Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of safety profile in adult and adolescent patients
The incidence of adverse events in adult and adolescent 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 adult and adolescent 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 in adult and adolescent patients 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 below.
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.

Bilastine       All Bilastine       Placebo
System Organ Class
20 mg             Doses            N = 1362
Frequency        Adverse reaction
N=1697            N=2525
Infections and infestations
Uncommon       Oral herpes                        2 (0.12%)         2 (0.08%)         0 (0.0%) Metabolism and nutrition disorders
Uncommon       Increased appetite                10 (0.59%)        11 (0.44%)        7 (0.51%) Psychiatric disorders
Uncommon       Anxiety                            6 (0.35%)         8 (0.32%)         0 (0.0%) Insomnia                           2 (0.12%)         4 (0.16%)         0 (0.0%) Nervous system disorders
Somnolence                        52 (3.06%)        82 (3.25%)        39 (2.86%) Common
Headache                          68 (4.01%)        90 (3.56%)        46 (3.38%) Uncommon       Dizziness                         14 (0.83%)        23 (0.91%)         8 (0.59%) Ear and labyrinth disorders
Uncommon       Tinnitus                           2 (0.12%)         2 (0.08%)         0 (0.0%) Vertigo                            3 (0.18%)         3 (0.12%)         0 (0.0%) Cardiac disorders
Uncommon       Right bundle branch block          4 (0.24%)         5 (0.20%)        3 (0.22%) Sinus arrhythmia                   5 (0.30%)         5 (0.20%)        1 (0.07%) Electrocardiogram QT
9 (0.53%)        10 (0.40%)        5 (0.37%) prolonged
Other ECG abnormalities            7 (0.41%)        11 (0.44%)        2 (0.15%) Respiratory, thoracic and mediastinal disorders

Bilastine      All Bilastine     Placebo
System Organ Class
20 mg            Doses          N = 1362
Frequency         Adverse reaction
N=1697           N=2525
Uncommon      Dyspnoea                         2 (0.12%)        2 (0.08%)        0 (0.0%) Nasal discomfort                 2 (0.12%)        2 (0.08%)        0 (0.0%) Nasal dryness                    3 (0.18%)        6 (0.24%)        4 (0.29%) Gastrointestinal disorders
Uncommon      Upper abdominal pain             11 (0.65%)       14 (0.55%)       6 (0.44%) Abdominal pain                   5 (0.30%)        5 (0.20%)        4 (0.29%) Nausea                           7 (0.41%)        10 (0.40%)      14 (1.03%) Stomach discomfort               3 (0.18%)        4 (0.16%)        0 (0.0%) Diarrhoea                        4 (0.24%)        6 (0.24%)        3 (0.22%) Dry mouth                        2 (0.12%)        6 (0.24%)        5 (0.37%) Dyspepsia                        2 (0.12%)        4 (0.16%)        4 (0.29%) Gastritis                        4 (0.24%)        4 (0.16%)        0 (0.0%) Skin and subcutaneous tissue disorders
Uncommon      Pruritus                         2 (0.12%)        4 (0.16%)        2 (0.15%) General disorders and administration site conditions
Uncommon      Fatigue                          14 (0.83%)       19 (0.75%)      18 (1.32%) Thirst                           3 (0.18%)        4 (0.16%)        1 (0.07%) Improved pre-existing                                              1 (0.07%) 2 (0.12%)        2 (0.08%) condition
Pyrexia                          2 (0.12%)        3 (0.12%)        1 (0.07%) Asthenia                         3 (0.18%)        4 (0.16%)        5 (0.37%) Investigations
Uncommon      Increased gamma-                                                   2 (0.15%) 7 (0.41%)        8 (0.32%) glutamyltransferase
Alanine aminotransferase                                           3 (0.22%) 5 (0.30%)        5 (0.20%) increased
Aspartate aminotransferase                                         3 (0.22%) 3 (0.18%)        3 (0.12%) increased
Blood creatinine increased       2 (0.12%)        2 (0.08%)        0 (0.0%) Blood triglicerides
2 (0.12%)        2 (0.08%)        3 (0.22%) increased
Increased weight                 8 (0.47%)        12 (0.48%)       2 (0.15%) 
Frequency not known (cannot be estimated from the available data):
Palpitations, tachycardia, hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, rash, localised oedema/local swelling, and erythema), and vomiting have been observed during the post-marketing period.

Description of selected adverse reactions in adult and adolescent patients Somnolence, headache, dizziness and fatigue were observed either in patients treated with bilastine 20 mg or with placebo. The frequency reported was 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.

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 as observed 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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/