BILAXTEN ORAL SOLUTION 2.5MG/ML [SIN15963P]

Product Info

BILAXTEN ORAL SOLUTION 2.5MG/ML

[SIN15963P]

4.1 Therapeutic indications

Symptomatic treatment of allergic rhino-conjunctivitis and urticaria. Bilaxten is indicated in children aged 6 to 11 years with a body weight of at least 20 kg.

4.2 Posology and method of administration

Posology

Paediatric population

• Children 6 to 11 years of age with a body weight of at least 20 kg
  10 mg bilastine (1 orodispersible tablet) once daily for the relief of symptoms of allergic rhino-conjunctivitis and urticaria.

10 mg bilastine (4 ml of oral solution) once daily for the relief of symptoms of allergic rhino-conjunctivitis and urticaria.

• Children under 6 years of age and under 20 kg
  Currently available data are described in section 4.4, 4.8, 5.1 and 5.2 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 orodispersible tablet should be taken one hour before or two hours after intake of food or fruit juice (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The oral solution should be taken one hour before or two hours after intake of food or fruit juice (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In adults and adolescents (over 12 years of age) the administration of bilastine 20 mg tablets is appropriate.

Duration of treatment:
For allergic rhino-conjunctivitis the treatment should be limited to the period of exposure to allergens. For urticaria the duration of treatment depends on the type, duration and course of the complaints.

Special populations
Renal impairment
The safety and efficacy of bilastine in renally impaired children have not been established. 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 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
The safety and efficacy of bilastine in hepatically impaired children have not been established. There is no clinical experience in both adult and paediatric 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 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
Oral use

The orodispersible tablet is to be placed in the mouth where it disperses rapidly in saliva, so it can be easily swallowed.
Alternatively, the orodispersible tablet may be dispersed in water before administration. Grapefruit juice or any other fruit juices should not be used for dispersion (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The bottle of oral solution is provided with a child-proof cap and must be opened as follows: press the plastic screw-cap downwards and simultaneously turn anti-clockwise.
The oral solution is accompanied by a measuring cup for dosage with a mark of 4 ml (= 10 mg bilastine per dosing).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.