Razole 20 mg Gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rabeprazole sodium

Available from:

Rowa Pharmaceuticals Limited

ATC code:

A02BC; A02BC04

INN (International Name):

Rabeprazole sodium

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral use

Units in package:

1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98 or 120 gastro-resistant tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

Alimentary tract and metabolism, Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), proton pump inhibitors

Therapeutic area:

Proton pump inhibitors; rabeprazole

Therapeutic indications:

It is indicated in:
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 in patients with peptic ulcer disease.

Authorization status:

Not marketed

Authorization date:

2009-09-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAZOLE 10 MG GASTRO-RESISTANT TABLETS
RAZOLE 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 Razole is and what it is used for
2.
What you need to know before you take Razole
3.
How to take Razole
4.
Possible side effects
5.
How to store Razole
6.
Contents of the pack and other information
1.
WHAT RAZOLE IS AND WHAT IT IS USED FOR
Razole contains the active substance 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.
Razole is 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 Razole 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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAZOLE
DO NOT TAKE RAZOLE
▪
if you are allergic to rabeprazole sodium or any of the other
ingredients of this med

Summary of Product characteristics

Health Products Regulatory Authority
28 November 2022
CRN00D62W
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Razole 20 mg Gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Razole is indicated in:

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_ in
patients with peptic ulcer disease. See section 4.2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults/elderly:
_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, some patients may require an additional four weeks
of treatment to achieve healing. Most patients with benign active
gastric ulcer heal within six weeks. However again some
patients may require an additional six weeks of treatment to achieve
healing.
_ _
_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 _
_therapy): _For
long-term
management,
a
maintenance dose is 20 mg or 10 mg once daily can be used, depending
upon patient response.