BYLASTIN TABLET 20MG [SIN17556P]

Product Info

BYLASTIN TABLET 20MG

[SIN17556P]

Indication

Therapeutic Indications
Symptomatic treatment of allergic rhinoconjunctivitis and urticaria.
BYLASTIN is indicated for use in adults and adolescents (12 years of age and over).

Dosing

Posology and Method of Administration
Posology:
Adults and Adolescents (12 years of age and over)
Bilastine 20mg (1 tablet) once daily for relief of symptoms of allergic rhinoconjunctivitis and urticaria.
The tablet should be taken 1 hour before or 2 hours after intake of food or fruit juice (See section Interaction with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Duration of Treatment
For allergic rhinoconjunctivitis, treatment should be limited to the period of exposure to allergens. For seasonal allergic rhinitis, treatment could be discontinued after symptoms have resolved and reinitiated upon their reappearance. In perennial allergic rhinitis, continued treatment may be proposed to patients during the allergen exposure periods. For urticaria, duration of treatment depends on the type, duration and course of the complaints.

Special Populations:
Elderly
No dosage adjustments are required in elderly patients (see section Pharmacodynamic and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment
Studies conducted in adults in special risk groups (renally impaired patients) indicate that it is not necessary to adjust the dose of bilastine in adults (see section Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic Impairment
There is no clinical experience in adult patients with hepatic impairment. However, since bilastine is not metabolized and is eliminated as unchanged in urine and feces, hepatic impairment is not expected to increase systemic exposure above the safety margin in adult patients. Therefore, no dosage adjustment is required in adult patients with hepatic impairment (see section Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric Population

• Children 6 to 11 years of age with a body weight of at least 20kg: bilastine 10mg orodispersible tablets and bilastine 2.5mg/mL oral solution are appropriate for administration to this population.

• Children under 6 years of age and under 20kg: currently available data are described in section Special Warnings and Precautions for Use, Undesirable Effects, Pharmacodynamic Properties and Pharmacokinetic Properties but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Therefore, bilastine should not be used in this age group.

The safety and efficacy of bilastine in renally and hepatically impaired children have not been established.

Method of Administration:
Oral use.
The tablet is to be swallowed with water. It is recommended to take the daily dose in one single intake.

Contraindications

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.