Xyzal

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

levocetirizine (levocetirizine dihydrochloride)

Verfügbar ab:

Aesica Pharmaceuticals S.r.l.

INN (Internationale Bezeichnung):

levocetirizine (levocetirizine dihydrochloride)

Dosierung:

5mg

Darreichungsform:

tablets film-coated

Verschreibungstyp:

OTC

Fachinformation

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Xyzal, Levocetirizine dihydrochloride, 5 mg, film-coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
3. PHARMACEUTICAL FORM
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
White to off-white, oval, film-coated tablet with a Y logo on one
side.
4. CLINICAL INFORMATION
4.1 INDICATIONS
For the symptomatic treatment of:
•
allergic rhinitis (including persistent allergic rhinitis),
•
urticaria.
4.2 DOSAGE AND ADMINISTRATION
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
The film-coated tablet must be taken orally, swallowed whole with
liquid and may be
taken with or without food. It is recommended to take the daily dose
in one single intake.
_Duration of use _
Intermittent allergic rhinitis (symptoms < 4 days/week or during less
than 4 weeks a year)
has to be treated according to the disease and its history; it can be
stopped once the
symptoms have disappeared and can be restarted again when symptoms
reappear.
Page 2 of 16
In case of persistent allergic rhinitis (symptoms > 4 days/week or for
more than 4 weeks a
year), continuous therapy can be proposed to the patient during the
period of exposure to
allergens.
There is clinical experience with the use of levocetirizine for
treatment periods of at least
6 months. For chronic urticaria and chronic allergic rhinitis, up to
one year's clinical
experience is available for the racemate.
ROUTE OF ADMINISTRATION
For oral use.
ADULTS AND ADOLESCENTS 12 YEARS AND ABOVE:
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
The daily recommended dose is 5 mg (1 film-coated tablet)._ _
CHILDREN
_Children aged less than 2 years _
The administration of levocetirizine to infants and toddlers aged less
than 2 years is not
recommended _(see Section Warnings and Precautions)_._ _
_Children aged 2 to 6 years _
_Levocetirizine dihydrochlo