Adverse reactions : תופעות לוואי

4.8.     Undesirable effects

A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.

As with other inhalation therapy, paradoxical bronchospasm may occur after dosing.
Immediate treatment with a short-acting bronchodilator should be initiated, Qvar should be discontinued immediately and an alternative prophylactic treatment introduced.

Systemic effects of inhaled corticosteroids may occur, particularly with high doses prescribed for prolonged periods. These include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density and the occurrence of cataract and glaucoma.

Commonly, when taking Qvar, hoarseness and candidiasis of the throat and mouth may occur.
To reduce the risk of hoarseness and candida infection, patients are advised to rinse their mouth after using their inhaler.

Based on the MedDra system organ class and frequencies, adverse events are listed in the table below according to the following frequency estimate: 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), not known (cannot be estimated from the available data).


MedDra – system organ class                           Frequency and Symptom Infections and infestations                           Common: Candidiasis in mouth and throat

Immune system disorders                               Rare: Allergic reactions, angioedema in eyes, throat, lips and face

Endocrine disorders                                   Very rare: Adrenal suppression,*, growth retardation * (in children and adolescents), bone density decreased*

Psychiatric Disorders                                 Unknown: Psychomotor hyperactivity, sleep disorders, anxiety, depression,
aggression, behavioural changes
(predominantly in children)

Nervous system disorders                              Uncommon: Headache, vertigo, tremor 
Eye disorders                                         Uncommon: Vision, blurred (see also section 4.4)

Very rare: Cataract,* glaucoma*

Not known: Central serous retinopathy
Respiratory, thoracic and mediastinal                 Common: Hoarseness, pharyngitis disorders
Uncommon: Cough, increased asthma symptoms

Rare: Paradoxical bronchospasm

Gastrointestinal disorders                            Common: Taste disturbances 
Uncommon: Nausea

Skin and subcutaneous tissue disorders                Uncommon: Urticaria, rash, pruritus, erythema, purpura

Musculoskeletal and connective tissue        Very rare: Decrease bone mineral density disorders
*Systemic reactions are a possible response to inhaled corticosteroids, especially when a high dose is prescribed for a prolonged time (see section 4.4 Special warnings and precautions for use).

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