Nexium 40 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Esomeprazole

Available from:

Lexon (UK) Ltd

ATC code:

A02BC; A02BC05

INN (International Name):

Esomeprazole

Dosage:

40 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; esomeprazole

Authorization date:

2018-08-24

Patient Information leaflet

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 aged 12 years and above
•
‘Gastroesophageal reflux disease’ (GERD). This
is where acid from the stomach escapes into
the gullet (the

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2020
CRN009SZF
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nexium 40 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 44.5 mg esomeprazole magnesium
trihydrate equivalent to 40 mg esomeprazole.
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 Croatia_
A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one
side
and on the other side.
4 CLINICAL PARTICULARS
As per PA2242/013/003
5 PHARMACOLOGICAL PROPERTIES
As per PA2242/013/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol monostearate 40-55,
hyprolose,
hypromellose,
iron oxide ( reddish-brown ) (E 172),
magnesium stearate,
methacrylic acid ethyl acrylate copolymer (1:1)
dispersion 30 per cent,
cellulose microcrystalline,
synthetic paraffin,
macrogols,
polysorbate 80,
crospovidone,
sodium stearyl fumarate,
sugar spheres (sucrose and maize starch),
talc,
titanium dioxide (E 171),
triethyl citrate.
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
30 June 2020
CRN009SZF
Page 2 of 3
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister 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. Keep this medicine in the original package
in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 gastro-resistant tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
_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 from clogging the tube.
2. Immediately shake the syri