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PULMICORT 0.5MG RESPULES

Active substance(s): BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PULMICORT® 0.5MG RESPULES®
(budesonide)
Your medicine is available using the name Pulmicort 0.5mg
Respules but will be referred to as Pulmicort Respules throughout
this leaflet.

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 yours.
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.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Pulmicort Respules are and what they are used for
What you need to know before you use Pulmicort Respules
How to use Pulmicort Respules
Possible side effects
How to store Pulmicort Respules
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.

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.

Instructions for using Pulmicort Respules

1.
2.
3.
4.
5.

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).

6.
7.
8.
9.

Pregnancy, breast-feeding and fertility

10.





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.

11.
12.
13.

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
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 recommended 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 0.5mg to 1 mg, twice a day.

Croup

The recommended 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.
Page 1 of 2

Break off a Respule from the strip. Leave the rest in the foil
envelope.
Shake the Respule gently.
Hold upright. Twist off the top of the Respule to open.
Place the open end of the Respule firmly inside the nebuliser
cup. Squeeze slowly to put the liquid in the cup.
Throw the empty Respule away. Put the top back on the
nebuliser cup.
Connect one end of the cup to the face mask or mouthpiece.
Connect the other end of the cup to the air pump.
Gently shake the cup.
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.
You will know when your treatment is complete because the
fine mist will stop coming out of your mask or mouthpiece.
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.
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.
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

5. How to store Pulmicort Respules

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.

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, 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.






Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.





Keep out of the sight and reach of children.
Do not use your Respules after the expiry date printed on
the carton and foil envelope.
Do not store above 30°C.
Store in the original package. Protect from light.
Use within 3 months of opening the foil envelope.
If only 1ml of the suspension is used, the remaining
suspension in the Respule should be thrown away
immediately.
If your Respules appear to be discoloured or show any other
signs of deterioration, please return to your pharmacist who
will advise you further.
If your doctor tells you to stop using Pulmicort Respules,
please take them back to the pharmacist for safe disposal.
Only keep the Pulmicort Respules if your doctor tells you to.

6. Contents of the pack and other
information
What Pulmicort Respules contain

Each 2ml Respule contains budesonide 0.25mg/ml as the active
ingredient.
Each single dose unit Respule contains 0.5mg of budesonide as a
suspension.
Pulmicort Respules also contain disodium edetate, sodium
chloride, polysorbate 80, citric acid, sodium citrate and water for
injection.
Each Pulmicort Respule contains 2ml of a suspension to be
nebulised (made into a fine mist for inhalation).

What Pulmicort Respules look like and the contents
of the pack
Pulmicort Respules are a white to off white nebuliser suspension
presented in a sealed foil pouch containing a strip of five
translucent plastic dose-units. Each unit dose has 'PULMICORT®
0.25mg/ml' printed on them in black ink on one side and plain on
the reverse. The strip is embossed with EXP and Lot on the top
tabs.

Pulmicort Respules are available in a pack of 20 Respules, packed
in 4 foil envelopes, each containing a strip of 5 plastic unit dose
ampoules.

Manufacturer

Pulmicort Respules are manufactured by: AstraZeneca AB,
S-151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
POM

Pulmicort 0.5mg Respules

Page 2 of 2

PL No: 04423/0620

To listen to or request a copy of this leaflet in Braille, large print
or audio please call, 01302 365000
Please be ready to give the following information:
Product name
Pulmicort 0.5mg Respules
Reference number 04423/0620
Leaflet revision and issue date (Ref): 05.02.15
Pulmicort® and Respules® are registered trademarks of
AstraZeneca group of companies.

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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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