Method of administration
For nasal inhalation.
Potassium sorbate (E202)
Microcrystalline cellulose (E460)
Carboxymethylcellulose sodium (E466)
Polysorbate 80 (E433)
Tabulated list of adverse reactions
Adverse reactions, which have been associated with budesonide, are given below, listed by system organ class and frequency. Frequency is 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), very rare (<1/10,000) and not known (cannot be estimated from available data).
Immune system disorders
Immediate and delayed hypersensitivity reactions including urticaria, rash, dermatitis angioedema and pruritus
Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation.
Raised intraocular pressure or Glaucoma
Respiratory, thoracic and mediastinal disorders
Haemorrhagic secretion and epistaxis
Nasal Irritation (sneezing, stinging and dryness)
Nasal septum perforation
Ulceration of mucous membrane
Musculoskeletal and connective tissue disorders
Injury, poisoning and procedural complications
* based on mechanistic plausibility and extrapolation from other budesonide/corticosteroid formulations.
In rare cases, signs or symptoms of systemic glucocorticosteroid-side effects such as Cushing's syndrome, Cushingoid features, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children), may occur with nasal glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity (see section 4.4).
Growth retardation has been reported in children receiving intranasal steroids. Due to the risk of growth retardation in the paediatric population, growth should be monitored as described in 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
Treatment should be stopped or the advice of a doctor or pharmacist should be sought if an improvement is not seen within 2 weeks or if symptoms have improved but are not adequately controlled.
This medicine should not be used for more than 3 months continuously without consulting a doctor or pharmacist.
Special care is demanded in treatment of patients transferred from oral steroids to this medicine where disturbances of the hypothalamic-pituitary-adrenal (HPA) axis could be expected.
Special care is needed in patients with fungal and viral infections of the airways and in patients with active or quiescent pulmonary tuberculosis.
Special care is needed where there is an infection in the nasal passages or sinuses, or in the case of recent surgery to the nose, or problems with ulceration in the nose.
Concomitant treatment of seasonal rhinitis may sometimes be necessary to counteract eye symptoms caused by the allergy.
Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
The long-term effects of nasal glucocorticosteroids in children are not fully known. Physicians should closely follow the growth of children taking glucocorticosteroids for longer term by any route, and weigh the benefits of the glucocorticosteroid therapy against the possibility of growth suppression.
This medicine should not be used for children or adolescents under 18 years of age.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Co-treatment with CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products is expected to increase the risk of systemic corticosteroid side effects. Therefore, the combination should be avoided unless the benefit outweighs this increased risk, in which case patients should be monitored for systemic corticosteroid side effects. This is of limited clinical importance for short-term (1-2 weeks) treatment with itraconazole or ketoconazole or other potent CYP3A inhibitors, but should be taken into consideration during long-term treatment. A reduction in the dose of budesonide should also be considered.
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