Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
canagliflozin, metformin hydrochloride
Janssen-Cilag International NV
A10BD16
canagliflozin, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Vokanamet 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 not adequately controlled on their maximally tolerated doses of metformin alonein patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control.in patients already being treated with the combination of canagliflozin and metformin as separate tabletsFor 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: 22
Authorised
2014-04-23
50 B. PACKAGE LEAFLET 51 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VOKANAMET 50 MG/850 MG FILM-COATED TABLETS VOKANAMET 50 MG/1,000 MG FILM-COATED TABLETS VOKANAMET 150 MG/850 MG FILM-COATED TABLETS VOKANAMET 150 MG/1,000 MG FILM-COATED TABLETS canagliflozin/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 Vokanamet is and what it is used for 2. What you need to know before you take Vokanamet 3. How to take Vokanamet 4. Possible side effects 5. How to store Vokanamet 6. Contents of the pack and other information 1. WHAT VOKANAMET IS AND WHAT IT IS USED FOR Vokanamet contains two different active substances, canagliflozin and metformin. These are two medicines that work together in different ways to lower blood glucose (sugar) levels and can help prevent heart disease in adults with type 2 diabetes. This medicine can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels. You may already be taking one or more of these to treat your type 2 diabetes. Vokanamet is used when your blood sugar cannot be adequately controlled by metformin alone or together with other diabetes medicines. If you are already taking both canagliflozin and metformin as single tablets, Vokanamet can replace them in one tablet. It is important to keep following adv Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1,000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vokanamet 50 mg/850 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride. Vokanamet 50 mg/1,000 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 1,000 mg of metformin hydrochloride. Vokanamet 150 mg/850 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 850 mg of metformin hydrochloride. Vokanamet 150 mg/1,000 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Vokanamet 50 mg/850 mg film-coated tablets The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and debossed with “CM” on one side and “358” on the other side. Vokanamet 50 mg/1,000 mg film-coated tablets The tablet is beige, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “551” on the other side. Vokanamet 150 mg/850 mg film-coated tablets The tablet is light yellow, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “418” on the other side. Vokanamet 150 mg/1,000 mg film-coated tablets The tablet is purple, capsule-shaped, 22 mm in length, film-coated, and debossed with “CM” on one side and “611” on the other side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vokanamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise: in patients insufficiently controlled on their maximally tolerated dose Прочетете целия документ