Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
pioglitazone, glimepiride
CHEPLAPHARM Arzneimittel GmbH
A10BD06
pioglitazone, glimepiride
Drugs used in diabetes
Diabetes Mellitus, Type 2
Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Revision: 22
Authorised
2007-01-08
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TANDEMACT 30 MG/2 MG TABLETS TANDEMACT 30 MG/4 MG TABLETS pioglitazone/glimepiride 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 Tandemact is and what it is used for 2. What you need to know before you take Tandemact 3. How to take Tandemact 4. Possible side effects 5. How to store Tandemact 6. Contents of the pack and other information 1. WHAT TANDEMACT IS AND WHAT IT IS USED FOR Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level. It is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes mellitus. This type 2 diabetes usually develops in adulthood where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces. Tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing the amount of insulin available and helping your body make better use of it. Your doctor will check whether Tandemact is working 3 to 6 months after you start taking it. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANDEMACT DO NOT TAKE TANDEMACT - if you are allergic to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, 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 diabetic ketoacidos Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tandemact 30 mg/2 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride. _Excipient with known effect_ Each tablet contains approximately 125 mg lactose monohydrate (see section 4.4). Tandemact 30 mg/4 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride. _Excipient with known effect_ Each tablet contains approximately 177 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Tandemact 30 mg/2 mg tablets White to off-white, round, convex and debossed ‘4833 G’ on one face and ‘30/2’ on the other. Tandemact 30 mg/4 mg tablets White to off-white, round, convex and debossed ‘4833 G’ on one face and ‘30/4’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride. 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 The recommended dose of Tandemact is one tablet taken once daily. If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered. 3 If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiri Прочетете целия документ