Biltin™ 10 mg ODT: Each tablet contains Bilastine INN 10 mg.
Biltin™ 20 mg Tablet: Each tablet contains Bilastine INN 20 mg.
Biltin™ 30 ml Oral Solution: Each ml contains Bilastine INN 2.5 mg.
Biltin™ 60 ml Oral Solution: Each ml contains Bilastine INN 2.5 mg.
Biltin TM:
Bilastine INN Tablets and Oral Solution.
Biltin™ is a preparation of Bilastine. Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibited histamine-induced wheal and flare skin reactions for 24 hours following single doses.
Adults and adolescents (12 years of age and over): 20 mg (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (Seasonal allergic rhinitis and perennial allergic rhinitis) and urticaria.
The tablet should be taken by oral route one hour before or two hours after intake of food or fruit juice. It is recommended to take the daily dose in one single intake.
Elderly: No dosage adjustments are required in elderly patients. There is little experience in patients above the age of 65.
Children under 12 years:
10 mg ODT- 10 mg once daily for the relief of symptoms of allergic rhinoconjunctivitis (Seasonal allergic rhinitis and perennial allergic rhinitis) and urticaria in children aged in children 6 to 11 years of age with a body weight of at least 20 kg.
Oral Solution- 4 mL of oral solution once daily for the relief of symptoms in children 6 to 11 years of age with a body weight of at least 20 kg with allergic rhinoconjunctivitis (Seasonal allergic rhinitis and perennial allergic rhinitis) and urticaria.
Duration of treatment: For allergic rhinitis the treatment should be limited to the period of exposure to allergens. For seasonal allergic rhinitis treatment could be discontinued after the symptoms have resolved and reinitiated upon their reappearance. In perennial allergic rhinitis continued treatment may be proposed to the patients during the allergen exposure periods. For urticaria the duration of treatment depends on the type, duration and course of the complaints.
There are no or limited amount of data from the use of bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of bilastine during pregnancy. It is unknown whether bilastine is excreted in human breast milk. The excretion of bilastine in milk has not been studied in human. A decision on whether to continue/discontinue therapy with bilastine should be made taking into account the benefit of breast-feeding to the child and the benefit of bilastine therapy to the mother.
Efficacy and safety of bilastine in children under 6 years of age have not been established. In patients with moderate or severe renal impairment coadministration 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, coadministration of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.
Store at or below 30°C temperature. Keep away from light and wet place. Keep out of reach of children.