JINARC tolvaptan 15 mg + 45 mg tablet blister composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tolvaptan, Quantity: 45 mg

Available from:

Otsuka Australia Pharmaceutical Pty Ltd

INN (International Name):

Tolvaptan

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

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 chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see PHARMACOLOGY).

Product summary:

Visual Identification: A blue square shallow-convex tablet debossed with "OTSUKA" and "45" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-03-24

Patient Information leaflet

JINARC
®
J
i
n
a
r
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING JINARC?
JINARC contains the active ingredient tolvaptan. JINARC is used to
treat a disease called Autosomal Dominant Polycystic Kidney
Disease (ADPKD).
For more information, see Section 1. Why am I using JINARC? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE JINARC?
Do not use if you have ever had an allergic reaction to JINARC or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
JINARC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with JINARC and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE JINARC?
•
JINARC is to be taken in two different doses every day.
•
The dose combinations are 45 mg + 15 mg or 60 mg + 30 mg or 90 mg + 30
mg.
More instructions can be found in Section 4. How do I use JINARC? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING JINARC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
JINARC
•
MAKE SURE YOU DRINK ENOUGH WATER
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dosage without checking
with your doctor
•
Do not take JINARC to treat any other complaints unless your doctor
tells you to
•
Do not give your medicine to anyone else, even if they have the same
condition as you
DRIVING
OR USING
MACHINES
•
JINARC may cause side effects that can affect your ability to drive or
use machines
•
JINARC may make you feel dizzy or sleepy, particularly at the
beginning of treatment. If this happens to
you, do not drive or use any tools or machines.
DRIN

Summary of Product characteristics

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
JINARC
® (TOLVAPTAN) TABLETS
Tolvaptan has been associated with idiosyncratic elevations of blood
alanine and aspartate
aminotransferases (ALT and AST), rarely associated with concomitant
elevations in bilirubin-
total (BT). To help mitigate the risk of liver injury, blood testing
for hepatic transaminases is
required prior to initiation of JINARC, then continually monthly for
18 months, then every
3 months thereafter during treatment with JINARC. (See Section 4.4
SPECIAL WARNINGS
AND PRECAUTIONS FOR USE.). Prescriber education and certification on
the risk of liver
injury and the importance of regular liver function monitoring is
mandatory. These are
available through the IMADJIN
®
Program, which is run and maintained by, or for, the
sponsor of JINARC (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR
USE).
1
NAME OF THE MEDICINE
Tolvaptan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JINARC tablets for oral use contain 15 mg, 30 mg, 45 mg, 60 mg or 90
mg of tolvaptan.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
JINARC 15 mg Tablet: A blue triangular shallow-convex tablet debossed
with “OTSUKA”
and “15” on one side.
JINARC 30 mg Tablet: A blue round shallow-convex tablet debossed with
“OTSUKA” and
“30” on one side.
JINARC 45 mg Tablet: A blue square shallow-convex tablet debossed with
“OTSUKA and
“45” on one side.
JINARC 60 mg Tablet: A blue modified rectangular shallow convex tablet
debossed with
“OTSUKA” and “60” on one side.
JINARC 90 mg Tablet: A blue pentagonal shallow-convex tablet debossed
with “OTSUKA”
and “90” on one side.
Page 2 of 28
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 adults with
chronic kidney disease
(CKD) stage 1 to 3 at initiation of treatment with evidence o