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PULMICORT 100 MICROGRAMS TURBOHALER

Active substance(s): BUDESONIDE

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Pulmicort® 100 micrograms Turbohaler®
Pulmicort® 100 micrograms Turbuhaler®
Budesonide 100 micrograms Turbohaler®
Budesonide 100 micrograms Turbuhaler®
(budesonide)
Your medicine is known by the above name, but will be referred to as
Pulmicort Turbohaler throughout this:
Patient Information Leaflet
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.
Pulmicort Turbohaler is available in other strengths.
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: 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 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 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 the 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.
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.
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 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.
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.
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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5) How to store Pulmicort Turbohaler
• Keep out of the sight and reach of children.
• Do not store above 30°C. Replace cover properly after use.
• Do not use Budesonide 100 micrograms 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 inhaler fails to work properly or show signs of deterioration you
should seek the advice of your pharmacist who will tell you what to do.

6) Further information
What Pulmicort Turbohaler contains
The active substance is budesonide.
Each actuation contains 100 micrograms of the active ingredient
Budesonide.
Pulmicort Turbohaler does not contain any other ingredients.
What Pulmicort Turbohaler looks like and contents of the pack
Your Turbohaler is a breath-actuated, metered dose powder inhaler with a
dark brown turning grip and a white plastic body and cover containing
inhalation powder. ‘Budesonide 100’ is embossed at the bottom of the
turning grip.
Pulmicort Turbohaler contains 200 actuations.
PL 10383/1692

Pulmicort 100 Turbohaler
POM
Pulmicort 100 Turbuhaler
Budesonide 100 micrograms Turbohaler
Budesonide 100 micrograms Turbuhaler

Who makes and repackages your medicine?
Your medicine is manufactured by AstraZeneca AB, S-151 85 Sodertalje,
Sweden. Procured from within the EU and repackaged by Product Licence
Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 15.02.2015
Pulmicort, Turbuhaler and Turbohaler are trademarks of the AstraZeneca
group of companies.

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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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