PARIET 20 mg TABLET

Nazione: Sudafrica

Lingua: inglese

Fonte: South African Health Products Regulatory Authority (SAHPRA)

Commercializzato da:

Janssen Pharmaceutica (Pty) Ltd

Dosaggio:

See ingredients

Forma farmaceutica:

TABLET

Composizione:

EACH TABLET CONTAINS RABEPRAZOLE SODIUM 20,0 mg

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2001-12-02

Foglio illustrativo

JANSSEN PHARMACEUTICA (PTY) LTD
PARIET® range : 10 mg and 20 mg tablets (rabeprazole)
CLEAN FINAL PATIENT INFORMATION LEAFLET
Submitted: 18 August 2015 ref: RA/2015/07/080cp
SUBMISSION TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015
_ _
_ _
CCDS: JUNE 2011 + JULY 2009 + CCDS JAN 2013 PAGE 1 OF 10
CLEAN FINAL PATIENT INFORMATION LEAFLET
_(Clean version submitted 18 August 2015) _
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
PARIET
®
10 mg tablets
PARIET
®
20 mg tablets
RABEPRAZOLE SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PARIET.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

PARIET has been prescribed for you personally and you should not share
it with
other people. It may harm them, even if their symptoms are the same as
yours.
1.0 WHAT PARIET CONTAINS
The active substance is rabeprazole sodium. Each yellow PARIET tablet
contains 20 mg
rabeprazole sodium; and each pink PARIET tablet contains 10 mg of
rabeprazole sodium.
The other ingredients are: calcium carboxymethylcellulose, carnauba
wax, diacetylated
monoglycerides, ethylcellulose, ferric oxide, hydroxypropyl cellulose,
hypromellose
phthalate, low-substituted hydroxypropyl cellulose, magnesium oxide,
magnesium stearate,
mannitol, talc, titanium dioxide.
Ferric oxide red is used as an excipient in all 10 mg tablets and
ferric oxide yellow is used
as an excipient in all 20 mg tablets.
JANSSEN PHARMACEUTICA (PTY) LTD
PARIET® range : 10 mg and 20 mg tablets (rabeprazole)
CLEAN FINAL PATIENT INFORMATION LEAFLET
Submitted: 18 August 2015 ref: RA/2015/07/080cp
SUBMISSION TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015
_ _
_ _
CCDS: JUNE 2011 + JULY 2009 + CCDS JAN 2013 PAGE 2 OF 10
2.0 WHAT PARIET IS USED FOR
PARIET belongs to a group of medicines called “Proton Pump
Inhibitors” (PPIs). They
work by lowering the amount of acid that your stomach produces.
PARIET tablets are used to treat the following conditions:

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Scheda tecnica

JANSSEN PHARMACEUTICA (PTY) LTD
PARIET® range: 10 mg and 20 mg tablets (rabeprazole)
CLEAN FINAL PACKAGE INSERT
Submitted: 18 August 2015; Reference: RA/2015/07/080cp
AMENDMENT TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015
CCDS January 2013
Page 1
of 16
CLEAN FINAL PACKAGE INSERT
_(Clean version submitted 18 August 2015) _
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME (AND DOSAGE FORM)
PARIET
®
10 mg tablets
PARIET
®
20 mg tablets
COMPOSITION
10mg: Each enteric-coated delayed release tablet contains 10 mg of
rabeprazole sodium,
equivalent to 9,42 mg rabeprazole (racemate).
20 mg: Each enteric-coated delayed release tablet contains 20 mg of
rabeprazole sodium,
equivalent to 18,85 mg rabeprazole (racemate).
Inactives:
Calcium carboxymethylcellulose, carnauba wax, diacetylated
monoglycerides, ethylcellulose,
ferric oxide, hydroxypropyl cellulose, hypromellose phthalate,
low-substituted hydroxypropyl
cellulose, magnesium oxide, magnesium stearate, mannitol, talc,
titanium dioxide.
Ferric oxide red is used as an excipient in all 10 mg tablets and
ferric oxide yellow is used as
an excipient in all 20 mg tablets.
PHARMACOLOGICAL CLASSIFICATION
A 11.4.3
Medicines acting on gastro-intestinal tract.
JANSSEN PHARMACEUTICA (PTY) LTD
PARIET® range: 10 mg and 20 mg tablets (rabeprazole)
CLEAN FINAL PACKAGE INSERT
Submitted: 18 August 2015; Reference: RA/2015/07/080cp
AMENDMENT TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015
CCDS January 2013
Page 2
of 16
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Rabeprazole sodium is a gastric proton-pump inhibitor, blocking the
final step of acid
production. This effect is dose-related and leads to inhibition of
both basal and stimulated acid
secretion irrespective of the stimulus. Animal studies indicate that
after administration,
rabeprazole sodium rapidly disappears from both the plasma and gastric
mucosa.
Anti-secretory Activity:
After oral administration of a 20 mg dose of rabeprazole sodium the
onset of the anti-secretory
effect occurs within one hour, with the maximum effect oc