Xyzal tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levocetirizine (levocetirizine dihydrochloride)

Available from:

Aesica Pharmaceuticals S.r.l.

ATC code:

R06AE09

INN (International Name):

levocetirizine (levocetirizine dihydrochloride)

Dosage:

5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-12-12

Summary of Product characteristics

Page 1 of 13
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.
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.
Page 2 of 13
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