Rabeprazole 10mg gastro-resistant tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Rabeprazole sodium

Dostępny od:

Zentiva Pharma UK Ltd

Kod ATC:

A02BC04

INN (International Nazwa):

Rabeprazole sodium

Dawkowanie:

10mg

Forma farmaceutyczna:

Gastro-resistant tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 01030500; GTIN: 5000283655756

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RABEPRAZOLE SODIUM 10MG GASTRO-RESISTANT TABLETS
AND
RABEPRAZOLE SODIUM 20MG 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 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
1.
WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR
The name of your medicine is Rabeprazole Sodium 10mg Gastro-resistant
tablets or
Rabeprazole Sodium 20mg Gastro-resistant tablets (called Rabeprazole
throughout this
leaflet). 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 is 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 are infected with
bacteria called ‘_Helicobacter pylori_’ (_H. pylori_), you will
also be given antibiotics. Using
rabeprazole 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
DO NOT T

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rabeprazole Sodium 10mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 10 mg rabeprazole sodium (as
anhydrate or
monohydrate), equivalent to 9.42 mg rabeprazole
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet
Rabeprazole Sodium 10 mg tablets: round, pink, film coated biconvex
tablet with a
diameter of about 5.5 mm.
4.1
THERAPEUTIC INDICATIONS
Rabeprazole sodium 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 people: _
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 20 mg or 10 mg once dai