4.1. Therapeutic indications

For the treatment of seasonal allergic rhinitis including hay fever.

This medicine also provides symptomatic relief of sneezing, itchy and runny nose, itchy and watery eyes, nasal congestion and associated sinus discomfort.

4.2. Posology and method of administration

For administration by the intranasal route only.

Adults aged 18 years and over: For the treatment of seasonal allergic rhinitis: -

Two sprays into each nostril once a day, preferably in the morning. Once symptoms are under control a maintenance dose of one spray 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 two sprays into each nostril.

Elderly:- The normal adult dosage is applicable.

Children under 18 years of age: Should not be used by children and adolescents under 18 years of age.

For full therapeutic benefit regular usage is recommended.

Maximum benefit may require 3-4 days of continuous treatment in some people (see section 5.1, Pharmacodynamic Properties).

Shake gently before use.

Before use the bottle needs to be primed by pumping until a fine spray is produced.

4.3. Contraindications

Hypersensitivity to fluticasone propionate or any of the other ingredients. Concomitant use with HIV medicines (see section 4.5).

4.4. Special warnings and precautions for use

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 or pharmacist should also be sought if symptoms have improved but are not adequately controlled.

This medicine should not be used for more than 1 month 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.

Significant interactions between fluticasone propionate and potent inhibitors of the cytochrome P450 3A4 system, e.g. protease inhibitors, such as ritonavir, and cobicstat may occur. This may result in increased systemic exposure to fluticasone propionate.

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, cataract, glaucoma and more rarely, 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.

The full benefit of fluticasone propionate aqueous nasal spray may not be achieved until treatment has been administered for several days.

Although fluticasone propionate aqueous nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy.

Contains Benzalkonium Chloride which may cause bronchospasm.

4.5. Interaction with other medicinal products and other forms of interaction

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations. Cases of Cushing's syndrome and adrenal suppression have been reported. Although not studied, concomitant use of intranasal fluticasone and cobicistat-containing regimens for the treatment of HIV may increase plasma concentrations of fluticasone and result in reduced serum cortisol concentrations.The combination of fluticasone and potent P450 3A4 inhibitors should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.

Other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) increases in systemic exposure to fluticasone propionate without notable reductions in serum cortisol concentrations. Care is advised when co-administering cytochrome P450 3A4 inhibitors, especially in long-term use and in case of potent inhibitors, as there is potential for increased systemic exposure to fluticasone propionate.

4.6. Fertility, pregnancy and lactation

There is inadequate evidence of the safety of fluticasone propionate in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. It should be noted however that the foetal changes in animals occur after relatively high systemic exposure; direct intranasal application ensures minimal systemic exposure. As with other drugs the use of this medicine during human pregnancy requires that the possible benefits of the drug be weighed against the possible hazards.

The secretion of fluticasone propionate in human breast milk has not been investigated. Subcutaneous administration of fluticasone propionate to lactating laboratory rats produced measurable plasma levels and evidence of fluticasone propionate in milk. However, following intranasal administration to primates, no drug was detected in the plasma, and it is therefore unlikely that the drug would be detectable in milk. When this medicine is used in breast feeding mothers the therapeutic benefits must be weighed against the potential hazards to mother and baby.

The label will include a warning that medical opinion should be sought, before using this medicine, in the case of pregnancy or breast feeding.

4.7. Effects on ability to drive and use machines

None reported.

4.8. Undesirable effects

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

Respiratory, thoracic and mediastinal disorders

Epistaxis

Very common

Nasal dryness, nasal irritation, throat dryness, throat irritation

Common

Nasal septal perforation

Very rare

Nasal Ulcers

Unknown

As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell, headache and epistaxis have been reported.

Nasal ulceration and nasal septal perforation have been reported following the use of intranasal corticosteroids, usually when there has been previous nasal surgery.

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 Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9. Overdose

There are no data available on the effects of acute or chronic overdosage with this medicine. Intranasal administration of fluticasone propionate at 20 times the recommended starting dose in adults (2mg twice daily) for seven days to healthy human volunteers had no effect on hypothalamic-pituitary-adrenal axis function.