BILAXTEN ORODISPERSIBLE TABLET 20 MG

FAES FARMA, S.A. (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Dec 2, 2025
Approval ID: d9b28a1eeb0f9ed8
Company: FAES FARMA, S.A. (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: d9b28a1eeb0f9ed8
Drug Name: BILAXTEN ORODISPERSIBLE TABLET 20 MG
Product Name: BILAXTEN ORODISPERSIBLE TABLET 20 MG
Approval Number: SIN17410P
Approval Date: 2025-12-02
Registrant: A. MENARINI SINGAPORE PTE. LTD.
Licence Holder: A. MENARINI SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, ORALLY DISINTEGRATING
Dosage: 4.2 Posology and method of administration Posology Adults and adolescents (12 years of age and over). 20 mg bilastine once daily for the relief of symptoms of allergic rhinoconjunctivitis and urticaria. The 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). 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 – 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 5.2 – 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 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population <ul class="dash"> <li>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.</li> <li>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.</li> </ul> The safety and efficacy of bilastine in renally and hepatically impaired children have not yet been established. 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).
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Symptomatic treatment of allergic rhino-conjunctivitis and urticaria. BILAXTEN is indicated in adults and adolescents (12 years of age and over).
Contraindications: 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.

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 2, 2025

Approval ID

d9b28a1eeb0f9ed8

Type

Therapeutic

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