Pantoprazole 40 mg gastro-resistant tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Pantoprazole sodium sesquihydrate

Tilgjengelig fra:

Wockhardt UK Limited

ATC-kode:

A02BC; A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosering :

40 milligram(s)

Legemiddelform:

Gastro-resistant tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Proton pump inhibitors; pantoprazole

Autorisasjon status:

Not marketed

Autorisasjon dato:

2010-08-13

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE 40MG GASTRO-RESISTANT
TABLETS
Pantoprazole
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. 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 Pantoprazole Tablets are and what they are used for
2. What you need to know before you take Pantoprazole Tablets
3. How to take Pantoprazole Tablets
4. Possible side effects
5. How to store Pantoprazole Tablets
6. Contents of the pack and other information
1.
WHAT PANTOPRAZOLE TABLET ARE AND WHAT THEY ARE USED FOR
Pantoprazole Tablets are selective “proton pump inhibitors”, which
are medicines that reduce the
amount of acid produced in your stomach. They are used for treating
acid-related diseases of the
stomach and intestine.
PANTOPRAZOLE TABLETS ARE USED FOR TREATING:
_Adults and adolescents 12 years of age and above:_
• Reflux oesophagitis. An inflammation of your oesophagus (the tube
which connects your throat to
your stomach) accompanied by the regurgitation of stomach acid.
_Adults:_
• An infection with a bacterium called _Helicobacter pylori _in
patients with duodenal ulcers and stomach
ulcers in combination with two antibiotics (Eradication therapy). The
aim is to get rid of the bacteria
and so reduce the likelihood of these ulcers returning.
• Stomach and duodenal ulcers
• Zollinger-Ellison-Syndrome and other conditions producing too much
acid in the stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS:
• If you are allergic to pantoprazole or to any of the other
ingredients in Pant

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant tablet contains:
40 mg Pantoprazole (as pantoprazole sodium sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
A yellow, oval, biconvex gastro-resistant tablet; plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
-
Reflux oesophagitis.
_Adults_
-
Eradication of_ Helicobacter pylori_ (_H. pylori_) in combination with
appropriate antibiotics therapy in patients
with_ H. pylori_ associated ulcers.
-
Gastric and duodenal ulcer.
-
Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above:_
Reflux oesophagitis
One pantoprazole 40 mg gastro-resistant tablet per day. In individual
cases the dose may be doubled (increase to two
tablets daily) especially when there has been no response to other
treatment. A four week period is usually required for
the treatment of reflux oesophagitis. If this is not sufficient,
healing will usually be achieved within a further four
weeks.
_Adults:_
Eradication of_ H. pylori_ in combination with two appropriate
antibiotic
In_ H. pylori_ positive patients with gastric and duodenal ulcers,
eradication of the germ by a combination therapy should
be achieved. Considerations should be given to official local guidance
(e.g. national recommendations) regarding
bacterial resistance and the appropriate use and prescription of
antibacterial agents. Depending upon the resistance
patter, the following combinations can be recommended for the
eradication of_ H. pylori_:
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