Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
pioglitazone hydrochloride
Krka, d.d., Novo mesto
A10BG03
pioglitazone
Drugs used in diabetes
Diabetes Mellitus, Type 2
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 inappropriate because of contraindications or intolerance;as dual oral therapy in combination with- 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; Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin 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: 2
Withdrawn
2012-03-21
55 B. PACKAGE LEAFLET Medicinal product no longer authorised 56 PACKAGE LEAFLET: INFORMATION FOR THE USER PIOGLITAZONE KRKA 15 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 Pioglitazone Krka is and what it is used for 2. What you need to know before you take Pioglitazone Krka 3. How to take Pioglitazone Krka 4. Possible side effects 5. How to store Pioglitazone Krka 6. Contents of the pack and other information 1. WHAT PIOGLITAZONE KRKA IS AND WHAT IT IS USED FOR Pioglitazone Krka contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non- insulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood. Pioglitazone Krka 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 Krka is working 3 to 6 months after you start taking it. Pioglitazone Krka 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 sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE KRKA DO NOT TAKE PIOGLITAZONE KRKA: - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6). - if yo Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Pioglitazone Krka 15 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of pioglitazone (as hydrochloride). Excipient with known effect: Each tablet contains 88.83 mg of lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm). 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 inappropriate because of contraindications or intolerance; as DUAL ORAL THERAPY in combination with - 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; - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily. Medicinal pro Διαβάστε το πλήρες έγγραφο