Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
pioglitazone hydrochloride
Accord Healthcare S.L.U.
A10BG03
pioglitazone
Drugs used in diabetes
Diabetes Mellitus, Type 2
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.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.
Revision: 7
Authorised
2012-03-21
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PIOGLITAZONE ACCORD 15 MG TABLETS PIOGLITAZONE ACCORD 30 MG TABLETS PIOGLITAZONE ACCORD 45 MG TABLETS Pioglitazone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICIN e 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 Pioglitazone Accord is and what it is used for 2. What you need to know before you take Pioglitazone Accord 3. How to take Pioglitazone Accord 4. Possible side effects 5. How to store Pioglitazone Accord 6. Contents of the pack and other information 1. WHAT PIOGLITAZONE ACCORD IS AND WHAT IT IS USED FOR Pioglitazone Accord contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non- insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood. Pioglitazone Accord 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. Your doctor will check whether Pioglitazone Accord is working 3 to 6 months after you start taking it. Pioglitazone Accord may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulfonylurea or insulin) which have failed to provide sufficient control of blood sugar. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE ACCORD DO NOT TAKE PIOGLITAZONE ACCORD: • if you are allergic to pioglitazone Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pioglitazone Accord 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). _Excipient_ _ with known effect_ _: _ Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4). Pioglitazone Accord 30 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride). _Excipient with known effect: _ Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4). Pioglitazone Accord 45 mg tablets Each tablet contains 45 mg of pioglitazone (as hydrochloride). _Excipient_ _ with known effect_ _: _ Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Pioglitazone Accord 15 mg tablets The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P’ on one side and ‘15’ on other side. Pioglitazone Accord 30 mg tablets The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘30’ on the other side. Pioglitazone Accord 45 mg tablets The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as MONOTHERAPY - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as DUAL ORAL THERAPY in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in Lugege kogu dokumenti