Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
alogliptin
Takeda Pharma A/S
A10BH04
alogliptin benzoate
Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors
Diabetes Mellitus, Type 2
Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Revision: 10
Authorised
2013-09-18
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIPIDIA 25 MG FILM-COATED TABLETS VIPIDIA 12.5 MG FILM-COATED TABLETS VIPIDIA 6.25 MG FILM-COATED TABLETS alogliptin 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 Vipidia is and what it is used for 2. What you need to know before you take Vipidia 3. How to take Vipidia 4. Possible side effects 5. How to store Vipidia 6. Contents of the pack and other information 1. WHAT VIPIDIA IS AND WHAT IT IS USED FOR Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti-diabetics”. It is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus or NIDDM. Vipidia works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body. It must be taken together with other anti-diabetic medicines, which your doctor will have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin. Vipidia is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral anti-diabetic medicines. It is important that you continue to take your other anti-diabetic medicine, and continue to follow the advice on diet and exercise that your nurse or doctor has given yo Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vipidia 6.25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin. Vipidia 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin. Vipidia 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Vipidia 6.25 mg film-coated tablets Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side. Vipidia 12.5 mg film-coated tablets Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side. Vipidia 25 mg film-coated tablets Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg film-coated tablets. 3 _Adults (≥ 18 years old) _ The recommended dose of alogliptin is one tablet of 25 mg once daily as add-on therapy to metformin, a thiazolidinedione, a sulphonylurea, or insulin or as triple therapy with metformin and a thiazo Pročitajte cijeli dokument