Giona Easyhaler Adverse Reactions

Frequency of reported adverse reactions: Common (>1/100, <1/10): Respiratory system disorders: hoarseness, cough and throat irritation.
Resistance mechanism disorders: oropharyngeal candidiasis.
Gastrointestinal disorders: difficulty in swallowing.
Infections and Infestations: Pneumonia (in COPD patients).
Rare (>1/10,000, <1/1000): Skin and appendages disorders: easy bruising, skin thinning, urticaria, rash, dermatitis, pruritus, erythema.
Psychiatric disorders: depression, aggressive reactions, irritability, anxiety, psychosis, behavioural changes in children, restlessness, increased motorial activity.
Endocrine disorders: hypocorticism, hypercorticism.
Respiratory system disorders: bronchospasm (see Precautions).
Body as a whole: general disorders: anaphylactic shock, angioedema, immediate and delayed hypersensitivity reactions.
Musculoskeletal, connective tissue and bone disorders: growth retardation.
Very rare including isolated cases (<1/10,000): Psychiatric disorders: nervousness.
Endocrine disorders: adrenal suppression.
Eye disorders: cataract, glaucoma.
Musculoskeletal, connective tissue and bone disorders: Decreased bone density.
Treatment with inhaled budesonide may result in candida infection in the oropharynx. Experience has shown that candida infection occurs less often when inhalation is performed before meals and/or when the mouth is rinsed after inhalation. In most cases this condition responds to topical anti-fungal therapy without discontinuing treatment with inhaled budesonide.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, and susceptibility to infections. The ability to adapt to stress may be impaired. The systemic effects described, however, are much less likely to occur with inhaled budesonide than with oral corticosteroids.