Pantoprazole Teva Pharma 20 mg gastro-resistant tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Pantoprazole sodium sesquihydrate

Tillgänglig från:

Teva Pharma B.V.

ATC-kod:

A02BC; A02BC02

INN (International namn):

Pantoprazole sodium sesquihydrate

Dos:

20 milligram(s)

Läkemedelsform:

Gastro-resistant tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Proton pump inhibitors; pantoprazole

Bemyndigande status:

Marketed

Tillstånd datum:

2010-12-17

Bipacksedel

Pantoprazole, IE/H/0211/001, 16.06.21
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE TEVA PHARMA 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 Pantoprazole Teva Pharma is and what it is used for
2.
What you need to know before you take Pantoprazole Teva Pharma
3.
How to take Pantoprazole Teva Pharma
4.
Possible side effects
5.
How to store Pantoprazole Teva Pharma
6.
Contents of the pack and other information
1.
WHAT PANTOPRAZOLE TEVA PHARMA IS AND WHAT IT IS USED FOR
Pantoprazole Teva Pharma contains the active substance pantoprazole.
Pantoprazole Teva Pharma 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.
Pantoprazole Teva Pharma is used to treat adults and adolescents 12
years of age and above for
•
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.
Pantoprazole Teva Pharma is used to treat adults for
•
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

Produktens egenskaper

Health Products Regulatory Authority
08 May 2023
CRN00D9RK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole Teva Pharma 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, oval, biconvex, smooth film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Pantoprazole Teva Pharma 20 mg is indicated for use in adults and
adolescents 12 years of age and above for:_
● Symptomatic gastro-oesophageal reflux disease
● Long-term management and prevention of relapse in reflux
oesophagitis.
_Pantoprazole Teva Pharma 20 mg is indicated for use in adults for:_
● 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 Pantoprazole Teva Pharma 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 Pantoprazole
Teva Pharma 20 mg tablet per day is recommended,
increasing to 40 mg pantoprazole per day if a relapse occurs.
Pantoprazole Teva Pharma 40 mg is available for this case. After
healing of the relapse the dose can