Pantoflux 20mg 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:

20 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 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, 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:
_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 caused 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 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharma

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 20mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of pantoprazole (as 22.58
mg pantoprazole sodium sesquihydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Elliptical, biconvex, light yellow gastro-resistant tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
Symptomatic gastro-oesophageal reflux disease.
For long-term management and prevention of relapse in reflux
oesophagitis.
_Adults_
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs
(NSAIDs) in patients at risk with a need for continuous NSAID
treatment (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above_
Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one Pantoflux 20 mg gastro-resistant
tablet per day. Symptom relief is generally accomplished
within 2-4 weeks. If this is not sufficient, symptom relief will
normally be achieved within a further 4 weeks. When symptom
relief has been achieved, reoccurring symptoms can be controlled using
an on-demand regimen of 20 mg once daily, when
required. A switch to continuous therapy may be considered in case
satisfactory symptom control cannot be maintained with
on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of one Pantoflux 20 mg
gastro-resistant tablet per day is recommended,
increasing to 40 mg pantoprazole per day if a relapse occurs.
Pantoflux 40 mg is available for this case. After healing of the
relapse the dose can be reduced again to 20 mg pantoprazole.
_Adults_
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory dr