Pantoprazole 20mg gastro-resistant Tablets

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

PANTOPRAZOLE

Prieinama:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC kodas:

A02BC02

INN (Tarptautinis Pavadinimas):

PANTOPRAZOLE 20 mg

Vaisto forma:

GASTRO-RESISTANT TABLET

Sudėtis:

PANTOPRAZOLE 20 mg

Recepto tipas:

POM

Gydymo sritis:

DRUGS FOR ACID RELATED DISORDERS

Autorizacija statusas:

Withdrawn

Leidimo data:

2010-05-18

Pakuotės lapelis

Page 1 of 6
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 ing

Prekės savybės

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERSITICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole 20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
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.
Page 2 of 12
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-steroid