PULMICORT RESPULES 1MG NEBULISER SUSPENSION

Active substance: 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.

PULMICORT® RESPULES® 1mg NEBULISER SUSPENSION
(budesonide)
Patient Information Leaflet
27mm

This medicine is available as the above name, but will be referred to as Pulmicort 1mg Respules throughout
this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

PROOF HISTORY:
v.1 - waymade - 08/05/13

Leaflet Flat Size = 148 x
01/13

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 1mg Respules are and what they are used for
2. Before you use Pulmicort 1mg Respules
3. How to use Pulmicort 1mg Respules
4. Possible side effects
5. How to store Pulmicort 1mg Respules
6. Further information
1. What Pulmicort 1mg Respules are and what they are used for
Pulmicort 1mg Respules contain 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.
• Pulmicort 1mg Respules are used to treat asthma. They are also used to treat croup in infants and
children.
• A Respule is a small plastic container that contains a liquid. The liquid is put into a machine called
a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face
mask or mouthpiece.
2. Before you use Pulmicort 1mg Respules
Do not use Pulmicort 1mg Respules if:
• You are allergic (hypersensitive) to budesonide or any of the other ingredients of Pulmicort 1mg
Respules (listed in Section 6: Further information).

WARNING!

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
1mg Respules can affect the way some medicines work and some medicines can have an effect on
Pulmicort 1mg Respules.

DATE:

CUSTOMER
APPROVED:

Take special care with Pulmicort 1mg Respules
Before you use Pulmicort 1mg Respules, tell your doctor or pharmacist if:
• You have a lung infection.
• You have a cold or chest infection.
• You have liver problems.



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3. How to use Pulmicort 1mg Respules
Always use Pulmicort 1mg Respules exactly as your doctor, nurse or pharmacist has told you.
Ask one of them for advice if you are not sure.
The solution in a Respule must be put into a nebuliser and made into a fine mist before it can be
breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your
nebuliser are given after the section ‘How much to take’.

Note: Do not use an ultrasonic nebuliser with Pulmicort 1mg Respules.


Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to
have its full effect. It is important to use Pulmicort 1mg Respules every day, even if you have no
asthma symptoms at the time.

How much to take
Asthma
Your doctor will tell you how much to take. This will depend on how severe your asthma is.
Your doctor may lower your dose as your asthma improves.
• The usual starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a
day.
• Children under 12 years are usually prescribed lower doses (0.5 mg to 1 mg, twice a day).
Croup
The usual dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be
given followed by another 1 mg 30 minutes later.
Instructions for using Pulmicort 1mg Respules
1. Break off a Respule from the strip. Leave the rest in the foil envelope.
2. Shake the Respule gently.
3. Hold upright. Twist off the top of the Respule to open.
4. Place the open end of the Respule firmly inside the nebuliser cup. Squeeze slowly to put the liquid in
the cup.
5. Throw the empty Respule away. Put the top back on the nebuliser cup.
6. Connect one end of the cup to the face mask or mouthpiece.
7. Connect the other end of the cup to the air pump.
8. Gently shake the cup.
9. Turn on the nebuliser and breathe in the mist calmly and deeply using the face mask or mouthpiece.
If you are using a face mask, make sure the face mask fits tightly.
10. You will know when your treatment is complete because the fine mist will stop coming out of your mask
or mouthpiece.
11. How long it takes to nebulise all the medicine depends on the type of equipment you use. It will also
depend on the amount of medicine to be used.
12. Rinse your mouth with water. Spit out the water. Do not swallow it. If you have used a face mask, wash
your face as well.
13. After each use, you must wash the nebuliser cup and mouthpiece (or face mask) in warm soapy water
and rinse well. After washing, dry these parts by connecting to the air outlet or the compressor and blow
air through them.

Colour
Swatch

Black

WARNING!

DATE:
08/05/13

Driving and using machines
Pulmicort 1mg Respules are not likely to affect you being able to drive or use any tools or machines.

CODE:

DT
ARTWORKER:
Pulmicort Respules 1mg
PRODUCT:

PRE-PRESS NO.:
Waymade
CUSTOMER:

DATE OF PROOF:

Q.A.
APPROVED:
05-0269

Pregnancy and breast-feeding
• If you are pregnant, or planning to get pregnant, talk to your doctor before using Pulmicort 1mg
Respules - do not use Pulmicort 1mg Respules unless your doctor tells you to.
• If you get pregnant while using Pulmicort 1mg Respules, do not stop using Pulmicort 1mg
Respules but talk to your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Pulmicort 1mg Respules.

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.

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).

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.

Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using Pulmicort 1mg Respules, you should continue
to use Pulmicort 1mg Respules 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.

If you forget to use Pulmicort 1mg Respules
If you forget to take a dose, skip the missed dose and take the next dose as usual.
4. Possible side effects
Like all medicines, Pulmicort 1mg Respules can cause side effects, although not everybody gets them.
If either of the following happen to you, stop using Pulmicort 1mg Respules 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. 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 Pulmicort 1mg Respules.
• Mild sore throat, coughing and a hoarse voice.



08/05/13




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DATE OF PROOF:

DATE:




WARNING!

5. How to store Pulmicort 1mg Respules
Once you have opened a single respule, it should be used within 12 hours. After this time the
respule and any remaining contents should be thrown away.
Do not store above 30°C. Do not freeze. Keep in the foil envelope to protect from sunlight.
Once a foil envelope has been opened, the respules inside should be used within 3 months. (It is
best to mark the opening date on the envelope to help you remember).
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use after the expiry date printed on the foil envelope or carton.

6. Further Information
What Pulmicort 1mg Respules contains
Your medicine is called Pulmicort Respules 1mg Nebuliser Suspension. Each 2ml plastic unit (respule) of
suspension contains 1mg of the active ingredient budesonide in a suspension for nebulising (made into a
fine mist for inhalation).
Pulmicort 1mg Respules contains the following inactive ingredients:
disodium edetate, sodium chloride, polysorbate 80, citric acid anhydrous, sodium citrate and purified water.
What Pulmicort 1mg Respules look like and contents of the pack
Pulmicort 1mg Respules are packed in strips of 5 inside a foil envelope. Each carton contains 4 foil
envelopes containing a total of 20 respules.

6464/1689D

DT
ARTWORKER:
Pulmicort Respules 1mg

05-0269
Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

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 1mg Respules are a white to off white suspension for nebulisation in a plastic respule.
Marketing Authorisation holder and Manufacturer

CODE:

PRODUCT:

CUSTOMER:

POM

PL No: 6464/1689 Pulmicort Respules 1mg Nebuliser Suspension

This product is manufactured by AstraZeneca AB, Sodertalje, Sweden and is 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.) 08.05.2013
Pulmicort® and Respules® are registered trademarks of AstraZeneca AB

Colour
Swatch

Black

WARNING!

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.

DATE:

CUSTOMER
APPROVED:

Rare (affects less than 1 in 1,000 people)
• Rash on the face after using the face mask. You can stop this from happening by washing your
face after using the face mask.
• 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).

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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

PROOF HISTORY:
v.1 - waymade - 08/05/13

Leaflet Flat Size = 148 x
01/13

If you use more Pulmicort 1mg Respules 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
1mg Respules than you should, contact your doctor or pharmacist for advice.

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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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