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RHINOCORT AQUA 64 MICROGRAMS NASAL SPRAY

Active substance(s): BUDESONIDE / BUDESONIDE / BUDESONIDE

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Package leaflet: Information for the user

PS09769

Rhinocort® Aqua, 64 micrograms, Nasal Spray
Budesonide
Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• 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.
In this leaflet:
1. What Rhinocort Aqua is and what it is
used for
2. What you need to know before you use
Rhinocort Aqua
3. How to use Rhinocort Aqua
4. Possible side effects
5. How to store Rhinocort Aqua
6. Contents of the pack and other
information
1. What Rhinocort Aqua is and what it is
used for
Rhinocort Aqua contains a medicine called
budesonide. This belongs to a group of
medicines called corticosteroids.
• Corticosteroids help to prevent
inflammation.
• Rhinocort Aqua is used to treat the
effects of allergies, such as hay fever,
and inflammation inside the nose (rhinitis).
• It can also stop these effects from
coming on.
• It is also used to treat small growths
inside the nose (nasal polyps).
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 Rhinocort Aqua
Do not use Rhinocort Aqua:
• 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.
If you are not sure if this applies to you, talk
to your doctor or pharmacist before using
Rhinocort Aqua.
Warnings and Precautions
Talk to your doctor or pharmacist before
using Rhinocort Aqua if:
• You have TB (tuberculosis).
• You have a chest infection.
• You have reduced liver function.
Contact your doctor if you experience
blurred vision or other visual disturbances.
If you are not sure if either of the above
apply to you, talk to your doctor or
pharmacist before using Rhinocort Aqua.
Other medicines and Rhinocort Aqua
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 Rhinocort can affect the way some
medicines work and some medicines can
have an effect on Rhinocort and your doctor
may wish to monitor you carefully.
In particular, talk to your doctor if:
• You are taking medicines to treat fungal
infections (such as itraconazole or
ketoconazole).
• You are taking HIV medicines (such as
ritonavir or cobicistat-containing products).
• You have been taking steroid tablets. Your
doctor may ask you to take fewer of them
after starting to use Rhinocort Aqua. 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 breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before using this
medicine.
• If you get pregnant while using
Rhinocort Aqua, talk to your doctor
straight away.

Rhinocort Aqua leaflet
Job ID #: 306032
Version: 3
Date: 24 August 2017

306032

Driving and using machines
Rhinocort Aqua is not likely to affect you
being able to drive or use any tools or
machines.
3. How to use Rhinocort Aqua
Always use this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Read the label to remind you of what they said.
How much Rhinocort Aqua to use
Allergies such as hay fever
• The recommended dose for adults
and the elderly is two sprays of
Rhinocort Aqua into each nostril in
the morning. Alternatively, your doctor
may ask you to take one spray of
Rhinocort Aqua into each nostril every
morning and evening.
• This may be reduced by your doctor
once your symptoms have improved.
It is important to use Rhinocort Aqua
regularly. Try to use it before you come into
contact with whatever causes the allergy.
For example, pollen is what causes hay
fever, so you will be more at risk outdoors.
Nasal polyps
• The recommended dose is one spray of
Rhinocort Aqua into each nostril every
morning and evening.
Treatment for allergies such as hay fever and for
nasal polyps can continue for up to 3 months.
Use in children
Rhinocort Aqua is not recommended for use
in children.
Instructions for use
1. Priming the nozzle
Before using
Rhinocort Aqua 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 Rhinocort Aqua
• 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
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
Rhinocort Aqua 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.

VA

Malta,UK
03
24 August 2017

11:15

Black

Profile

PS09769
AZL010/A
Pack Line Code Data:

7482

Technical
Info

Rhinocort Aqua leaflet

Font family: Nimbus Sans
Body text size:
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9.5 pt
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Additional information about using
Rhinocort Aqua
• If you are about to have an operation
or during times of stress, please tell the
doctor that you use Rhinocort Aqua. The
doctor may ask you to take steroid tablets
as well, particularly if you have been
taking a high dose of Rhinocort Aqua, 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.
• Long-term treatment: If you use
Rhinocort Aqua every day for a long time,
your doctor will need to have a regular
check of the inside of your nose (the
nasal mucosa).
• Children and adolescents: If a child or
adolescent is prescribed Rhinocort Aqua
and uses a high dose for a long time, the
doctor will need to check how well they are
growing.
If you use more Rhinocort Aqua 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 Rhinocort Aqua,
talk to your doctor or pharmacist straight away.
If you forget to use Rhinocort Aqua
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 use a double dose to make up for a
forgotten dose.
If you stop using Rhinocort Aqua
You may not notice any effects of the
medicine for the first few days. Do not
stop using this medicine. Keep taking the
medicine as you have been told to. If you
still feel no different after a few more days,
talk to your doctor or pharmacist.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
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 Rhinocort Aqua 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 Rhinocort Aqua.
• 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 of 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 the available data)
• Glaucoma (increased pressure in the eye).
• Cataract.
If any of these side effects occur, they
usually go away after a short time.

Rhinocort Aqua leaflet
Job ID #: 306032
Version: 3
Date: 24 August 2017

306032

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 also 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 Rhinocort Aqua
• K
 eep 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 or
label. The expiry date refers to the last
day of that 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 to protect the environment.
6. Contents of the pack and other
information
What Rhinocort Aqua contains
• The active ingredient is budesonide.
Rhinocort Aqua 64 micrograms 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 Rhinocort Aqua contains
120 or 240 sprays.
What Rhinocort Aqua looks like and
contents of the pack
Rhinocort Aqua is a metered pump nasal
spray. Rhinocort Aqua is available in either
a 10ml or 20 ml amber/brown glass bottle.
Each bottle is fitted with a spray pump and
contains either 120 or 240 sprays. Not all
pack sizes are marketed
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder for
Rhinocort Aqua marketed in the UK is
McNeil Products Limited, Maidenhead,
Berkshire, SL6 3UG, UK.
Rhinocort Aqua is manufactured by
AstraZeneca UK Limited, Silk Road
Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.
This leaflet was last revised: August 2017.

VA

Malta,UK
03
24 August 2017

11:15

Black

Profile

PS09769
AZL010/A
Pack Line Code Data:

7482

Technical
Info

Rhinocort Aqua leaflet

Font family: Nimbus Sans
Body text size:
9.5 pt
9.5 pt
N

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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