PULMICORT 400 TURBOHALER

Active substance: BUDESONIDE

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Pulmicort 400 Turbohaler/
Pulmicort 400 Turbuhaler/
Budesonide 400 microgram Turbohaler/
Budesonide 400 microgram Turbuhaler
(budesonide)
This product is available as any of the above names but will be referred to
as Budesonide 400 microgram Turbohaler throughout the following:
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.
This medicine is also available in other strengths.
In this leaflet:
1) What Budesonide 400 microgram Turbohaler is and what it is used for
2) Before you use Budesonide 400 microgram Turbohaler
3) How to use Budesonide 400 microgram Turbohaler
4) Possible side effects
5) How to store Budesonide 400 microgram Turbohaler
6) Further information

1) What Budesonide 400 microgram Turbohaler is and what it
is used for
Budesonide 400 microgram 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: Budesonide 400
microgram Turbohaler and a separate ‘reliever inhaler’.
 Use Budesonide 400 microgram 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 Budesonide 400 microgram Turbohaler
Do not use Budesonide 400 microgram Turbohaler if:
 You are allergic (hypersensitive) to budesonide, (the only ingredient in
this medicine).
Take special care with Budesonide 400 microgram Turbohaler
Before you use Budesonide 400 microgram 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.

Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using Budesonide
400 microgram Turbohaler, you should continue to use Budesonide 400
microgram 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 Budesonide 400 microgram 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).

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 Budesonide 400
microgram Turbohaler can affect the way some medicines work and some
medicines can have an effect on Budesonide 400 microgram 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 in the evening.
 The maximum dose is 400 micrograms a day.

Pregnancy and breast-feeding
 If you are pregnant, or planning to get pregnant, talk to your doctor
before using Budesonide 400 microgram Turbohaler - do not use
Budesonide 400 microgram Turbohaler unless your doctor tells you to.
 If you get pregnant while using Budesonide 400 microgram Turbohaler,
do not stop using Budesonide 400 microgram Turbohaler but talk to your
doctor immediately.
 If you are breast-feeding, talk to your doctor before using Budesonide
400 microgram Turbohaler.

Unscrew the white cover and lift it off.

Driving and using machines
Budesonide 400 microgram 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 Budesonide
400 microgram Turbohaler
If you are using a high dose of Budesonide 400 microgram Turbohaler
your doctor may ask you to carry a steroid warning card. This explains to
others about your medication.

3) How to use Budesonide 400 microgram Turbohaler
 Always use Budesonide 400 microgram Turbohaler exactly as your
doctor, nurse or pharmacist has told you. Ask one of them for advice if
you are not sure.
 If Budesonide 400 microgram 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 Budesonide 400 microgram 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.

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 Budesonide 400 microgram Turbohaler to treat asthma
symptoms - use your ‘reliever inhaler’.
How to prepare a new Turbohaler for use
Before using Budesonide 400 microgram Turbohaler for the first time you
need to prepare the Turbohaler for use.

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.
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 Budesonide 400 microgram 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 Budesonide 400 microgram Turbohaler than you should,
contact your doctor or pharmacist for advice.
If you forget to use Budesonide 400 microgram Turbohaler
If you forget to take a dose, skip the missed dose and take the next dose
as usual.
If you stop using Budesonide 400 microgram 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, Budesonide 400 microgram Turbohaler can cause side
effects, although not everybody gets them.
If either of the following happen to you, stop using Budesonide 400
micrograms 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.

5) How to store Budesonide 400 microgram Turbohaler
 Keep out of the sight and reach of children.
 Budesonide 400 microgram Turbohaler should be stored below 30°C in a
dry place with the cap properly replaced after use.
 When not in use, Budesonide 400 microgram Turbohaler should be
stored with the cover tightened.
 Do not use Budesonide 400 microgram 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 Budesonide 400 microgram Turbohaler contains
The active substance is budesonide.
Each metered actuation or puff contains 400 micrograms of the active
ingredient Budesonide.
What Budesonide 400 microgram 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. A braille code
for identification of Pulmicort Turbuhaler and Budesonide 400 are
embossed at the bottom of the turning grip.
Budesonide 400 microgram Turbohaler contains 50 metered actuations
or puffs.
PL 10383/0698

Pulmicort 400 Turbohaler/
Pulmicort 400 Turbuhaler/
POM
Budesonide 400 microgram Turbohaler/
Budesonide 400 microgram Turbuhaler

Who makes and repackages your medicine?
Your medicine is manufactured by AstraZeneca Production AB, 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: 18.03.2013

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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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