Pantoprazole 40mg gastro-resistant tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Pantoprazole sodium sesquihydrate

Verfügbar ab:

Arrow Generics Ltd

ATC-Code:

A02BC02

INN (Internationale Bezeichnung):

Pantoprazole sodium sesquihydrate

Dosierung:

40mg

Darreichungsform:

Gastro-resistant tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 01030500; GTIN: 5060034834076

Gebrauchsinformation

_E_
_NOGEN _
_HEALTHCARE _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE 40 MG GASTRO-RESISTANT TABLETS
pantoprazole (as sodium sesquihydrate)
The name
of
this medicine is Pantoprazole 40 mg Gastro-Resistant
Tablets, which will be referred to as Pantoprazole Tablets
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet.
You
may need
to
read it again.
•
If
you have further questions, ask your doctor
or
your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it
on
to
others; it may harm them, even
if
their symptoms are the same
as
yours.
•
If
any
of
the side effects gets serious, or
if
you notice any side
effects not listed in this leaflet, please tell your doctor
or
pharmacist.
IN THIS LEAFLET:
1. What Pantoprazole Tablets are and what they are used for
2.
Before you take Pantoprazole Tablets
3.
How to take Pantoprazole Tablets
4.
Possible side effects
5.
How to store Pantoprazole Tablets
6.
Further information
1.
WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY
ARE 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. BEFORE YOU TAKE PANTOPRAZOLE TABLETS
DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU:
•
ARE

Fachinformation

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 of pantoprazole (as 45.16
mg
pantoprazole sodium sesquihydrate).
For a 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
_Pantoprazole is indicated for use in adults and adolescents 12 years
of age and _
_above for: _
-Reflux oesophagitis.
_Pantoprazole is indicated in adult 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 Pantoprazole 40 mg gastro-resistant tablet per day. In individual
cases the
dose may be doubled (increase to 2 Pantoprazole 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 prescription of
antibacterial
agents. Depending upon the resistance pattern, the following
combinations can
be recommended for the eradication of _H. pylori_:
a)
Pantoprazole 40 mg gastro-resistant tablet twice daily one
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromy