Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Competact is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day).
Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Competact.
When clinically appropriate, direct change from metformin monotherapy to Competact may be considered.
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4).
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 4.4 Fluid retention and cardiac failure).
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at 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.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR <60 mL/min. If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination.
| GFR mL/min | Metformin | Pioglitazone |
|---|---|---|
| 60-89 | Maximum daily dose is 3,000 mg. Dose reduction may be considered in relation to declining renal function. | No dose adjustment. Maximum daily dose is 45 mg |
| 45-59 | Maximum daily dose is 2,000 mg. The starting dose is at most half of the maximum dose. | |
| 30-44 | Maximum daily dose is 1,000 mg. The starting dose is at most half of the maximum dose. | |
| <30 | Metformin is contra-indicated |
Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established. No data are available.
Tablets should be swallowed with a glass of water. Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
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.
The most effective method to remove lactate and metformin is haemodialysis.
3 years.
This medicinal product does not require any special storage conditions.
Aluminium/aluminium blisters.
Packs of 56, 112.
Not all pack sizes may be marketed.
No special requirements.
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