AIRCORT Nasal spray, suspension Ref.[50135] Active ingredients: Budesonide

Revision Year: 2012  Publisher: Italchimici SpA, Via Pontina 5, Km 29, 00040 Pomezia (Rome)

4.1. Therapeutic indications

Seasonal allergic rhinitis, perennial allergic and non-allergic rhinitis.

Treatment of nasal polyps.

Preventive against nasal polyps after polypectomy.

4.2. Posology and method of administration

Dosage should be individually determined.

Treatment of rhinitis: Recommended dose for adults and children 6 years of age or older: two 50 ยตg administrations (100 micrograms into each nostril) twice daily, morning and evening – or two 100ยตg administrations (200 micrograms into each nostril) once daily in the morning.

Treatment/prevention of nasal polyps: 200 micrograms twice daily into each nostril.

Note: The patient should be informed that the full effect of Aircort is not achieved until after a few days of treatment (in rare cases not until after 2 weeks). Treatment of seasonal rhinitis should, if possible, start before exposure to allergens. Concomitant treatment with, for example, an antihistamine may sometimes be necessary to control eye symptoms caused by allergy. If the nasal passages are severely blocked a nasal vasoconstrictor may be used during the first 2-3 days of treatment.

4.9. Overdose

Acute overdose with Aircort nasal spray, even in excessive doses, is not a clinical problem.

6.3. Shelf life

AIRCORT 100 micrograms/spray: 36 months if stored correctly and in the original pack.

AIRCORT 50 micrograms/spray: 24 months if stored correctly and in the original pack.

6.4. Special precautions for storage

Store at a temperature below 25ยฐC.

Store inside the original carton.

6.5. Nature and contents of container

200 sprays 15 ml amber glass bottle fitted with a 50 microlitre metered dose pump.

6.6. Special precautions for disposal and other handling

Before each administration:

  1. Shake vigorously the bottle before use.
  2. Remove the dust cap from the nasal applicator.
  3. Hold the bottle between your fingers and away from your face. Activate the valve by pressing it between your fingers a few times until a fine mist is produced. Once the valve is primed it will remain activated for future administrations unless the bottle is opened or not used for a long time.
  4. Before using Aircort, blow your nose gently in order to free your nostrils of mucous secretions.
  5. Keep your head slightly tilted backwards, close one nostril with your finger, insert the nasal applicator into the other nostril and press down the valve to produce the spray mist.
  6. Remove the applicator from the nose, keep your head tilted backwards for a few more seconds then repeat the procedure with the other nostril.
  7. Replace the dust cap onto the applicator.

Warning: Use within 3 months of opening. In the case of valve blockage, remove the nasal applicator from the bottle and rinse it with warm water for few minutes. Do not attempt to poke it with pointed objects.

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