Kraj: Unia Europejska
Język: angielski
Źródło: myHealthbox
Metformin Hydrochloride, Dapagliflozin Propanediol Monohydrate
AstraZeneca AB
A10BD15
Dapagliflozin, Metformin
5 mg/1,000 mg
Film-coated tablet (tablet)
Oral use
14,28,56,60,196
Subject to medical prescription
AstraZeneca GmbH/Bristol-Myers Squibb Company
Drugs used in diabetes, Combinations of oral blood glucose-lowering drugs
Diabetes Mellitus, Type 2
Indicated in adults aged 18 years and older 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 glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products - in patients already being treated with the combination of dapagliflozin and metformin as separate tablets
Authorized
2014-01-16
73 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 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. This medicine 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 yo Przeczytaj cały dokument
27 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 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 aged 18 years and older 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 glucose-lowering medicinal products, 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 dapagliflozin and metformin as separate tablets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _For patients inadequately controlled on metformin monotherapy or metformin in combination with other _ _glucose-lowering medicinal products including insulin _ The recommended dose is one tablet twice daily. Each tablet contains a fixed dose of dapagliflozin and metformin (see section 2). Patients not adequately controlled on metformin alone or in combination with Przeczytaj cały dokument