FLIXONASE Nasal drops Ref.[27691] Active ingredients: Fluticasone

Posology

The dose should be titrated to the lowest dose at which effective control of disease is maintained.

For full therapeutic benefit regular usage is essential. The absence of an immediate effect should be explained to the patient as maximum relief may not be obtained until after several weeks of treatment. However, if no improvement in symptoms is seen after four to six weeks, alternative therapies should be considered.

Unilateral polyposis rarely occurs, and could be indicative of other conditions. Diagnosis should be confirmed by a specialist.

Adults

The contents of one container (400 micrograms) to be instilled once or twice daily. The dose should be divided between the affected nostrils.

Elderly

The normal adult dosage is applicable.

Paediatric population

There are insufficient data at present to recommend the use of fluticasone propionate for the treatment of nasal polyps in children less than 16 years.

Method of administration

Flixonase Nasule Drops are for administration by the intranasal route only, contact with the eyes should be avoided.

After shaking and opening the container, the patient should adopt one of the positions outlined in the patient information leaflet. The dose should be divided between the nostrils by either counting approximately 6 drops into each nostril or by holding the dimpled sides of the container and squeezing once into each nostril (one squeeze delivers approximately half the dose).

Full instructions for use are given in the patient information leaflet.

There are no data available from patients on the effects of acute or chronic overdosage with Flixonase Nasule Drops.

In healthy volunteers, intranasal administration of 2 milligrams fluticasone propionate twice daily for seven days had no effect on hypothalamic-pituitary-adrenal axis (HPA) function. Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of the adrenal function. In these patients, treatment with fluticasone propionate should be continued at a dose sufficient to control symptoms; the adrenal function will recover in a few days and can be verified by measuring plasma cortisol.

3 years.

After removal of foil: 28 days.

Do not freeze.

Keep the containers in the outer carton.

Store upright.

Do not store above 30°C.

Strips of polyethylene single dose (400 micrograms) containers, within foil wrapping are available in the following pack sizes:

28 containers (4 strips of 7 Nasules)

84 containers (12 strips of 7 Nasules)

Not all pack sizes may be marketed.

No special requirements.