Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions are nasopharyngitis (6%) and upper respiratory tract infection (5%).

Tabulated list of adverse reactions
The safety profile of umeclidinium was evaluated in patients with COPD who received doses of 55 micrograms or greater for up to one year. This includes patients who received the recommended dose of 55 micrograms once daily.


The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed from efficacy studies , the long-term safety study (which involved patients who received umeclidinium), post-marketing studies and spontaneous reporting.

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 available data).

System Organ Class              Adverse reactions                               Frequency 
Infections and infestations     Nasopharyngitis                                 Common Upper respiratory tract infection               Common
Urinary tract infection                         Common
Sinusitis                                       Common
Pharyngitis                                     Uncommon
Immune system disorders         Hypersensitivity reactions including: Rash, urticaria and pruritus                    Uncommon
Anaphylaxis                                     Rare
Nervous system disorders        Headache                                        Common Dysgeusia                                       Uncommon
Dizziness                                       Not known
Eye disorders                   Eye pain                                        Rare Glaucoma                                        Not known
Vision blurred                                  Not known
Intraocular pressure increased                  Not known
Cardiac disorders               Tachycardia                                     Common Atrial fibrillation                             Uncommon
Rhythm idioventricular                          Uncommon
Supraventricular tachycardia                    Uncommon
Supraventricular extrasystoles                  Uncommon

Respiratory, thoracic and       Cough                                           Common mediastinal disorders           Oropharyngeal pain                              Common Dysphonia                                       Uncommon
Gastrointestinal disorders      Constipation                                    Common Dry mouth                                       Uncommon
Renal and urinary disorders     Urinary retention                               Not known Dysuria                                         Not known

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 GSK Israel (il.safety@gsk.com).