Pantium 40mg Gastro-Resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Clonmel Healthcare 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:

2008-10-03

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTIUM 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 Pantium is and what it is used for
2. What you need to know before you take Pantium
3. How to take Pantium
4. Possible side effects
5. How to store Pantium
6. Contents of the pack and other information
1. WHAT PANTIUM IS AND WHAT IT IS USED FOR
Pantium is a medicine that reduces the production of stomach acid
(selective proton pump inhibitor).
Pantium is used
•
in combination with antibiotics for the treatment of duodenal ulcers
and gastric ulcers. This treatment
involves eradicating Helicobacter pylori, a disease-causing
microorganism (pathogen) responsible
for causing ulcers of the stomach and intestines.
•
for the treatment of duodenal ulcers
•
for the treatment of gastric ulcers
•
for the treatment of moderate and severe forms of reflux oesophagitis
(inflammation of the gullet)
•
for the long-term treatment of conditions whereby too much stomach
acid is produced (e.g. Zollinger-
Ellison syndrome)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTIUM
DO NOT TAKE PANTIUM
•
If you are allergic to pantoprazole, peanut or soya or any of the
other ingredients of this medicine
(listed in section 6.).
•
If you are allergic to medicines containing other proton pump
inhibitors.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pantium. Especially:
•
If you have severe liver problems. Please tell your do

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2023
CRN00DFH6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantium 40mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains:
40 mg of pantoprazole (equivalent to 45.1 mg pantoprazole sodium
sesquihydrate)
Excipients with known effect
Each gastro-resistant tablet contains 76.85 mg maltitol, 0.690 mg
lecithin (derived from soya oil).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Yellow, oval tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Combination therapy with two suitable antibiotics for the eradication
of _Helicobacter pylori_ and for the prevention
of relapse of peptic ulcers in patients with _Helicobacter pylori_
associated ulcers.

duodenal ulcers.

gastric ulcers.

moderate and severe forms of reflux oesophagitis.

long-term treatment of Zollinger-Ellison syndrome and other disorders
accompanied by pathological gastric acid
hypersecretion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above_
Reflux oesophagitis
One tablet of Pantium 40 mg per day.
In individual cases the dose may be doubled (increase to 2 tablets
pantoprazole 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 era