PULMICORT TURBOHALER 400

Active substance: BUDESONIDE

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PS01910

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pulmicort® Turbohaler®
budesonide

Read all of this leaflet carefully before you start
taking this medicine.
• 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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Pulmicort Turbohaler is and what it is
used for
2. Before you use Pulmicort Turbohaler
3. How to use Pulmicort Turbohaler
4. Possible side effects
5. How to store Pulmicort Turbohaler
6. Further information
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. Before you use Pulmicort Turbohaler
Do not use Pulmicort Turbohaler if:
• You are allergic (hypersensitive) to budesonide
(the only ingredient in this medicine).
Take special care with Pulmicort Turbohaler
Before you use Pulmicort Turbohaler, tell your
doctor or pharmacist 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.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken 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 and breast-feeding
• If you are pregnant, or planning to get pregnant,
talk to your doctor before using Pulmicort - 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.
• If you are breast-feeding, talk to your doctor
before using Pulmicort Turbohaler.
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.
3. How to use Pulmicort Turbohaler
• Always use Pulmicort Turbohaler exactly as
your doctor, nurse or pharmacist has told you.
Ask one of them for advice 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.

365253-A01
07-02-13
PS01910
AZL014A
7488
Pulmicort Turbuhaler 100mcg,
200mcg, 400mcg Leaflet: Patient UK
JR

Black

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.
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.
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 usual 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.
Children (5 - 12 years of age)
• The usual 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 usual 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).
Children (5 - 12 years of age)
• The usual 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.
The Turbohaler is now ready for use, and you
should not repeat the above 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.

Rare (affects less than 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.
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).
• 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.
If any of the side effects get serious or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. How to store Pulmicort Turbohaler

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.

• Keep out of the reach and sight of children.
• Do not store above 30°C.
• When not in use, Pulmicort Turbohaler should
be stored with the cover tightened.
• Do not use Pulmicort Turbohaler after the expiry
date printed on the carton or on the label of your
Turbohaler. The expiry date refers to the last
day of that month.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. This will help to protect
the environment.
6. Further information
What Pulmicort Turbohaler contains
The active substance is budesonide. There are
three different strengths.
Pulmicort Turbohaler 100 contains 200 doses
(inhalations). Each metered dose contains
100 micrograms of budesonide.
Pulmicort Turbohaler 200 contains 100 doses
(inhalations). Each metered dose contains
200 micrograms of budesonide.
Pulmicort Turbohaler 400 contains 50 doses
(inhalations). Each metered dose contains
400 micrograms of budesonide.
There are no other ingredients.
What Pulmicort Turbohaler looks like and
contents of the pack
Pulmicort Turbohaler is an inhaler containing your
medicine. Each Turbohaler contains 50, 100 or
200 doses (inhalations) and has a white body with
a brown base.

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.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for
Pulmicort Turbohaler are held by
AstraZeneca UK Ltd, 600 Capability Green,
Luton, LU1 3LU, UK.
Pulmicort Turbohaler is manufactured by
AstraZeneca AB, S-151 85 Södertälje, Sweden.

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.

To listen to or request a copy of
this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Reference number
Pulmicort Turbohaler 100
17901/0162
Pulmicort Turbohaler 200

17901/0163
Pulmicort Turbohaler 400

17901/0164

If you stop using Pulmicort Turbohaler
Do not stop using this medicine even when your
asthma gets better, unless your doctor tells you to.
4. Possible side effects
Like all medicines, Pulmicort Turbohaler 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 (affects less than 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.

365253-A01
07-02-13
PS01910
AZL014A
7488
Pulmicort Turbuhaler 100mcg,
200mcg, 400mcg Leaflet: Patient UK
JR

Black

This is a service provided by the
Royal National Institute of Blind
People.
Leaflet updated: January 2013
© AstraZeneca 2013
Pulmicort and Turbohaler are trade marks of the
AstraZeneca group of companies.
RSP 13 0003

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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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