Each tablet contains Bilastine 20mg + Montelukast 10 mg.
For the symptomatic treatment of allergic rhinoconjunctivitis in adults.
Bilastine is an antihistamine; its principal 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. Montelukast acts by blocking the receptor on which leukotriene acts, hence allergic reaction and inflammation is suppressed.
Adults and adolescents (15 years of age and over): 1 tablet consumed once daily in the night for the relief of symptoms of allergic rhinitis. The tablet should be taken one hour before or two hours after intake of food or fruit juice.
Hypersensitivity to any ingredient in the formulation.
Coadministration of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.
Pregnancy: There are no adequate and well controlled studies hence not recommended in pregnant women. Lactation / Breast-feeding: There are no adequate and well controlled studies, hence not recommended. Paediatrics: The safety and efficacy in children under 15 years of age have not been established.
Concomitant intake of bilastine 20 mg o.d. and ketoconazole 400 mg o.d. or erythromycin 500 mg t.i.d. increased plasma concentration of bilastine. Montelukast: No dose adjustment is needed when co-administered with theophylline,prednisolone, oral contraceptives, digoxin, warfarin, thyroid hormones, sedativehypnotics, non-steroidal anti-inflammatory agents, decongestants, and CytochromeP450 (CYP) enzyme inducers.
The most commonly reported adverse events are headache, somnolence, dizziness, and fatigue.
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