NASACORT 55 micrograms/dose, nasal spray, suspension

Triamcinolone acetonide

Bottles of NASACORT contain 16.5 g of suspension (9.075 mg triamcinolone acetonide respectively). Each actuation delivers 55 micrograms triamcinolone acetonide.

Excipient : benzalkonium chloride (15 micrograms/actuation).

For a full list of excipients, see section 6.1.

Nasal spray, suspension.

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

NASACORT is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis.

NASACORT is for nasal use only.

Patients aged 12 years and over: The recommended starting 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).

Paediatric patients aged 6 to 12 years: The recommended dose is 110 micrograms as 1 spray in each nostril once daily. In patients with more severe symptoms, a dose of 220 micrograms may be used. But once symptoms are controlled, patients should be maintained on the lowest effective dose.

Until further evidence is available, continuous use beyond 3 months in children under 12 years is not recommended.

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

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

After using the spray: Wipe the nozzle carefully with a clean tissue or handkerchief, and replace the dust-cap.

If the spray does not work and it may be blocked, clean it as follows. NEVER try to unblock it or enlarge the tiny spray hole with a pin or other sharp object because this will destroy the spray mechanism.

The nasal spray should be cleaned at least once a week or more often if it gets blocked.

TO CLEAN THE SPRAY

1. Remove the dust-cap and the spray nozzle only* (pull off).

2. Soak the dust-cap and spray nozzle in warm water for a few minutes, and then rinse under cold running tap water.

3. Shake or tap off the excess water and allow to air-dry.

4. Re-fit the spray nozzle.

5. Prime the unit as necessary until a fine mist is produced and use as normal.

* Part as indicated on diagram below,

Also, the bottle should be discarded after 30 actuations or within one month of starting treatment (6.5 g pack), or after 120 actuations or within 2 months of starting treatment (16.5 g pack). Do not transfer any remaining suspension to another bottle.

Hypersensitivity to the active substance or to any of the excipients.

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.

In clinical studies with NASACORT 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 NASACORT.

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

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.

As experience with NASACORT in children under 6 years of age is limited, use in this age group is not recommended.

Reduction in growth velocity has been reported in children receiving nasal corticosteroids at licensed doses.

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, 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. The long-term effects of reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height are unknown.

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.

No interaction with other medicaments are known.

Clinical experience in pregnant women is limited. In animal studies, corticosteroids have been shown to induce teratogenic effects. Triamcinolone acetonide may pass into human breast milk. Triamcinolone acetonide should not be administered during pregnancy or lactation unless the therapeutic benefit to the mother is considered to outweigh the potential risk to the foetus/baby.

NASACORT has no known effect on the ability to drive and operate machines.

The adverse events reported in clinical trials with NASACORT 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 and children 6 years of age and older 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. Growth retardation has been reported in children receiving intranasal steroids.

Like any other nasally administered corticosteroid, acute overdosing with NASACORT is unlikely in view of the total amount of active ingredient present. In the event that the entire contents of the bottle were administered all at once, via either oral or nasal application, clinically significant systemic adverse events would most likely not result. The patient may experience some gastrointestinal upset if taken orally.

Pharmacotherapeutic group: nasal corticosteroid, ATC code: R 01 AD.

Triamcinolone acetonide is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective in the treatment of allergic diseases in man.

NASACORT does not have an immediate effect on allergic signs and symptoms. An improvement in some patient symptoms may be seen within the first day of treatment with NASACORT and relief may be expected in 3 to 4 days. When NASACORT is prematurely discontinued symptoms may not recur for several days.

In clinical studies performed in adults and children at doses up to 440 mcg/day intranasally, no suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis has been observed.

Single dose intranasal administration of 220 micrograms of NASACORT in normal adult subjects and in adult patients with allergic rhinitis demonstrated low absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 ng/mL (range 0.1 to 1 ng/mL) and occurred at 1.5 hours post dose. The mean plasma drug concentration was less than 0.06 ng/mL at 12 hours and below the assay detection limit at 24 hours. The average terminal half life was 3.1 hours. Dose proportionality was demonstrated in normal subjects and in patients following a single intranasal dose of 110 micrograms or 220 micrograms NASACORT. Following multiple doses in pediatric patients, plasma drug concentrations, AUC, Cmax and Tmax were similar to those values observed in adult patients.

In pre-clinical studies, only effects typical of glucocorticoids were observed.

Like other corticosteroids, triamcinolone acetonide (administered by inhalation or other routes) has been shown to be teratogenic in rats and rabbits, resulting in cleft palate and/or internal hydrocephaly and axial skeletal defects. Teratogenic effects, including CNS and cranial malformations, have also been observed in non-human primates.

No evidence of mutagenicity was detected in in-vitro gene mutation tests.

Carcinogenicity assays in rodents show no increase in the incidence of individual tumour types.

- microcrystalline cellulose

- carmellose sodium (Avicel CL-611),

- polysorbate 80,

- purified water,

- anhydrous glucose,

- benzalkonium chloride,

- disodium edentate

- hydrochloric acid or sodium hydroxide (for pH-adjustment).

Not applicable

Unopened: 2 years.

After first opening: 2 months

Do not store above 25°C

NASACORT is contained in a 20 ml high density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit.

Bottles of NASACORT contain 16.5 g of suspension, providing 120 actuations.

No special requirements

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0287

19^th January 2007

13 October 2011