Pantoprazole 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5025903008217

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOLE 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 Pantoprazole is and what it is used for
2.
What you need to know before you take Pantoprazole
3.
How to take Pantoprazole
4.
Possible side effects
5.
How to store Pantoprazole
6.
Contents of the pack and other information.
1.
WHAT PANTOPRAZOLE 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.
PANTOPRAZOLE 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 cause 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
DO NOT TAKE PANTOPRAZOLE
-
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 proton pump
inhibitors.
-
if you are taking medicines for the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pantoprazole 20 mg gastro-resistant tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet_ _contains 20 mg of pantoprazole (as
sodium sesquihydrate).
Excipient with known effect:
Each gastro-resistant tablet contains 19.06 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow to ochre elongated coated_ _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
_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, 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 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 gastroduodenal ulcers induced by non