nasal corticosteroid - ATC code: R 01 AD

triamcinolone acetonide

The active component of Nasacort Allergy Nasal Spray is triamcinolone acetonide. Each bottle of Nasacort Allergy Nasal Spray contains 3.575 mg triamcinolone acetonide and provides at least 30 actuations each containing 55 micrograms of active compound after initial priming.

Nasal Spray suspension. It is an unscented, thixotropic suspension of microcrystalline triamcinolone acetonide in an aqueous medium

Nasacort Allergy Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis.

The recommended dose is 220 micrograms as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 micrograms (1 spray in each nostril once daily). The minimum effective dose should be used to ensure continued control of symptoms.

Medical advice should be sought if symptoms worsen or persist after 14 days treatment.

It is important to shake the bottle gently before each use.

Each actuation delivers 55 micrograms triamcinolone acetonide from the nasal actuator to the patient (estimated from in vitro testing) after an initial priming of 5 sprays until a fine mist is achieved. Nasacort Allergy Nasal Spray will remain adequately primed for 2 weeks. If the product is unused for more than 2 weeks, then it can be adequately re-primed with one spray. The nozzle should be pointed away from you while you are doing this.

Not recommended for children or adolescents under 18 years of age.

Hypersensitivity to any of the ingredients of this preparation or an infection in the nose contraindicates its 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 Nasacort Allergy. Patients taking steroids should consult their doctor before using this product.

In clinical studies with Nasacort Allergy or Triamcinolone 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 discontinuation of treatment with Nasacort Allergy.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have had recent nasal surgery or recent prolonged nose-bleeds or any other nasal problems should consult their doctor before using this product.

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).

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.

This product should not be used for longer than 3 months without consulting a doctor.

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.

None known.

The adverse events reported in clinical trials with Nasacort Allergy most commonly involved the mucous membranes of the nose and throat.

The following frequency rating has been used, when applicable:

Very common 10%; Common 1 and < 10%; Uncommon 0.1 and < 1%; Rare 0.01 and < 0.1%; Very rare < 0.01% and not known (frequency cannot be estimated from available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The most frequent adverse reactions in adults were:

• Infections and infestations

Common: flu syndrome, pharyngitis, rhinitis

• Immune system disorders

Not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema)

• Psychiatric disorders

Not known: insomnia

• Nervous system disorders

Common: headache

Not known: dizziness and alterations of taste and smell

• Eye disorders

Not known: cataract, glaucoma, increased ocular pressure

• Respiratory, thoracic and mediastinal disorders

Common: bronchitis, epistaxis, cough

Rare: nasal septum perforations

Not known: nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea

• Gastrointestinal disorders

Common: dyspepsia, tooth disorder

Not known: nausea

• General disorders and administration site conditions

Not known: fatigue

• Investigations

Not known: decreased blood cortisol

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

sanofi-aventis

(POM)

13 February 2012