Posology : מינונים

4.2   Posology and method of administration
Posology
Adults and adolescents (12 years of age and over)
20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis
(SAR and PAR) and urticaria.
The tablet should be taken one hour before or two hours after intake of food or fruit juice (see section 4.5).
Duration of treatment
For allergic rhino-conjunctivitis the treatment should be limited to the period of exposure to allergens. For seasonal allergic rhinitis treatment could be discontinued after the symptoms have resolved and reinitiated upon their reappearance. In perennial allergic rhinitis continued treatment may be proposed to the patients during the allergen exposure periods. For urticaria the duration of treatment depends on the type, duration and course of the complaints.


Special populations
Elderly
No dosage adjustments are required in elderly patients (see sections 5.1 and 5.2).


Renal impairment
Studies conducted in adults in special risk groups (renally impaired patients) indicate that it is not necessary to adjust the dose of bilastine in adults (see section 5.2).


Hepatic impairment
There is no clinical experience in adult patients with hepatic impairment. However, since bilastine is not metabolized and is eliminated as unchanged in urine and faeces, hepatic impairment is not expected to increase systemic exposure above the safety margin in adult patients. Therefore, no dosage adjustment is required in patients with hepatic impairment (see section 5.2).


Paediatric population
There is no relevant use of bilastine in children aged 0 to 2 years for the indications of allergic rhino-conjunctivitis and urticaria. The safety and efficacy in children below 12 years have not yet been established.


Method of administration
Oral use.
The tablet is to be swallowed with water. It is recommended to take the daily dose in one single intake.