Clinically significant drug interactions have been reported post-marketing in patients treated with fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate with ritonavir should be avoided unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects (see section 4.5).
Systemic effects of nasal corticosteroids may occur, particularly when high doses are prescribed for prolonged periods. These effects are far less likely to occur than with oral corticosteroids and may vary between individual patients and between different corticosteroid preparations. Potential systemic effects 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 disturbances, anxiety, depression or aggression (particularly in children).
Dymol undergoes extensive first-pass hepatic metabolism; therefore, systemic exposure to fluticasone propionate is likely to be increased in patients with severe hepatic impairment. This may increase the frequency of systemic adverse reactions. Caution is advised when treating these patients.
Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence that higher than recommended doses are being used, additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Doses of intranasal fluticasone preparations should generally be reduced to the lowest dose at which effective control of rhinitis symptoms is maintained. Doses higher than the recommended dosage (see section 4.2) have not been evaluated with Dymol. As with all intranasal corticosteroids, the total systemic corticosteroid burden should be taken into account whenever other forms of corticosteroid therapy are prescribed concomitantly.
Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. Since growth also continues during adolescence, it is recommended that the height of adolescents receiving prolonged treatment with nasal corticosteroids is monitored regularly. If growth is slowed, therapy should be reviewed and, where possible, the dose of nasal corticosteroid reduced to the lowest dose at which effective control of symptoms is maintained.
Visual disturbances may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which has been reported after the use of systemic and topical corticosteroids.
Close monitoring is warranted in patients with a change in vision or with a history of raised intraocular pressure, glaucoma and/or cataract.
If there is any reason to suppose that adrenal function is impaired, care should be taken when transferring patients from systemic steroid treatment to Dymol.
In patients with tuberculosis, any kind of untreated infection, or those who have recently undergone surgery or sustained an injury to the nose or mouth, the potential benefits of treatment with Dymol should be weighed against the possible risks.
Infections of the nasal airways should be treated with antibacterial or antifungal preparations but do not constitute a contraindication to treatment with Dymol.
Dymol contains benzalkonium chloride. Long-term use may cause oedema of the nasal mucosa.
