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BUDESONIDE 400MICROGRAM TURBOHALER

Active substance(s): BUDESONIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

BUDESONIDE 200 microgram TURBOHALER/PULMICORT
200 microgram TURBOHALER and
BUDESONIDE 400 microgram TURBOHALER/
PULMICORT 400 microgram TURBOHALER
(Budesonide)
Patient Information Leaflet

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.
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: 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).

WARNING!

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.

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).

DATE:

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.

6464/0423 0424F

TVT CHECKED

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.

CODE:

DT

Driving and using machines
Pulmicort Turbohaler is not likely to affect you being able to drive or use any tools or machines.

DATE OF PROOF: 02/04/13

ARTWORKER:
pulmicort 200mg 400mg Turbo
PRODUCT:

JANUARY 2013
Waymade
CUSTOMER:

REF:

Q.A.
APPROVED:

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.

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’.

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WARNING!

DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

«PAdBì

PROOF HISTORY:
v.1 - waymade - 02/04/13

Leaflet Flat Size = 180 x 429

This medicine is available as either of the above names, but will be referred to as Pulmicort Turbohaler throughout this leaflet.
Another strength (100 micrograms) is also available.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.
27mm

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.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.

WARNING!

Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

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.

DATE:

pulmicort 200mg 400mg Turbo

6464/0423 0424F
CODE:

TVT CHECKED

DT

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.

PRODUCT:

DATE OF PROOF: 02/04/13

4. POSSIBLE SIDE EFFECTS
Like all medicines, Pulmicort Turbohaler can cause side effects, although not everybody gets them.

Waymade

ARTWORKER:

If you stop using Pulmicort Turbohaler
Do not stop using this medicine even when your asthma gets better, unless your doctor tells you to.

CUSTOMER:

REF:

JANUARY 2013

Q.A.
APPROVED:

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.

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 PULMICORT TURBOHALER
• Your turbohaler should be stored, with the cap screwed on, at room temperature (below 30°C) in a dry place.
• Do not use after the expiry date printed on the turbohaler label or carton.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using the turbohaler, please take it back to the pharmacist for safe disposal. Only keep the
turbohaler if your doctor tells you to.
• If the turbohaler does not work properly or shows any signs of deterioration, you should seek the advice of your pharmacist who
will advise you what to do.
6. FURTHER INFORMATION
Your medicine is called Budesonide 200 microgram Turbohaler/Pulmicort 200 microgram Turbohaler and Budesonide 400
microgram Turbohaler/Pulmicort 400 microgram Turbohaler. These Turbohalers are breath-actuated, metered dose inhalers,
Budesonide 200 microgram Turbohaler/Pulmicort 200 microgram Turbohaler contains the active ingredient, budesonide 200
micrograms in each actuation. Budesonide 400 microgram Turbohaler/Pulmicort 400 microgram Turbohaler contains the active
ingredient budesonide 400 micrograms in each actuation.
Budesonide 200 microgram Turbohaler/Pulmicort 200 microgram Turbohaler and
Budesonide 400 microgram Turbohaler/Pulmicort 400 microgram Turbohaler do not contain any other ingredients.
Budesonide 200 microgram Turbohaler/Pulmicort 200 microgram Turbohaler contains 100 metered actuations.
Budesonide 400 microgram Turbohaler/Pulmicort 400 microgram Turbohaler contains 50 metered actuations.
POM

PL No: 6464/0423 200 microgram Turbohaler
PL No: 6464/0424 400 microgram Turbohaler

These products are manufactured by AstraZeneca AB, Sodertalje, Sweden and are procured from within the EU and repackaged
by the Product Licence holder who is:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 02.04.2013
Pulmicort® and Turbohaler® are registered trademarks of ASTRAZENECA AB

˪‹‚‡
d5„2°

Ī52¬

WARNING!

DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

«PAdBì

PROOF HISTORY:
v.1 - waymade - 02/04/13

Leaflet Flat Size = 180 x 429

2. Hold your Turbohaler upright with the brown base at the bottom.

Expand view ⇕

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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