Pantoprazole 40mg Gastro-Resistant Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PANTOPRAZOLE SODIUM, SESQUIHYDRATE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE 40 mg

Pharmaceutical form:

GASTRO-RESISTANT TABLET

Composition:

PANTOPRAZOLE SODIUM SESQUIHYDRATE 40 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2014-07-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE 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 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 is and what it is used for
2.
What you need to know before you take Pantoprazole
3.
How to take Pantoprazole
4.
Possible side effects
5.
How to store Pantoprazole
6.
Contents of the pack and other information
1.
WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR
Pantoprazole contains the active substance pantoprazole. Pantoprazole
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.
_Pantoprazole is used to treat Adults and adolescents 12 years of age
and above for: _
-
Reflux oesophagitis .An inflammation of your oesophagus (the tube
which connects your
throat to your stomach) accompanied by the regurgitation of stomach
acid.
_Pantoprazole is used to treat Adults for: _
-
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
DO NOT TAKE PANTOPRAZOLE
-
If you are allergic to pantoprazole or to any of the other ingredien

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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.
Yellow colored, enteric coated oval biconvex tablets plain on both the
sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pantoprazole is indicated for use in Adults and adolescents 12 years
of age and above for
_ _
•
Reflux oesophagitis.
Pantoprazole is indicated for use in Adults for
_ _
•
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 tablet of Pantoprazole per day. In individual cases the dose may
be doubled (increase to 2 tablets
Pantoprazole 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
prescription of antibacterial agents. Depending upon the resistance
pattern, the following
combinations can be recommended for the eradication of H. pylori:
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a)
twice daily one tablet Pantoprazole
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromyc