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BUDESONIDE 64 MICROGRAMS/ACTUATION AQUEOUS NASAL SPRAY

Active substance(s): BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Budesonide 64 micrograms/actuation,
Aqueous Nasal Spray

SZ00000LT000

Budesonide

Read all of this leaflet carefully before you start taking 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.

What is in this leaflet:
1. What Budesonide Nasal Spray is and
what it is used for
2. What you need to know before you
take Budesonide Nasal Spray
3. How to take Budesonide Nasal Spray
4. Possible side effects
5. How to store Budesonide Nasal Spray
6. Contents of the pack and other
information

1

Driving and using machines
This medicine does not affect your ability
to drive and use machines at the
recommended dose (see section 3. How
to use Budesonide Nasal Spray).

What Budesonide Nasal
Spray is and what it is used
for

Budesonide Nasal Spray contains
potassium sorbate
Potassium sorbate is an ingredient of
Budesonide Nasal Spray. It may cause
irritation of the skin or mucous
membranes (e.g. contact dermatitis).

Budesonide Nasal Spray contains
budesonide, a synthetic corticosteroid.
Corticosteroids are a group of medicines
which help fight inflammation.
Budesonide Nasal Spray is used for:
• the treatment and prevention of the
symptoms of allergies like hay fever
(e.g. caused by grass pollen)
• the treatment and prevention of the
symptoms of year-round nasal allergy
caused for example by house dust
(chronic rhinitis)
• the treatment of symptoms of nasal
polyps (small growths on the lining of
the nose).

2

3 Nasal Spray

How to take Budesonide

Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

What you need to know
before you take Budesonide
Nasal Spray

Budesonide Nasal Spray is intended for
nasal use. It should be sprayed into your
nostrils as described below.

Do not take Budesonide Nasal Spray
• if you are allergic to budesonide, or any
of the other ingredients of this medicine
(listed in section 6).

Dosage
The dose should be adjusted to suit you.
Use the lowest dose which still relieves
your symptoms.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Budesonide Nasal Spray
• if you have been taking this medicine
continuously for a long time, your
doctor will want to examine the inside of
your nose at least every six months.
• if you have been taking higher than
recommended doses of this medicine:
Your doctor may prescribe steroid
tablets during periods of stress (such as
if you have an infection) or before an
operation.
• if you have any ulcers in your nose.
• if your have infectious blisters on your
lips (a cold sore), in the nose or around
your eyes.
• if you suffer from nosebleeds.
• if you have had an operation on your
nose or any other injury to your nose
that has not yet fully recovered.
• if you have a bacterial, viral or fungal
infection of your nose: You should use
Budesonide Nasal Spray if you were
prescribed treatment for the infection as
well.
• if you have problems with your liver
because the amount of budesonide
could build up in your body. Your doctor
might need to check your liver, and as a
result, may need to reduce your dose.
• if you were switched from another
dosage form to the nasal spray and
have problems with your adrenal
function.
• if you were told by your doctor you have
infection of airways or lung
tuberculosis. This is an infection that
can affect your lungs.

Allergic rhinitis
Starting dose
Adults, adolescents (12 years of age and
older) and children older than 6 years of
age:
The recommended starting dose of
Budesonide Nasal Spray is a total of 4
sprays (256 micrograms) each day.

You can either use this medicine:
• once daily by applying 2 sprays into
each nostril in the morning
or
• twice daily by applying 1 spray into
each nostril in the morning and 1 spray
into each nostril in the evening.
Children should be treated under
guidance of an adult.

Ideally, you should start to use this
medicine up to 14 days before you expect
your symptoms to start. For example, if
you have hay fever, start using this
medicine about 2 weeks before your hay
fever symptoms usually begin to be a
problem and stop using this medicine
after the end of season of allergen
exposure.
Maintenance dose
It takes 7 to 14 days for this medicine to
work. After this, your doctor may lower
your dose.

Nasal polyps
Adults, adolescents (12 years of age and
older) and children older than 6 years of
age:
The recommended starting dose of
Budesonide Nasal Spray is a total of 4
sprays (256 micrograms) each day.

Children
• if you are a child and are taking
high doses of this medicine for a long
time, your doctor will check your height
regularly

You can either use this medicine:
• once daily by applying 2 sprays into
each nostril in the morning
or
• twice daily by applying 1 spray into
each nostril in the morning and 1 spray
into each nostril in the evening.

Other medicines and Budesonide
Nasal Spray
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

Children should be treated under
guidance of an adult.

Make sure you tell your doctor if you are
taking ketoconazole tablets, a medicine
used to treat fungal infections, such as
thrush. It may increase the concentration
of budesonide in your body.

Once the effect is achieved, the lowest
dose which relieves your symptoms
should be used.

You should also tell your doctor if you are
taking any other medicines such as:
• troleandomycin, a medicine to treat
bacterial infections
• itraconazole, a medicine to treat fungal
infections
• ciclosporin, immune suppression drug
used e.g. in connection with transplants
• ethinylestradiol, used for contraception.
It is possible that these medicines could
also increase the concentration of
budesonide in your body.

Using more than the recommended 4
sprays of this medicine each day will not
make this medicine work any better.
Duration of treatment:
Your doctor will tell how long your
treatment with Budesonide Nasal Spray
will last. You must use this medicine
regularly or it will not work properly. Do
not stop treatment even if you feel better
unless told to by your doctor.
If you don’t experience an immediate
relief, you should continue using your
medicine regularly as it may take a few
days to start working.

Pregnancy and breast-feeding
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 taking this
medicine.

Method of administration
1. Gently blow your nose to clean the
nostrils, if necessary.
2. Shake the bottle. Remove the
protective cap (figure 1).

You should not use Budesonide nasal
spray if you are pregnant unless you have
discussed this with your doctor.
Breast-feeding mothers can use
Budesonide nasal spray, but only if the
doctor decides that the benefits for the
mother are weighted against the risk for
the suckling child. Be sure to tell your
doctor immediately if you are
breast-feeding.

Figure 1.

Continued on the next page >>

Artwork Proof Box
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Ref: V013 - Art. 45 Paediatric WS (NL/W/0001/pdWS/001)
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Date prepared:
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Colours:
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Dimensions: 130 x 540 mm

Font size:
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Fonts:
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3. Hold the bottle as shown in figure 2.
Before using Budesonide Nasal Spray
for the first time you must prime the
nozzle (i.e. fill it with medicine). Pump
the nozzle up and down several times
(5-10 times), spraying into the air until
an even mist is seen. The priming
effect remains for approximately 24
hours. If a longer period of time
passes before the next dose is taken,
the nozzle must be primed (filled with
medicine) again. If Budesonide Nasal
Spray is used at shorter intervals it is
sufficient to spray just once into the
air.






(angioedema): in very rare cases also
severe allergic reaction is possible: if
this happens you should contact your
doctor immediately
hives (an itchy rash that looks like nettle
rash)
rash
itching
irritation of the skin

Rare side effects (may affect up to 1 in
1,000 people):
These may occur after using this medicine
for a long time:
• fragile bones
• increased pressure in the eyes
• clouding of the eye lenses
• slowing of the growth rate in children
and adolescents, particularly after
taking high doses for a long time
• adrenal supression. This may cause
symptoms such as anorexia, abdominal
pain, weight loss, nausea, headache,
vomiting, decreased level of
consciousness, low blood sugar levels
and seizures. Situations which may
potentially trigger acute adrenal crisis
include trauma, infection, surgery or
any rapid reduction in dosage. If you
notice these symptoms you should
contact your doctor immediately.

Figure 2.

4. Insert the tip of the nozzle into your
nostril as shown in figure 3. Spray
once (or more if your doctor has told
you to). Spray into the other nostril in
the same way. Note, it is not
necessary to breathe in at the same
time as you spray.

Very rare side effects (may affect up to
1 in 10,000 people), or where the
frequency is not known (cannot be
estimated from the available data):
• a hole in the cartilage dividing your
nostrils
• voice disorder
• sore patches in your nose
This medicine can cause side effects on
the whole body, particularly if high doses
are used for a long time. These side
effects are generally rare.

Potassium sorbate, an ingredient of this
medicine, might cause irritation of the skin
or mucous membranes, such as the
inside if your nose.

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
(www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide
more information on the safety of this
medicine.

Figure 3.

5. Wipe the nozzle with a clean tissue
and replace the protective cap.
6. Store the bottle in an upright position.

Cleaning your Budesonide Nasal Spray
You should clean the plastic nozzle of
Budesonide Nasal Spray regularly, and at
any time the spray of medicine is not
coming out as it should. If this happens,
first check if the nozzle is primed with
medicine (see earlier). If after priming the
nozzle again the pump is still not working,
clean the nozzle by using the following
instructions:
• Remove the plastic nozzle with a clean
tissue and wash in warm – not hot –
water.
• Rinse the nozzle thoroughly, dry it and
then replace onto the top of the bottle.
• Never try to unblock the nozzle by
using a pin or other sharp object.
• After cleaning, the nozzle must be
primed (filled with medicine) again
before use.

5 Nasal Spray

How to store Budesonide

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 after
EXP. The expiry date refers to the last day
of that month.
Do not store above 30°C.
Do not freeze.

If you use more Budesonide Nasal
Spray 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 use more Budesonide Nasal Spray
than you should, continue with your usual
dose. You are unlikely to experience any
medical problems.
However if you have been using more
than 4 sprays a day for more than a
month consult your doctor immediately.

Discard the opened bottle with any
remaining solution after 3 months.

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 other information

Contents of the pack and

What Budesonide Nasal Spray
contains
• The active substance is budesonide
Each 0.05 ml dose (one spray) of this
nasal spray, suspension, contains
64 micrograms of budesonide.

If you forget to take Budesonide Nasal
Spray
If you forget to use your medicine on time,
use it as soon as possible, then go back
to your regular dosing schedule. Never
use more sprays in one day than your
regular dosing schedule, to make up for a
missed dose.

• The other ingredients are:
Dispersible cellulose (microcrystalline
cellulose and carboxymethylcellulose
sodium, (89:11, w/w))
Polysorbate 80
Potassium sorbate (E202)
Glucose, anhydrous
Disodium edetate
Hydrochloric acid, concentrated
Ascorbic acid (E300)
Purified water

If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4 Possible side effects

What Budesonide Nasal Spray
Suspension looks like and contents of
the pack
Budesonide Nasal Spray looks like a
white homogeneous suspension.

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

This medicine generally only treats
symptoms affecting the nose (e.g.
congestion or a “runny nose”). If you were
previously treated with steroid tablets or
injections but your doctor has now
prescribed this medicine instead, you
might experience a worsening of some of
your other symptoms (e.g. red and itchy
eyes). If this happens, your doctor will
need to treat these other symptoms
separately.

Budesonide Nasal Spray is supplied as an
amber type glass bottle fitted with a
plastic nasal spray pump and
polypropylene nasal applicator: pack size
of 1 x 120 (1 x 10 ml) doses, 3 x 120 (3 x
10 ml) doses, 10 x 120 (10 x 10 ml)
doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Side effects of nasal corticosteroids are
more likely to occur if you have been
using them at high doses for a number of
months.
The following side effects can occur
during treatment with Budesonide Nasal
Spray:

Manufacturer:
Lek Pharmaceuticals d.d.,
Verovśkova 57, 1526 Ljubljana,
Slovenia or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or
LEK S.A.,
ul. Podlipie 16,
95010 Stryków, Poland or
LEK S.A.,
ul. Domaniewska 50C,
02-672 Warsaw, Poland.

Common side effects (may affect up to
1 in 10 people):
These may occur immediately after using
this medicine:
• occasional sneezing, dry nose or
stinging in your nose
• slightly bloody discharge from your
nose
• nose bleed
Uncommon side effects (may affect up
to 1 in 100 people):
• swollen face, tongue and/or pharynx
and/or difficulty to swallow or hives
together with difficulties to breathe

This leaflet was last revised in 05/2014.
00000000
SZ00000LT000

Artwork Proof Box
draft: 5201636
laetus code: 0000
mat.no.: 00000000

Ref: V013 - Art. 45 Paediatric WS (NL/W/0001/pdWS/001)
Proof no.
004.0

Date prepared:
16/05/2014

Colours:
Black
Dimensions: 130 x 540 mm

Font size:
8pt
Fonts:
Helvetica

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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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