Pantoprazole 40mg gastro-resistant tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Pantoprazole sodium sesquihydrate

Tilgjengelig fra:

Sigma Pharmaceuticals Plc

ATC-kode:

A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosering :

40mg

Legemiddelform:

Gastro-resistant tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 01030500

Informasjon til brukeren

PAGE 1 OF 13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE 20 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 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:
_Adults and adolescents 12 years of age and above:_
-
Treating symptoms (e.g. heartburn, acid regurgitation, pain on
swallowing) associated to
gastro-oesophageal reflux disease cause by reflux of acid from the
stomach.
-
Long-term management of reflux oesophagitis (inflammation of the
oesophagus accompanied
by the regurgitation of stomach acid) and preventing its return.
_Adults: _
_ _
-
Preventing duodenal and stomach ulcers caused by non-steroidal
anti-inflammatory drugs
(NSAIDs, for example ibuprofen) in patients at risk who need to take
NSAIDs continuously.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE
DO NOT TAKE PANTOPRAZOLE
-
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.
-
if you are taking medi

Preparatomtale

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