GENEMIST Nasal spray, suspension Ref.[115274] Active ingredients: Fluticasone furoate

Posology

For full therapeutic benefit regular scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. It may take several days of treatment to achieve maximum benefit. An absence of an immediate effect should be explained to the patient.

Seasonal allergic rhinitis and perennial allergic rhinitis

Adults and adolescents (12 years and over)

The recommended starting dosage is two sprays (27,5 μg of fluticasone furoate per spray) in each nostril once daily (total daily dose: 110 μg).

Once adequate control of symptoms is achieved, dose reduction to one spray in each nostril (total daily dose: 55 μg) may be effective for maintenance.

Children (2 to 11 years of age)

The recommended starting dosage is one spray (27,5 μg of fluticasone furoate per spray) in each nostril once daily (total daily dose: 55 μg).

Patients not adequately responding to one spray in each nostril once daily (total daily dose: 55 μg) may use two sprays in each nostril once daily (total daily dose: 110 μg). Once adequate control of symptoms is achieved, dose reduction to one spray in each nostril once daily (total daily dose: 55 μg) is recommended.

Children under 2 years of age

There is no experience in children under the age of 2 years.

Elderly patients

The normal adult dosage is applicable.

Renal patients

The normal adult dosage is applicable.

Hepatic patients

No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Method of administration

GENEMIST nasal spray is for administration by the intranasal route only.

Shake the nasal spray before use.

Patients should be instructed that the device must be primed before first use and re-primed if the cap is left off or the device does not seem to be working. In order to prime the device the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. This is important as fluticasone furoate is a thick suspension that becomes liquid when vigorously shaken. It will only spray when it becomes liquid. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen, to ensure a full dose is delivered. Once primed the patient must shake the nasal spray vigorously each time before use. The cap must be replaced after use to keep the nozzle clean and to prevent the need for re-priming.

In a bioavailability study, intranasal doses of up to 2 640 μg per day were administered over three days with no adverse systemic effects observed. Acute overdose is unlikely to require any therapy other than observation.

3 years.

Store at or below 30ºC in the container specified.

Do not refrigerate or freeze.

The nasal spray container consists of an inner container within an outer device. The inner container consists of a Type I or Type III amber glass bottle, closed with a metering spray pump. The outer device is a predominantly off-white side-actuated plastic delivery system with a light blue lever and lid containing a stopper. The outer plastic cover has a window for viewing the bottle contents.

GENEMIST is available in three pack sizes:

• 30 sprays with a target net content of 4,5 g
• 60 sprays with a target net content of 6,5 g
• 120 sprays with a target net content of 10 g.

Not all pack sizes may be marketed.

No special requirements for disposal.