Bilanâ„¢ 20 mg Tablet: Each tablet contains Bilastine INN 20 mg.
Bilanâ„¢ Kids (10 mg Orally Disintegrating Tablet): Each Orally Disintegrating Tablet contains Bilastine INN 10 mg.
Bilanâ„¢ 2.5 mg/ml Oral Solution: Each ml Oral Solution contains Bilastine INN 2.5 mg.
Bilastine is an antihistamine. Its principal effects are mediated via selective inhibition of peripheral Hâ‚-receptors. The antihistaminic activity of Bilastine has been documented in a variety of animal and human models. It shows moderate to high affinity for histamine Hâ‚-receptors and no affinity for muscarinic, serotonergic, dopaminergic and noradrenergic receptors.
Route of administration: Oral.
Adults & adolescents (12 years of age and over): 20 mg once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilanâ„¢ once daily and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilanâ„¢ once daily should be swallowed with water on an empty stomach to achieve optimal therapeutic effect.
Children (Between 2 to 11 years): 10 mg once daily (10 mg orally disintegrating tablet: once daily or 2.5 mg/ml oral solution: 4 ml once daily) for the symptomatic relief of allergic rhinoconjunctivitis and urticaria in children aged 2 to 11 years with a body weight of at least 20 kg. Orally disintegrating tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva without any water and can be easily swallowed. The orally disintegrating tablet should be taken one hour before or two hours after intake of food or fruit juice.
Use in Patients with Impaired Hepatic & Renal Function:
There is no clinical experience in patients with hepatic impairment. Since Bilastine is not metabolized and renal clearance is its major elimination route, hepatic impairments not expected to increase systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment. No dosage adjustment is required in patients with renal impairment.
With medicine:
With food & others: Bilastine tablets should not be taken with food or with grapefruit juice or other fruit juices, as this will decrease the effect of Bilastine.
Overdose:
Information regarding acute overdose of Bilastine is retrieved from the experience of clinical trials conducted during the development and the post-marketing surveillance. In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) to healthy volunteers, the frequency of treatment emergent adverse events were two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Until such data become available, Bilastine should be avoided during pregnancy, unless advised by a physician.
Lactation: It is not known whether Bilastine secreted in the breast-milk or not. So, caution is advised.
The safety and efficacy of Bilastine in children under 2 years of age have not been established.
No dosage adjustments are necessary in patients over 65 years.
Bilastine should be taken cautiously in case of moderate to severe renal impairment.
Store below 30°C temperature and dry place, protected from light. Keep of all medicines out of reach of children.