Jinarc

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Tolvaptan

Available from:

Otsuka Pharmaceutical Netherlands B.V.

ATC code:

C03XA01

INN (International Name):

tolvaptan

Therapeutic group:

Diuretics,

Therapeutic area:

Polycystic Kidney, Autosomal Dominant

Therapeutic indications:

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.

Product summary:

Revision: 20

Authorization status:

Authorised

Authorization date:

2015-05-27

Patient Information leaflet

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

Summary of Product characteristics

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