FLIXOTIDE ACCUHALER

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 Accuhaler is for oral inhalation use only. Flixotide Accuhaler is suitable for many patients, including those who cannot use a metered-dose inhaler successfully. The dose may be increased until control is achieved or reduced to the minimum effective dose, according to the individual response.

The onset of therapeutic effect is within 4 to 7 days. 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. The maximum licensed dose in children is 200 micrograms twice daily. 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. Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate to the severity of their disease.

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

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 Accuhaler. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Flixotide Accuhaler. 4). 4). This should be treated immediately with a fast-acting inhaled bronchodilator.

Flixotide Accuhaler 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. Flixotide Accuhaler 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. 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.

Fluticasone propionate is not for use in acute asthma attacks, but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms. 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 Accuhaler 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. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

1 (including lactose, which contains small amounts of milk-protein).