Jinarc

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tolvaptan 30mg;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosage:

30 mg

Pharmaceutical form:

Tablet

Composition:

Active: Tolvaptan 30mg   Excipient: Hyprolose Indigo carmine aluminium lake Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose

Prescription type:

Prescription

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 4 at initiation of treatment with evidence of rapidly progressing disease.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 7 tablets - 48 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, - 28 tablets - 48 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2018-05-15

Patient Information leaflet

JINARC
®
J
i
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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 25
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
JINARC
®
15 mg, 30 mg, 45 mg, 60 mg or 90 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JINARC tablets for oral use contain 15 mg, 30 mg, 45 mg, 60 mg or 90
mg of tolvaptan.
Tolvaptan is practically insoluble in water and the aqueous solubility
of the drug substance is
poor (~ 0.1 mg/250 mL) across all pH ranges. It is slightly soluble in
ethyl acetate, sparingly
soluble in ethanol, soluble in methanol and freely soluble in benzyl
alcohol. The octanol: water
partition coefficient was reported to be greater than 5000 at 25°C.
Excipients with known effect
Lactose
JINARC contains lactose as an excipient. Patients with rare hereditary
problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take
this medicine.
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.
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 4 at initiation of treatment with evidence of rapidly
progressing disease (see
Section 5.1 PHARMACODYNAMIC PROPERTIES).
Page 2 of 25
4.2
DOSE AND METHOD OF ADMINISTRATION
JINARC treatment must be initiated and monitored under the supervision
of physicians with
expertise in managing ADPKD and a full understand