Pantoprazole Mylan Tablets Gastro-Resistant 20mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PANTOPRAZOLE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE 20 mg

Pharmaceutical form:

GASTRO-RESISTANT TABLET

Composition:

PANTOPRAZOLE 20 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2011-03-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE MYLAN 20MG 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
Pantoprazole
Mylan is and what it is used for
2.
What you need to know before you take
Pantoprazole
Mylan
3.
How to take Pantoprazole Mylan
4.
Possible side effects
5.
How to store
Pantoprazole
Mylan
6.
Contents of the pack and other information.
1. WHAT
PANTOPRAZOLE MYLAN IS AND WHAT IT IS USED FOR
Pantoprazole 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.
IT CAN BE USED FOR:
_Adults and adolescents 12 years of age and above: _
-
Treating symptoms (e.g. heartburn, acid regurgitation, pain on
swallowing) associated to
gastrooesophageal 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
PANTOPRAZOLE MYLAN
DO NOT TAKE
PANTOPRAZOLE MYLAN
-
if you are allergic to pantoprazole or any of the other ingredients of
this medicine (listed in
section 6).
_ _
-
if you are allergic to medicines containing other pr

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole Mylan 20 mg Gastro-resistant Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet
_ _
contains 22.550 mg of pantoprazole sodium sesquihydrate, equivalent to
20 mg of pantoprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Dark yellow film coated, oval, approximately 4.3 mm x 8.4 mm, biconvex
tablet
that is blank on both
sides.
.
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
_Recommended dose _
_ _
_Adults and adolescents 12 years of age and above _
_ _
Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one gastro-resistant tablet Pantoprazole
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
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For long-term management, a maintenance dose of one gastro-resistant
tablet Pantoprazole 20 mg
per day is recommended, increasing to 40 mg pantoprazole per day if a
relapse occurs. Pantoprazole
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 gastrod