Axiago 10 mg Enterogranulat till oral suspension i dospåse

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

esomeprazolmagnesiumtrihydrat

Tillgänglig från:

Grünenthal GmbH

ATC-kod:

A02BC05

INN (International namn):

magnesium trihydrate

Dos:

10 mg

Läkemedelsform:

Enterogranulat till oral suspension i dospåse

Sammansättning:

sockersfärer Hjälpämne; esomeprazolmagnesiumtrihydrat 11,1 mg Aktiv substans; glukos (vattenfri) Hjälpämne

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Esomeprazol

Produktsammanfattning:

Förpacknings: Dospåsar, 28 st

Bemyndigande status:

Godkänd

Tillstånd datum:

2007-12-07

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AXIAGO 10 MG GASTRO-RESISTANT GRANULES FOR ORAL SUSPENSION, SACHET
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 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 Axiago is and what it is used for
2.
What you need to know before you take Axiago
3.
How to take Axiago
4.
Possible side effects
5.
How to store Axiago
6.
Contents of the pack and other information
1.
WHAT AXIAGO IS AND WHAT IT IS USED FOR
Axiago 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.
Axiago is used to treat the following conditions:
_Children over 1 year of age_
Axiago 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 AXIAGO
DO NOT TAKE AXIAGO

If you are allergic to esomeprazole or other similar proton pump
inhi

Produktens egenskaper

1(13)
Produktinformationen för Axiago 10 mg enterogranulat till oral
suspension i dospåse, MTnr
24627, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att
uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma
anledning finns inte
någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
2(13)
SUMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
AXIAGO 10 mg gastro-resistant granules for oral suspension, sachet
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each sachet contains: 10 mg esomeprazole (as magnesium trihydrate).
Excipients: Sucrose 6.8 mg and glucose 2.8 g
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Gastro-resistant granules for oral suspension, sachet
Pale yellow fine granules. Brownish granules may be visible.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Axiago oral suspension is primarily indicated for:
_Children 1-11years 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_
Axiago oral suspension may also be used by patients having difficulty
swallowing dispersed
Axiago gastro-resistant tablets. For indications in patients from the
age of 12 years reference
is made to the Axiago gastro-resistant tablet SmPC.
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.
W