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Active substance: BUDESONIDE

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Pulmicort Respules 1mg/2ml/
Pulmicort Suspension for Nebulisation 1mg/2ml
Budesonide Respules 1mg/2ml/
Budesonide Suspension for Nebulisation 1mg/2ml
Your medicine is known by the either of the above names but will be
referred to as Pulmicort Respules throughout the following patient
information leaflet.
Patient Information 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 become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Pregnancy and breast-feeding
 If you are pregnant, or planning to get pregnant, talk to your doctor before
using Pulmicort Respules - 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.
 If you are breast-feeding, talk to your doctor before using Pulmicort
Driving and using machines
Pulmicort Respules are not likely to affect you being able to drive or use any
tools or machines.

In this leaflet:
1) What Pulmicort Respules are and what they are used for
2) Before you use Pulmicort Respules
3) How to use Pulmicort Respules
4) Possible side effects
5) How to store Pulmicort Respules
6) Further information

3) How to use Pulmicort Respules

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

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

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) Before you use Pulmicort Respules
Do not use Pulmicort Respules if:
 You are allergic (hypersensitive) to budesonide or any of the other
ingredients of Pulmicort Respules (listed in Section 6: Further
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 Pulmicort Respules can affect the way some
medicines work and some medicines can have an effect on Pulmicort
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
 HIV protease inhibitors (such as ritonavir and nelfinavir).

 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’.

 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 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.
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 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
 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 your dose 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

4) Possible side effects
Like all medicines, Pulmicort Respules 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 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.
 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, overexcited 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
 Keep all medicines out of the sight and reach of children.
 Do not use after the expiry date printed on the carton label or foil pouch.
 Pulmicort Respules should be stored below 30°C. Use within 3 months of
opening the foil envelope (it is best to mark the opening date on the foil
envelope to help you remember).
 Store the respules in their original carton out of direct sunlight and use the
opened respule within 12 hours of opening.
 If only some of the suspension is used, the remaining suspension in the
respule should be thrown away immediately.
 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.
 If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

6) Further information
What Pulmicort Respules contain
The active substance is budesonide.
Each 2ml single dose unit of suspension contains 1mg of the active
ingredient budesonide
Pulmicort Respules also contain the following inactive ingredients: sodium
chloride, polysorbate 80, citric acid, sodium citrate, disodium edetate and
purified water
What Pulmicort Respules look like and the contents of the pack
Pulmicort Respules is a white to off-white suspension for nebulisation
(made into a fine mist for inhalation).
Pulmicort Respules are available as foil pouches each containing (1 x 5) or
(4 x 5) 2ml ampoules of suspension for nebulisation.
PL No: 10383/0495

1mg/2ml POM

Marketing Authorisation Holder and Manufacturer
Your medicines are manufactured by AstraZeneca Farmaceutica Spain,
S.A. A. Relva, S/N – O Porrino (Pontevedra) Spain They are procured from
within the EU and repackaged by the Product Licence holder: Primecrown
Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5
Leaflet date: 16.04.2013.

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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.