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BUDESONIDE 100 MICROGRAMS DRY POWDER INHALER

Active substance(s): BUDESONIDE

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6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Pulmicort Turbohaler contains
The active substance is budesonide.
Pulmicort Turbohaler 100 contains 200 doses
(inhalations). Each actuation delivers 100
micrograms of budesonide.
There are no other ingredients.
What Pulmicort Turbohaler looks like and
contents of the pack
Pulmicort 100 micrograms Turbohaler is a breath
actuated metered dose powder inhaler with a
brown turning grip and a white plastic body and
cover. A Braille code for identification is embossed
at the bottom of the turning grip and ‘budesonide
100’ is also written at the bottom of the turning
grip.
The inhaler delivers a white powder and contains
200 doses (inhalations).
Manufacturer and Product Licence holder
Pulmicort Turbohaler is manufactured by
AstraZeneca AB., Forskargatan 18, SE-15185
Sodertalje, Sweden.
Minakem Dunkerque S.A.S., 224 Avenue de la
Dordogne, 59640 Dunkerque, France.
Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge
Close, Harrow, Middlesex, HA1 1XD. Repackaged
by Servipharm Ltd.

POM

PL 20636/1713

Leaflet revision and issue date (Ref) 27.08.16[21]
Pulmicort and Turbohaler are trademarks of
AstraZeneca.

PATIENT INFORMATION LEAFLET
®

®

1713
27.08.16[21]

PULMICORT 100 MICROGRAMS TURBOHALER
BUDESONIDE 100 MICROGRAMS DRY POWDER INHALER
(budesonide)
This medicine is available using any of the above
names but will be referred to as Pulmicort
Turbohaler throughout this leaflet.
Pulmicort Turbohaler is also available in other
strengths.
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.
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
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.
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.
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 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 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.
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.

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).



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.

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.

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.

Reporting of side effects
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.

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.

5. HOW TO STORE PULMICORT 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.
• 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.
• If your inhalation powder becomes discoloured
or shows any other signs of deterioration please
contact your doctor or pharmacist.

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 to1 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.

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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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