Pantoprazole 40mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Dowelhurst Ltd

ATC code:

A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

40mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500

Patient Information leaflet

PATIENT INFORMATION LEAFLET
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 ALLERGIC (HYPERSENSITIVE) to PANTOPRAZOLE, or to any of

Summary of Product characteristics

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