Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The presentation of the safety profile is based on the experience with Duaklir Genuair and the individual components.


Summary of the safety profile
The safety experience with Duaklir Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience.
Adverse reactions associated with Duaklir Genuair were similar to those of the individual components. As Duaklir Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Duaklir Genuair.
The most frequently reported adverse reactions with Duaklir Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Tabulated summary of adverse reactions
The Duaklir Genuair clinical development programme was conducted in patients with moderate or severe COPD. A total of 1222 patients were treated with Duaklir Genuair 340 micrograms /12 micrograms. The frequencies assigned to the adverse reactions are based on crude incidence rates observed with Duaklir Genuair 340 micrograms /12 micrograms in the pooled analysis of randomised, placebo-controlled Phase III clinical studies of at least six months duration, or on experience with individual components.
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                      Preferred term                                         Frequency 
Infectious and infestations             Nasopharyngitis3                                       Common 1
Urinary tract infection
Sinusitis2
Tooth abscess1

Immune system disorders                 Hypersensitivity4                                      Rare 
Angioedema4                                            Not known
Anaphylactic reaction2
Metabolism and nutrition disorders      Hypokalaemia3                                          Uncommon 
Hyperglycaemia3                                        Uncommon

Psychiatric disorders                   Insomnia2                                              Common 2
Anxiety

Agitation3                                             Uncommon

Nervous system disorders                Headache3                                              Common 3
Dizziness
Tremor2

Dysgeusia3                                             Uncommon

Eye disorders                           Blurred vision2                                        Uncommon 
Cardiac disorders                       Tachycardia2                                           Uncommon 2
Electrocardiogram QTc prolonged
Palpitations3
Angina pectoris3
Respiratory, Thoracic and mediastinal Cough3                                                   Common disorders                               Dysphonia2                                             Uncommon 3
Throat irritation
Bronchospasm, including paradoxical4              Rare

Gastrointestinal disorders             Diarrhoea3                                        Common 3
Nausea
Dry mouth2
Stomatitis3                                       Uncommon

Skin and subcutaneous tissue           Rash3                                             Uncommon 3 disorders                              Pruritus

Musculoskeletal and connective tissue Myalgia2                                           Common 2 disorders                              Muscle spasms

Renal and urinary disorders            Urinary retention3                                Uncommon 
Investigations                         Blood creatine phosphokinase increased1           Common 
Blood pressure increased3                         Uncommon

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