Rabeprazole 10mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rabeprazole sodium

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

A02BC04

INN (International Name):

Rabeprazole sodium

Dosage:

10mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500

Patient Information leaflet

Version 2
01.11.2017
RABEPRAZOLE 10MG AND 20MG
GASTRO-RESISTANT TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
• The full name of the product is
Rabeprazole 10mg and 20mg Gastro-
resistant Tablets but within the leaflet it
will be referred to as Rabeprazole tablets.
WHAT IS IN THIS LEAFLET:
1
WHAT RABEPRAZOLE TABLETS ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RABEPRAZOLE TABLETS
3 HOW TO TAKE RABEPRAZOLE TABLETS
4
POSSIBLE SIDE EFFECTS
5 HOW TO STORE RABEPRAZOLE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT RABEPRAZOLE TABLETS ARE AND
WHAT THEY ARE USED FOR
Rabeprazole tablets belong to a group of
medicines called Proton Pump Inhibitors
(PPIs).
Rabeprazole tablets act by reducing the
amount of acid made by the stomach.
Rabeprazole tablets are 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 tablets may
be used as a long term treatment of GORD
(GORD maintenance). Rabeprazole tablets
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
ext

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rabeprazole 10mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rabeprazole 10mg gastro-resistant tablet contains rabeprazole sodium
10mg
corresponding to 9.42mg rabeprazole.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
10mg: Pink, coated, elliptical, biconvex tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rabeprazole 10mg Gastro-resistant 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 20 mg or
10 mg once
daily can be used depending upon patient response.
_ _
_Symptoma