PantoMylan Tablets Gastro-Resistant 40mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PANTOPRAZOLE

Tilgjengelig fra:

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

ATC-kode:

A02BC02

INN (International Name):

PANTOPRAZOLE 40 mg

Legemiddelform:

GASTRO-RESISTANT TABLET

Sammensetning:

PANTOPRAZOLE 40 mg

Resept typen:

POM

Terapeutisk område:

DRUGS FOR ACID RELATED DISORDERS

Autorisasjon status:

Authorised

Autorisasjon dato:

2011-03-11

Informasjon til brukeren

Page 1 of 8
P
ACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOMYLAN 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 PantoMylan is and what it is used for
2.
Before you take PantoMylan
3.
How to take PantoMylan
4.
Possible side effects
5.
How to store PantoMylan
6.
Contents of the pack and other information.
1.
WHAT PANTOMYLAN 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 PANTOMYLAN
DO NOT TAKE PANTOMYLAN:
-
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.
P

Preparatomtale

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 14
1.
NAME OF THE MEDICINAL PRODUCT
PantoMylan 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
(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 clarithromycin
Page