DYMISTA Nasal spray, suspension Ref.[115137] Active ingredients: Azelastine Fluticasone

Posology

For full therapeutic benefit regular usage is essential.

Contact with the eyes should be avoided.

Adults and adolescents (12 years and older)

One actuation in each nostril twice daily (morning and evening).

Children below 12 years

Azelastine/Fluticasone Nasal Spray is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group.

Elderly

No dose adjustment is required in this population.

Renal and hepatic impairment

There are no data in patients with renal and hepatic impairment.

Duration of treatment

Azelastine/Fluticasone Nasal Spray is suitable for long-term use.

The duration of treatment should correspond to the period of allergenic exposure.

Method of administration

Azelastine/Fluticasone Nasal Spray is for nasal use only.

Instruction for use

Preparing the spray:

The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards and the protective cap be removed afterwards. Prior to first use Azelastine/Fluticasone Nasal Spray must be primed by pressing down and releasing the pump 6 times. If Azelastine/Fluticasone Nasal Spray has not been used for more than 7 days it must be reprimed once by pressing down and releasing the pump.

Using the spray:

After blowing the nose the suspension is to be sprayed once into each nostril keeping the head tilted downward (see figure). After use the spray tip is to be wiped and the protective cap to be replaced.

With the nasal route of administration overdose reactions are not anticipated.

There are no data from patients available on the effects of acute or chronic overdosage with intranasal fluticasone propionate.

Intranasal administration of 2 milligrams fluticasone propionate (10 times the recommended daily dose) twice daily for seven days to healthy human volunteers has no effect on hypothalamo-pituitary-adrenal (HPA) axis function.

Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.

In these patients, treatment with Azelastine/Fluticasone Nasal Spray 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.

In the event of overdose after incidental oral uptake, disturbances of the central nervous system (including drowsiness, confusion, coma, tachycardia and hypotension) caused by azelastine hydrochloride are to be expected based on the results of animal experiments.

Treatment of these disorders must be symptomatic. Depending on the amount swallowed, gastric lavage is recommended. There is no known antidote.

Bottle with 6.4 g suspension in 10 ml bottles: 1 year.

Bottle with 23 g suspension in 25 ml bottles: 2 years.

In-use shelf life (after first use): 6 months.

Do not refrigerate or freeze.

Type I amber glass bottle fitted with a spray pump, a nasal polypropylene applicator (actuator) and a dust cap, containing 6.4 g (at least 28 actuations) and 23 g (at least 120 actuations) suspension.

Pack sizes:

1 bottle with 6.4 g suspension in 10 ml bottles (at least 28 actuations), 1 bottle with 23 g suspension in 25 ml bottles (at least 120 actuations).

Multipacks containing 64 g (10 bottles with 6.4 g) nasal spray, suspension Multipacks containing 69 g (3 bottles with 23 g) nasal spray, suspension.

Not all pack sizes may be marketed.

Shake the bottle gently before use.

No special requirements for disposal.