Rabeprazole Aurobindo 20 mg Gastro-resistant tablets

Pays: Malte

Langue: anglais

Source: Malta Medicines Authority

Ingrédients actifs:

RABEPRAZOLE SODIUM

Disponible depuis:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Code ATC:

A02BC04

DCI (Dénomination commune internationale):

RABEPRAZOLE SODIUM 20 mg

forme pharmaceutique:

GASTRO-RESISTANT TABLET

Composition:

RABEPRAZOLE SODIUM 20 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

DRUGS FOR ACID RELATED DISORDERS

Statut de autorisation:

Authorised

Date de l'autorisation:

2012-08-13

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RABEPRAZOLE AUROBINDO 10 MG GASTRO-RESISTANT TABLETS
RABEPRAZOLE AUROBINDO 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 Rabeprazole Aurobindo is and what it is used for
2.
What you need to know before you take Rabeprazole Aurobindo
3.
How to take Rabeprazole Aurobindo
4.
Possible side effects
5.
How to store Rabeprazole Aurobindo
6.
Contents of the pack and other information
1.
WHAT RABEPRAZOLE AUROBINDO IS AND WHAT IT IS USED FOR
Rabeprazole Aurobindo tablet contains 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.
Rabeprazole Aurobindo 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
Rabeprazole Aurobindo 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 RABEPRAZOLE AURO

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rabeprazole Aurobindo 10 mg Gastro-resistant tablets
Rabeprazole Aurobindo 20 mg Gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10mg:
Each gastro-resistant tablet contains 10 mg rabeprazole sodium,
equivalent to 9.42 mg rabeprazole.
20mg:
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
10mg:
Round (diameter 5.72 mm), white, biconvex, enteric-coated tablets.
20mg:
Round (diameter 7.17 mm), yellow, biconvex, enteric-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rabeprazole Aurobindo 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
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.
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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 da