RABEPRAZOLE 20 Milligram Tablets Gastro-Resistant

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

RABEPRAZOLE SODIUM

Disponible depuis:

McDermott Laboratories Ltd t/a Gerard Laboratories

Code ATC:

A02BC04

DCI (Dénomination commune internationale):

RABEPRAZOLE SODIUM

Dosage:

20 Milligram

forme pharmaceutique:

Tablets Gastro-Resistant

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Proton pump inhibitors

Statut de autorisation:

Authorised

Date de l'autorisation:

2012-10-19

Notice patient

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RABEPRAZOLE 10 MG GASTRO-RESISTANT TABLETS
RABEPRAZOLE 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rabeprazole is and what it is used for
2.
What you need to know before you take Rabeprazole
3.
How to take Rabeprazole
4.
Possible side effects
5.
How to store Rabeprazole
6.
Contents of the pack and other information
The name of your medicine is Rabeprazole 10 mg or 20 mg
Gastro-resistant Tablets (referred to as
Rabeprazole throughout this leaflet).
1.
WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR
Rabeprazole contains rabeprazole which belongs to a group of medicines
called ‘Proton Pump
Inhibitors’ (PPIs). They work by lowering the amount of acid that
your stomach produces.
RABEPRAZOLE TABLETS CAN BE USED TO TREAT THE FOLLOWING CONDITIONS:

Symptomatic treatment of erosive or ulcerative ‘Gastro-Oesophageal
Reflux Disease’
(GORD) commonly referred to as inflammation of the gullet caused by
stomach acid and
associated with heartburn, or for long-term treatment of GORD (GORD
maintenance). GORD
is caused when acid and food from your stomach escapes into your food
pipe and can cause
inflammation (oesophagus).

The symptomatic treatment of moderate to very severe
gastro-oesophageal reflux disease
(symptomatic GORD) also associated with heartburn.

Ulcers in your stomach or the upper part of your gut (intestine). If
these ulcers are infected
with bacteria called ‘_Helic

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabeprazole 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, round, biconvex tablet imprinted with ‘R4’ in
black ink on one side of the tablet and blank on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole 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_ 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 20mg 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.
_Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GORD)_: The
recommended oral dose for this condition is
20mg 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 20mg or 10mg once daily can be used depending upon
patient response.
_Symptomatic trea