Panrazol 20mg gastro-resistant Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PANTOPRAZOLE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE 20 mg

Pharmaceutical form:

GASTRO-RESISTANT TABLET

Composition:

PANTOPRAZOLE 20 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2008-10-06

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANRAZOL 20 MG GASTRO-RESISTANT TABLETS
Pantoprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
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.
WHAT IS IN THIS LEAFLET:
1.
What Panrazol is and what it is used for
2.
What you need to know before you take Panrazol
3.
How to take Panrazol
4.
Possible side effects
5.
How to store Panrazol
6.
Contents of the pack and other information
1.
WHAT PANRAZOL IS WHAT IS USED FOR
Panrazol is a selective “proton pump inhibitor”, a medicine which
reduces the amount of acid
produced in your stomach. It is used for treating acid-related
diseases of the stomach and intestine.
PANRAZOL IS 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 the 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANRAZOL
DO NOT TAKE PANRAZOL
-
If you are allergic to pantoprazole or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are allergic to medicines containing other proton pump
inhibitors.
Page 2 of 7
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Panrazol 20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of pantoprazole (as 22.58
mg pantoprazole sodium
sesquihydrate).
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Elliptical, biconvex, light yellow gastro-resistant tablet.
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 dose is one Panrazol 20 mg gastro-resistant
tablet per day. Symptom relief is
generally accomplished within 2-4 weeks. If this is not sufficient,
symptom relief will normally be
achieved within a further 4 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.
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Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of one Panrazol 20 mg
gastro-resistant tablet per
day is recommended, increasing to 40 mg pantoprazole per day if a
relapse occurs. Panrazol 40 mg
is available for this case. After healing of the relapse the dose can
be reduced again to 20 mg
pantoprazole.
_ _
_Adults _
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs
(NSAIDs) i