Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Since Symbicort Turbuhaler contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug related adverse reactions are pharmacologically predictable side effects of β2 adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.
Adverse reactions, which have been associated with budesonide or formoterol, are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000) and very rare (< 1/10 000).
Table 1

Adverse Drug reaction
SOC                                Frequency


Candida infections in the oropharynx
Infections and infestations        Common
Immune system disorders          Rare        Immediate and delayed hypersensitivity reactions, e.g.
exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction

Endocrine disorders              Very rare   Cushing's syndrome, adrenal suppression, growth retardation, decrease in bone mineral density

Metabolism and nutrition         Rare        Hypokalaemia disorders
Very rare   Hyperglycaemia

Psychiatric disorders            Uncommon    Aggression, psychomotor hyperactivity, anxiety, sleep disorders

Very rare   Depression, behavioural changes (predominantly in children)

Nervous system disorders
Common      Headache, tremor
Uncommon    Dizziness
Taste disturbances
Very rare


Eye disorders
Uncommon    Vision blurred (see also section 4.4)
Very rare
Cataract and glaucoma
Cardiac disorders
Common      Palpitations


Uncommon    Tachycardia


Rare        Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Very rare   Angina pectoris. Prolongation of QTc-interval


Vascular disorders
Very rare   Variations in blood pressure
Respiratory, thoracic and                    Mild irritation in the throat, coughing, dysphonia including Common mediastinal disorders                        hoarseness


Rare
Bronchospasm

Gastrointestinal disorders
Uncommon    Nausea
Skin and subcutaneous tissue
Uncommon    Bruises disorders

Musculoskeletal and connective
Uncommon    Muscle cramps tissue disorders
Candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth out with water after each maintenance dose will minimise the risk. Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid. If oropharyngeal thrush occurs, patients should also rinse their mouth out with water after the as-needed inhalations.
As with other inhalation therapy, paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. Symbicort should be discontinued immediately, the patient should be assessed and an alternative therapy instituted if necessary (see section 4.4).
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's Syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur. Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity.
Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Paediatric population
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored (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/