Allergic Rhinitis: Bilastine is indicated for the symptomatic relief of nasal and non-nasal symptoms of allergic rhinitis.
Allergic Rhinoconjunctivitis: Bilastine is indicated for the relief of the symptoms associated with allergic rhinoconjunctivitis.
Urticaria: Bilastine is indicated for the relief of the symptoms associated with urticaria (e.g. pruritus and hives).
Dosage & Administration
Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.
Bilastine should be taken cautiously in case of moderate to severe renal impairment.
Use in Specific Population
Use in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. Until such data become
available, Bilastine should be avoided during pregnancy, unless advised otherwise by a physician.
Use in patients with impaired hepatic & renal function: There is no clinical experience in patients with hepatic impairment. Since
Bilastine is not metabolized and renal clearance is its major elimination route, hepatic impairments not expected to increase systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment. No dosage adjustment is required in patients with renal impairment.
Geriatrics (>65 years of age): No dosage adjustments are necessary in patients over 65 years.
Pediatrics (<12 years of age): The safety and efficacy of Bilastine in children under 12 years of age have not been established.