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PULMICORT TURBOHALER 100MICROGRAMS

Active substance(s): BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PULMICORT ® TURBOHALER® 100 MICROGRAMS

Revision date: 29.04.2016
Leaflet reference: PUL100/UT

(budesonide)
Driving and using machines
Your medicine will be referred to as Pulmicort Turbohaler throughout
this leaflet.
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.
Information you may have to carry while you are using Pulmicort®
Read all of this leaflet carefully before you start using this medicine
Turbohaler®
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
If you are using a high dose of Pulmicort® Turbohaler ® your doctor may
 If you have any further questions, ask your doctor or pharmacist.
ask you to carry a steroid warning card. This explains to others about your
 This medicine has been prescribed for you only. Do not pass it on to
medication.
others. It may harm them, even if their signs of illness are the same as
yours.
3. HOW TO USE PULMICORT® TURBOHALER®
 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
 Always use this medicine exactly as your doctor or pharmacist has told
4.
you. Check with your doctor or pharmacist if you are not sure.
What is in this leaflet
 If Pulmicort® Turbohaler ® is to be used by your child, make sure they
use it correctly as your doctor has told you.
1. What Pulmicort® Turbohaler® is and what it is used for
 It is important to use Pulmicort® Turbohaler® every day, even if you
2. What you need to know before you use Pulmicort® Turbohaler®
have no asthma symptoms at the time.
3. How to use Pulmicort® Turbohaler®
 Your breathing may improve within 2 days. However it can take up to 4
4. Possible side effects
weeks for the medicine to have its full effect.
5. How to store Pulmicort® Turbohaler®
6. Contents of the pack and other information
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.

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®

If your doctor has told you to use your Turbohaler® twice a day:
Adults and children (13 years and above)

Do not use Pulmicort ® Turbohaler®: If you are allergic to budesonide.

 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.

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®.

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.

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).

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)

Pregnancy, breast-feeding and fertility

 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).

 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.

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Use in Children (5-12 years of age)

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 ®.

 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’.

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

How to prepare a new Turbohaler®
for use
®

When to start using a new Turbohaler ®

®

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

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.

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
above procedure again. To take a
dose, please follow the instructions
below.

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.

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.

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
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.
 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.





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
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.

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.

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.

5. HOW TO STORE 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.

4. POSSIBLE SIDE EFFECTS

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

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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.

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.

Reporting of side effects

If you forget to use Pulmicort® Turbohaler®

If you stop using Pulmicort® Turbohaler ®

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

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.

What is in your medicine
Each actuation contains 100 micrograms of the active ingredient
budesonide in each actuation.
There are no other ingredients.
Pulmicort® Turbohaler® contains 200 metered actuations.
Who manufactured your medicine
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.
PL 16378/0234

POM

Revision date: 29.04.2016
Leaflet reference: PUL100/UT
Pulmicort® and Turbohaler® are trademarks of the AstraZeneca group of
companies.

Other possible side effects:
Common (may affect up to 1 in 10 people)

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
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).

7. If you are to take a second inhalation,
repeat steps 2 to 6.

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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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