PROTIUM 20 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

Takeda UK Limited

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosage:

20 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors

Authorization status:

Authorised

Authorization date:

2016-09-30

Patient Information leaflet

Protium
®
20 mg gastro-resistant tablets
Pantoprazole
PACKAGE LEAFLET:
Information for the user
llllllII
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llllllII
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Product name
Protium 20 mg
Reason of
change
CR xxxxx (corporate design)
old MID: IRL F.6/0317/6083061
New MID (Item No)
IRL F.x/0317/6083061
Code
xxx
Printed colours
schwarz
Not printed
colours
Dimensions
148 x 420 mm
SOB/AW / A. Dohmen
READY FOR PRINT.
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 Protium is and what it is used for
2. What you need to know before you take
Protium
3. How to take Protium
4. Possible side effects
5. How to store Protium
6. Contents of the pack and other
information
1. WHAT PROTIUM IS AND WHAT IT IS USED FOR
Protium contains the active substance
pantoprazole. Protium 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.
Protium 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.
Protium 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Protium 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
Yellow, oval biconvex film-coated tablet imprinted with “P20” in
brown ink on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Protium is indicated for use in adults and adolescents 12 years of age
and above for:
Symptomatic gastro-oesophageal reflux disease.
Long-term management and prevention of relapse in reflux oesophagitis.
Protium 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 Protium 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 Protium 20 mg tablet per day is recommended,
increasing to
40 mg pantoprazole per day if a relapse occurs.
Protium 40 mg tablet
is available for this case.
After healing of the
relapse the dose can be reduced again to Protium 20 mg tablet.
_Adults_
Prevention of
gastroduodenal
ulcers induced by non-selective non-steroidal
anti-inflammatory drug