NEXIUM

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESOMEPRAZOLE

Available from:

AstraZeneca UK Limited

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE

Dosage:

10 Milligram

Pharmaceutical form:

Granules for Oral Suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

esomeprazole

Authorization status:

Not Marketed

Authorization date:

2008-08-01

Patient Information leaflet

566505-A01
22-03-17
PS10335
AZL4008B
7520
BL
Nexium 10mg Leaflet: Combined
UK
Black
Technical Info
Profile
BODY TEXT SIZE
9.5 pt
SMALLEST TEXT SIZE
6.0 pt
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 symptoms 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 substance called esomeprazole. This belongs to a
group of medicines
called proton pump inhibitors. These work by reducing the amount of
acid that your
stomach produces.
Nexium is used to treat the following conditions:
_Children over 1 year of age _
Nexium is used to treat a condition called “gastroesophageal reflux
disease” (GERD).
•
This is where acid from the stomach escapes into the gullet
(esophagus) causing pain,
inflammation and heartburn. Heartburn is a burning feeling rising from
the stomach or
lower chest up towards the neck.
•
In children, the symptoms of the condition can include the return of
stomach contents
into the mouth (regurgitation), being sick (vomiting) and poor weight
gain.
_Children over 4 years of age_
•
Ulcers which are infected with bacteria called ‘_Helicobacter
pylori’_. If your child has this
condition, your doctor may also prescribe antibiotics to treat the
infection and allow the
ulcer to heal.
2. What you need to know before you take Nexium
Do not take Nexium:
•
If you are allergic to esomeprazole or o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nexium 10 mg gastro-resistant granules for oral suspension, sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains: 10 mg esomeprazole (as magnesium trihydrate).
Excipient(s) with known effect
Each sachet contains 6.8 mg sucrose and 2.8 g glucose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant granules for oral suspension, sachet.
Pale yellow fine granules. Brownish granules may be visible.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nexium oral suspension is primarily indicated for:
Paediatric population
_Children 1-11 years old_
_Gastroesophageal Reflux Disease (GERD)_
-
treatment of endoscopically proven erosive reflux esophagitis
-
symptomatic treatment of gastroesophageal reflux disease (GERD)
_Children over 4 years of age_
In combination with antibiotics in treatment of duodenal ulcer caused
by_ Helicobacter pylori_.
_Adults and adolescents from the age of 12 years_
For indications in patients from the age of 12 years reference is made
to the Nexium gastro-resistant tablet SmPC.
Nexium oral suspension may also be used by patients having difficulty
swallowing dispersed Nexium gastro-resistant
tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paediatric population
_CHILDREN 1 – 11 YEARS WITH A BODYWEIGHT OF_
_10 KG_
_Gastroesophageal Reflux Disease (GERD)_
_- Treatment of endoscopically proven erosive reflux esophagitis_
Weight
10- <20 kg: 10 mg once daily for 8 weeks.
Weight
20 kg: 10 mg or 20 mg once daily for 8 weeks.
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