PULMICORT RESPULES 0.5MG NEBULISER SUSPENSION

Active substance: BUDESONIDE

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PATIENT INFORMATION LEAFLET
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PULMICORT RESPULES 0.5mg NEBULISER SUSPENSION
(budesonide)
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This product is available using the above name but will be referred to as Pulmicort Respules
throughout the remainder of this 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.
In this leaflet:
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1. What Pulmicort Respules are and what they are used for
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2. Before you use Pulmicort Respules
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3. How to use Pulmicort Respules
4. Possible side effects
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5. How to store Pulmicort Respules
6. Further information
1. WHAT PULMICORT® RESPULES® ARE AND WHAT THEY ARE USED FOR
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Pulmicort 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.
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 Pulmicort 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® RESPULES®
Do not use Pulmicort® Respules® if:
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 You are allergic (hypersensitive) to budesonide or any of the other ingredients of Pulmicort
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Respules (listed in Section 6: Further information).
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Take special care with Pulmicort Respules
Before you use Pulmicort® Respules®, tell your doctor or pharmacist if:
 You have a lung infection.
 You have a cold or chest infection.
 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
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Pulmicort Respules can affect the way some medicines work and some medicines can have an
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effect on Pulmicort Respules .
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
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 If you are pregnant, or planning to get pregnant, talk to your doctor before using Pulmicort
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Respules - do not use Pulmicort Respules unless your doctor tells you to.
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 If you get pregnant while using Pulmicort Respules , do not stop using Pulmicort Respules but
talk to your doctor immediately.
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 If you are breast-feeding, talk to your doctor before using Pulmicort Respules .
Driving and using machines
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Pulmicort Respules are not likely to affect you being able to drive or use any tools or machines.
3. HOW TO USE PULMICORT® RESPULES®
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 Always use Pulmicort 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’.
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Note: Do not use an ultrasonic nebuliser with Pulmicort 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® 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 a lower dose of 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.
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Instructions for using Pulmicort 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.

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



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If you use more Pulmicort 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
Respules than you should, contact your doctor or pharmacist for advice.
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If you forget to use Pulmicort 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® Respules® can cause side effects, although not everybody gets them.
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If either of the following happens to you, stop using Pulmicort Respules and talk to your
doctor immediately:
 Swelling of your face, particularly around your mouth (with possible swelling of the lips, tongue,
eyes, 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
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after using Pulmicort Respules .
 Mild sore throat, coughing and a hoarse voice.
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).
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 RESPULES®
 Do not use after the expiry date printed on the carton label or foil pouch.
 Do not store above 30°C. Use within 3 months of opening the foil envelope. Protect the opened
ampoules from light and use the opened ampoule within 12 hours of opening.
 Keep out of the sight and reach of children.
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 If your doctor tells you to stop using the Respules , please take them back to the pharmacist for
safe disposal. Only keep the Respules if your doctor tells you to.
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 If the Respules become discoloured or show signs of any deterioration, you should seek the
advice of your pharmacist.
 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® Respules® contain
Each 2ml single dose unit (respule) contains 0.5mg of the active ingredient budesonide.
The other ingredients are sodium chloride, polysorbate 80, citric acid anhydrous, sodium citrate,
disodium edetate and purified water.
What Pulmicort® Respules® look like and the contents of the pack
Each Respule contains 2 millilitres (ml) of solution.
Your medicine is a white to off-white suspension for nebulisation.
The solution must be nebulised (made into a fine mist) before it can be breathed in.
Pulmicort® Respules® are available as 4 foil envelopes each containing 5, 2ml respules of suspension
for nebulisation. Each carton contains 20 respules.
PL No: 15814/0912

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Pulmicort Respules 0.5mg Nebuliser Suspension

POM

This product is manufactured by AstraZeneca AB, Sodertalje, Sweden and procured from within the
EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd, Watford, Herts WD2
4PR.
Leaflet revision and issue date (Ref.) 20/03/2013.
Pulmicort and Respules are registered Trade Marks of AstraZeneca Group of Companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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