Pantoflux 40 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Actavis Group PTC ehf

ATC code:

A02BC; A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

40 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; pantoprazole

Authorization status:

Marketed

Authorization date:

2008-06-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOFLUX 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pantoflux is and what it is used for
2.
What you need to know before you take Pantoflux
3.
How to take Pantoflux
4.
Possible side effects
5.
How to store Pantoflux
6.
Contents of the pack and other information
1.
WHAT PANTOFLUX IS AND WHAT IT IS USED FOR
Pantoflux 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.
PANTOFLUX 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 PANTOFLUX
DO NOT TAKE PANTOFLUX
-
If you are allergic to pantoprazole or to any of the other ingredients
of this medicine (listed in
section 6).
-
If you are allergic to medicines containing other proton pump
inhibitors.

Summary of Product characteristics

Health Products Regulatory Authority
11 September 2019
CRN0099GT
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoflux 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 the 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
_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
_Adults and adolescents 12 years of age and above _
Reflux oesophagitis
One Pantoflux 40 mg gastro-resistant tablet per day. In individual
cases the dose may be doubled (increase to 2 Pantoflux 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) Pantoflux 40 mg gastro-resistant tablet twice daily one
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin
b) Pantoflux 4