Source: European Medicines Agency (EU) Publisher: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
as monotherapy:
as dual oral therapy in combination with:
as triple oral therapy in combination with:
Rosiglitazone therapy is usually initiated at 4 mg/day. This dose can be increased to 8 mg/day after eight weeks if greater glycaemic control is required. In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone 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 4.4 and 4.8).
Rosiglitazone may be given once or twice a day.
Rosiglitazone may be taken with or without food.
No dose adjustment is required in the elderly.
No dose adjustment is required in patients with mild and moderate renal insufficiency. Limited data are available in patients with severe renal insufficiency (creatinine clearance <30 ml/min) and therefore rosiglitazone should be used with caution in these patients.
Rosiglitazone should not be used in patients with hepatic impairment.
There are no data available on the use of rosiglitazone in patients under 10 years of age. For children aged 10 to 17 years, there are limited data on rosiglitazone as monotherapy (see sections 5.1 and 5.2).
The available data do not support efficacy in the paediatric population and therefore such use is not recommended.
Limited data are available with regard to overdose in humans. In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated, as dictated by the patient’s clinical status. Rosiglitazone is highly protein bound and is not cleared by haemodialysis.
2 years.
This medicinal product does not require any special storage conditions.
Opaque blister packs (PVC/aluminium). 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets, unit dose pack.
Not all pack sizes may be marketed.
Any unused product should be disposed of in accordance with local requirements.
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