Beltas 20 Tablet: Each tablet contains Bilastine INN 20 mg. Beltas Kids Tablet: Each orodispersible tablet contains Bilastine INN 10 mg.
Beltas Oral Solution: Each 5 ml contains Bilastine INN 12.5 mg.
Bilastine is a non-sedating, long acting antihistamine with high selectivity and high affinity to H1 receptor. Bilastine does not show affinity for other receptors such as muscarinic, serotonergic, dopaminergic and noradrenergic receptors or subtypes of other histamine receptors (H2, H3, H4). Therefore, it shows very good efficacy and safety profile in treating allergic conditions.
Mode of action:
Bilastine is a selective Histamine H1 receptor antagonist. During allergic response mast cells undergo degranulation which release Histamine and other substances. By binding to and preventing activation of the H1 receptor, Bilastine reduces the development of allergic symptoms due to the release of Histamine from mast cells.
Bilastine is indicated for the symptomatic treatment of allergic rhinitis, rhinoconjunctivitis and urticaria (pruritus and hives).
For the symptomatic treatment of allergic rhinitis, allergic rhinoconjunctivitis and urticaria- Adults & adolescents (12 years of age and over): Beltas 20 Tablet: 20 mg tablet once daily. Children between 6 to 11 years: Beltas Kids Tablet: 10 mg orodispersible tablet once daily. Children between 2 to 11 years: Beltas oral solution: 4 ml once daily.
To achieve optimal exposure of Beltas , once daily dose should be taken with water on an empty stomach.
Concomitant intake of Bilastine and Ketoconazole, Erythromycin or Diltiazem increased plasma concentration of Bilastine. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
Pregnancy: 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. Lactation: It is not known whether Bilastine is excreted in human milk. So it should be used with caution in lactating mothers. Pediatrics (<2 years of age): The safety and efficacy of Bilastine in children under 2 years of age have not been established.
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.
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.
Keep out of reach of children. Store in a dry place, below 25 C temperature and protected from light.