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NASACORT HAYFEVER 55 MICROGRAMS/DOSE NASAL SPRAY SUSPENSION

Active substance: TRIAMCINOLONE ACETONIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NASACORT Hayfever 55 micrograms/dose, nasal spray, suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Triamcinolone acetonide
Bottles of NASACORT Hayfever contain either 6.5 g or 16.5 g of suspension (with
3.575 mg or 9.075 mg triamcinolone acetonide respectively). One delivered dose
contains 55 micrograms of triamcinolone acetonide.
Excipient with known effect: 15 micrograms of benzalkonium chloride/delivered
dose.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Nasal spray, suspension.
It is an unscented, thixotropic suspension of microcrystalline triamcinolone acetonide
in an aqueous medium.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NASACORT Hayfever is indicated for the treatment of symptoms of seasonal
allergic rhinitis.

4.2

Posology and method of administration

Posology
Patients aged 18 years and over: The recommended starting dose is 220 micrograms
as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be
maintained on 110 micrograms (1 spray in each nostril once daily).

Without medical supervision, Nasacort Hayfever is not recommended for use longer
than three months. If symptoms of seasonal allergic rhinitis are not relieved or if they
worsen within 14 days, a physician must be consulted.
Special population
Paediatric population
NASACORT Hayfever is not recommended in children and adolescents under 18
years of age.
Method of administration
NASACORT Hayfever is for nasal use only.
It is important to shake the bottle gently before each use.
Each actuation delivers 55 micrograms of triamcinolone acetonide from the nose
piece to the patient (estimated from in vitro testing) after an initial priming of 5 sprays
until a fine mist is achieved. NASACORT Hayfever will remain adequately primed
for 2 weeks. If the product is unused for more than 2 weeks, then it can be adequately
reprimed with one spray. The nozzle should be pointed away from you while you are
doing this.
After using the spray: Wipe the nozzle carefully with a clean tissue or handkerchief,
and replace the dust-cap.
If the spray does not work and it may be blocked, clean it as follows. NEVER try to
unblock it or enlarge the tiny spray hole with a pin or other sharp object because this
will destroy the spray mechanism.
The nasal spray should be cleaned at least once a week or more often if it gets
blocked.
TO CLEAN THE SPRAY
1.

Remove the dust-cap and the spray nozzle only* (pull off).

2.

Soak the dust-cap and spray nozzle in warm water for a few minutes, and then
rinse under cold running tap water.

3.

Shake or tap off the excess water and allow to air-dry.

4.

Re-fit the spray nozzle.

5.

Prime the unit as necessary until a fine mist is produced and use as normal.

* Part as indicated on diagram below,

Also, the bottle should be discarded after 30 actuations or within one month of
starting treatment (6.5 g pack), or after 120 actuations or within 2 months of starting
treatment (16.5 g pack). Do not transfer any remaining suspension to another bottle.
4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section
6.1.
4.4

Special warnings and precautions for use

If there is any reason to suppose that adrenal function is impaired, care must be taken
while transferring patients from systemic steroid treatment to NASACORT Hayfever.
In clinical studies with NASACORT Hayfever administered intranasally, the
development of localised infections of the nose and pharynx with Candida albicans
has rarely occurred. When such an infection develops it may require treatment with
appropriate local therapy and temporary discontinuation of treatment with
NASACORT Hayfever.
Because of the inhibitory effect of corticosteroids on wound healing in patients who
have experienced recent nasal septal ulcers, nasal surgery or trauma, NASACORT
Hayfever should be used with caution until healing has occurred.
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).
Treatment with higher than recommended doses may result in clinically significant
adrenal suppression. If there is evidence of using higher than recommended doses,
then additional systemic corticosteroid cover should be considered during periods of
stress or elective surgery.

Glaucoma and/or cataracts have been reported in patients receiving nasal
corticosteroids. Therefore, close monitoring is warranted in patients with a change in
vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
NASACORT Hayfever contains benzalkonium chloride, an irritant, which may cause
skin reactions.
Paediatric population
NASACORT Hayfever is not recommended in children and adolescents under 18
years of age.
4.5

Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.

4.6

Fertility, pregnancy and lactation
Clinical experience in pregnant women is limited. In animal studies,
corticosteroids have been shown to induce teratogenic effects. Triamcinolone
acetonide may pass into human breast milk. Triamcinolone acetonide should
not be administered during pregnancy or lactation unless the therapeutic
benefit to the mother is considered to outweigh the potential risk to the
foetus/baby.

4.7

Effects on ability to drive and use machines
NASACORT Hayfever has no or negligible influence on the ability to drive and use
machines.

4.8

Undesirable effects

The adverse reactions reported in clinical trials with NASACORT Hayfever most
commonly involved the mucous membranes of the nose and throat.
The following terminologies have been used in order to classify the occurrence of
adverse reactions:
Very common (≥ 1/10); Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to <
1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (1/10,000); and not known (cannot
be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of
decreasing seriousness.

The most frequent adverse reactions were:

Infections and infestations
Common: flu syndrome, pharyngitis, rhinitis

Immune system disorders
Not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema)

Psychiatric disorders
Not known: insomnia

Nervous system disorders
Common: headache
Not known: dizziness, alterations of taste and smell

Eye disorders
Not known: cataract, glaucoma, increased ocular pressure

Respiratory, thoracic and mediastinal disorders
Common: bronchitis, epistaxis, cough
Rare: nasal septum perforations
Not known: nasal irritation, dry mucous membrane, nasal congestion, sneezing,
dyspnoea

Gastrointestinal disorders
Common: dyspepsia, tooth disorder
Not known: nausea

General disorders and administration site conditions
Not known: fatigue

Investigations
Not known: decreased blood cortisol
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at
high doses 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9

Overdose
Like any other nasally administered corticosteroid, acute overdosing with
NASACORT Hayfever is unlikely in view of the total amount of active ingredient
present. In the event that the entire contents of the bottle were administered all at
once, via either oral or nasal application, clinically significant systemic adverse

events would most likely not result. The patient may experience some gastrointestinal
upset if taken orally.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: DECONGESTANTS AND OTHER NASAL
PREPARATIONS FOR TOPICAL USE, Corticosteroids, ATC code: R 01 AD11.
Mechanism of action
Triamcinolone acetonide is a more potent derivative of triamcinolone and is
approximately 8 times more potent than prednisone. Although the precise mechanism
of corticosteroid antiallergic action is unknown, corticosteroids are very effective in
the treatment of allergic diseases in man.
Pharmacodynamic effects
NASACORT Hayfever does not have an immediate effect on allergic signs and
symptoms. An improvement in some patient symptoms may be seen within the first
day of treatment with NASACORT Hayfever and relief may be expected in 3 to 4
days. When NASACORT Hayfever is prematurely discontinued symptoms may not
recur for several days.
In clinical studies performed in adults and children at doses up to 440 µg/day
intranasally, no suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis has
been observed.
5.2

Pharmacokinetic properties
Single dose intranasal administration of 220 micrograms of NASACORT
Hayfever in normal adult subjects and in adult patients with allergic rhinitis
demonstrated low absorption of triamcinolone acetonide. The mean peak
plasma concentration was approximately 0.5 ng/ml (range 0.1 to 1 ng/ml) and
occurred at 1.5 hours post dose. The mean plasma drug concentration was less
than 0.06 ng/ml at 12 hours and below the assay detection limit at 24 hours.
The average terminal half life was 3.1 hours. Dose proportionality was
demonstrated in normal subjects and in patients following a single intranasal
dose of 110 micrograms or 220 micrograms NASACORT Hayfever.
Following multiple doses in paediatric patients, plasma drug concentrations,
AUC, Cmax and Tmax were similar to those values observed in adult patients.

5.3

Preclinical safety data
In pre-clinical studies, only effects typical of glucocorticoids were observed.

Like other corticosteroids, triamcinolone acetonide (administered by
inhalation or other routes) has been shown to be teratogenic in rats and rabbits,
resulting in cleft palate and/or internal hydrocephaly and axial skeletal defects.
Teratogenic effects, including CNS and cranial malformations, have also been
observed in non-human primates.
No evidence of mutagenicity was detected in in vitro gene mutation tests.
Carcinogenicity assays in rodents show no increase in the incidence of individual
tumour types.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
microcrystalline cellulose and carmellose sodium (dispersible cellulose)
polysorbate 80
purified water
anhydrous glucose
benzalkonium chloride (50% w/v solution)
disodium edetate
hydrochloric acid or sodium hydroxide (for pH-adjustment).

6.2

Incompatibilities
Not applicable

6.3

Shelf life
Unopened: 2 years.
After first opening: 1 month for the 6.5 g (30 actuation) pack and 2 months for the
16.5 g (120 actuation) pack

6.4

Special precautions for storage

Do not store above 25°C
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5

Nature and contents of container
NASACORT Hayfever is contained in a 20 ml high density polyethylene (HDPE)
bottle fitted with a metered-dose spray pump unit.
One bottle of NASACORT Hayfever contains either 6.5 g or 16.5 g of suspension,
providing 30 or 120 actuations respectively.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
50 Kings Hill Avenue
West Malling
Kent
ME19 4AH
United Kingdom
Or Trading as:Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 04425/0669

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/08/2011

10

DATE OF REVISION OF THE TEXT

02/01/2015

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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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