Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions with Eklira Genuair were headache (6.6%) and nasopharyngitis (5.5%).

Tabulated summary of adverse reactions
The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Eklira Genuair) observed with Eklira Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.

The frequency of adverse reactions is defined using the following convention: 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) and not known (cannot be estimated from the available data).

System organ class                 Preferred term            Frequency Infections and infestations        Sinusitis                 Common
Nasopharyngitis           Common
Immune system disorders            Hypersensitivity          Rare

Angioedema                  Not known
Anaphylactic reaction       Not known
Nervous system disorders               Headache                    Common Dizziness                   Uncommon
Eye disorders                          Blurred vision              Uncommon Cardiac disorders                      Tachycardia                 Uncommon Palpitations                Uncommon
Respiratory, thoracic and              Cough                       Common mediastinal disorders                  Dysphonia                   Uncommon Gastrointestinal disorders             Diarrhoea                   Common Nausea*                     Common
Stomatitis                  Uncommon
Dry mouth                   Uncommon
Skin and subcutaneous tissue           Rash                        Uncommon disorders                              Pruritus                    Uncommon Renal and urinary disorders            Urinary retention           Uncommon * The incidence of nausea in clinical trials was lower for aclidinium than for placebo (43.9 vs 48.3 per 1000 patient-years respectively)

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.