PROTIUM 20 Milligram Tablets Gastro-Resistant

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Tilgjengelig fra:

Clear Pharmacy

ATC-kode:

A02BC02

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosering :

20 Milligram

Legemiddelform:

Tablets Gastro-Resistant

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Proton pump inhibitors

Autorisasjon status:

Authorised

Autorisasjon dato:

2011-02-11

Informasjon til brukeren

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 TAKE PROTIUM
DO NOT TAKE PROTIUM

If you are allergic to pantoprazole, soya oil or to any of the other
ingredients
of this medicine (listed in section 6).

If you are allergic to medicines containing

Preparatomtale

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).
Excipients: Soya lecithin
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
_Product imported from Hungary:_
A yellow, oval biconvex film-coated tablet imprinted with “P20” in
brown ink on one side.
4 CLINICAL PARTICULARS
As per PA1547/009/002
4.3 CONTRAINDICATIONS
Protium tablets contain soya lecithin. If you are allergic to peanut
or soya, do not use this medicinal product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Soya oil_
This medicinal product contains soya oil. If the patient is allergic
to peanut or soya, do not use this medicinal product
(see section 4.3).
5 PHARMACOLOGICAL PROPERTIES
As per PA1547/009/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Anhydrous sodium carbonate
Mannitol
Crospovidone
Povidone k90
Calcium stearate
Hypromellose 2910
Povidone k25
Propylene glycol
Methacrylic acid-ethylacrylate-copolymer
Polysorbate 80
Sodium lauril sulfate
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Triethyl citrate
Titanium dioxide (E171)
Yellow iron oxide (E172)
Shellac
Red iron oxide (E172)
Black iron oxide (E172)
Soya lecithin
Polydi