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BUDESONIDE 200 MICROGRAM TURBOHALER

Active substance(s): BUDESONIDE

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Package leaflet: Information for the user
®

Pulmicort 200 micrograms Turbohaler®/
Budesonide 200 micrograms Turbohaler
(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.

3. How to use Pulmicort Turbohaler
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
If Pulmicort Turbohaler is to be used by your
child, make sure they use it correctly as your
doctor has told you.
It is important to use Pulmicort Turbohaler every
day, even if you have no asthma symptoms at
the time.
Your breathing may improve within 2 days.
However it can take up to 4 weeks for the
medicine to have its full effect.

The name of your medicine is
Pulmicort/Budesonide 200 micrograms Turbohaler
but will be referred to as Pulmicort Turbohaler or
Turbohaler throughout this leaflet. Please note that
this leaflet contains information about other
strengths Pulmicort/Budesonide
100 micrograms and 400 micrograms Turbohaler.

Important information about your asthma
symptoms
If you feel you are getting breathless or wheezy
while using Pulmicort Turbohaler, you should
continue to use Pulmicort Turbohaler but go to see
your doctor as soon as possible, as you may need
additional treatment.

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

Contact your doctor immediately if:
Your breathing is getting worse or you often
wake up at night with asthma.
Your chest starts to feel tight in the morning or
your chest tightness lasts longer than usual.
These signs could mean that your condition is not
being properly controlled and you may need
different or additional treatment immediately.

1. What Pulmicort Turbohaler is and what
it is used for
Pulmicort Turbohaler is an inhaler. It contains a
medicine called budesonide. This belongs to a
group of medicines called ‘corticosteroids’. It works
by reducing and preventing swelling and
inflammation in your lungs.
Your doctor has prescribed this medicine to treat
asthma. Your doctor will prescribe two asthma
inhalers: Pulmicort Turbohaler and a separate
‘reliever inhaler’.
Use Pulmicort Turbohaler every day, as your
doctor has told you to. This helps to prevent
asthma symptoms from happening.
Use your ‘reliever inhaler’ when you get asthma
symptoms, to make it easier to breathe again.

2. What you need to know before you use
Pulmicort Turbohaler
Do not use Pulmicort Turbohaler:
If you are allergic to budesonide.
Warnings and precautions
Talk to your doctor or pharmacist before using
Pulmicort Turbohaler if:
You have a lung infection.
You have a cold or chest infection or any
problems with your breathing.
You have or have ever had tuberculosis (TB).
You have liver problems.
Other medicines and Pulmicort Turbohaler
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 Pulmicort Turbohaler can affect the way
some medicines work and some medicines can
have an effect on Pulmicort Turbohaler.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
Steroid medicines.
Medicines to treat fungal infections (such as
itraconazole and ketoconazole).
HIV protease inhibitors (such as ritonavir and
nelfinavir).
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. Do not use
Pulmicort Turbohaler unless your doctor tells
you to.
If you get pregnant while using
Pulmicort Turbohaler, do not stop using
Pulmicort Turbohaler but talk to your doctor
immediately.
Driving and using machines
Pulmicort Turbohaler is not likely to affect you
being able to drive or use any tools or machines.
Information you may have to carry while you
are using Pulmicort Turbohaler
If you are using a high dose of Pulmicort
Turbohaler your doctor may ask you to carry a
steroid warning card. This explains to others about
your medication.

Use your Pulmicort Turbohaler every day.
This helps to prevent asthma symptoms from
happening. Your doctor will advise you of the
correct dose to treat your asthma. Your doctor will
reduce your medication to the lowest dose needed
to control your asthma.
If your doctor has told you to use your
Turbohaler twice a day:
Adults and children (13 years and above)
The recommended dose is 1 or 2 inhalations,
twice a day (in the morning and in the evening).
Your doctor may increase this to a maximum of
1600 micrograms a day.
If your asthma is getting worse and you are
using your ‘reliever inhaler’ more often or you
have more symptoms:
- double your dose of Pulmicort Turbohaler
immediately and talk to your doctor as soon
as possible
- double your dose by taking twice as many
inhalations each time.
Use in Children (5 - 12 years of age)
The recommended dose is 1 or 2 inhalations,
twice a day (in the morning and in the evening).
The doctor may increase this to a maximum of
800 micrograms a day.
If your doctor has told you to use your
Turbohaler once a day:
Only use your Turbohaler once a day if your
doctor has told you to.
Use your Turbohaler at the same time each
evening.
Adults and children (13 years and above)
The recommended dose is 1 or 2 inhalations, in
the evening.
If your asthma is getting worse and you are
using your ‘reliever inhaler’ more often or you
have more symptoms:
- double your dose immediately and talk to
your doctor as soon as possible
- double your dose by taking the same
number of inhalations your doctor has told
you twice a day (once in the morning and
once in the evening).
Use in Children (5 - 12 years of age)
The recommended dose is 1 or 2 inhalations, in
the evening.
The maximum dose is 400 micrograms a day.
Use your separate ‘reliever inhaler’ to treat
asthma symptoms when they happen. Always
keep your ‘reliever inhaler’ with you to use when
you need it. Do not use Pulmicort Turbohaler to
treat asthma symptoms - use your ‘reliever inhaler’.
How to prepare a new Turbohaler for use
Before using Pulmicort Turbohaler
for the first time you need to
prepare the Turbohaler for use.
Unscrew the white cover and lift it off.
Hold your Turbohaler upright with
brown base at the bottom. Do not
hold the mouthpiece when you turn
the grip. Turn the brown base as
far as it will go in one direction.
Then turn it back as far as it will
go in the other direction. It does not
matter which way you turn first. You should hear a
click sound. Perform the procedure twice.

The Turbohaler is now ready for use, and you
should not repeat the overleaf procedure again.
To take a dose, please follow the instructions
below.
How to take an inhalation
Every time you need to take an inhalation, follow
the instructions below.
1. Unscrew the white cover and lift it off.
2. Hold your Turbohaler upright with the brown
base at the bottom.
3. Do not hold the mouthpiece when you load your
Turbohaler. To load your Turbohaler with a
dose, turn the brown base as far as it will go
in one direction. Then turn it as far as it will
go in the other direction. It does not matter
which way you turn it first. You should hear a
click sound. Your Turbohaler is now loaded and
ready to use. Only load your Turbohaler when
you need to use it.
4. Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your Turbohaler.
5. Place the mouthpiece gently
between your teeth. Close your
lips. Breathe in as deeply and
as hard as you can through your
mouth. Do not chew or bite on the
mouthpiece.
6. Remove your Turbohaler from your mouth.
Then breathe out gently. The amount of
medicine that is inhaled is very small. This
means you may not be able to taste it after
inhalation. If you have followed the instructions,
you can still be confident that you have inhaled
the dose and the medicine is now in your lungs.
7. If you are to take a second
inhalation, repeat steps 2 to 6.
8. Replace the cover by screwing
it back on tightly after use.
9. Rinse your mouth out with
water after inhaling your prescribed dose.
Do not try to remove or twist the mouthpiece. It is
fixed to your Turbohaler and must not be taken off.
Do not use your Turbohaler if it has been damaged
or if the mouthpiece has come apart from your
Turbohaler.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week
with a dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
When you first see a red mark in
the indicator window, there are
about 20 doses left. You will then
need to see your doctor for another
prescription. When the red mark
has reached the bottom of the
indicator window, you must start
using your new Turbohaler.
Note:
The brown base will still twist and ‘click’ even
when your Turbohaler is empty.
The sound that you hear as you shake your
Turbohaler is produced by a drying agent and
not the medicine. Therefore the sound does not
tell you how much medicine is left in your
Turbohaler.
If you load your Turbohaler more than once by
mistake before taking your dose, you will still
only receive one dose.
If you use more Pulmicort Turbohaler 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 not increase or decrease your dose
without seeking medical advice. If you use more
Pulmicort Turbohaler than you should, contact your
doctor or pharmacist for advice.
If you forget to use Pulmicort Turbohaler
If you forget to take a dose, skip the missed dose
and take the next dose as usual. Do not take a
double dose to make up for a forgotten dose.
If you stop using Pulmicort Turbohaler
Do not stop using this medicine even when your
asthma gets better, unless your doctor tells you to.
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 either of the following happen to you, stop
using Pulmicort Turbohaler and talk to your
doctor immediately:
Swelling of your face, particularly around your
mouth (with possible swelling of the lips, tongue,
eyes and ears), rash, itching, contact dermatitis
(a skin problem), hives and bronchospasm
(tightening of the muscles in the airways which
causes wheezing). This may mean that you are
having an allergic reaction. This happens rarely,
affecting less than 1 in 1,000 people.

Sudden wheezing after inhaling your medicine.
If this happens, also use your ‘reliever’ inhaler
straight away. This happens very rarely,
affecting less than 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Thrush (a fungal infection) in the mouth. This is
less likely if you rinse your mouth out with water
after using your Turbohaler.
Mild sore throat, coughing and a hoarse voice.
Rare (may affect up to 1 in 1,000 people)
Sleeping problems, depression or feeling
worried, restless, nervous, over-excited or
irritable. These effects are more likely to occur
in children.
Bruising of the skin.
Loss of voice.
Hoarse voice (in children).
Inhaled corticosteroids can affect the normal
production of steroid hormones in your body,
particularly if you use high doses for a long time, for
example 400 micrograms or more daily for
several years. The effects include:
changes in bone mineral density (thinning of the
bones)
cataract (clouding of the lens in the eye).
glaucoma (increased pressure in the eye)
a slowing of the rate of growth of children and
adolescents (rare). If high doses are given over
several years, final adult height may be reduced
by about 1 cm.
an effect on the adrenal gland (a small gland
next to the kidney) (rare).
These effects are much less likely to happen with
inhaled corticosteroids than with corticosteroid
tablets.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: 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 Pulmicort Turbohaler
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30°C.
Store in the original package.
Keep the cover tightly closed after use in order to
protect from moisture.
Do not use the medicine after the expiry date which
is stated on the carton and canister label, after
‘Exp.’ The expiry date refers to the last day of that
month.
If the medicine becomes discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Remember if your doctor tells you to stop taking
this medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other
information
The active ingredient in Pulmicort is budesonide
Each metered actuation delivers 200 micrograms
of the active ingredient budesonide.
Pulmicort Turbohaler does not contain any other
ingredients.
Pulmicort Turbohaler contains 100 metered
actuations, in a breath actuated metered dose
inhaler with a dark brown turning grip and a white
plastic body and cover. The bottom of the turning
grip is embossed ‘BUDESONIDE 200’ and has the
Braille code character ‘2’.
Manufactured by:
AstraZeneca AB, Kvarnbergagatan 12, SE - 151 85
Sodertalje, Sweden.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®
®
Pulmicort 200 micrograms Turbohaler /
Budesonide 200 micrograms Turbohaler
PL 18799/2668
Leaflet date: 30.08.2016
Pulmicort and Turbohaler are registered
trademarks of ASTRAZENECA AB.

POM

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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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