Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
pioglitazone hydrochloride
Vaia S.A.
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: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 with:metformin and a sulphonylurea, in adult 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 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 three to six 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).
Revision: 1
Withdrawn
2012-03-09
B. PACKAGE LEAFLET 53 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER SEPIOGLIN 15 MG TABLETS Pioglitazone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Sepioglin is and what it is used for 2. Before you take Sepioglin 3. How to take Sepioglin 4. Possible side effects 5. How to store Sepioglin 6. Further information 1. WHAT SEPIOGLIN IS AND WHAT IT IS USED FOR Sepioglin 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. Sepioglin 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 Sepioglin is working 3 to 6 months after you start taking it. Sepioglin 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 in blood sugar . 2. BEFORE YOU TAKESEPIOGLIN DO NOT TAKE SEPIOGLIN - if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Sepioglin. - if you have heart failure or have had heart failure in the past. - if you have liver disease. - if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting). - if you have or have ever had blad Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Sepioglin15 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of pioglitazone (as hydrochloride). Excipients: Each tablet contains 36.866 mg of lactose monohydrate (see section 4.4). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round, flat tablets, with “15” embossed on one side and a diameter of approximately 5.5 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 - 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 with - metformin and a sulphonylurea, in adult 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 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, pre Прочетете целия документ