Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
(30mg Tablet) Tolvaptan; (60mg Tablet) Tolvaptan
OTSUKA PHARMACEUTICALS (SINGAPORE) PTE. LTD.
C03XA01
TABLET
(30mg Tablet) Tolvaptan 30.000mg; (60mg Tablet) Tolvaptan 60.000mg
ORAL
Prescription Only
Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate)
ACTIVE
2022-09-23
Page 1 of 15 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, debossed with “OTSUKA” and “15” on one side. JINARC 30 mg tablets Blue, round, debossed with “OTSUKA” and “30” on one side. JINARC 45 mg tablets Blue, square, debossed with “OTSUKA” and “45” on one side. Page 2 of 15 JINARC 60 mg tablets Blue, modified rectangular, debossed with “OTSUKA” and “60” on one side. JINARC 90 mg tablets Blue, pentagonal, debossed with “OTSUKA” and “90” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS JINARC is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in Read the complete document