BECONASE Aqueous suspension for intranasal inhalation Ref.[27911] Active ingredients: Beclometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Glaxo Wellcome UK Ltd., Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

4.1. Therapeutic indications

Beconase Aqueous Nasal Spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hayfever, and vasomotor rhinitis. Beclometasone dipropionate has a potent anti-inflammatory effect within the respiratory tract, with a lower incidence and severity of adverse events than those observed when corticosteroids are administered systemically.

4.2. Posology and method of administration

Beconase Aqueous Nasal Spray is for administration by the intranasal route only.

Adults and children over six years of age: The recommended dosage is two sprays into each nostril twice daily (400 micrograms/day). Once control has been established it may be possible to maintain control with fewer sprays. A dosage regimen of one spray into each nostril morning and evening has been shown to be efficacious in some patients. However, should symptoms recur, patients should revert to the recommended dosage of two sprays into each nostril morning and evening. The minimum dose should be used at which effective control of symptoms is maintained. Total daily administration should not normally exceed eight sprays.

For full therapeutic benefit regular usage is essential. The co-operation of the patient should be sought to comply with the regular dosage schedule and it should be explained that maximum relief may not be obtained within the first few applications.

For children under six years old, there are insufficient clinical data to recommend use.

4.9. Overdose

The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of Hypothalamic-Pituitary-Adrenal (HPA) function. No special emergency action need be taken. Treatment with Beconase Aqueous Nasal Spray should be continued at the recommended dose. HPA function recovers in a day or two.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

There is no specific treatment for an overdose of beclometasone dipropionate. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

6.3. Shelf life

24 months when not stored above 30°C.

6.4. Special precautions for storage

Beconase Aqueous Nasal Spray should not be stored above 30°C.

Keep container in the outer carton.

6.5. Nature and contents of container

A 25ml amber neutral glass bottle fitted with a metering atomising pump, or a 30ml polypropylene bottle fitted with a tamper-resistant metering atomising pump. The pumps are manufactured by: Valois S.A. Le Prieure BPG, 27110 Le Neubourg, France.

Pack size: 200 Metered Spray.

6.6. Special precautions for disposal and other handling

Refer to Patient Information Leaflet.

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