GFR < 30mL/min).

• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.

• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.

• Hepatic insufficiency, acute alcohol intoxication, alcoholism.