Axiago 20 mg Enterotablett

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:

20 mg

Läkemedelsform:

Enterotablett

Sammansättning:

natriumlaurilsulfat Hjälpämne; sockersfärer Hjälpämne; esomeprazolmagnesiumtrihydrat 22,3 mg Aktiv substans

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Esomeprazol

Produktsammanfattning:

Förpacknings: Burk, 1 x 28 tabletter; Burk, 1 x 5 tabletter; Burk, 1 x 14 tabletter; Burk, 1 x 56 tabletter; Burk, 1 x 60 tabletter; Burk, 1 x 100 tabletter; Burk, 1 x 30 tabletter; Burk, 1 x 140 (5 x 28) tabletter; Burk, 1 x 2 tabletter; Burk, 1 x 7 tabletter; Burk, 1 x 15 tabletter; Blister, 1 x 15 tabletter; Blister, 1 x 28 tabletter; Blister, 1 x 30 tabletter; Blister, 1 x 140 tabletter; Blister, 1 x 56 tabletter; Blister, 1 x 14 tabletter; Blister, 1 x 60 tabletter; Blister, 1 x 98 tabletter; Blister, 1 x 3 tabletter; Blister, 1 x 7 tabletter; Blister, 50 x 1 tabletter (endos); Blister, 25 x 1 tabletter (endos); Blister, 100 x 1 tabletter (endos); Blister, 7 x 1 tabletter (endos); Blister, 1 x 90 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2000-10-06

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AXIAGO 20 MG GASTRO-RESISTANT TABLETS
AXIAGO 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 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 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.
Axiago 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). Axiago 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 Axiago.
Adolescents

Produktens egenskaper

1
Produktinformationen för Axiago 20 mg, 40 mg enterotablett, MTnr
16312, 16315, 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
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
AXIAGO 20 mg gastro-resistant tablets
AXIAGO 40 mg gastro-resistant tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium
trihydrate).
Excipients: Axiago 20 mg: Sucrose 28 mg. Axiago 40 mg: Sucrose 30 mg.
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Gastro-resistant tablet
20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20
mg on one side and
A/EH on the other side.
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on
one side and A/EI on
the other side.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Axiago tablets are indicated for:
Adults
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
-
treatment of erosive reflux esophagitis
-
long-term management of patients with healed esophagitis to prevent
relapse
-
symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR
THE ERADICATION
OF _HELICOBACTER PYLORI_ AND
-
healing of
_Helicobacter pylori_
associated duodenal ulcer and
-
prevention of relapse of peptic ulcers in patients with
_Helicobacter pylori_
associated
ulcers
PATIENTS REQUIRING CONTINUED NSAID THERAPY
Healing of gastric ulcers associated with NSAID therapy.
Prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.
PROLONGED TREATMENT AFTE