PantoMylan 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
PANTOMYLAN 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 PantoMylan is and what it is used for
2.
What you need to know before you take PantoMylan
3.
How to take PantoMylan
4.
Possible side effects
5.
How to store PantoMylan
6.
Contents of the pack and other information.
1. WHAT PANTOMYLAN 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 PANTOMYLAN
DO NOT TAKE PANTOMYLAN:
-
If you are allergic (hypersensitive) to pantoprazole or any of the
other ingredients of
Pantoprazole (see section 6).
-
If you are allergic to medicines containing other proton pump
inhibitors.
WARNINGS AND PRECAUTIONS
Pa

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
PantoMylan 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
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.
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_Adults _
Prevention of gast