Protium 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Takeda Products Ireland Ltd

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:

1999-01-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROTIUM
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 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 who need to take NSAIDs
continuously.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROTIUM
DO NOT TAKE PROTIUM
-
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

Summary of Product characteristics

Health Products Regulatory Authority
06 June 2023
CRN00D38Q
Page 1 of 10
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_
Pr