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BILAMIN

BILASTIN INN

NAME STRENGTH PACK SIZE DOSAGE FORM
BILAMIN 20 MG 20 MG 30 S TABLET
BILAMIN 10 MG 10 MG 30 S ODT
BILAMIN 12.5 MG/ 5 ML 12.5 MG/ 5 ML 60 ML ORAL SOLUTION
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Bilamin 20 mg Tablet: Each tablet contains Bilastine INN 20 mg.

Bilamin Kids (10 mg orally dispersible Tablet): Each tablet contains Bilastine INN 10 mg.

Bilamin Oral Solution: Each 5 ml syrup contains Bilastine INN 12.5 mg.

The antihistaminic activity of bilastine has been documented in a variety of animal and human models. It shows moderate to high affinity for histamine H1-receptors and no affinity for muscarinic, serotonergic, dopaminergic and noradrenergic receptors. Bilastine has been demonstrated to have limited distribution to the brain following oral administration.

Seasonal Allergic Rhinitis: Bilastine is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Chronic Spontaneous Urticaria: Bilastine is indicated for the relief of the symptoms associated with chronic spontaneous urticaria (CSU) (e.g. pruritus and hives), in patients 18 years of age and older.

Adults & adolescents (12 years of age and over): 20 mg once daily for Symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine once daily and should not be exceeded. if a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine once daily should be swallowed with water on an empty stomach to achieve optimal therapeutic effect. Children (Between 2 to 11 years): 10 mg once daily (10 mg orally disintegrating tablet once daily or 2.5 mg/ml oral solution: 4 ml once daily) for the symptomatic relief of allergic rhinoconjunctivitis and urticaria in children aged 2 to 11 years with a body weight of at least 20 kg. Orally disintegrating tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva without any water and can be easily swallowed. The orally disintegrating tablet should be taken one hour before or two hours after intake of food or fruit juice.

Bilastine is contraindicated in patients with hypersensitivity to bilastine or to any ingredient in the formulation or component of the container. Bilastine is also contraindicated in patients with a history of QT prolongation or congenital long QT syndromes.

Bilastine should be taken cautiously in case of moderate to severe renal impairment.

The most common side effects of Bilastine include: headache, dizziness and fatigue.

It is unknown whether bilastine is excreted in human breast milk. It should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

Concomitant intake of Bilastine and Ketoconazole or Erythromycin and Diltiazem 60 mg increase Bilastine concentration. The psychomotor performance after concomitant intake of Alcohol and 20 mg Bilastine was similar to that observed after intake of Alcohol and placebo.

Most frequently reported adverse reactions due to overdosage include dizziness, headache and nausea.

Store between 15°C – 30°C. Keep out of reach and sight of children.

Bilamin 20 mg Tablet: Each box contains 3 x 10 tablets in Alu-Alu blister pack.

Bilamin Kids (10 mg orally dispersible Tablet): Each box contains 3 x 10 tablets in Alu-Alu blister pack.

Bilamin Oral Solution: Each bottle containing 60 ml Oral Solution.