NEXIUM 20 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Available from:

Clear Pharmacy

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Dosage:

20 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors

Authorization status:

Authorised

Authorization date:

2010-09-10

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.
Adolescent

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nexium 20 mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 20mg esomeprazole (as magnesium trihydrate).
Also contains sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro resistant tablet
_Product imported from the UK, Italy and Romania:_
A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on
one side and A/EH on the other side.
4 CLINICAL PARTICULARS
As per PA0970/027/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/027/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol monostearate 40-55
hyprolose
hypromellose
reddish-brown iron oxide (E172)
yellow iron oxide (E172)
magnesium stearate
methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent
cellulose microcrystalline
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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_2_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_6_
_4_
_9_
_6_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer packaging 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 orig