For the prophylaxis and treatment of allergic rhinitis including hay fever and that caused by other
airborne allergens such as house dust mite and animal dander.
This medicine also provides symptomatic relief of sneezing, itchy and runny nose, itchy and watery eyes,
nasal congestion and associated sinus discomfort.

For administration by the intranasal route only.
Adults aged 18 years and over: For the prophylaxis and treatment of allergic rhinitis:
Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each
nostril twice daily may be required. 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 four 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.
Prophylaxis of allergic rhinitis requires treatment before contact with allergen. 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.

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 control This medicine should not be
used for more than 3 months continuously without consulting a doctor.

in most cases, an abnormally heavy challenge of summer allergens may in certain
instances necessitate appropriate additional therapy.
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
fever or an infection in the nasal passages or sinuses.
recent injury or surgery to the nose, or problems with ulceration in the nose.
Local infection: infections of the nasal airways should be appropriately treated but do not
constitute a specific contraindication to treatment with intranasal fluticasone propionate.
Care must be taken when withdrawing patients from systemic steroid treatment, and
commencing therapy with intranasal fluticasone propionate, particularly if there is any
reason to suspect that their adrenal function is impaired.

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. ketoconazole and protease inhibitors, such as ritonavir
and cobicistat, 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.
Contains Benzalkonium Chloride which may cause bronchospa

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. The combination should be avoided
unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
Other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and minor
(ketoconazole) 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.

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.

None reported.

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.

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.
To report any side effect(s):
• Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
• Other GCC States:
- Please contact the relevant competent authority.

Administration of doses higher than those recommended over a long period of time may lead to
temporary suppression of adrenal function.
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.

ATC Code: R01AD08
Fluticasone propionate is a glucocorticosteroid which has potent anti-inflammatory activity by acting via
the glucocorticoid receptor. However, when used at up to four times the recommended daily dose on the
nasal mucosa, has no detectable systemic activity and causes little or no hypothalamic pituitary adrenal
(HPA) axis suppression. Following intranasal dosing of fluticasone propionate, (200 micrograms/day) no
significant change in 24h serum cortisol AUC was found compared to placebo (ratio 1.01, 90%CI 0.9-
1.14).
Fluticasone propionate has been shown to reduce inflammatory mediators in both the early and late phase
reactions of allergic rhinitis.
Once daily dosing with 200μg fluticasone propionate is sufficient to help relieve symptoms (particularly
nasal congestion) for up to 24 hours.

Absorption: Following intranasal dosing of fluticasone propionate, (200 micrograms/day) steady-state
maximum plasma concentrations were not quantifiable in most subjects (<0.01ng/mL). The highest Cmax
observed was 0.017ng/mL. Direct absorption in the nose is negligible due to the low aqueous solubility
with the majority of the dose being eventually swallowed. When administered orally the systemic
exposure is <1% due to poor absorption and pre-systemic metabolism. The total systemic absorption
arising from both nasal and oral absorption of the swallowed dose is therefore negligible.
Distribution: Fluticasone propionate has a large volume of distribution at steady-state (approximately
318L). Plasma protein binding is moderately high (91%).

Metabolism: Fluticasone propionate is cleared rapidly from the systemic circulation, principally by
hepatic metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Swallowed fluticasone propionate is also subject to extensive first pass metabolism. Care should be taken
when co-administering potent CYP3A4 inhibitors such as ketoconazole and ritonavir as there is potential
for increased systemic exposure to fluticasone propionate.
Elimination: The elimination rate of intravenous administered fluticasone propionate is linear over the
250-1000 micrograms dose range and are characterized by a high plasma clearance (CL=1.1L/min). Peak
plasma concentrations are reduced by approximately 98% within 3-4 hours and only low plasma
concentrations were associated with the 7.8h terminal half-life. The renal clearance of fluticasone
propionate is negligible (<0.2%) and less than 5% as the carboxylic acid metabolite. The major route of
elimination is the excretion of fluticasone propionate and its metabolites in the bile.

There are no preclinical data of relevance to the prescriber which are additional to that already included
in the other sections of the SPC.

Dextrose (anhydrous)
Microcrystalline cellulose
Carboxymethylcellulose sodium
Phenylethyl alcohol
Benzalkonium chloride
Polysorbate 80
Purified water
Dilute hydrochloric acid

None reported

Do not store above 30ºC.

An amber glass bottle fitted with a metering pump and a nasal applicator. Each bottle provides
approximately 60 metered sprays or 120 metered sprays.

No special instructions.