Pantoprazole 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Torrent Pharma (UK) 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: 5060623370497

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE
20 MG GASTRO-RESISTANT TABLETS
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.
IN THIS LEAFLET:
1.
What Pantoprazole 20 mg Gastro-resistant Tablets are and what they are
used for
2.
What you need to know before you take Pantoprazole 20 mg
Gastro-resistant Tablets
3.
How to take Pantoprazole 20 mg Gastro-resistant Tablets
4.
Possible side effects
5.
How to store Pantoprazole 20 mg Gastro-resistant Tablets
6.
Contents of the pack and other information
1.
WHAT PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE
USED FOR
Pantoprazole 20 mg Gastro-resistant Tablets contains the active
substance pantoprazole. Pantoprazole 20 mg
Gastro-resistant Tablets 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 20 MG GASTRO-RESISTANT TABLETS IS USED TO TREAT:
_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.
_Pantoprazole is used to treat adults for: _
_ _
-
Preventing duodenal and stomach ulcers caused by non-steroidal
anti-inflammatory drugs (NSAIDs,
for example, ibuprofen) in patie

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