Adverse reactions : תופעות לוואי

4.8        Undesirable effects
Summary of the safety profile
The most commonly reported adverse reaction during treatment with Ryaltris was dysgeusia (a substance-specific unpleasant taste), epistaxis and nasal discomfort.


Tabulated list of adverse reactions
The following adverse reactions have been reported during clinical studies and post- marketing data and are classified according to 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 <1/1000), very rare (<1/10,000) or not known (cannot be estimated from the available data).


Frequency                  Common                 Uncommon            Rare                   Not known 
System Organ
Class

Infection and                                                         Bacterial              Pharyngitis* infestations                                                          vaginosis Upper respiratory tract infection*

Immune                                                                                       Hypersensitivity system                                                                                       including disorders                                                                                    anaphylactic reactions,
angioedema,
bronchospasm,
and dyspnoea*

Psychiatric                                                           Anxiety disorders
Depression
Insomnia
Nervous                    Dysgeusia           Dizziness            Lethargy system disorder            (unpleasa
Headaches            Migraine nt taste)
Somnolence


Eye disorders                                                       Blurred vision              Cataracts* Dry eye                     Glaucoma*
Eye                         Increased discomfort                  intraocular pressure*

Ear and                                                             Ear pain labyrinth disorder

Respiratory,               Epistaxis           Nasal                Nasal                       Nasal septum thoracic and                                   dryness              inflammation                perforation* Nasal mediastinal discomfor t                                 Nasal mucosal disorders disorder
Oropharyngeal pain
Sneezing
Throat irritation

Gastrointestinal                               Dry mouth            Constipation disorders
Abdominal            Sore tongue pain
Nausea

General                                        Fatigue disorders and administration site conditions

Injury,                                                             Laceration poisoning and procedural complications

*reported with the use of corticosteroids.

Systemic effects of some nasal corticosteroids may occur, particularly when administered at high doses for prolonged periods (see section 4.4).
Growth retardation has been reported in children receiving nasal corticosteroids.
Growth retardation may be possible in adolescents, too (see section 4.4).


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