COMPETACT Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Competact 15 mg/850 mg film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet). The tablets are white to off-white, oblong, film-coated, embossed 15 / 850 on one face and 4833M on the other.
4.1. Therapeutic indications
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 ...
4.2. Posology and method of administration
Posology Adults with normal renal function (GFR ≥90 mL/min) 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 ...
4.3. Contraindications
Competact is contraindicated in patients with: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Cardiac failure or history of cardiac failure (NYHA stages I to ...
4.4. Special warnings and precautions for use
There is no clinical experience of pioglitazone in triple combination with other oral antidiabetic medicinal products. Lactic acidosis Lactic acidosis, a very rare but serious metabolic complication, most ...
4.5. Interaction with other medicinal products and other forms of interaction
There have been no formal interaction studies for Competact. The following statements reflect the information available on the individual active substances (pioglitazone and metformin). Metformin Concomitant ...
4.6. Pregnancy and lactation
For Competact no preclinical or clinical data on exposed pregnancies or lactation are available. Women of childbearing potential / Contraception in males and females Competact is not recommended in women ...
4.7. Effects on ability to drive and use machines
Competact has no or negligible influence on the ability to drive and use machines. However patients who experience visual disturbance should be cautious when driving or using machines.
4.8. Undesirable effects
Summary of the safety profile Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1). At the initiation of the treatment abdominal pain, ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, combinations of oral blood glucose lowering drugs <b>ATC code:</b> A10BD05 Competact combines two antihyperglycaemic active substances with complementary ...
5.2. Pharmacokinetic properties
Competact Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets. Food had no effect on the ...
5.3. Preclinical safety data
No animal studies have been conducted with the combined products in Competact. The following data are findings in studies performed with pioglitazone or metformin individually. Pioglitazone In toxicology ...
6.1. List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate <u>Film coat:</u> Hypromellose Macrogol 8000 Talc Titanium dioxide (E171)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Aluminium/aluminium blisters. Packs of 56, 112. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
8. Marketing authorization number(s)
EU/1/06/354/005 EU/1/06/354/010
10. Date of revision of the text
08/2023
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