Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Saxagliptin, dapagliflozin propanediol monohydrate
Astra Zeneca AB
A10BD21
saxagliptin, dapagliflozin
Drugs used in diabetes
Diabetes Mellitus, Type 2; Diabetes Mellitus; Nutritional and Metabolic Diseases; Metabolic Diseases; Glucose Metabolism Disorders
Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
Revision: 11
Authorised
2016-07-15
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT QTERN 5 MG/10 MG FILM-COATED TABLETS saxagliptin/dapagliflozin 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, pharmacist or nurse. - 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 Qtern is and what it is used for 2. What you need to know before you take Qtern 3. How to take Qtern 4. Possible side effects 5. How to store Qtern 6. Contents of the pack and other information 1. WHAT QTERN IS AND WHAT IT IS USED FOR Qtern contains the active substances saxagliptin and dapagliflozin. Each belongs to a group of medicines called “oral anti-diabetics”. These medicines are taken by mouth for diabetes. Qtern is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older). If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of sugar in your blood. The two active substances in Qtern work in different ways to help control the level of sugar in your blood and remove excess sugar from your body via your urine. Qtern is used to treat type 2 diabetes when: - saxagliptin or dapagliflozin alone together with metformin and/or sulphonylurea cannot control your diabetes. - you are already being treated with saxagliptin and dapagliflozin as single tablets. Your doctor may ask you to switch to this medicine. It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse. 2. WHAT YOU NEED TO KN Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Qtern 5 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin. Excipient with known effect Each tablet contains 40 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light brown to brown, biconvex, 0.8 cm round, film-coated tablet, with “5/10” printed on one side, and “1122” printed on the other side, in blue ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: - to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control, - when already being treated with the free combination of dapagliflozin and saxagliptin. (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one 5 mg saxagliptin/10 mg dapagliflozin tablet once daily (see sections 4.5 and 4.8). _Missed dose_ If a dose is missed and it is ≥ 12 hours until the next dose, the dose should be taken. If a dose is missed and it is < 12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time. _Special populations_ _Renal impairment_ Qtern should not be initiated in patients with a glomerular filtration rate (GFR) < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min. It should also not be used in patients with end-stage renal disease (ESRD) (see sections 4.4, 4.8, 5.1 and 5.2). No dose adjustment is recommended based on renal function. 3 _Hepatic impairment_ This medicinal product can be used in patients with mild or moderate hepatic impairment. Прочетете целия документ