Pantoprazole Mylan Tablets Gastro-Resistant 40mg

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

PANTOPRAZOLE

Disponible depuis:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Code ATC:

A02BC02

DCI (Dénomination commune internationale):

PANTOPRAZOLE 40 mg

forme pharmaceutique:

GASTRO-RESISTANT TABLET

Composition:

PANTOPRAZOLE 40 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

DRUGS FOR ACID RELATED DISORDERS

Statut de autorisation:

Authorised

Date de l'autorisation:

2011-03-11

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PANTOPRAZOLE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Pantoprazole Mylan
3.
How to take Pantoprazole Mylan
4.
Possible side effects
5.
How to store Pantoprazole Mylan
6.
Contents of the pack and other information.
1.
WHAT PANTOPRAZOLE MYLAN IS AND WHAT IT IS USED FOR
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 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 PANTOPRAZOLE MYLAN
DO NOT TAKE PANTOPRAZOLE MYLAN:
-
if you are allergic to pantoprazole or any of the other ingredients of
this medicine (listed in
section

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole Mylan 40 mg Gastro-resistant Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet
_ _
contains 45.100 mg of pantoprazole sodium sesquihydrate, equivalent to
40 mg of pantoprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Banana yellow film coated, oval, approximately 5.7 mm x 11.6 mm,
biconvex tablet that is blank on
both sides.
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
_Recommended dose _
_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
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(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_
:
a)
twice daily one tablet pantoprazole
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg c