PARIET 20 mg gastro-resistant tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rabeprazole sodium

Available from:

Janssen Sciences Ireland UC

ATC code:

A02BC; A02BC04

INN (International Name):

Rabeprazole sodium

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Proton pump inhibitors; rabeprazole

Authorization status:

Marketed

Authorization date:

1998-10-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARIET
™
 10 MG AND 20 MG GASTRO-RESISTANT TABLETS
Rabeprazole sodium
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 Pariet is and what it is used for
2.
What you need to know before you take Pariet
3.
How to take Pariet
4.
Possible side effects
5.
How to store Pariet
6.
Contents of the pack and other information
1.
WHAT PARIET IS AND WHAT IT IS USED FOR
Pariet tablets contain the active ingredient rabeprazole sodium. This
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:
•
‘Gastro-oesophageal reflux disease’ (GORD), which can include
heartburn. GORD is caused when
acid and food from your stomach escapes into your food pipe
(oesophagus)
•
Ulcers in your stomach or the upper part of your gut (intestine). If
these ulcers are infected with
bacteria called ‘Helicobacter pylori’ (H. Pylori), you will also
be given antibiotics. Using Pariet
tablets and antibiotics together gets rid of the infection and makes
the ulcer heal. It also stops the
infection and ulcer from coming back
•
Zollinger-Ellison Syndrome where your stomach produces too much acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARIET
DO NOT TAKE PARIET IF
•
You are allergic (hypersensitive) to rabeprazole sodium, or any of the
other ingredients of this
medicine (listed in Section 6 )
•
You are pregnant or think that y

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2022
CRN00D6JF
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PARIET 20 mg gastro-resistant tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, film coated biconvex tablet with ‘E 243’ printed on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PARIET tablets are indicated for the treatment of:
- Active duodenal ulcer.
- Active benign gastric ulcer.
- Symptomatic erosive or ulcerative gastro-oesophageal reflux disease
(GORD).
- Gastro-Oesophageal Reflux Disease Long-term Management (GORD
Maintenance)
- Symptomatic treatment of moderate to very severe gastro-oesophageal
reflux disease (symptomatic GORD).
- Zollinger-Ellison Syndrome.
- In combination with appropriate antibacterial therapeutic regimens
for the eradication of Helicobacter pylori (H. pylori) in
patients with peptic ulcer disease. See section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults /older people_
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended
oral dose for both active duodenal ulcer and active
benign gastric ulcer is 20 mg to be taken once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks.
However a few patients may require an additional four weeks
of therapy to achieve healing. Most patients with active benign
gastric ulcer heal within six weeks. However again a few
patients may require an additional six weeks of therapy to achieve
healing.
Health Products Regulatory Authority
20 December 2022
CRN00D6JF
Page 2 of 10
Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GORD): The
recommended oral dose for this condition is 20 mg to
be taken once daily for four to eight weeks.
Gastro-Oesophageal Reflux Disease Long-term Management (GORD
Maintenance): For long-term management, a
maintenance dose of PARIET 20 mg or 10