Merck Sharp & Dohme Limited

The following additions have been made to section 4.4 Special warnings and precautions for use of the SmPC as follows:

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). Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.

The following additions have been made to section 4.8 Undesirable effects of the SmPC as follows:

 As with other intranasal corticosteroids rare cases of nasal septum perforation have been reported.

Rare cases of glaucoma, increased intraocular pressure and/or cataracts have been reported with the use of intranasal corticosteroids.

 Update made following the assessment of the Period Safety Update Report.

After Table 2, the following paragraph has been added:

In patients treated for acute rhinosinusitis,  the incidence of epistaxis for NASONEX was 3.3% vs. 2.6% for placebo and similar to that observed for patients treated with allergic rhinitis.

Section 5.1

 The following paragraph has been added to this section:

Section 10

 The date of revision of text has been revised