Corticosteroids (steroids).

Budesonide

Each actuation contains: Budesonide 64 micrograms (1.28 mg/ml).

Nasal spray, suspension.

Seasonal and perennial allergic rhinitis and vasomotor rhinitis. Treatment of nasal polyps.

For nasal inhalation. Dosage should be individualised.

Rhinitis (Adults including elderly)

Nasal Polyps (Adults including elderly)

Treatment can be continued for up to 3 months.

Patients should be reminded of the importance of taking this medicine regularly.

The dose should be titrated to the lowest dose at which effective control of symptoms is achieved.

Children: There are insufficient data to recommend the use of Rhinocort Aqua in children. However, it is unlikely that the risk/benefit ratio in children is different from that in adults.

Not recommended.

Hypersensitivity to any of the ingredients.

Special care is demanded in treatment of patients transferred from oral steroids to Rhinocort 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 lung tuberculosis.

The patient should be informed that the full effect of Rhinocort is not achieved until after a few days treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens. Concomitant treatment may sometimes be necessary to counteract eye symptoms caused by the allergy. In continuous long-term treatment, the nasal mucosa should be inspected regularly e.g. every 6 months.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should also be given to referring the patient to a paediatric specialist.

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.

In vivo studies have shown that oral administration of itraconazole and ketoconazole (known inhibitors of CYP3A4 activity in the liver and in the intestinal mucosa, see also section 4.5 Interactions) may cause an increase in the systemic exposure to budesonide. This is of limited clinical importance for short-term (12 weeks) treatment with itraconazole or ketoconazole, but should be taken into consideration during long-term treatment.

The metabolism of budesonide is primarily mediated by CYP3A4, a subfamily of cytochrome P450. Inhibitors of this enzyme, e.g. itraconazole and ketoconazole, can therefore increase systemic exposure to budesonide. However, the use of itraconazole or ketoconazole concomitant with Rhinocort Aqua for shorter periods is of limited importance.

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 and <1/10), uncommon (1/1000 and <1/100), rare (1/10 000 and <1/1000), very rare (<1/10 000) and not known (reported spontaneously and cannot be estimated from available post marketing data).

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

AstraZeneca

(POM)

21 May 2009