AERONATE

5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. 5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms). Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).

Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended. For full therapeutic benefit regular, scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration.

1). The duration of treatment should be restricted to the period that corresponds to allergenic exposure. Children under 6 years of age The safety and efficacy of Aeronate in children under the age of 6 years has not been established.

2 but no recommendation on a posology can be made. 2). 2). 2). Method of administration Aeroate nasal spray is for administration by the intranasal route only.

Testing the Aeronte spray:

If Aeronate is to be used for the first time, the spray device must be tested for error- free operation. The intranasal device should be shaken vigorously before use. Protective cap should be removed to activate the spray mechanism. The device is primed by pressing down to spray pump for at least six spray actuations (until a fine mist is seen), whilst holding the device upright.

The device should be cleaned after each use and the cap replaced. Re- priming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.

Applying the Aeronate spray: 1. Before applying the spray, the nostrils must be cleaned by blowing your nose. 2. The spray must not be sprayed into the eyes; if the spray accidentally gets into the eyes, the eyes must be thoroughly rinsed with water.

3. The head is tilted forward slightly. The spray is held vertically and the tip is placed in one of the nostrils. The tip is held against the outer wall of the nose (see Figure 1). Figure 1 4. While inhaling through the nose, press down to spray pump once to ensure that the medication is sprayed into the nose (see Figure 2).

The tip is removed from the nose and exhaled through the mouth. Figure 2 5. The application is repeated in the other nostril. If 2 sprays are required, repeat steps 4 and 5. After each application, the tip and the inside of the cap should be wiped clean with a clean, dry cloth.

The cap should always be kept closed to ensure it remains clean.

Summary of the safety profile The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache. The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).

Tabulated list of adverse reactions There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.

Data from large clinical trials were used to determine the frequency of adverse reactions.

The following convention has been used for the classification of frequencies:

Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare <1/10,000; Not known (cannot be estimated from the available data). Immune system disorders Rare Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.

Nervous system disorders Common Headache. 4) Respiratory, thoracic and mediastinal disorders Very common *Epistaxis Common Nasal ulceration, dyspnoea** Uncommon Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.

Very rare Nasal septum perforation Not known Bronchospasm, Dysphonia, Aphonia Musculoskeletal and connective tissue disorders (Children) Not known ***Growth retardation (see Clinical experience). Description of selected adverse reactions Epistaxis *Epistaxis was generally mild to moderate in intensity.

In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short- term use (up to 6 weeks). 4). Growth retardation has been reported in children receiving nasal corticosteroids. **Dyspnoea cases were reported in more than 1% of patients during clinical trials with fluticasone furoate; similar rates were also observed in placebo groups.

Paediatric population The safety in children under 6 years has not been well established. Frequency, type and severity of adverse reactions observed in the paediatric population are similar to those in the adult population. Epistaxis *In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.

27 cm per year in growth velocity was observed compared to placebo (see Clinical efficacy and safety). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Systemic corticosteroid effects Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.

Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects. However the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.

As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently. If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.

Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Growth retardation Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. 1). 2). It is recommended that the growth of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.

If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. 1). 5). Excipients This medicinal product contains benzalkonium chloride.

Long-term use may cause oedema of the nasal mucosa. This medicine contains less than 1 mmol (23 mg) sodium per capsule, that is to say essentially “sodium-free”.

1.