Pantoprazole 20mg gastro-resistant tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Pantoprazole sodium sesquihydrate

Dostupné s:

Waymade Healthcare Plc

ATC kód:

A02BC02

INN (Mezinárodní Name):

Pantoprazole sodium sesquihydrate

Dávkování:

20mg

Léková forma:

Gastro-resistant tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 01030500

Informace pro uživatele

PAGE 1 OF 13
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 medi

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pantoprazole 20mg gastro-resistant tablets
2
.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as
pantoprazole sodium
sesquihydrate).
Excipient with known effect:
-
sorbitol: 18 mg/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet
A light brownish yellow, oval, slightly biconvex 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
_ _
_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.
_Adults_
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory
drugs (NSAIDs)