Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Like all medicines, Aerovent can cause side effects.
a)    Summary of the safety profile
Many of the undesirable effects listed can be attributed to the anticholinergic properties of Aerovent.
 b)      Tabulated summary of undesirable effects
Aerovent                                                                Proposed prescribing information Boehringer Ingelheim                                                        January 2022- Minor Update 

The undesirable effects listed were identified from clinical trial data and postmarketing surveillance.
Their frequency is defined using the following convention:
Very common                  (≥ 1/10)
Common                       (≥ 1/100 - < 1/10)
Uncommon                     (≥ 1/1000 - < 1/100)
Rare                         (≥ 1/10,000 - < 1/1000)
Very rare                    (< 1/10,000)
Not known                    (Frequency cannot be estimated from the available data) 
Immune system disorders
Uncommon:                                            Anaphylactic reactions, hypersensitivity 
Nervous system disorders
Common:                                              Headache, dizziness 
Eye disorders
Uncommon:                                            Blurred vision, mydriasis, increased intraocular pressure (sometimes with eye pain), foggy vision,
halo or rainbow vision, conjunctival hyperaemia and corneal oedema, glaucoma
Rare:                                                Accommodation disorders 
Cardiac disorders
Uncommon                                             Palpitations, (supraventricular) tachycardia Rare:                                                Atrial fibrillation 
Respiratory, thoracic and mediastinal disorders
Common:                                              Cough, throat irritation Uncommon:                                            (Paradoxical) bronchospasm, laryngospasm, phar- yngeal oedema, dry throat

Gastrointestinal disorders
Common:                                              Dry mouth, taste disturbance, gastrointestinal mo- tility disorders, nausea
Uncommon:                                            Constipation, diarrhoea, abdominal pain, vomiting, stomatitis, oral oedema

Skin and subcutaneous tissue disorders
Uncommon:                                            Rash, pruritus, angioedema Rare:                                                Urticaria

Renal and urinary disorders
Uncommon:                                            Urinary retention  c)       Common undesirable effects
As with any other inhaled medication, Aerovent may also be associated with local irritation in the throat. The most common undesirable effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastrointestinal motility disorders (including constipation, diarrhoea and vomiting), nausea and dizziness.

Reporting of suspected adverse reactions
Aerovent                                                             Proposed prescribing information Boehringer Ingelheim                                                      January 2022- Minor Update 

You can report side effects to the Ministry of Health by following the link ‘Reporting Side Effects of Drug Treatment' on the Ministry of Health home page (www.health.gov.il) which links to an online form for reporting side effects. You can also use this link: https://sideeffects.health.gov.il