Nexium 40 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Esomeprazole

Available from:

Primecrown 2010 Limited

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 status:

Authorised

Authorization date:

2010-05-28

Patient Information leaflet

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.
Adolesc

Summary of Product characteristics

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 40 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 the UK_
Pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side
and
on the other side
4 CLINICAL PARTICULARS
As per PA0970/027/002.
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/027/002.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol Monostearate 40-55
Hyprolose
Hypromellose
Iron oxide (reddish-brown) (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.
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6.3 SHELF LIFE
The shelf life expiry date of this product shall be 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