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PIRINASE HAYFEVER RELIEF FOR ADULTS 0.05% NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE MICRONISED / FLUTICASONE PROPIONATE MICRONISED / FLUTICASONE PROPIONATE MICRONISED

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Aqueous suspension of 0.05% micronised fluticasone propionate. Each actuation
contains 50 micrograms of fluticasone propionate.
Excipient with known effect:
Benzalkonium Chloride
For full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Nasal spray, suspension.

4

CLINICAL PARTICULARS

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 other of the 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 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.
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 (see section 4.5).
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, cataract, glaucoma 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).
Contains benzalkonium chloride which may cause irritation and, especially on long term use,
oedema of the nasal mucosa (see section 5.3).

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. 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.

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

Immune system
disorders

Adverse Event

Hypersensitivity reactions,
anaphylaxis/anaphylactic reactions,
bronchospasm, skin rash, oedema of
the face or tongue

Frequency

Very rare

Nervous system,
disorders

Headache, unpleasant taste, unpleasant Common
smell

Eye disorders

Glaucoma, raised intraocular pressure,
cataract

Very rare

Epistaxis

Very common

Nasal dryness, nasal irritation, throat
dryness, throat irritation

Common

Nasal septal perforation

Very rare

Respiratory,
thoracic and
mediastinal
disorders

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
at:www.mhra.gov.uk/yellowcard.

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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids
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.

5.2

Pharmacokinetic properties
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 steadystate (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.

5.3

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

6

PHARMACEUTICAL PARTICULARS

6.1

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

6.2

Incompatibilities
None reported

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
An amber glass bottle fitted with a metering pump and a nasal applicator.
Each bottle provides approximately 60 metered sprays.

6.6

Special precautions for disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road

Brentford
Middlesex
TW8 9GS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 44673/0100

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/12/2015

10

DATE OF REVISION OF THE TEXT
21/04/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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