- Approval Id
- 616335711ec99228
- Drug Name
- BILAXTEN TABLET 20 mg
- Product Name
- BILAXTEN TABLET 20 mg
- Approval Number
- SIN14661P
- Approval Date
- 2014-11-11
- Registrant
- A. MENARINI SINGAPORE PTE. LTD.
- Licence Holder
- A. MENARINI SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p>Posology</p>
<p><u>Adults and adolescents (12 years of age and over)</u><br>
20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis and urticaria.<br>
The tablet should be taken one hour before or two hours after intake of food or fruit juice. (See section Interaction with other medicinal products and other forms of interaction – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><u>Duration of treatment:</u><br>
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.</p>
<p><em>Special populations</em></p>
<p><u>Elderly</u><br>
No dosage adjustments are required in elderly patients (see section Pharmacodynamics and Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Renal impairment</u><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Hepatic impairment</u><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric population</u></p>
<ul class="dash">
<li>Children 6 to 11 years of age with a body weight of at least 20 kg<br>
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.<br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>. Therefore bilastine should not be used in this age group.</li>
</ul>
<p>The safety and efficacy of bilastine in renally and hepatically impaired children have not been established.</p>
<p><u>Method of administration:</u><br>
Oral use.<br>
The tablet is to be swallowed with water. It is recommended to take the daily dose in one single intake.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Symptomatic treatment of allergic rhino-conjunctivitis and urticaria.<br>
BILAXTEN is indicated in adults and adolescents (12 years of age and over).</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Hypersensitivity to the active substance or to any of the excipients listed in (section List of excipients – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- R06AX29
- Atc Item Name
- bilastine
- Pharma Manufacturer Name
- A. MENARINI SINGAPORE PTE. LTD.
