PROTIUM 20 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

IMED Healthcare Ltd.

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:

2008-11-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
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 TA

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).
Excipient
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant coated tablet.
_Product imported from Poland:_
Yellow, oval biconvex coated tablets marked ‘P20’ on one side.
4 CLINICAL PARTICULARS
As per PA1421/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1421/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core:_
Sodium carbonate, anhydrous
Mannitol (E421)
Crospovidone
Povidone K90
Calcium stearate
_Coating:_
Hypromellose
Povidone K25
Titanium dioxide (E171)
Yellow iron oxide (E172)
Propylene glycol
Methacrylic acid-ethyl acrylate copolymer (1:1)
Polysorbate 80
Sodium laurilsulfate
Triethyl citrate
_Printing ink:_
Shellac
Red iron oxide (E172)
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/06/2016_
_CRN 2177384_
_page number: 1_
Black iron oxide (E172)
Yellow iron oxide (E172)
Ammonia solution, concentrated
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister (ALU/ALU blister) without cardboard reinforcement.
28 gastro-resistant tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
I