PANTOPRAZOLE 20 Milligram Tablets Gastro-Resistant

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Commercializzato da:

PCO Manufacturing

Codice ATC:

A02BC02

INN (Nome Internazionale):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosaggio:

20 Milligram

Forma farmaceutica:

Tablets Gastro-Resistant

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Proton pump inhibitors

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2014-11-24

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER 

PANTOPRAZOLE 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 Pantoprazole is and what it is used for  
2. What you need to know before you take Pantoprazole 
3. How to take Pantoprazole  
4. Possible side effects  
5. How to store Pantoprazole  
6. Contents of the pack and other information  

1. WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR  

Pantoprazole 
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 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. 

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
_Product imported from United Kingdom:_
Yellow, oval biconvex film-coated tablet imprinted with ‘P20’ in brown ink 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)
Black iron oxide (E172)
Yellow iron oxide (E172)
Ammonia solution, concentrated
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 04/03/2016_
_CRN 2174044_
_page number: 1_
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on
the market 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 packs of 28 tablets in a cardboard carton.
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
PCO Man