Protium 40 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Takeda Products Ireland Ltd

ATC code:

A02BC; A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

40 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; pantoprazole

Authorization status:

Marketed

Authorization date:

1995-09-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 or to any of the other ingredients
of this medicine (listed in
section 6).
_ _
-
If you

Summary of Product characteristics

Health Products Regulatory Authority
06 June 2023
CRN00D38Q
Page 1 of 10
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 of pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro‑resistant tablet (tablet).
Yellow, oval, biconvex film-coated tablet imprinted with "P40" in
brown ink on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Protium is indicated for usein adults and adolescents 12 years of age
and above for:
- Reflux oesophagitis.
Protium is indicated in adults for:
- Eradication of _Helicobacter pylori_ (_H. pylori_) in combination
with appropriate antibiotic therapy in patients with _H. pylori_
associated ulcers.
- Gastric and duodenal ulcer.
- Zollinger-Ellison Syndrome and other pathological hypersecretory
conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above_
_ _
_Reflux oesophagitis_
One tablet of Protium per day. In individual cases the dose may be
doubled (increase to 2 tablets Protium daily) especially
when there has been no response to other treatment. A 4‑week period
is usually required for the treatment of reflux
oesophagitis. If this is not sufficient, healing will usually be
achieved within a further 4 weeks.
_Adults_
_Eradication of H. pylori in combination with two appropriate
antibiotics_
In _H. pylori_ positive patients with gastric and duodenal ulcers,
eradication of the germ by a combination therapy should be
achieved. Considerations should be given to official local guidance
(e.g., national recommendations) regarding bacterial
resistance and the appropriate use and prescription of antibacterial
agents. Depending upon the resistance pattern, the
following combinations can be recommended for the eradication of _H.
pylori_:
a) Twice daily one tablet Protium
+ twice daily 1000 mg amoxicillin
+ twice daily 500 m