Billi® Metab. Box containing 30 tablets in 3x10’s Au-Alu form packs. Each orally dispensed tablet contains Bilastine INN 10 mg Billi® 20 Tablet: Each tablet contains Bilastine INN 20 mg. Billi® Oral Solution:** 60 ml solution in amber glass bottle. Each ml contains Bilastine INN 2.5 mg.
Billi® is a preparation of Bilastine. Bilastine is a non-sedating, long acting histamine antagonist with high selectivity and high affinity to H1 receptor. (3 times higher than Cetirizine and 6 times higher than Faxodamine). Even at high concentration, Bilastine does not show affinity for 30 other receptors including muscarinic, serotonergic, dopaminergic and noradrenergic receptors or other receptor subtypes (H₂, H₃, H₄). Therefore, it shows very good efficacy and safety profile in treating allergic conditions.
Children 6 to 11 years (a body weight of at least 20 kg): 10 mg.
Orally dispensed tablet or 4 ml Oral Solution once daily.
The maximum recommended daily dose is 10 mg in children, which should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. Bilastine oral dispensed tablet should be placed in mouth and it will disperse rapidly and then swallowed. Alternatively, the tablet can be dispensed in a tea spoon of water before being swallowed by the children.
Adults & adolescents (12 years of age and over): 20 mg tablet once daily.
Early/No dosage adjustments are recommended in patients over 65 years of age.
The maximum recommended daily dose in adults is 20 mg, which should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. Bilastine, once daily, should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.
Concomitant administration of Bilastine and ketoconazole, Diltiazem, Cyclosporine or erythromycin increases plasma concentration of Bilastine. Concomitant intake of Bilastine and lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of lorazepam. The concurrent use of Bilastine with other OTC prolonging drugs is not recommended.
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. Animal studies do not indicate major direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development.
Lactation: It is not known whether Bilastine is excreted in human milk. So it should be used with caution in lactating mothers.
Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups. In patients with moderate or severe renal impairment co-administration of Bilastine with P-glycoprotein inhibitors, such as e.g., ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may increase plasmatic levels of Bilastine and therefore increase the risk of adverse effects of Bilastine. Therefore, co-administration of Bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.