Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Local infection: Infections of the nasal airways should be appropriately treated but do not constitute a specific contra-indication to treatment with Flixonase Nasule Drops.

Unilateral polyposis rarely occurs, and could be indicative of other conditions. Diagnosis should be confirmed by a specialist.

Nasal polyps require regular medical assessment to monitor severity of the condition.
Contact with the eyes and broken skin should be avoided.

Care must be taken when withdrawing patients from systemic steroid treatment, and commencing therapy with Flixonase Nasule Drops, particularly if there is any reason to suppose that their adrenal function is impaired.

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 (see section 5.2). Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses. It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist, if growth is retarded.

It is possible that long term treatment with higher than recommended doses of nasal corticosteroids could result in clinically significant adrenal suppression. If there is evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects. There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5)

Visual disturbance

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 which have been reported after use of systemic and topical corticosteroids.

Effects on Driving

4.7   Effects on ability to drive and use machines

Not relevant.
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