PROTIUM 40 Milligram Tablets Gastro-Resistant

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dostupné z:

IMED Healthcare Ltd.

ATC kód:

A02BC02

INN (Medzinárodný Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dávkovanie:

40 Milligram

Forma lieku:

Tablets Gastro-Resistant

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Proton pump inhibitors

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2008-11-03

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER 
PROTIUM® 40 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 


Reflux oesophagitis. An inflammation of your oesophagus (the
tube which connects your throat to your 
stomach) accompanied by the regurgitation of stomach acid. 

Protium is used to treat adults for 


An infection with a bacterium called _Helicobacter pylori _in
patients with duodenal ulcers and stomach 
ulcers in combination with two antibiotics (eradication
therapy). The aim is to get rid of the bacteria and 
so reduce the likelihood of these ulcers returning. 


Stomach and duodenal ulcers. 


Zollinger-Ellison-Syndrome and other conditions producing too much
acid in the stom

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Protium 40 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 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 the Poland:_
Yellow, oval biconvex coated tablets marked ‘P40’ in brown ink on one side.
4 CLINICAL PARTICULARS
As per PA1421/001/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1421/001/003
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
28 gastro-resistant tablets
Blister (ALU/ALU blister) without cardboard reinforcement.
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 AU