NASACORT Nasal Spray suspension Ref.[6451] Active ingredients: Triamcinolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

4.1. Therapeutic indications

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

4.2. Posology and method of administration

Patients aged 18 years and over: 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.

Children: not recommended for children or adolescents under 18 years of age.

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.

After using the spray: Wipe the nozzle carefully with a clean tissue or handkerchief, and replace the 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 cap and the spray nozzle only* (pull off).
  2. Soak the 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. Do not transfer any remaining suspension to another bottle.

4.9. Overdose

Like any other nasally administered corticosteroid, acute overdosing with Nasacort Allergy or Triamcinolone Nasal Spray 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.

6.3. Shelf life

The shelf-life of Nasacort Allergy or Triamcinolone Nasal Spray is 24 months.

The shelf life after the bottle is first opened is 1 month.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Nasacort Allergy or Triamcinolone Nasal Spray is contained in a 20 ml high density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Each bottle of Nasacort Allergy or Triamcinolone Nasal Spray contains 6.5 g of suspension and provides at least 30 actuations.

6.6. Special precautions for disposal and other handling

No special requirements.

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