PROTIUM 40 Milligram Tablets Gastro-Resistant

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Tilgjengelig fra:

PCO Manufacturing

ATC-kode:

A02BC03

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosering :

40 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:

2001-07-27

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTIUM
® 40MG
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 or to any of the other ingredients
of
this medicine (listed in section 6).
�

Preparatomtale

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 40mg pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from Spain, United Kingdom, Italy, Germany and
Hungary_
Yellow, oval, biconvex film-coated tablet imprinted with “P 40” in
brown ink on one side.
4 CLINICAL PARTICULARS
As per PA1547/009/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1547/009/003
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)
Black iron oxide (E172)
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_6_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_7_
_6_
_0_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
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 SPECIA