Merck Sharp & Dohme Limited

A request from the MHRA regarding a decision taken by the Pharmacovigilance Working Party (PhVWP) relating to risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids has resulted in changes suggested by the PhVWP to our SmPC and PIL where relevant. sections affected include:

4.4 Special warnings and precautions for use

Systemic effects of inhaled 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. Possible systemic effects may include Cushing’s syndrome. Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Therefore, it is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

4.8 Undesirable effects

"Psychiatric disorders: Psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression" has been added to table 1 Treatment-related undesirable effects seen in clinical trials and post-marketing reporting with a frequency of 'not known'

In section 4.5 the active name has been written out fully, so now reads mometasone furoate.

In section 4.6 it is now stated that breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Section 4.8 table now includes Immune System disorders, asthma aggravation. There is also additional information on Bronchospasm and how the patient should discontinue Asmanex immediately if this is to occur.

Section 6.1 now references that lactose anhydrous contains trace amounts of milk protein.

Section 6.5 makes reference to the strength of the product.

Change of ownership from Schering-Plough Ltd to Merck Sharpe & Dohme Limited. Therefore the following sections have been updated with the new details.

MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

MARKETING AUTHORISATION NUMBER

PL 00025/0589

DATE OF REVISION OF THE TEXT

January 2011