FOR UK HEALTHCARE PROFESSIONALS
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148.
Fluticasone propionate 400 micrograms (1 mg/ml) nasal drops suspension Prescribing Information
(Please refer to the full SmPC before prescribing)
Indications: Regular treatment of nasal polyps and associated symptoms of nasal obstruction. Method of administration: Intranasal route only, avoid contact with the eyes. After shaking and opening the container, the patient should adopt one of the positions outlined in the patient information leaflet. Divide the dose between the nostrils by either counting approximately 6 drops into each nostril or by holding the dimpled sides of the container and squeezing once into each nostril (one squeeze delivers approximately half the dose). Full instructions for use are given in the patient information leaflet. Dosage: Titrate to the lowest effective dose for maintaining disease control. Adults: Instil the contents of one container (400 micrograms) once or twice daily. Divide the dose between the affected nostrils. Elderly: Normal adult dosage. Paediatric population: Insufficient data to recommend fluticasone propionate for the treatment of nasal polyps in children less than 16 years. Contraindications: History of hypersensitivity to the active substance Fluticasone Propionate or any of the excipients. Special warnings and precautions for use: Appropriately treat local Infections of the nasal airways but these do not constitute a specific contra-indication to treatment with Fluticasone propionate. Unilateral polyposis rarely occurs and could be indicative of other conditions. Diagnosis should be confirmed by a specialist. Regularly assess nasal polyps to monitor severity of the condition. Avoid contact with the eyes and broken skin. Caution when withdrawing patients from systemic steroid treatment, and commencing therapy with Fluticasone propionate, particularly if there is potential that their adrenal function is impaired. Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents and more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression
(particularly in children). Regularly monitor the height of children receiving prolonged treatment with nasal corticosteroids, consider referring to a paediatrician if growth is retarded. If there is evidence of higher than recommended doses being used, then consider additional systemic corticosteroid cover during periods of stress or elective surgery. If a patient presents with visual disturbances or blurred vision, consider referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy which have been reported after use of systemic and topical corticosteroids. If also using inhaled steroids for asthma, consider cumulative steroid burden and potential excess steroid load which might also affect growth retardation. Interactions: Ritonavir can greatly increase fluticasone propionate plasma concentration. Avoid concomitant use unless the potential benefit outweighs the risk of systemic corticosteroid side-effects. Combining fluticasone propionate with other potent CYP3A inhibitors also increases systemic side effect risk. Fertility, pregnancy, and breastfeeding: Pregnancy There is inadequate evidence of safety in human pregnancy. Breast-feeding: The excretion of fluticasone propionate into human breast milk has not been investigated. Carefully consider risk/benefit balance before use in Pregnancy and Lactation Side effects: Common and serious side effects included here. For full list of side effects consult SmPC. Very common (≥1/10): Epistaxis. Common (≥1/100 to <1/10): Nasal dryness, nasal irritation, throat dryness, throat irritation. Very rare serious: Hypersensitivity reactions, anaphylaxis/anaphylactic reactions, bronchospasm, rash, oedema of face and mouth, glaucoma, raised intraocular pressure, cataract, nasal septal perforation, Unknown frequency serious: nasal ulcers. MA number: PL35533/0183 Cost: £15.99. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Legal category: POM. Date last reviewed: September 2023. Version Number: 10105772081 v 1.0
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