ILAXTEN Tablet Ref.[6522] Active ingredients: Bilastine

Posology

Adults and adolescents (12 years of age and over)

20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (SAR and PAR) and urticaria.

The tablet should be taken one hour before or two hours after intake of food or fruit juice (see section 4.5).

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.

Special populations

Elderly

No dosage adjustments are required in elderly patients (see sections 5.1 and 5.2).

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 5.2).

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 faeces, 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).

Paediatric population

Children 6 to 11 years of age with a body weight of at least 20 kg

Bilastine 10 mg orodispersible tablets and bilastine 2.5 mg/mL oral solution are appropriate for administration to this population.

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. 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.

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 26 adult healthy volunteers frequency of treatment emergent adverse events was two times higher than with placebo. 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. The information collected in the post-marketing surveillance is consistent with that reported in clinical trials.

Critical evaluation of bilastine’s multiple dose (100 mg x 4 days) effect on ventricular repolarization by a “thorough QT/QTc cross-over study” involving 30 healthy adult volunteers did not show significant QTc prolongation.

There are no data for overdose in children.

In the event of overdose symptomatic and supportive treatment is recommended.

There is no known specific antidote to bilastine.

5 years.

This medicinal product does not require any special storage conditions.

The medicinal product is packaged in a blister, consisting of two parts:

• Laminate, consisting of oriented polyamide (outer side of laminate), aluminium and PVC (inner side of laminate).
• Aluminium foil.

The aluminium foil is thermosealed with a heat-seal lacquer (PVC-PVAC copolymer and resins of butylmethacrylate) to the laminate after molding and filling of the tablets.

Each blister contains 10 tablets. The blisters are packaged in cardboard boxes.

Pack sizes: 10, 20, 30, 40 or 50 tablets.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.