Active substance(s): BECLOMETASONE DIPROPIONATE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 Micrograms Beclometasone Dipropionate BP per 100mg actuation.
Excipient with known effect: benzalkonium chloride.
For the full list of excipients, see section 6.1.
Aqueous Nasal Spray
Beconase Allergy / Hayfever is indicated for the prevention and treatment of allergic
rhinitis, including hayfever, in adults aged 18 and over. Beconase Allergy/Hayfever
provides symptomatic relief from nasal congestion, runny nose, sneezing, itchy nose,
eye symptoms (such as itching, watering, redness) and associated sinus discomfort.
Posology and Method of Administration
Method of Administration
Beconase Allergy / Hayfever is for administration by the intranasal route only.
Adults aged 18 and over: The recommended dosage is two sprays into each nostril
morning and evening (400 micrograms/day). Once control has been established, it
may be possible to maintain control with fewer sprays. A dosage regimen of one
spray into each nostril morning and evening has been shown to be efficacious in some
patients. However, should the symptoms recur, patients should revert to the
recommended dosage of two sprays into each nostril morning and evening. The
minimum dose should be used at which effective control of symptoms is maintained.
Total daily administration should not exceed eight sprays (400 micrograms).
Beconase Allergy / Hayfever quickly starts to reduce inflammation and swelling in
the nose. But for best effect patients should start to use Beconase Allergy / Hayfever
two or three days before they expect to get symptoms to prevent them from
developing. For full therapeutic benefit Beconase Allergy / Hayfever should be used
If symptoms have not improved after 14 days treatment, medical advice must be
Beconase Allergy / Hayfever is not recommended for children or adolescents under
18 years of age.
Beconase Allergy / Hayfever is contra-indicated in patients with a history of
hypersensitivity to the active substance or to any of the excipients listed in section
Special Warnings and Precautions for Use
Systemic effects of nasal corticosteroids may occur, particularly at high doses
when used 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
Treatment with higher than recommended doses may result in clinically
significant adrenal suppression. If there is evidence for higher than
recommended doses being used then additional systemic corticosteroid cover
should be considered during periods of stress or elective surgery.
This product should not be used continuously for longer than 3 months without
consulting a doctor.
Infections of the nasal passages and paranasal sinuses should be appropriately
treated but do not constitute a specific contra-indication to treatment with
Beconase Allergy / Hayfever.
Although Beconase Allergy / Hayfever will control seasonal allergic rhinitis in
most cases, an abnormally heavy challenge of summer allergens may, in
certain instances, necessitate appropriate additional therapy particularly to
control eye symptoms.
Medical advice should be sought before using Beconase Allergy / Hayfever in
the case of recent injury or surgery to the nose, or problems with ulceration in
the nose. Beconase Allergy/Hayfever contains Benzalkonium Chloride which
may cause bronchospasm and local reactions.
Interaction with other medicinal products and other forms of interaction
Beclomethasone is less dependent on CYP3A metabolism than some other
corticosteroids, and in general interactions are unlikely; however the possibility
of systemic effects with concomitant use of strong CYP3A inhibitors (e.g.
ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate
monitoring is advised with the use of such agents.
Fertility, Pregnancy and Lactation
No known effect.
There is inadequate evidence of safety in human pregnancy. Administration of
corticosteroids to pregnant animals can cause abnormalities of fetal development
including cleft palate and intra-uterine growth retardation. There may therefore be a
very small risk of such effects in the human fetus. It should be noted, however, that
the fetal changes in animals occur after relatively high systemic exposure. Beconase
Allergy / Hayfever delivers beclometasone dipropionate directly to the nasal mucosa
and so minimises systemic exposure.
The use of beclometasone dipropionate should be avoided during pregnancy unless
thought essential by the doctor.
No specific studies examining the transference of beclometasone dipropionate into
the milk of lactating animals have been performed. It is reasonable to assume that
beclometasone dipropionate is secreted in milk, but at the dosages used for direct
intranasal administration there is low potential for significant levels in breast milk.
Beconase Allergy / Hayfever should not be used during lactation without consulting a
Effect on Ability to Drive and Use Machines
Rare cases of nasal septal perforation have been reported following the use of
As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant
taste and smell and epistaxis have been reported rarely.
Rare cases of raised intra-ocular pressure, glaucoma or cataract in association with
intranasal formulations of beclometasone dipropionate have been reported.
Very rare cases of hypersensitivity reactions including rashes, urticaria, pruritus and
erythema, and oedema of the eyes, face, lips and throat, anaphylactoid / anaphylactic
reactions, dyspnoea and/or bronchospasm have been reported.
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 MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
The only harmful effect that follows inhalation of large amounts of the drug over a
short time period is suppression of hypothalamic-pituitary adrenal (HPA) function.
No special emergency action need be taken. HPA function recovers in a day or two
after discontinuation of treatment with Beconase Allergy / Hayfever.
Following topical administration, beclometasone 17,21-dipropionate (BDP) produces
potent anti-inflammatory and vasoconstrictor effects.
BDP is a pro-drug with weak corticosteroid receptor binding affinity. It is hydrolysed
via esterase enzymes to the highly active metabolite beclometasone -17monopropionate (B-17-MP), which has high topical anti-inflammatory activity.
Beclometasone dipropionate offers a preventative background treatment for hayfever
when taken prior to allergen challenge. After which, with regular use, BDP can
continue to prevent allergy symptoms from reappearing.
Following intranasal administration of BDP in healthy males, the systemic absorption
was assessed by measuring the plasma concentrations of its active metabolite B-17MP, for which the absolute bioavailability following intranasal administration is 44%
(95% CI 28%, 70%). After intranasal administration, <1% of the dose is absorbed by
the nasal mucosa. The remainder, after being cleared from the nose, either by
drainage or mucocilary clearance, is available for absorption from the gastrointestinal
tract. Plasma B-17-MP is almost entirely due to conversion of BDP absorbed from
the swallowed dose.
Following oral administration of BDP the systemic absorption was also assessed by
measuring the plasma concentrations of its active metabolite B-17-MP, for which the
absolute bioavailability following oral administration is 41% (95% CI 27%, 62%).
Following an oral dose, B-17-MP is absorbed slowly with peak plasma levels reached
3-5 hours after dosing.
The tissue distribution at steady-state for BDP is moderate (201) but more extensive
for B-17-MP (4241). Plasma protein binding of BDP is moderately high (87%).
BDP is cleared very rapidly from the circulation and plasma concentrations are
undetectable (< 50pg/ml) following oral or intranasal dosing. There is rapid
metabolism of the majority of the swallowed portion of BDP during its first passage
through the liver. The main product of metabolism is the active metabolite (B-17MP). Minor inactive metabolites, beclometasone -21-monopropionate (B-21-MP)
and beclometasone (BOH), are also formed but these contribute little to systemic
The elimination of BDP and B-17-MP are characterised by high plasma clearance
(150 and 1201/h) with corresponding terminal elimination half-lives of 0.5h and 2.7h.
Following oral administration of tritiated BDP, approximately 60% of the dose was
excreted in the faeces within 96 hours mainly as free and conjugated polar
metabolites. Approximately 12% of the dose was excreted as free and conjugated
polar metabolites in the urine.
Preclinical safety data
List of excipients
Avicel RC 591
Anhydrous Dextrose for
(added as Benzalkonium Chloride
36 months. After first opening the shelf life is 3 months.
Special precautions for storage
Beconase Allergy / Hayfever should not be stored above 30°C. Keep container in the
outer carton. Do not refrigerate.
Nature and contents of container
Beconase Allergy / Hayfever is supplied in 17ml or 25ml amber glass bottles fitted
with a metering, atomising pump and nasal applicator or in a 20ml or 30ml plastic
bottle fitted with a tamper resistant, metering atomising pump and nasal applicator. A
combined nasal adaptor/actuator covered with a dust cap is fitted on the pump. The
glass bottle provides 80, 100, 180 or 200 metered sprays, and the plastic bottle
provides 100, 180 or 200 sprays.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
32 Vauxhall Bridge Road
LONDON, SW1V 2SA
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
Date of first authorisation: 23 August 2007
DATE OF REVISION OF THE TEXT