Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pioglitazone hydrochloride
CHEPLAPHARM Arzneimittel GmbH
A10BG03
pioglitazone
Drugs used in diabetes
Diabetes Mellitus, Type 2
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapy:in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Revision: 30
Authorised
2000-10-13
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTOS 15 MG TABLETS ACTOS 30 MG TABLETS ACTOS 45 MG TABLETS pioglitazone 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 Actos is and what it is used for 2. What you need to know before you take Actos 3. How to take Actos 4. Possible side effects 5. How to store Actos 6. Contents of the pack and other information 1. WHAT ACTOS IS AND WHAT IT IS USED FOR Actos 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. Actos 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 Actos is working 3 to 6 months after you start taking it. Actos 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, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACTOS DO NOT TAKE ACTOS - if you are allergic to pioglitazone 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 have liver disease. - if you have had diabetic ketoa Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Actos 15 mg tablets Actos 30 mg tablets Actos 45 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Actos 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). _Excipient with known effect_ Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4). Actos 30 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride). _Excipient with known effect_ Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4). Actos 45 mg tablets Each tablet contains 45 mg of pioglitazone (as hydrochloride). _Excipient with known effect_ Each tablet contains 114.51 mg of lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Actos 15 mg tablets The tablets are white to off-white, round, convex and marked ‘15’ on one face and ‘ACTOS’ on the other face. Actos 30 mg tablets The tablets are white to off-white, round, flat and marked ‘30’ on one face and ‘ACTOS’ on the other face. Actos 45 mg tablets The tablets are white to off-white, round, flat and marked ‘45’ on one face and ‘ACTOS’ on the other face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: 3 as MONOTHERAPY - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate 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 adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as TRIPLE ORAL THERAPY in combination Aqra d-dokument sħiħ