FLIXOTIDE

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 200 mcg dose of beclometasone dipropionate (CFC containing) or budesonide. 8). 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 4 years 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.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data).

Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. 4) Very Rare Psychiatric Disorders Anxiety, sleep disorders, behavioural changes, including hyperactivity and irritability (predominantly in children) Depression, aggression (predominantly in children) Very Rare Not known Respiratory, Thoracic & Mediastinal Disorders Hoarseness/dysphonia Paradoxical bronchospasm Epistaxis Common Very Rare Not known Gastrointestinal Disorders Dyspepsia Very Rare Skin & Subcutaneous Tissue Disorders Contusions Common Musculoskeletal & Connective Tissue Disorders Arthralgia Very Rare Hoarseness and candidiasis of the mouth and throat (thrush) occurs in some patients.

Such patients may find it helpful to rinse out their mouth with water after using the inhaler. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with Flixotide Evohaler. 4). 4). This should be treated immediately with a fast-acting inhaled bronchodilator.

Flixotide Evohaler should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted. There was an increased reporting of pneumonia in studies of patients with COPD receiving FLIXOTIDE 500 micrograms.

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Patients’ inhaler technique should be checked regularly to make sure that inhaler actuation is synchronised with inspiration to ensure optimum delivery to the lungs.

During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in a vertical position. Sudden and progressive deterioration in asthma control is potentially life- threatening and consideration should be given to increasing corticosteroid dosage.

In patients considered at risk, daily peak flow monitoring may be instituted. Flixotide Evohaler is not designed to relieve acute symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available.

Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death. Increasing use of short-acting inhaled β2-agonists to relieve symptoms indicates deterioration of asthma control.

If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. g. higher doses of inhaled corticosteroids or a course of oral corticosteroids).

Severe exacerbations of asthma must be treated in the normal way. 8). This should be considered in particular when prescribing to patients with a history of diabetes mellitus. As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.

Flixotide Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods.

3. Contra-indications Hypersensitivity to any ingredient of the preparation.