PULMICORT TURBUHALER 200

Active substance: BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pulmicort® Turbohaler® 200
Pulmicort® Turbuhaler® 200
Budesonide 200 micrograms Turbohaler®
Budesonide 200 micrograms Turbuhaler®
(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.
Your medicine is called by any of the above names,
but will be referred to as Pulmicort Turbohaler.

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.

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 take an inhalation

4. Possible side effects

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 tightly
after use.
9. Brush your teeth or rinse your
mouth with water and spit it
out.

Like all medicines, Pulmicort Turbohaler can cause
side effects, although not everybody gets them.

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.

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.

Cleaning your Turbohaler

• Keep out of the sight and reach 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.
• If your Turbohaler fails to work properly or you
notice any other signs of deterioration, you
should seek the advice of your pharmacist.
• 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.

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

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.

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:
• 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.

5. How to store Pulmicort Turbohaler

6. Further information
What Pulmicort Turbohaler contains
The active substance is budesonide.
Pulmicort Turbohaler 200 contains 100 doses
(inhalations). Each metered dose contains
200 micrograms of budesonide.
Pulmicort Turbohaler 200 does not contain any
propellants, lubricants, preservatives or any other
additives.

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 your dose or
decrease your dose without seeking medical
advice. If you use more Pulmicort Turbohaler than
you should, contact your doctor or pharmacist for
advice.

There are no other ingredients.

If you forget to use Pulmicort Turbohaler

Pulmicort Turbohaler is manufactured by
AstraZeneca AB, S-151 85 Södertälje, Sweden.

If you forget to take a dose, skip the missed dose
and take the next dose as usual.

If you stop using Pulmicort Turbohaler
Do not stop using this medicine even when your
asthma gets better, unless your doctor tells you to.

What Pulmicort Turbohaler looks like and
contents of the pack
Pulmicort Turbohaler 200 holds 100 actuations and
is a breath actuated metered dose powder inhaler.

Manufacturer

Procured from within the EU. Product Licence
Holder and repackaged by: S.C.A.C. Ltd., Unit 2a,
Bandeath Industrial Estate, Throsk, Stirling,
FK7 7NP.
POM Pulmicort Turbohaler 200 PL: 30984/0110
Leaflet updated: 31.10.2012
Pulmicort®, Turbohaler® and Turbuhaler® are
trademarks of AstraZeneca AB.

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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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