AVANDAMET Film-coated tablet Ref.[51379] Active ingredients: Metformin Metformin and Rosiglitazone Rosiglitazone

The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus 2000 mg/day metformin hydrochloride.

Rosiglitazone can be increased to 8 mg/day after 8 weeks if greater glycaemic control is required. The maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus 2000 mg metformin hydrochloride.

The total daily dose of AVANDAMET should be given in two divided doses.

Dose titration with rosiglitazone (added to the optimal dose of metformin) may be considered before the patient is switched to AVANDAMET.

When clinically appropriate, direct change from metformin monotherapy to AVANDAMET may be considered.

Taking AVANDAMET with or just after food may reduce gastrointestinal symptoms associated with metformin.

Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4)

• Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken. An increase in the rosiglitazone component to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient’s risk of developing adverse reactions relating to fluid retention (see sections 4.4 and 4.8).
• Patients established on triple oral therapy: when appropriate, AVANDAMET may substitute rosiglitazone and metformin doses already being taken.

Where appropriate, AVANDAMET may be used to substitute concomitant rosiglitazone and metformin in existing dual or triple oral therapy to simplify treatment.

Elderly

As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking AVANDAMET should have their renal function monitored regularly (see sections 4.3 and 4.4).

Patients with renal impairment

AVANDAMET should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels >135 μmol/l in males and >110 μmol/l in females and/or creatinine clearance <70 ml/min (see sections 4.3 and 4.4).

Children and adolescents

AVANDAMET is not recommended for use in children and adolescents below 18 years of age as there are no data available on its safety and efficacy in this age group (see sections 5.1 and 5.2).

No data are available with regard to overdose of AVANDAMET.

Limited data are available with regard to overdose of rosiglitazone in humans. In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.

A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.

In the event of an overdose, it is recommended that appropriate supportive treatment is initiated as dictated by the patient’s clinical status. The most effective method to remove lactate and metformin is haemodialysis, however rosiglitazone is highly protein bound and is not cleared by haemodialysis.

3 years.

This medicinal product does not require any special storage conditions.

Opaque blisters (PVC/PVdC/aluminium). Packs of 28, 56, 112, 336 (3x112) and 360 tablets.

Not all pack sizes may be marketed.

Any unused product should be disposed of in accordance with local requirements.