PROTIUM 20 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

PCO Manufacturing

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:

2001-07-27

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTIUM
® 20MG
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 prot

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 tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
_Product imported from Spain, United Kingdom, Italy and Hungary._
Yellow, oval biconvex film-coated tablet imprinted with ‘P20’ in
brown ink on one side.
4 CLINICAL PARTICULARS
As per PA1547/009/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1547/009/002
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)
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Yellow iron oxide (E172)
Titanium dioxide (E171)
Antifoam DC 1510 (dimeticone emulsion)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is 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