FLIXOTIDE EVOHALER Pressurised inhalation, suspension Ref.[6859] Active ingredients: Fluticasone

Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic.

If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

Flixotide Evohaler is for oral inhalation use only. Flixotide Evohaler may be used with a Volumatic spacer device by patients who find it difficult to synchronise aerosol actuation with inspiration of breath.

The onset of therapeutic effect is within 4 to 7 days.

Adults and children over 16 years: 100 to 1,000 micrograms twice daily, usually as two twice daily inhalations.

Prescribers should be aware that fluticasone propionate is as effective as other inhaled steroids approximately at half the microgram daily dose. For example, a 100mcg of fluticasone propionate is approximately equivalent to 200mcg dose of beclometasone dipropionate (CFC containing) or budesonide.

Due to the risk of systemic effects, doses above 500 micrograms twice daily should be prescribed only for adult patients with severe asthma where additional clinical benefit is expected, demonstrated by either an improvement in pulmonary function and/or symptom control, or by a reduction in oral corticosteroid therapy (see 4.4 Special Warnings and Precautions for Use and 4.8 Undesirable Effects).

Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate to the severity of their disease.

The dose may be increased until control is achieved or reduced to the minimum effective dose, according to the individual response.

Typical Adult Starting Doses

For patients with mild asthma, a typical starting dose is 100 micrograms twice daily. In moderate and more severe asthma, starting doses may need to be 250 to 500 micrograms twice daily. Where additional clinical benefit is expected, doses of up to 1000 micrograms twice daily may be used. Initiation of such doses should be prescribed only by a specialist in the management of asthma (such as a consultant physician or general practitioner with appropriate experience).

The dose should be titrated down to the lowest dose at which effective control of asthma is maintained

Typical starting doses for children over 4years of age

50 to 100 micrograms twice daily.

Many children’s asthma will be well controlled using the 50 to 100 microgram twice daily dosing regime. For those patients whose asthma is not sufficiently controlled, additional benefit may be obtained by increasing the dose up to 200 micrograms twice daily.

The maximum licensed dose in children is 200 micrograms twice daily.

The starting dose should be appropriate to the severity of the disease. The dose should be titrated down to the lowest dose at which effective control of asthma is maintained.

Should Flixotide 50 microgram Evohaler presentation not offer the exact paediatric dose prescribed by the physician, please see data sheets of alternative Flixotide presentation (Accuhaler, Nebules).

Administration of doses above 1000 micrograms (500 micrograms twice daily) should be via a spacer device to help reduce side-effects in the mouth and throat. (See section 4.4)

Special patient groups

There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment.

Acute

Inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not necessitate emergency action being taken. In these patients treatment with fluticasone propionate by inhalation should be continued at a dose sufficient to control asthma adrenal function recovers in a few days and can be verified by measuring plasma cortisol.

If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis occurring in children exposed to higher than approved doses (typically 1000 micrograms daily and above), over prolonged periods (several months or years); observed features included hypoglycaemia and sequelae of decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in dosage.

Chronic

Refer to section 4.4: risk of adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment with inhaled fluticasone propionate should be continued at a dose sufficient to control asthma.

Treatment

Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.

24 months.

Do not store above 30°C (86°F). Do not refrigerate or freeze. Protect from frost and direct sunlight.

As with most medicines in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold.

The canister should not be punctured, broken or burnt even when apparently empty.

Replace the mouthpiece cover firmly and snap into position.

An inhaler comprising an aluminium alloy can sealed with a metering valve, actuator and dust cap. Each canister contains 120 metered actuations of either 50, 125 or 250 micrograms of fluticasone propionate. (60 metered actuation hospital packs are available in the 125 or 250 microgram products).

The aerosol spray is inhaled through the mouth into the lungs. After shaking the inhaler the patient should exhale, the mouthpiece should be placed in the mouth and the lips closed around it. The actuator is depressed to release a spray, which must coincide with inspiration of breath.

For detailed instructions for use refer to the Patient Information Leaflet in every pack.