PULMICORT TURBUHALER 200

Active substance: BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pulmicort Turbohaler 200
Pulmicort® Turbohaler® 100
Pulmicort Turbuhaler 200 micrograms/Budesonide 200 micrograms Turbohaler
(budesonide)
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 available using any of the above names
but will be referred to as Pulmicort Turbohaler throughout
this leaflet.
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

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. 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 have 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.

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’.

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.

Product: Pulmicort 100 & 200 Turbohaler
Colours: Black

PLPI: 17211/0198, 0361 & 0859
Item Code: PUL2006BFS/C

Dimensions: 210mm x 400mm
Proof: 5

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 tightly after use.
9. Brush your teeth or rinse your mouth
with water and spit it out.
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 (depicted
as grey) 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:
- 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. H

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.

6. Further information
What Pulmicort Turbohaler contains
The active substance is budesonide.
Pulmicort Turbohaler 200 contains 100 doses
(inhalations). Each metered dose contains 200
micrograms of budesonide.
Pulmicort Turbohaler 100 contains 200 doses
(inhalations). Each metered dose contains 100
micrograms of Budesonide
Pulmicort Turbuhaler 200 micrograms/Budesonide
200 micrograms Turbohaler contains 100 doses
(inhalations). Each metered dose contains 200
micrograms of Budesonide.
There are no other ingredients.
What Pulmicort Turbohaler looks like and contents
of the pack
Pulmicort Turbohaler is an inhaler containing your
medicine. Each Turbohaler contains 100 or 200 doses
(inhalations) and has a white body with a brown base.
Manufacturer
A.S.P. S.A., 224 Avenue de la Dordogne, 59640 Dunkirk,
France and procured from within the EU by the Product
Licence Holder Polyfarma Ltd and repackaged by Kent
Pharmaceuticals Ltd both at Repton Road, Measham,
DE12 7DT, UK.
POM
Pulmicort Turbohaler 200
Pulmicort Turbohaler 100
Pulmicort Turbuhaler 200
micrograms/Budesonide
200 micrograms Turbohaler

PL 17211/0198
PL 17211/0361
PL 17211/0859

Leaflet revision and issue date: 14.11.2012
Pulmicort and Turbohaler are trademarks of the
AstraZeneca group of companies.
Product: Pulmicort 100 & 200 Turbohaler
Colours: Black

PLPI: 17211/0198, 0361 & 0859
Item Code: PUL2006BFS/C

Dimensions: 210mm x 400mm
Proof: 5

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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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