Bilastin 20 Tablet: Each tablet contains 20 mg Bilastine INN.
Bilastin kids Tablet: Each mouth dissolving tablet contains 10 mg Bilastine INN.
Bilastin Syrup: Each 5 ml contains 12.5 mg Bilastine INN.
Bilastine is a non-sedating, long-acting H1 receptor selective antagonist. Its effects are mediated via selective inhibition of peripheral H1-receptors. It shows moderate to high affinity for histamine H1-receptors and no affinity for muscarinic, serotonergic, dopaminergic and noradrenergic receptors. Bilastine inhibits histamine induced flare skin reactions for 24 hours following single doses.
Bilastine is indicated for the symptomatic relief of symptoms of allergic rhinitis, rhinoconjunctivitis and urticaria (pruritus and hives).
Children between 2 to 11 years: For the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria.
Adults & adolescents (12 years of age and over): For the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria.
To achieve optimal exposure to Bilastine, once daily dose should be taken with water on an empty stomach.
*Prescription only*
Concomitant intake of Bilastine and Ketoconazole, Erythromycin or Diltiazem increased Cmax of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after the intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
Use in Specific Population:
Use in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. Until such data becomes available, Bilastine should be avoided during pregnancy, unless advised otherwise by a physician. Geriatrics (>65 years of age): No dosage adjustments are necessary in patients over 65 years. Pediatrics (<2 years of age): The safety and efficacy of Bilastine in children under 2 years of age have not been established.
Overdosage:
No serious adverse events have been reported in case of over dosage. However, in the event of overdosage, symptomatic and supportive treatment have been reported.
Co-administration of Bilastine and P-glycoprotein inhibitors (e.g: Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.