Adults and adolescents (12 years of age and over)20 mg Bilastine (1 tablet) once daily for the relief of symptoms of allergic rhino conjunctivitis (SAR and PAR) and urticaria. The tablet should be taken one hour before or two hours after intake of food or fruit juice.

Hypersensitivity to the active substance or to any of the excipients.

Co-administration of Bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment. 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 year

• Pregnancy- There are no or limited amount of data from the use of Bilastine in pregnant women. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy
• Breast feeding- The excretion of Bilastine in milk has not been studied in humans. Bilastine therapy must be made considering the benefit of breast- feeding for the child and the benefit of Bilastine therapy for the mother Fertility: There are no or limited amount of clinical data

The most common adverse events reported are headache, somnolence, dizziness, and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.

In the event of overdose symptomatic and supportive treatment is recommended. There is no known specific antidote to Bilastine. Information regarding acute overdose of Bilastine is retrieved from the experience of clinical trials conducted during the development and the post-marketing surveillance. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported