Pantoprazole Bluefish 20 mg gastro-resistant tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Pantoprazole sodium sesquihydrate

Disponible desde:

Bluefish Pharmaceuticals AB

Código ATC:

A02BC; A02BC02

Designación común internacional (DCI):

Pantoprazole sodium sesquihydrate

Dosis:

20 milligram(s)

formulario farmacéutico:

Gastro-resistant tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Proton pump inhibitors; pantoprazole

Estado de Autorización:

Marketed

Fecha de autorización:

2010-12-03

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE BLUEFISH 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 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet, See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Pantoprazole Bluefish is and what it is used for
2.
What you need to know before you take Pantoprazole Bluefish
3.
How to take Pantoprazole Bluefish
4.
Possible side effects
5.
How to store Pantoprazole Bluefish
6.
Contents of the pack and other information
1. WHAT PANTOPRAZOLE BLUEFISH IS AND WHAT IT IS USED FOR
Pantoprazole Bluefish contains the active substance pantoprazole.
Pantoprazole Bluefish 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 Bluefish is used to treat adults and adolescents 12 years
of age and above for
•
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.
Pantoprazole Bluefish is used to treat adults for
•
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 BLUEFISH
DO NOT TAKE PANTOPRAZOLE

Ficha técnica

Health Products Regulatory Authority
21 December 2022
CRN00D7N9
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole Bluefish 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as
pantoprazole sodium sesquihydrate 22.55 mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, oval, biconvex and smooth tablets
The tablet dimensions are the following:
- Width: 5.85 mm ± 0.29 mm (5.56 mm – 6.14 mm)
- Length: 8.35 mm ± 0.42 mm (7.93 mm – 8.77 mm)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pantoprazole Bluefish is indicated for use in adults and adolescents
12 years of age and above for:

Symptomatic gastro-oesophageal reflux disease.

For Long-term management and prevention of relapse in reflux
oesophagitis.
Pantoprazole Bluefish is indicated for use in adults for:

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 Pantoprazole Bluefish 20 mg 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, taking
one tablet 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 Pantoprazole
Bluefish 20 mg tablet per day is recommended,
increasing to 40 mg pantoprazole per