PULMICORT TURBOHALER 100MICROGRAMS

Active substance: BUDESONIDE

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Revision date: 15. 04. 2013
Leaflet reference: PUL100/UT

PACKAGE LEAFLET: INFORMATION FOR THE USER
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PULMICORT TURBOHALER 100 MICROGRAMS
(budesonide)
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Your medicine will be referred to as Pulmicort Turbohaler throughout
this leaflet.

Driving and using machines
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Pulmicort Turbohaler is not likely to affect you being able to drive or use
any tools or machines.

This product is also available in other strengths.
Read all of this leaflet carefully before you start taking this medicine.

Information you may have to carry while you are using Pulmicort
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Turbohaler

 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.

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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®

In this leaflet:

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 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.
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 If Pulmicort Turbohaler is to be used by your child, make sure they
use it correctly as your doctor has told you.
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 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.

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1. What Pulmicort Turbohaler is and what it is used for
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2. Before you use Pulmicort Turbohaler
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3. How to use Pulmicort Turbohaler
4. Possible side effects
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5. How to store Pulmicort Turbohaler
6. Further information

1. WHAT PULMICORT® TURBOHALER® IS AND WHAT IT IS
USED FOR

Important information about your asthma symptoms
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If you feel you are getting breathless or wheezy while using Pulmicort
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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.
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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.

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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
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prescribe two asthma inhalers: Pulmicort Turbohaler and a separate
‘reliever inhaler’.
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 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®
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Do not use Pulmicort Turbohaler if:

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If your doctor has told you to use your Turbohaler twice a day:

 You are allergic (hypersensitive) to budesonide (the only ingredient in
this medicine).
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Take special care with Pulmicort Turbohaler
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Adults and children (13 years and above)

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 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:
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- 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.

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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
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a prescription and herbal medicines. This is because Pulmicort
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Turbohaler can affect the way some medicines work and some
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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).

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.
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If your doctor has told you to use your Pulmicort Turbohaler once
a day:
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 Only use your Turbohaler once a day if your doctor has told you to.
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 Use your Turbohaler at the same time each evening.

Pregnancy and breast-feeding

Adults and children (13 years and above)

 If you are pregnant, or planning to get pregnant, talk to your doctor
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before using Pulmicort Turbohaler – do not use Pulmicort
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Turbohaler unless your doctor tells you to.
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 If you get pregnant while using Pulmicort Turbohaler , do not stop
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using Pulmicort Turbohaler but talk to your doctor immediately.
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 If you are breast-feeding, talk to your doctor before using Pulmicort
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Turbohaler .

 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).
Continued overleaf

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Children (5-12 years of age)

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
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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
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Turbohaler .

 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
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you need it. Do not use Pulmicort
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Turbohaler to treat asthma
symptoms – use your ‘reliever
inhaler’.
How to prepare a new Turbohaler
for use
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Cleaning your Turbohaler

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Wipe the outside of the mouthpiece once a week with a dry tissue. Do not
use water or liquids.

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When to start using a new Turbohaler

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When you first see a red mark (depicted as
grey) 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 (depicted as grey) has reached the
bottom of the indicator window, you must
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start using your new Turbohaler .
Note:
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 The brown base will still twist and ‘click’ even when your Turbohaler is
empty.
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 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
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you how much medicine is left in your Turbohaler .
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 If you load your Turbohaler more than once by mistake before taking
your dose, you will still only receive one dose.

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Before using Pulmicort Turbohaler
for the first time you need to
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prepare the Turbohaler for use.
Unscrew the white cover and lift it off.
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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.
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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.

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If you forget to use Pulmicort Turbohaler
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If you stop using Pulmicort Turbohaler
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3. Do not hold the mouthpiece when you load your Turbohaler . To load
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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
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hear a click sound. Your Turbohaler is now loaded and ready to use.
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Only load your Turbohaler when you need to use it.

5. HOW TO STORE PULMICORT® TURBOHALER®
Do not store above 30°C.
Replace the cover properly.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the
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Turbohaler label or carton label.
 If your doctor tells you to stop taking the Turbohaler, please take it back
to your pharmacist for safe disposal. Only keep the Turbohaler, if your
doctor tells you to.
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 If your Turbohaler fails to work properly or shows signs of deterioration
or discolouration, you should seek the advice of your pharmacist who
will tell you what to do.





6. FURTHER INFORMATION
Your medicine is called Pulmicort Turbohaler.
It is a breath-actuated metered dose powder inhaler with a dark brown
turning grip and a white plastic body and cover. A Braille code for
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identification of Pulmicort Turbohaler is embossed at the bottom of the
turning grip and ‘Budesonide 100’ is also written at the bottom of the
turning grip.
What is in your medicine

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

2. Hold your Turbohaler upright with the brown base at the bottom.

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.

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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.
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If you use more Pulmicort Turbohaler than you should, contact your
doctor or pharmacist for advice.

Every time you need to take an inhalation, follow the instructions below.
1. Unscrew the white cover and lift it off.

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If you use more Pulmicort Turbohaler than you should

How to take an inhalation

The effects include:

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Each actuation contains 100 micrograms of the active ingredient
budesonide in each actuation.
There are no other ingredients.
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Pulmicort Turbohaler contains 200 metered actuations.

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

Who manufactured your medicine

4. POSSIBLE SIDE EFFECTS

Manufactured by AstraZeneca AB., S-151 85 Sodertajle, Sweden, and is
procured from within the EU and repackaged by Product Licence Holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.

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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
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Turbohaler and talk to your doctor immediately:

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4. Hold your Turbohaler away from
your mouth. Breathe out gently (as
far as is comfortable). Do not breathe
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out through your Turbohaler .

 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.

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.

PL 16378/0234

POM

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Revision date: 15.04.2013
Leaflet reference: PUL100/UT
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Pulmicort and Turbohaler are trademarks of the AstraZeneca group of
companies.

Other possible side effects:
Common (affects less than 1 in 10 people)

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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.

 Thrush (a fungal infection) in the mouth. This is less likely if you rinse
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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.

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.

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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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