PROTIUM 40 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

Clear Pharmacy

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosage:

40 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:

2011-02-11

Patient Information leaflet

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 stomach.
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 sec

Summary of Product characteristics

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 pantoprazole (as sodium
sesquihydrate).
Excipients: Soya oil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
_Product imported from Hungary:_
Yellow, oval, biconvex film-coated tablets imprinted with "P 40" in
brown ink on one side.
4 CLINICAL PARTICULARS
As per PA1547/009/003
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 PA1547/009/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Anhydrous Sodium Carbonate
Mannitol
Crospovidone
Povidone K90
Calcium Stearate
Hypromellose 2910
Povidone K25
Titanium Dioxide (E171)
Yellow Iron Oxide (E172)
Propylene Glycol
Poly(Ethylacrylcate, Methacrylic Acid)
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Polysorbate 80
Sodium Lauril Sulfate
Triethyl Citrate
Shellac
Red Iron Oxide (E172)
Black Iron Oxide (E172)
Soya Lecithin
Polydimethylsiloxa