Tandemact

Posology The recommended dose of Tandemact is one tablet taken once daily. If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered. 3 If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, patients should be stabilised with concomitant pioglitazone and glimepiride before switching to Tandemact.

Special populations Elderly Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section

1). Hypoglycaemic reactions mostly occur immediately due to the sulphonylurea component of Tandemact. Symptoms can almost always be promptly controlled by immediate intake of carbohydrates (sugar). 4). 4). 4). Tabulated list of adverse reactions Adverse reactions reported in double-blind studies and post marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.

Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.

Adverse reaction Frequency of adverse reactions Pioglitazone Glimepiride Tandemact Infections and infestations upper respiratory tract infection common common sinusitis uncommon uncommon Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon Blood and lymphatic system disorders changes in haematology1 rare rare Immune system disorders allergic shock2 very rare very rare allergic vasculitis2 very rare very rare hypersensitivity and allergic reactions3 not known not known Metabolism and nutrition disorders hypoglycaemia uncommon appetite increased uncommon Nervous system disorders dizziness common hypo-aesthesia common common headache uncommon insomnia uncommon uncommon Eye disorders visual disturbance4 common uncommon macular oedema not known not known Ear and labyrinth disorders vertigo uncommon Gastrointestinal disorders5 flatulence common vomiting very rare very rare diarrhoea very rare very rare nausea very rare very rare abdominal pain very rare very rare abdominal pressure very rare very rare 10 Adverse reaction Frequency of adverse reactions Pioglitazone Glimepiride Tandemact feeling of fullness in the stomach very rare very rare Hepatobiliary disorders6 hepatitis very rare very rare impairment of liver function (with cholestasis and jaundice) very rare very rare Skin and subcutaneous tissue disorders sweating uncommon hypersensitivity to light very rare very rare urticaria2 not known not known itching2 not known not known rash2 not known not known Musculoskeletal and connective tissue disorders bone fracture7 common common Renal and urinary disorders glycosuria uncommon proteinuria uncommon General disorders and administration site conditions oedema8 common fatigue uncommon Investigations weight increased9 common common common increased lactic dehydrogenase uncommon decrease in sodium serum concentrations very rare very rare alanine aminotransferase increase10 not known not known Description of selected adverse reactions 1 Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancyto-penia may occur.

4 Fluid retention and cardiac failure). 3). 4). Paediatric population The safety and efficacy of Tandemact in children and adolescents under 18 years of age have not been established. No data are available. Method of administration The tablets are taken orally shortly before or with the first main meal.

The tablets should be swallowed with a glass of water. 4 Special warnings and precautions for use There is no clinical trial experience of other oral anti-hyperglycaemic medicinal products added to treatment with Tandemact or concomitantly administered glimepiride and pioglitazone.

Hypoglycaemia When meals are taken at irregular hours or skipped altogether, treatment with Tandemact may lead to hypoglycaemia due to the sulphonylurea component. Symptoms can almost always be promptly controlled by immediate intake of carbohydrates (sugar).

Artificial sweeteners have no effect. It is known from other sulphonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Severe hypoglycaemia or prolonged hypoglycaemia, only temporarily 4 controlled by the usual amounts of sugar, require immediate medical treatment and occasionally hospitalisation.

Treatment with Tandemact requires regular monitoring of glycaemic control. Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose of pioglitazone and increase the dose gradually.

Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve. There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.

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