Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
canagliflozin
Janssen-Cilag International NV
A10BK02
canagliflozin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Revision: 23
Authorised
2013-11-15
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INVOKANA 100 MG FILM-COATED TABLETS INVOKANA 300 MG FILM-COATED TABLETS canagliflozin 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 Invokana is and what it is used for 2. What you need to know before you take Invokana 3. How to take Invokana 4. Possible side effects 5. How to store Invokana 6. Contents of the pack and other information 1. WHAT INVOKANA IS AND WHAT IT IS USED FOR Invokana contains the active substance canagliflozin which belongs to a group of medicines called “blood-glucose lowering drugs.” Invokana is used: to treat adults with type 2 diabetes. This medicine works by increasing the amount of sugar removed from your body in your urine. This reduces the amount of sugar in your blood and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering. Invokana can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as metformin, 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. It is also important to keep following advice about diet and exercise given by your doctor or nurse. WHAT IS TYPE 2 DIABE Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. _Excipient(s) with known effect_ Each tablet contains 39.2 mg lactose. Invokana 300 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin. _Excipient(s) with known effect_ Each tablet contains 117.78 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Invokana 100 mg film-coated tablets The tablet is yellow, capsule-shaped, approximately 11 mm in length, immediate-release and film-coated, with “CFZ” on one side and “100” on the other side. Invokana 300 mg film-coated tablets The tablet is white, capsule-shaped, approximately 17 mm in length, immediate-release and film-coated, with “CFZ” on one side and “300” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose of canagliflozin is 100 mg once daily. In patients tolerating canagliflozin 100 mg once daily who have an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m 2 or CrCl ≥ 60 mL/min and need tighter glycaemic control, the dose can be increased to 300 mg once daily (see section 4.4). For dose adjustment recommendations a Pročitajte cijeli dokument