Nolpaza 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole

Available from:

KRKA, d.d., Novo mesto

ATC code:

A02BC; A02BC02

INN (International Name):

Pantoprazole

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:

2009-03-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOLPAZA 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
What
IS IN THIS LEAFLET
1.
What Nolpaza is and what it is used for
2.
What you need to know before you take Nolpaza
3.
How to take Nolpaza
4.
Possible side effects
5.
How to store Nolpaza
6.
Contents of the pack and other information
1.
WHAT NOLPAZA IS AND WHAT IT IS USED FOR
Nolpaza 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.
NOLPAZA IS USED FOR:
_Adults and adolescents 12 years of age and above: _
-
Treating symptoms (e.g. heartburn, acid regurgitation, pain on
swallowing) associated to gastro-
oesophageal reflux disease caused by reflux of acid from the stomach.
-
Long-term management of reflux oesophagitis (inflammation of the
oesophagus accompanied
by the regurgitation of stomach acid) and preventing its return.
_Adults: _
-
Preventing duodenal and stomach ulcers caused by non-steroidal
anti-inflammatory drugs
(NSAIDs, for example, ibuprofen) in patients at risk who need to take
NSAIDs continuously.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOLPAZA
DO NOT TAKE NOLPAZA
-
if you are allergic to pantoprazole, sorbitol 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 or nurse before taking

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2024
CRN00F2N0
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nolpaza 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as
pantoprazole sodium sesquihydrate).
Excipient with known effect:
- sorbitol: 18 mg/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
A light brownish yellow, oval, slightly biconvex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
Symptomatic gastro-oesophageal reflux disease.
For long-term management and prevention of relapse in reflux
oesophagitis.
_Adults _
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 gastro-resistant tablet Nolpaza 20 mg
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, 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 gastro-resistant
tablet Nolpaza 20 mg per day is recommended,
increasing to 40 mg pantoprazole per day if a relapse occurs. Nolpaza
40 mg is available for this case. After healing of the
relapse the dose can be reduced again to 20 mg pantoprazole.
_ADULTS_
Prevention of gastroduodenal ulcers induced by non-selective