BILAXTEN

is indicated for the symptomatic treatment of allergic (seasonal and perannual) rhinoconjunctivitis and urticaria in adults and adolescents (aged 12 years and over).

Paediatric population

L-effectiveness and safety of bilastin n.

• have not been established in children under 2 years of age and clinical experience is very limited in children 2-5 years of age.

Therefore, bilastin should not be used for this.

In moderate to severe renal impairment, concomitant administration of bilastin and P-glycoprotein inhibitors such as ketoconazole, erythromycin, ciclosporin, ritonavir or diltiazem may increase plasma bilastin levels and therefore increase the risk of adverse effects of bilastin.

Therefore, it is appropriate to avoid the concomitant administration of bilastin, erythromycin, ciclosporin, ritonavir or diltiazem.

This is a low-level drug that is a low-level drug that is a low-level drug that is a low-level drug that is a low-level drug that is a low-level drug.

Pharmacotherapeutic group: antihistamines for systemic use, other antihistamines for systemic use, ATC code: R06AX29.

Mechanism of action

Bilastin is a non-sedative, long-acting antihistamine, selectively antagonistic effect on peripheral H1 receptors, and deaffinity for muscarinic receptors.

Bilastin administered as a single dose inhibited the erythemato-papulous reactions induced by histamine for 24 hours.

Efficacy and clinical safety

In clinical studies conducted in adults and adolescents with allergic rhino-conjunctivitis (seasonal and perannual), bilastin 20 mg once daily for 14-28 days improved symptoms such as a controlled drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug-like drug.

Summary of the safety profile in adults and adolescents In clinical studies in adults and adolescents, the frequency of adverse events observed in patients with allergic rhino-conjunctivitis or chronic idiopathic urticaria treated with bilastin 20 mg was comparable to that observed with placebo (12.7% versus 12.8%).

Clinical studies in clinical development included 2,525 adult and adolescent patients treated with different bilastin doses, of which 1 697 received 20 mg of bilastin.

In these studies, 1,362 patients received placebo.

The most frequent adverse reactions reported in patients receiving 20 mg of bilastin in the rhino-conjunctivitis indications were allergic or chronic idiopathic urticaria, of which 1 697 received 20 mg of bilastin.

The most frequent adverse reactions reported in patients receiving 20 mg of bilastin in the indiciar indications were: nhino-conjunctivitis (nergic or idiopathic urticaria) were: nh2-probetic (ne) are not known; nh2-probetic (ne) are not known; n2-probic (nemetic.