RABEPRAZOLE 10 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RABEPRAZOLE SODIUM

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

A02BC04

INN (International Name):

RABEPRAZOLE SODIUM

Dosage:

10 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors

Authorization status:

Authorised

Authorization date:

2014-03-14

Patient Information leaflet

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140 X 540 MM
RABEPRAZOLE SODIUM 10 MG,20 MG 28
LEAFLET
697660
470693
697660
PA 577/179/001 
PA 577/179/002
LABORATORIOS 
LICONSA
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1.  WHAT RABEPRAZOLE IS AND WHAT IT 
IS USED FOR
Rabeprazole contains rabeprazole which 
belongs to a group of drugs called proton 
pump inhibitors.
Rabeprazole works by reducing the 
production of gastric acid. This prevents 
irritation of the stomach’s mucosa, so that 
the gastric ulcer can heal. This relieves 
pain and discomfort caused by ulcers.
Rabeprazole is used for:
•  duodenal ulcers
•  benign gastric ulcers
•  pain or discomfort caused by gastric acid 
that flows back into the oesophagus (the 
tube from the mouth to the stomach). 
This action can irritate the oesophagus, 
causing heartburn and other symptoms.
•  once the symptoms disappear, 
Rabeprazole may also be used to prevent 
the recurrence of the disease
•  elimination of _Helicobacter pylori _
(bacteria that infects the stomach) in 
patients with benign gastric ulcers 
(peptic ulcers) in combination 
with antibiotics
•  Zollinger-Ellison Syndrome (disorder 
that causes tumors in the pancreas and 
duodenum and ulcers in the stomach 
and duodenum)
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 RABEPRAZOLE
DO NOT TAKE RABEPRAZOLE:
 ▪ if you are allergic to rabeprazole or any 
of the other ingredients of this medicine 
(listed in section 6).
 ▪ if you are pregnant, planning to becom

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabeprazole 10 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Rabeprazole 10 mg gastro-resistant tablets: Pink, film-coated, biconvex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole 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 mainte