RABEPRAZOLE SODIUM ACTAVIS 20 Milligram Tablets Gastro-Resistant

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

RABEPRAZOLE SODIUM

Disponible depuis:

Actavis Group PTC ehf

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:

2010-09-03

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RABEPRAZOLE SODIUM ACTAVIS 10 MG GASTRO-RESISTANT TABLETS
RABEPRAZOLE SODIUM ACTAVIS 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, pharmacist or
nurse.
-
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 Sodium Actavis is and what it is used for
2.
What you need to know before you take Rabeprazole Sodium Actavis
3.
How to take Rabeprazole Sodium Actavis
4.
Possible side effects
5.
How to store Rabeprazole Sodium Actavis
6.
Contents of the pack and other information
1.
WHAT RABEPRAZOLE SODIUM ACTAVIS IS AND WHAT IT IS USED FOR
Rabeprazole Sodium Actavis belongs to a group of medicines called
Proton Pump Inhibitors (PPIs).
Rabeprazole Sodium Actavis acts by reducing the amount of acid made by
the stomach.
Rabeprazole Sodium Actavis is used to treat:
-
ulcer in the upper part of the intestine (duodenal ulcer) and benign
stomach ulcer.
-
gastro-oesophageal reflux disease (GORD) with or without ulcer. GORD
is commonly referred to as
inflammation of the gullet caused by acid and associated with
heartburn. Heartburn is a burning
feeling rising from the stomach or lower chest up towards the neck.
Rabeprazole Sodium Actavis may
be used as a long term treatment of GORD (GORD maintenance).
Rabeprazole Sodium Actavis may
also be used for the symptomatic treatment of moderate to very severe
gastro-oesophageal reflux
disease (symptomatic GORD).
-
Zollinger-Ellison Syndrome, which is a condition when the stomach
makes extremely high amounts of
acid.
In c

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabeprazole Sodium Actavis 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains rabeprazole sodium 20 mg
corresponding to 18.85 mg rabeprazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, coated, elliptical, biconvex tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole Sodium Actavis 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 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.
_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 Rabeprazole Sodium Actavis 20 mg or 10 mg once
daily can be used depending upon patient
response.
_Symptomatic treatment_
_of_
_moderate to