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BENACORT 64 MICROGRAMS NASAL SPRAY

Active substance(s): BUDESONIDE

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PS11090

Package leaflet: Information for the user

Benacort™ 64 micrograms, Nasal Spray
Budesonide

Read all of this leaflet carefully before
you start using this medicine because
it contains important information for
you.
This medicine is available without
prescription. Always use this medicine
exactly as described in this leaflet or
as your pharmacist has told you.
■ Keep this leaflet. You may need to
read it again.
■ Ask your pharmacist if you need more
information or advice.
■ If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet.See section 4.
■ You must talk to a doctor if you do not
feel better or if you feel worse after
14 days.
What is in this leaflet
1. What Benacort™ is and what it is
used for
2. What you need to know before you
use Benacort™
3. How to use Benacort™
4. Possible side effects
5. How to store Benacort™
6. Contents of the pack and other
information

1. What Benacort™ is and
what it is used for

This nasal spray contains a medicine
called budesonide. This belongs to a
group of medicines called corticosteroids.
■ Corticosteroids help to dampen down
and prevent inflammation.
■ This nasal spray is used to treat
inflammation in the nose that can
occur as a result of an allergy to
things such as pollen. The
inflammation causes the nose to be
blocked and results in sneezing, these
are typical symptoms of hay fever.
■ Regular use of this nasal spray over
several days can reduce inflammation
in the nose and help prevent these
symptoms.
You must talk to a doctor if you do not feel
better or if you feel worse after 14 days.

2. What you need to know
before you use Benacort™

Do not use Benacort™:
■ If you are allergic to budesonide or
any of the other ingredients of this
medicine (listed in section 6).
■ If you are under 18 years of age.
Do not use this nasal spray if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
using it.

Warnings and precautions
Talk to your doctor or pharmacist before
using Benacort™ if:
■ You have an infection of your nose or
sinuses.
■ You have ulcers in your nose.
■ You have recently had surgery to your
nose.
■ You have TB (tuberculosis).
■ You have a chest infection.
■ You have reduced liver function.
If any of the above apply to you, or if you
are not sure, talk to your doctor or
pharmacist before using this nasal spray.
Contact your doctor if you experience
blurred vision or other visual disturbances.

Other medicines and Benacort™
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines. This is
because Benacort™ can affect the way
some medicines work and some
medicines can have an effect on
Benacort™ and your doctor may wish to
monitor you carefully.

In particular, talk to your doctor or
pharmacist if:
■ You are taking medicines to treat
fungal infections (such as itraconazole
or keto-conazole).
■ You are taking HIV medicines (such
as ritonavir or cobicistat-containing
products).

■ You have been taking steroid

tablets. Your doctor or pharmacist
may ask you to take fewer of them
after starting to use this nasal spray.
If you notice any unusual effects as a
result of this, tell your doctor.
■ You are taking oestrogens and
contraceptive steroids.

Pregnancy, breast-feeding and fertility
■ If you are pregnant or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
■ If you get pregnant while using this
nasal spray, talk to your doctor or
pharmacist straight away.
Driving and using machines
Benacort™ is not likely to affect you being
able to drive or use any tools or machines.

3. How to use Benacort™

Always use this medicine exactly as
described in this leaflet or as your doctor
or pharmacist have told you. Check with
your doctor or pharmacist if you are not
sure.
How much Benacort™ to use
Do not use more than two sprays into
each nostril in a day.

Using the nasal spray once a day:
■ The recommended dose is two sprays
into each nostril in the morning.
■ If your symptoms improve, reduce
this to one spray in each nostril in the
morning.
Using the nasal spray twice a day:

■ If you prefer, you can use one spray

into each nostril every morning and
evening.

When to start using the nasal spray
Try to start using this nasal spray before
you come into contact with whatever
causes the allergy. For example, if it is
a particular type of pollen that causes
your hay fever, use this nasal spray just
before and during the time when you are
exposed to it.
How long to use the nasal spray for

■ Use this nasal spray regularly. Keep

using it until you are no longer
exposed to whatever is causing your
allergy.
■ The full effect of treatments like this
nasal spray are not achieved until after
a few days of treatment. You may not
notice any effects for the first few days.
■ If there is no improvement in your
symptoms after 14 days, talk to your
doctor or pharmacist.
■ Do not use this nasal spray
continuously for longer than 3 months
without talking to your doctor.
Use in children
This nasal spray should not be used in
children and adolescents under 18 years.
Instructions for use

1. Priming the nozzle
Before using this nasal spray for the first
time, you must prime the nozzle (that is,
fill it with the medicine). To do this:
■ Shake the bottle and
remove the
protective cap.
■ Hold the bottle
upright as shown
in the picture.
■ Pump the nozzle
up and down several
times (5 to 10 times),
spraying into the air
until you see
an even mist.
The priming effect
remains for about 24 hours. If you leave
a gap of more than a day before the next
dose, you will need to prime the nozzle
again. This time spray it into the air just
once.
2. Using Benacort™

■ Blow your nose. Shake the bottle.

Remove the protective cap.

■ Hold the bottle as shown

in the picture.

■ Put the tip of the

nozzle into your
nostril, as shown.
Spray once (or more
if the doctor or
pharmacist has told
you to).
Use the spray in
the other nostril in
the same way. Note,
you do not need to
breathe in at the
same time as you spray.
■ Wipe the nozzle with a clean tissue
and replace the protective cap. Store
the bottle in an upright position.

3. Cleaning the nozzle
It is best to clean the plastic nozzle of this
nasal spray regularly. Also clean it if you
notice that the spray is not coming out as
it should. If this happens, first check the
nozzle is primed with medicine (see
“Priming the nozzle” above). If after
priming the nozzle again the pump is still
not working, clean the nozzle as follows:
■ Remove the plastic nozzle with a
clean tissue and wash it in warm
(not hot) water.
■ Rinse the nozzle thoroughly, dry it and
then replace it on the top of the bottle.
Never try to unblock the nozzle by
using a pin or other sharp object.
■ Prime the nozzle again (by filling it
with medicine) before use.
Additional information about using
Benacort™
■ If you are about to have an operation
or during times of stress, please tell
your doctor that you use this nasal
spray. Your doctor may ask you to
take steroid tablets as well,
particularly if you have been taking
a high dose of this nasal spray, or a
similar medicine, for a long time.
■ Eye problems: If you have an allergy,
which is also causing eye problems,
you may need to take another
medicine as well.
If you use more Benacort™ than you
should
It is important that you take your dose as
stated on the pharmacist’s label or as
advised by your doctor. You should use
only as much as your doctor recommends; using more or less may make
your symptoms worse.
If you take too many doses of this nasal
spray, talk to your doctor or pharmacist
straight away.
If you forget to use Benacort™
If you forget to take a dose, take it as
soon as you remember. However, if it is
almost time to take the next dose, wait
until then. Do not take a double dose to
make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

If any of the following happen to you,
stop using this nasal spray and talk to
your doctor straight away:
■ Skin rash, itching, lumpy rash
(hives), blistering of the skin.
Swelling of your face, lips, tongue
or throat (this may make it difficult
to swallow). These are uncommon,
affecting less than 1 in 100 people.
■ Severe allergic reaction. This is
rare, affecting less than 1 in 1000
people.
■ In addition to the above, sudden
wheezing and/or feeling faint may
occur. It is not known how often
these occur; however they are very
unlikely.
If any of the above occurs, you may
be having an allergic reaction.
Other possible side effects:
Common (may affect up to 1 in 10
people)
■ Occasional sneezing, dry nose, or
stinging in your nose. These can
happen straight after using this
nasal spray.
■ Slight bleeding from the nose.

Uncommon (may affect up to 1 in 100
people)
■ Muscle cramps

Rare (may affect up to 1 in 1000
people)
■ Slowing in the rate of growth of
children and adolescents.
Corticosteroids can affect the normal production of steroid
hormones in your body, particularly
if you use high doses for a long
time. This is much less likely to
happen with inhaled corticosteroids
than with corticosteroid tablets.
■ Perforation of the membrane
separating the nostrils (the nasal
septum).
■ Nasal ulcer.
■ Loss of voice.
■ Bruising of the skin.
■ Blurred vision.
Very rare (may affect up to 1 in 10,000
people)
■ Sore patches on the inside of the
nose.
Not known (frequency cannot be
estimated from available data)
■ Glaucoma (increased pressure in
the eye).
■ Cataract

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can report side effects
directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Benacort™

■ Keep this medicine out of the sight

and reach of children.

■ Do not use this medicine after the






expiry date which is stated on the
carton. The expiry date refers to the
last day of the month.
Do not store above 30°C.
Do not freeze or store in the fridge.
Store the bottle in an upright position.
Use within 2 months of opening the
bottle. You may find it helpful to write
on this leaflet when you first opened
the bottle:

Date bottle opened
………………………………………..

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and
other information

What Benacort™ contains
■ The active ingredient is budesonide.
This nasal spray contains 64
micrograms of budesonide in each
spray.
■ The other ingredients are disodium
edetate, potassium sorbate (E202),
glucose (anhydrous), microcrystalline
cellulose (E460), carboxymethylcellulose
sodium (E466), polysorbate 80
(E433), hydrochloric acid and purified
water.
■ Each bottle of this nasal spray
contains 120 sprays.

What Benacort™ looks like and
contents of the pack
This nasal spray is a metered pump nasal
spray. Benacort™ is available in a 10 ml
amber/brown glass bottle. Each bottle
is fitted with a spray pump and contains
120 sprays.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder for
Benacort™ marketed in the UK is McNeil
Products Limited, Maidenhead, Berkshire,
SL6 3UG, UK.
Benacort™ is manufactured by
AstraZeneca UK Limited, Silk Road
Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.
This leaflet was last revised in July 2017

Benacort 64 mcg Nasal Spray. PS11090 Version: LKL-c. Size: 406 x 160 mm.

17-0207

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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