Rinobil 20 Tablet:
Each tablet contains Bilastine INN 20 mg.
Rinobil Oral Solution:
Each 5 ml oral solution contains Bilastine INN 12.50 mg.
Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.
Bilastine is indicated for symptomatic treatment of Allergic rhinitis, Allergic rhino-conjunctivitis (seasonal and perennial) and Urticaria.
Dosage & Administrations:
Adults and adolescents (12 years of age and over):
20 mg Bilastine (1 tablet) once daily.
Children between 6- 11 years (a body weight of at least 20 kg):
4 ml of oral solution once daily.
The tablet and oral solution should be taken one hour before or two hours after intake of food
Elderly: No dosage adjustments are recommended in patients over 65 years of age.
Duration of treatment
For allergic rhino-conjunctivitis 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.
Warning & Precautions:
Efficacy and safety of Bilastine in children under 6 years of age have not been established. Co-administration of Bilastine and P-glycoprotein inhibitors (e.g.: Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.
The most common side effects of Bilastine include: headache, dizziness and fatigue.
Concomitant intake of Bilastine and Ketoconazole, Erythromycin or Diltiazem increased Cmax of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
Use in Special Groups:
Use in Pregnancy & Lactation
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. The excretion of Bilastine in milk has not been studied in humans so caution is advised.
Bilastine is contraindicated in patients with hypersensitivity to Bilastine or to any ingredient in the formulation or component.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.
Rinobil 20 Tablet: Each box contains 30 tablets in Alu-Alu blister pack.
Rinobil Oral Solution: Each box contains 30 ml oral solution in amber PET bottle with calibrated dropper.