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Active substance(s): BUDESONIDE

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Package leaflet: Information for the user

Pulmicort® 0.5mg Respules®
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
 If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
The name of your medicine is Pulmicort 0.5mg Respules, but will be referred to as Pulmicort Respules or Respules throughout this leaflet.
What is in this leaflet
1. What Pulmicort Respules are and what they are used for
2. What you need to know before you use Pulmicort Respules
3. How to use Pulmicort Respules
4. Possible side effects
5. How to store Pulmicort Respules
6. Contents of the pack and other information

1. What Pulmicort Respules are and what they are used for
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.

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. What you need to know before you use Pulmicort Respules
Do not use Pulmicort Respules:
 If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Pulmicort Respules, tell your doctor or pharmacist if:
 You have a lung infection.
 You have a cold or chest infection.
 You have liver problems.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Pulmicort Respules
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 Respules can affect the way some medicines work and some medicines
can have an effect on Pulmicort Respules and your doctor may wish to monitor you carefully.
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 medicines (such as ritonavir or cobicistat-containing products).
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 Respules unless your doctor tells you to.
 If you get pregnant while using Pulmicort Respules, do not stop using Pulmicort Respules but talk to your doctor immediately.
Driving and using machines
Pulmicort Respules are not likely to affect you being able to drive or use any tools or machines.

3. How to use Pulmicort Respules

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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 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
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 recommended starting dose in adults and children over 12 years is 1mg to 2mg (milligrams), twice a day.
Children under 12 years are usually prescribed a lower dose of 0.5mg to 1mg, twice a day.

The recommended dose for infants and children is 2mg a day. This may be given all in one go, or 1mg may be given followed by another 1mg
30 minutes later.
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
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.

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.
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.
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 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 (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 Pulmicort.
 Mild sore throat, coughing and a hoarse voice.
 Pneumonia (infection of the lung) in COPD patients.
Tell your doctor if you have any of the following while taking budesonide, they could be symptoms of a lung infection:
 fever or chills
 increased mucus production, change in mucus colour
 increased cough or increased breathing difficulties.
Uncommon (may affect up to 1 in 100 people)
 Feeling worried, restless and nervous.
 Depression.
 Trembling and shaking.
 Cataract (clouding of the lens in the eye).
 Muscle cramps.
 Blurred vision.
Rare (may affect up to 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, feeling 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).
 glaucoma (increased pressure in the eye).
 a slowing of the rate of growth of children and adolescents (rare). If high doses are given over several years, final height may be reduced
by about 1 cm.
 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.
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 any side effects directly via the Yellow Card Scheme at:
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pulmicort Respules

Keep out of the sight and reach of children.
Do not store above 30°C. Store Pulmicort Respules in their original carton and foil, to protect from light.
Once a foil envelope has been opened, the Respules inside should be used within 3 months.
Note: It is best to mark the opening date on the foil envelope to help you remember.
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.
If the nebulising suspension shows any signs of discolouration, seek the advice of your pharmacist.
Do not use the Respules after the expiry date which is stated on the carton and pouch label after ‘Exp’. The expiry date refers to the last day of
that month.
Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Pulmicort Respules contains
The active substance is budesonide.
Each Pulmicort 0.5mg Respule contains 0.5mg of the active ingredient, budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and purified water.
What Pulmicort Respules looks like and the contents of the pack
Each Respule contains 2millilitres (ml) of solution. The solution must be nebulised (made into a fine mist) before it can be breathed in.
Pulmicort Respules are packed in strips of 5 inside a foil envelope. Each carton contains 20 Respules.
Manufactured by: AstraZeneca AB, Sodertalje, Sweden.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Pulmicort® 0.5mg Respules; PL 18799/2742
Leaflet date: 21.06.2017


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