Axiago 20 mg Enterotablett

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

esomeprazolmagnesiumtrihydrat

Commercializzato da:

Orifarm AB

Codice ATC:

A02BC05

INN (Nome Internazionale):

magnesium trihydrate

Dosaggio:

20 mg

Forma farmaceutica:

Enterotablett

Composizione:

esomeprazolmagnesiumtrihydrat 22,3 mg Aktiv substans; sockersfärer Hjälpämne

Tipo di ricetta:

Receptbelagt

Area terapeutica:

Esomeprazol

Stato dell'autorizzazione:

Avregistrerad

Data dell'autorizzazione:

2007-06-05

Scheda tecnica

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME
OF
THE
MEDICINAL
PRODUCT
Axiago 20 mg gastro-resistant tablets
Axiago 40 mg gastro-resistant tablets
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
20 mg: Each gastro-resistant tablet contains: 22.3
esomeprazole magnesium trihydrate equivalent to
20 mg esomeprazole.
40 mg: Each gastro-resistant tablet contains esomeprazole 44.5
magnesium trihydrate equivalent to
40 mg esomeprazole.
Excipient (s) with known effect
20 mg: Each gastro-resistant tablet contains 28 mg sucrose
40 mg: Each gastro-resistant tablet contains 30 mg sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL
FORM
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
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Axiago tablets are indicated in adults for:
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 after i.v. induced prevention of rebleeding of
peptic ulcers.
Treatment of Zollinger Ellison Syndrome
2
Axiago tablets are indicated in adolescents from the age of 12 years
for: Gastroesophageal Reflux
Disease (GERD)
-
treatment of erosive reflux esophagitis
-
long-term management of patients with healed esophagitis to prevent
rela