Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Tolvaptan
Otsuka Pharmaceutical Netherlands B.V.
C03XA01
tolvaptan
Diuretics,
Polycystic Kidney, Autosomal Dominant
Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
Revision: 20
Authorised
2015-05-27
60 B. PACKAGE LEAFLET 61 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JINARC 15 MG TABLETS JINARC 30 MG TABLETS JINARC 45 MG TABLETS JINARC 60 MG TABLETS JINARC 90 MG TABLETS Tolvaptan This medicine 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 or pharmacist. - 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 Jinarc is and what it is used for 2. What you need to know before you take Jinarc 3. How to take Jinarc 4. Possible side effects 5. How to store Jinarc 6. Contents of the pack and other information 1. WHAT JINARC IS AND WHAT IT IS USED FOR Jinarc contains the active substance tolvaptan which blocks the effect of vasopressin, a hormone involved in the formation of cysts in the kidneys of ADPKD patients. By blocking the effect of vasopressin, Jinarc slows the development of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production. Jinarc is a medicine used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD). This disease causes growth of fluid-filled cysts in the kidneys, which put pressure on surrounding tissues and reduce kidney function, possibly leading to kidney failure. Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) stages 1 to 4 with evidence of rapidly progressing disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE JINARC DO NOT TAKE JINA Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jinarc 15 mg tablets Each tablet contains 15 mg of tolvaptan. Excipient(s) with known effect Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate). Jinarc 30 mg tablets Each tablet contains 30 mg of tolvaptan. Excipient(s) with known effect Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate). Jinarc 45 mg tablets Each tablet contains 45 mg of tolvaptan. Excipient(s) with known effect Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate). Jinarc 60 mg tablets Each tablet contains 60 mg of tolvaptan. Excipient(s) with known effect Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate). Jinarc 90 mg tablets Each tablet contains 90 mg of tolvaptan. Excipient(s) with known effect Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Jinarc 15 mg tablets Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side. Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side. 3 Jinarc 45 mg tablets Blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side Jinarc 60 mg tablets Blue, modified rectangular (major axis 9.9 mm, minor axis 5.6 mm), shallow-convex, debossed with “OTSUKA” and “60” on one side Jinarc 90 mg tablets Blue, pentagonal (major axis 9.7 mm, minor axis 9.5 mm), shallo Прочетете целия документ