Panrazol 40mg 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 40 mg

Pharmaceutical form:

GASTRO-RESISTANT TABLET

Composition:

PANTOPRAZOLE 40 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Withdrawn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 40 MG 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, 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 AND WHAT IT 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 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 PANRAZOL
DO NOT TAKE PANRAZOL
-
If you are allergic to pantoprazole or to any of the other ingredients
of this medicine (listed in
section 6).
-
If you are allergic to medicines containing other proton pump
inhibito

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Panrazol 40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg of pantoprazole (as 45.16
mg pantoprazole sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Elliptical, biconvex, dark yellow gastro-resistant tablet.
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 antibiotic
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 Panrazol 40 mg gastro-resistant tablet per day. In individual
cases the dose may be doubled
(increase to 2 Panrazol 40 mg tablets daily) especially when there has
been no response to other
treatment. A 4-week period is usually required for the treatment of
reflux oesophagitis. If this is not
sufficient, healing will usually be achieved within a further 4 weeks.
_Adults _
Eradication of _H. pylori _in combination with two appropriate
antibiotics
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
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prescription of antibacterial agents. Depending upon the resistance
pattern, the following
combinations can be recommended for the eradication of _H. pylori_:
a)
Panrazol 40 mg gastro-resistant tablet twice daily one
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin
b)
Panrazol 40 mg gastro-resist