Pantium 20 mg 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:

20 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 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 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
•
for the treatment of mild reflux disease (disorder of the gullet
because of backwash of acid from the
stomach) and associated symptoms (e.g. heartburn, acid regurgitation,
pain on swallowing)
•
for the long-term treatment and prevention of recurrent reflux
oesophagitis (inflammation of the
gullet)
•
for the prevention of gastric and duodenal ulcers in patients
receiving constant medication for pain
(non-selective non-steroidal anti-inflammatory drugs [NSAIDs]).
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, pharmacist or nurse before taking Pantium.
Especially:
•
If you have severe liver problems. Please tell your doctor if you have
ever had problems with your
liver in the past. Your doctor will

Summary of Product characteristics

Health Products Regulatory Authority
26 April 2023
CRN00DFHT
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantium 20 mg Gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains:
20 mg of pantoprazole (equivalent to 22.6 mg pantoprazole
sodiumsesquihydrate)
Excipients with known effect
Each gastro-resistant tablet contains 38.425 mg maltitol, 0.345 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

For the treatment of mildreflux disease and associated symptoms (e.g.
heartburn, acid regurgitation, pain on
swallowing).

For long-term treatment management and prevention of relapse in reflux
oesophagitis.

Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory drugs (NSAIDs) in
patients at risk with a need for continuous NSAID treatment (see
section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above_
_ _
Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one Pantium 20 mg tablet per day. Symptom
relief is generally accomplished within 2-4 weeks.
If this is not sufficient, symptom relief will normally be achieved
within a further 4 weeks.
When symptom relief has been achieved, reoccurring symptoms can be
controlled using an on-demand regimen of 20 mg
once daily, taking one tablet when required. A switch to continuous
therapy may be considered in case satisfactory symptom
control cannot be maintained with on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of one Pantium 20 mg
tablet per day is recommended, increasing to 40 mg
pantoprazole per day if a relapse occurs. Pantium 40 mg is available
for this case. After healing of the relapse the dose can be
reduced again to 20 mg p