Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Rupatadine 10 mg tablets has been administered to over 2043 adult and adolescent patients in clinical studies, 120 of whom received rupatadine for at least 1 year.

The most common adverse reactions in controlled clinical studies were somnolence (9.4%), headache (6.9%) , fatigue (3.1%), asthenia (1.5%), dry mouth (1.2%) and dizziness (1.03%).
The majority of the adverse reactions observed in clinical trials were mild to moderate in severity and they usually did not require cessation of therapy.

The frequencies of adverse reactions are assigned as follows:
• Common (≥ 1/100 to < 1/10)
• Uncommon (≥ 1/1000 to < 1/100)
• Rare (≥1/10,000 to <1/1,000)

The frequencies of adverse reactions reported in patients treated with rupatadine 10 mg tablets during clinical trials and spontaneous reporting were as follows:
System Organ Class            Common                    Uncommon
(Body System)                 (≥ 1/100 to < 1/10)       (≥ 1/1000 to < 1/100) 
Infections and infestations                             Pharyngitis rhinitis
Metabolism and nutrition                                Increase appetite disorders
Nervous system disorders      Dizziness                 Disturbance in Attention Headache
Somnolence
Respiratory, Thoracic and                               Cough
Mediastinal Disorders                                   Dry Throat
Epistaxis
Nasal Dryness
Oropharyngeal Pain
Gastrointestinal disorders    Dry Mouth                 Abdominal Pain Abdominal Pain Upper
Diarrhoea
Dyspepsia
Nausea
Vomiting
Constipation
Skin and subcutaneous                                   Rash tissue disorders

Musculoskeletal,                                        Arthralgia connective tissues, and                                 Back Pain bone disorders                                          Myalgia

General Disorders and         Asthenia                  Malaise administration site           Fatigue                   Pyrexia condition                                               Thirst
Irritability
Investigations                                          Alanine aminotransferase Increased Aspartate aminotransferase Increased
Blood Creatine Phosphokinase Increased
Liver Function Test Abnormal
Weight increase

Additionally, two rare adverse reactions were reported in the post-authorisation period: Tachycardia and palpitations and hypersensitivity reactions (including anaphylactic reactions, angioedema and urticarial) have been reported in post-marketing experience with rupatadine 10 mg tablets.

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