Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
metformin hydrochloride, dapagliflozin propanediol monohydrate
AstraZeneca AB
A10BD15
dapagliflozin, metformin
Drugs used in diabetes, Combinations of oral blood glucose lowering drugs
Diabetes Mellitus, Type 2
Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:• in patients insufficiently controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products• in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Revision: 21
Authorised
2014-01-16
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XIGDUO 5 MG/850 MG FILM-COATED TABLETS XIGDUO 5 MG/1,000 MG FILM-COATED TABLETS dapagliflozin/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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xigduo is and what it is used for 2. What you need to know before you take Xigduo 3. How to take Xigduo 4. Possible side effects 5. How to store Xigduo 6. Contents of the pack and other information 1. WHAT XIGDUO IS AND WHAT IT IS USED FOR This medicine contains two different substances called dapagliflozin and metformin. Both belong to a group of medicines called oral anti-diabetics. These are medicines taken by mouth for diabetes. Xigduo is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are 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 (glucose) in your blood. Dapagliflozin works by removing excess sugar from your body via your urine and lowers the amount of sugar in your blood. It can also help prevent heart disease. Metformin works mainly by inhibiting glucose production in the liver. To treat diabetes: This medicine is taken in combination with diet and exercise. This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes. Your doctor may ask you to take this medicine on its o Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xigduo 5 mg/850 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride. Xigduo 5 mg/1,000 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride. Excipient(s) with known effect: Xigduo contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Xigduo 5 mg/850 mg film-coated tablets Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with “5/850” on one side and “1067” engraved on the other side. Xigduo 5 mg/1,000 mg film-coated tablets Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: in patients insufficiently controlled on their maximally tolerated dose of metformin alone in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products in patients already being treated with the combination of dapagliflozin and metformin as separate tablets. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min)_ The recommended dose is one tablet twice daily. Each tablet contain Przeczytaj cały dokument