Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
metformin hydrochloride, saxagliptin hydrochloride
AstraZeneca AB
A10BD10
saxagliptin, metformin hydrochloride
Drugs used in diabetes, Combinations of oral blood glucose lowering drugs
Diabetes Mellitus, Type 2
Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.
Revision: 20
Authorised
2011-11-24
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KOMBOGLYZE 2.5 MG/850 MG FILM-COATED TABLETS saxagliptin/metformin hydrochloride 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Komboglyze is and what it is used for 2. What you need to know before you take Komboglyze 3. How to take Komboglyze 4. Possible side effects 5. How to store Komboglyze 6. Contents of the pack and other information 1. WHAT KOMBOGLYZE IS AND WHAT IT IS USED FOR This medicine contains two different substances called: saxagliptin, part of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, part of a class of medicines called biguanides. Both belong to a group of medicines called oral anti-diabetics. WHAT KOMBOGLYZE IS USED FOR This medicine is used to treat a type of diabetes called ‘type 2 diabetes’. HOW KOMBOGLYZE WORKS Saxagliptin and metformin work together to control your blood sugar. They increase the levels of insulin after a meal. They also lower the amount of sugar made by your body. Along with diet and exercise, this helps lower your blood sugar. This medicine can be used alone or together with other antidiabetic medicines, including insulin. To control your diabetes, you still need to diet and exercise, even when you are taking this medicine. So it is important to keep following the advice about diet and exercise from your doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOMBOGLYZE DO NOT TAKE KOMBOGLYZE - If you are alle Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Komboglyze 2.5 mg/850 mg film-coated tablets Komboglyze 2.5 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Komboglyze 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850 mg of metformin hydrochloride. Komboglyze 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Komboglyze 2.5 mg/850 mg film-coated tablets Light brown to brown, biconvex, round, film-coated tablets, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink. Komboglyze 2.5 mg/1,000 mg film-coated tablets Pale yellow to light yellow, biconvex, oval shaped, film-coated tablets, with “2.5/1000” printed on one side and “4247” printed on the other side, in blue ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Komboglyze is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of metformin alone in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations) in patients already being treated with the combination of saxagliptin and metformin as separate tablets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (GFR ≥ 90 mL/min)_ _For patients inadequately controlled on maximal tolerated dose of metformin monotherapy_ Patients not adequately controlled on metformin alone should receive a dose of this medicinal product equivalent to the total daily dose of saxagliptin 5 mg, dosed as 2.5 mg twice daily, Прочетете целия документ