Nexium 20 mg gastro-resistant tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Esomeprazole

Disponible depuis:

IMED Healthcare Ltd.

Code ATC:

A02BC05

DCI (Dénomination commune internationale):

Esomeprazole

Dosage:

20 milligram(s)

forme pharmaceutique:

Gastro-resistant tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

esomeprazole

Statut de autorisation:

Authorised

Date de l'autorisation:

2008-04-11

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEXIUM 20 MG GASTRO-RESISTANT TABLETS
NEXIUM 40 MG GASTRO-RESISTANT TABLETS
esomeprazole
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 Nexium is and what it is used for
2. What you need to know before you take Nexium
3. How to take Nexium
4. Possible side effects
5. How to store Nexium
6. Contents of the pack and other information
1.
WHAT NEXIUM IS AND WHAT IT IS USED FOR
Nexium contains a medicine called esomeprazole. This belongs to a
group of medicines called ‘proton
pump inhibitors’. They work by reducing the amount of acid that your
stomach produces.
Nexium is used to treat the following conditions:
Adults
•
‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach escapes into the gullet
(the tube which connects your throat to your stomach) causing pain,
inflammation and heartburn.
•
Ulcers in the stomach or upper part of the gut (intestine) that are
infected with bacteria called
_‘Helicobacter pylori’_
. If you have this condition, your doctor may also prescribe
antibiotics to treat the
infection and allow the ulcer to heal.
•
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Nexium can also be used to stop stomach ulcers from forming if you are
taking NSAIDs.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison syndrome).
•
Prolonged treatment after prevention of rebleeding of ulcers with
intravenous Nexium.
Adolescents a

Résumé des caractéristiques du produit

Health Products Regulatory Authority
22 December 2021
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Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nexium 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium
trihydrate)
Excipient(s) with known effect:
Each gastro resistant tablet contains sucrose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from France, and Greece:_
Light pink, oblong, biconvex , film-coated tablet engraved ‘20 mg’
on one side and ‘A/EH’ on the other.
4 CLINICAL PARTICULARS
As per PA2242/013/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2242/013/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol monostearate 40-55
Hyprolose
Hypromellose
Iron oxide (reddish-brown, yellow) (E172)
Magnesium stearate
Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent
Microcrystalline cellulose
Synthetic paraffin
Macrogol
Polysorbate 80
Crospovidone
Sodium stearyl fumarate
Sugar spheres (sucrose and maize starch)
Talc
Titanium dioxide (E171)
Triethyl citrate.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
22 December 2021
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Page 2 of 2
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
France and Greece: Aluminium blisters with cardboard reinforcement
(blister wallet) in an over-labelled cardboard carton
containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
_Administration through gastric tube_
1. Put the tablet into an appropriate syringe and fill the syringe
with approximately 25 mL water and approximately 5 mL air.
For some tubes, dispersion in 50 mL water is needed to prevent the
pellets f