Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
levocetirizine (levocetirizine dihydrochloride)
Aesica Pharmaceuticals S.r.l.
R06AE09
levocetirizine (levocetirizine dihydrochloride)
5mg
tablets film-coated
(10/1x10/) in blister
OTC
Registered
2019-12-12
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 Citiți documentul complet