Pantoprazole 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Wockhardt UK Limited

ATC code:

A02BC; A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; pantoprazole

Authorization status:

Not marketed

Authorization date:

2010-08-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE 20MG 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 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 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 TABLETS 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:
_Adults and adolescents 12 years of age and above:_
•
Treating symptoms (e.g. heartburn, acid regurgitation, pain on
swallowing) associated to
gastro- oesophageal reflux disease caused by reflux of acid from the
stomach.
•
Long-term management of reflux oesophagitis (inflammation of the
oesophagus
accompanied by regurgitation of stomach acid) and preventing its
return.
_Adults:_
•
Preventing duodenal and stomach ulcers caused by non-steroidal
anti-inflammatory drugs
(NSAIDs, for example ibuprofen) in patients at risk who need to take
NSAIDs continuously.
K N O W B E F O R E YOU TAKE PANTOPRAZOLE TABLETS
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant tablet contains:
20 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_
Symptomatic gastro-oesophageal reflux disease.
For long-term management and prevention of relapse in reflux
oesophagitis.
_Adults_
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs (NSAIDs) in
patients at risk with a need for continuous NSAID treatment (see
section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above:_
Symptomatic gastro-oesophageal reflux disease
The recommended oral dosage is one pantoprazole 20 mg gastro-resistant
tablet per day. Symptom relief is generally
accomplished within two to four weeks. If this is not sufficient,
symptom relief will normally be achieved within a
further four weeks. When symptom relief has been achieved, reoccurring
symptoms can be controlled using an on-
demand regimen of 20 mg once daily, when required. A switch to
continuous therapy may be considered in case
satisfactory symptom control cannot be maintained with on-demand
treatment.
Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of one pantoprazole 20 mg
gastro-resistant tablet per day is
recommended, increasing to 40 mg pantoprazole per day if a relapse
occurs. Pantoprazole 40 mg gastro-resistant tablets
are available for this case. After healing of the relapse the dosage
can be reduced again to 20 mg pantoprazole.
_Adults:_
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs (NSAIDs) in
H