Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Clinical trials with rupatadine oral solution in children aged 2-11 years included 626 patients.
From these, 147 patients were treated with rupatadine 2.5 mg, 159 patients were treated with rupatadine 5 mg, 249 received placebo and 71 received desloratadine.

The frequencies of adverse reactions are assigned as follows:
• Common (≥ 1/100 to < 1/10)
• Uncommon (≥ 1/1,000 to < 1/100)

The frequencies of adverse reactions reported in patients treated with rupatadine oral solution during clinical trials were as follows:
System Organ Class term                               Rupatadine       Rupatadine Placebo 2.5 mg           5 mg

Frequency        Preferred term                       (n=147)          (n=159)        (n=249) 
Infections and infestations
Influenza                             0                1 (0.63%)      0 
Nasopharyngitis                       1 (0.68%)        0              0 Uncommon
Upper respiratory tract infection     1 (0.68%)        0              0 

Blood and lymphatic system disorders
Eosinophilia                          0                1 (0.63%)      0 
Uncommon
Neutropenia                           0                1 (0.63%)      0 
Nervous system disorders
Headache                              2 (1.36%)        4 (2.52%)      4 (1.61%) 
Common
Somnolence                            0                2 (1.26%)      0 
Dizziness                             0                1 (0.63%)      1 (0.40%) Uncommon

Gastrointestinal disorders
Uncommon        Nausea                                0                1 (0.63%)      2 (0.80%) Skin and subcutaneous tissue disorders
Eczema                          0                1 (0.63%)            1 (0.40%) Uncommon
Night sweats                    0                1 (0.63%)            0 General disorders and administration site conditions
Uncommon        Fatigue                         0                1 (0.63%)            0 
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 Additionally, you should also report to Kamada Ltd. to email address: pharmacovigilance@kamada.com