Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use
If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to STERONASE AQ NASAL SPRAY.

In clinical studies with STERONASE AQ NASAL SPRAY administered intranasally, the development of localised infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local therapy and temporary discontinuation of treatment with STERONASE AQ NASAL SPRAY.

Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, STERONASE AQ NASAL SPRAY should be used with caution until healing has occurred.

Systemic effects of nasal corticosteroids may occur, particularly when used for prolonged duration or 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 (may vary as per the potency, dosage form and pharmacokinetic properties (lipophilicity, volume of distribution and elimination half-life) of the steroid). 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).

Treatment with higher than recommended doses may result in clinically significant adrenal suppression.
If there is evidence of using higher than recommended doses then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.


The risks associated with sudden discontinuation of corticosteroids after prolonged use may include exacerbation or recurrence of the underlying disease, adrenocortical insufficiency or steroid withdrawal syndrome. However, these effects are extremely rare for nasal corticosteroids, and much less likely to occur with nasal corticosteroids than with oral corticosteroids.

Glaucoma and/or cataracts have been reported in patients receiving nasal corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.

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

STERONASE AQ NASAL SPRAY contains benzalkonium chloride, long term use may cause oedema of the nasal mucosa.

Paediatric population
STERONASE AQ NASAL SPARY is not recommended for use in children under 2 years of age.
Reduction in growth velocity has been reported in children receiving nasal corticosteroids, including STERONASE AQ NASAL SPRAY at licensed doses. See section 5.1.

It is recommended that the height of children receiving treatment with nasal corticosteroids is regularly monitored. Therapy should be managed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. The long-term effects of reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height are unknown. In addition, consideration should be given to referring the patient to a paediatric specialist, especially for children under the age of 6 years this is strongly recommended.

Effects on Driving

4.7 Effects on ability to drive and use machines
STERONASE AQ Nasal Spray has no or negligible influence on the ability to drive and use machines.