Summary of safety profile: The incidence of adverse events in patients suffering from allergic rhinoconjunctivitis or chronic idiopathic urticaria treated with 20 mg bilastine in clinical trials was comparable with the incidence in patients receiving placebo (12.7% versus 12.8%).
The phase II and III clinical trials performed during the clinical development included 2525 patients treated with different doses of bilastine, of which 1697 received bilastine 20 mg. In these trials 1362 patients received placebo. The ADRs most commonly reported by patients receiving 20 mg bilastine for the indication of allergic rhinoconjunctivitis or chronic idiopathic urticaria were headache, somnolence, dizziness, and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.
Tabulated summary of adverse reactions: ADRs at least possibly related to bilastine and reported in more than 0.1% of the patients receiving 20 mg Bilastine during the clinical development (N=1697) are tabulated as follows.
Frequencies are assigned as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data), Rare, very rare and reactions with unknown frequency have not been included in the table. (See table.)
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Frequency not known (cannot be estimated from the available data): Palpitations and tachycardia have been observed during the post-marketing period.
Description of selected adverse reactions: The most frequently reported adverse reactions were two common (somnolence and headache) and two uncommon (dizziness and fatigue). Their frequencies in bilastine vs. placebo were 3.06 % vs. 2.86% for somnolence; 4.01% vs. 3.38% for headache; 0.83% vs. 0.59% for dizziness, and 0.83% vs. 1.32% for fatigue.
Almost all the adverse reactions, included in the previously mentioned table, were observed either in patients treated with bilastine 20 mg or with placebo with a similar incidence.
The information collected during the post-marketing surveillance has confirmed the safety profile observed during the clinical development.
Paediatric population: During the clinical development the frequency, type and severity of adverse reactions in adolescents (12 years to 17 years) were the same seen in adults. The information collected in this population (adolescents) during the post-marketing surveillance has confirmed clinical trial findings.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed. The patient may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by calling Tel:03-78835550, or visiting the website www.bpfk.gov.my (Consumers→Reporting).