Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most frequently reported adverse reaction is nasopharyngitis (9%).

Tabulated list of adverse reactions
The safety profile of ANORO ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting. The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.

The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed in the integration of five 24-week studies and in the 12-month safety study.


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      Urinary tract infection                        Common Sinusitis                                      Common
Nasopharyngitis                                Common
Pharyngitis                                    Common
Upper respiratory tract infection              Common
Immune system disorders          Hypersensitivity reactions including: 
Rash                                           Uncommon

Anaphylaxis, angioedema, and urticaria         Rare
Nervous system disorders         Headache                                       Common Tremor                                         Uncommon
Dysgeusia                                      Uncommon
Dizziness                                      Not known
Eye disorders                    Vision blurred                                 Rare Glaucoma                                       Rare
Intraocular pressure increased                 Rare
Eye pain                                       Rare
Cardiac disorders                Atrial fibrillation                            Uncommon Supraventricular tachycardia                   Uncommon
Rhythm idioventricular                         Uncommon
Tachycardia                                    Uncommon
Supraventricular extrasystoles                 Uncommon
Palpitations                                   Uncommon
Respiratory, thoracic and        Cough                                          Common mediastinal disorders            Oropharyngeal pain                             Common Dysphonia                                      Uncommon
Paradoxical bronchospasm                       Rare
Gastrointestinal disorders       Constipation                                   Common Dry mouth                                      Common
Musculoskeletal and              Muscle spasms                                  Uncommon connective tissue disorders
Renal and urinary disorders      Urinary retention                              Rare Dysuria                                        Rare
Bladder outlet obstruction                     Rare

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).