Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
pioglitazone, metformin hydrochloride
CHEPLAPHARM Arzneimittel GmbH
A10BD05
pioglitazone, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Revision: 21
Authorised
2006-07-28
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COMPETACT 15 MG/850 MG FILM-COATED TABLETS pioglitazone/metformin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Competact is and what it is used for 2. What you need to know before you take Competact 3. How to take Competact 4. Possible side effects 5 How to store Competact 6. Contents of the pack and other information 1. WHAT COMPETACT IS AND WHAT IT IS USED FOR Competact contains pioglitazone and metformin. It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient. This type 2 diabetes usually develops in adulthood particularly as a result of the person being overweight and where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces. Your doctor will check whether Competact is working 3 to 6 months after you start taking it. Competact helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMPETACT DO NOT TAKE COMPETACT - if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6). - if you have heart failure or have had heart failure in the past. - if you recently had a heart attack, have severe circulatory problems including shock, or b Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. CLINICAL PARTICULARS 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 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 HbA 1c ). 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). 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 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. _Special populations _ _Elderly _ 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). 3 Physicians should start tre Прочетете целия документ