Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
For the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever and vasomotor rhinitis.
Nasobec is indicated in adults and children aged six years and over.
Nasobec can significantly delay the recurrence of nasal polyps after nasal polypectomy. Where polyps do recur, Nasobec can suppress their increase in size.
Two sprays twice daily into each nostril (400 mcg/day) is the recommendeddosage. It may be preferable for some patients to administer a single spray into each nostril three or four times daily. Once control has been established it may be possible to maintain control with fewer sprays. Dosage should be adjusted in each individual case to the lowest dose that achieves effective control of the symptoms.
The maximum daily dose of 400 mcg (eight sprays) should not normally be exceeded.
It should be made clear to patients that full therapeutic benefit will only be achieved after a few days treatment.
Dosage as for adults.
The safety and efficacy of Nasobec in children aged less than six years old has not been established.
For administration by the intranasal route only.
Exceeding the maximum prescribed dose for a short time can cause suppression of the HPA function.
No special emergency measures are necessary. Treatment should be continued at the prescribed dosage and the function of the hormonal feedback mechanism will generally be restored after 1-2 days.
3 years unopened.
Discard three months after first using the spray.
Store below 25ºC.
Keep the bottle in the outer carton.
Nasobec is supplied in polyethylene bottles of 30 ml capacity containing a nominal 200 doses fitted with a metering pump with a built in nasal adaptor. Each bottle is designed to deliver a nominal 100 milligrams of suspension per spray.
Use within three months of starting treatment.
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