FLUTICASONE PROPIONATE

Posology Adults aged 18 years and over:

The recommended dose is two actuations into each nostril once a day (200 micrograms fluticasone propionate), preferably in the morning. In cases of severe symptoms two actuations into each nostril twice daily may be required but only for short term use.

Once symptoms are under control a maintenance dose of one actuation per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose at which effective control of symptoms is maintained should be used.

The maximum daily dose should not exceed four actuations into each nostril. In some patients full benefit of treatment may not be achieved in the first few days and therefore treatment of patients with a history of seasonal allergic rhinitis may need to be initiated some days before the expected start of the pollen season to help prevent symptoms from occurring.

For full therapeutic benefit regular usage is recommended. Treatment should not exceed the period of allergen exposure. Maximum benefit may require 3-4 days of continuous treatment in some people.

Elderly:

The normal adult dosage is applicable. Paediatric population The nasal spray should not be used in children and adolescents under 18 years of age due to a lack of experience. Method of administration For administration by the intranasal route only.

Not to be used in the eyes or mouth. Shake gently before use. Before first use of a new bottle, or if the bottle has not been used for some time, the bottle needs to be primed by pumping until a fine spray is produced. To use the spray, place the nozzle in one nostril whilst the other is closed ensuring the nozzle is aimed away from the nasal septum.

Spray into the nostril whilst breathing in and then breathe out through the mouth.

The most common event experienced after administration is epistaxis; however most cases are non-serious in nature and self-limiting. The most serious events are anaphylaxis/anaphylactic reactions, bronchospasm and nasal septal perforation.

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) and very rare (<1/10,000) including isolated reports.

Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account.

System Organ Class Adverse Event Frequency Immune system disorders Hypersensitivity reactions, anaphylaxis/anaphylactic reactions, bronchospasm, skin rash, oedema of the face or tongue Very rare Nervous system disorders Headache, unpleasant taste, unpleasant smell Common Eye disorders Glaucoma, raised intraocular pressure, cataract Very rare Blurred vision Unknown Epistaxis Very common Nasal dryness, nasal irritation, throat dryness, throat irritation Common Respiratory, thoracic and mediastinal disorders Nasal septal perforation Very rare Nasal ulcer Unknown Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Treatment should be stopped or the advice of a doctor sought if an improvement is not seen within 7 days. The advice of a doctor should also be sought if symptoms have improved but are not adequately controlled. This medicine should not be used for more than 3 months continuously without consulting a doctor.

Medical advice should be sought before using this medicine in the case of: • concomitant use of other corticosteroid products, such as tablets, creams, ointments, asthma medications, similar nasal sprays or eye/nose drops. • an infection in the nasal passages or sinuses.

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

g. ketoconazole and protease inhibitors, such as ritonavir, and cobicistat - may occur. 5). Systemic effects of nasal corticosteroids 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 and more rarely bone mineral density reduction, effects on glucose metabolism and a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

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.

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. 3).

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