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BUDESONIDE 400MICROGRAMS TURBOHALER

Active substance(s): BUDESONIDE

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Pulmicort® 400 Turbohaler®/
Pulmicort® 400 Turbuhaler®/
Budesonide 400 microgram Turbohaler®/
Budesonide 400 microgram Turbuhaler®
(budesonide)
Your medicine is known by the above names, but will be referred to as
Pulmicort Turbohaler throughout this leaflet. Pulmicort Turbohaler is
available in other strengths.
Patient Information Leaflet
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.
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 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. Do not take a double dose to make up for a forgotten dose.
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 to 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 (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).
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).
– an effect on the adrenal gland (a small gland next to the kidney) (rare).
If high doses are given over several years, final adult height may be
reduced by about 1 cm.
These effects are much less likely to happen with inhaled corticosteroids
than with corticosteroid tablets.
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 25°C. Store in a dry place with the cap properly
replaced after use. Do not store in the refrigerator or freezer.
 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 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) Contents of the pack and other information
What Pulmicort Turbohaler contains
The active substance is budesonide.
Each metered actuation or puff contains 400 micrograms of the active
ingredient Budesonide.
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. For
identification, a Braille code of “Budesonide 400” is embossed at the
bottom of the turning grip.
PL 10383/0698

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

POM

Who makes and repackages your medicine?
Your medicine is manufactured by AstraZeneca Pharmaceutical
Production AB, Gartunavagen, Sodertalje, S-151 85 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: 14.06.2016
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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