Balisa Dosage/Direction for Use

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 Interactions).
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 Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 adult patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Children 6 to 11 years of age with a body weight of at least 20 kg: Bilastine 10 mg orodispersible tablets and bilastine 2.5 mg/mL oral solution are appropriate for administration to this population.
Children under 6 years of age and under 20 kg: Currently available data are described in Precautions, Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made. Therefore bilastine should not be used in this age group.
The safety and efficacy of bilastine in renally and hepatically impaired children have not 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.