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BUDESONIDE 1MG SUSPENSION FOR NEBULISATION

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S748 LEAFLET Pulmicort 20150506

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

Your medicine is known as Pulmicort 1mg Respules but will be
referred to as Pulmicort Respules throughout the following leaflet.



If you get pregnant while using Pulmicort Respules, do not stop
using Pulmicort Respules but talk to your doctor immediately.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Driving and using machines

PULMICORT 1mg RESPULES
(budesonide)



Keep this leaflet. You may need to read it again.

Pulmicort Respules are not likely to affect you being able to drive or
use any tools or machines.



If you have any further questions, ask your doctor or
pharmacist.

3. HOW TO USE PULMICORT RESPULES



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.





Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.

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 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’.

What is in this leaflet:

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

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

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.

6. Contents of the pack and other information
How much to take
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.

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 lower doses
(0.5 mg 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PULMICORT RESPULES

Instructions for using Pulmicort Respules

Do not use Pulmicort Respules:

1. Break off a Respule from the strip. Leave the rest in the foil
envelope.



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:

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.



You have a lung infection.



6. Connect one end of the cup to the face mask or mouthpiece.

You have a cold or chest infection.



7. Connect the other end of the cup to the air pump.

You have liver problems.

8. Gently shake the cup.

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.
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).

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

Reporting of side effects

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.

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.

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

These signs could mean that your condition is not being properly
controlled and you may need different or additional treatment
immediately.



Do not store above 30°C.



Opened Respules should be used within 12 hours. Respules
should be kept in the foil envelope and outer carton to protect
from light and used within 3 months of opening the envelope.
Note: It is best to mark the opening date on the foil envelope to
help you remember.



Do not use Pulmicort Respules after the expiry date printed on
the carton and foil envelope.



If your doctor decides to stop the treatment return the Pulmicort
Respules to the pharmacist for safe disposal. Only keep them if
your doctor tells you to.



If the suspension becomes discoloured or shows any other
signs of deterioration, you should consult your pharmacist who
will tell you what to do.



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 protect
the environment.

5. HOW TO STORE PULMICORT RESPULES

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pulmicort Respules contain

If either of the following happen to you, stop using Pulmicort
Respules and talk to your doctor immediately:



Each single dose unit (Respule) contains 1mg budesonide in
2ml of white to off-white suspension for nebulisation





The suspension also contains disodium edetate, sodium
chloride, polysorbate 80, citric acid anhydrous, sodium citrate
and purified water.

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.

What Pulmicort Respules look like and contents of the pack


The suspension is made into a fine mist in a nebuliser and is
inhaled.



The pack contains 4 foil envelopes each containing five 2ml unit
doses (Respules) equal to twenty 2ml unit doses.



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.



Hoarse voice (in children).

Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca AB, S-151 85
Södertälje, Sweden.
POM

PL No: 19488/0748

Loss of voice.



Product Licence holder

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.

Leaflet revision date: 06 May 2015
Pulmicort and Respules are trade marks of the AstraZeneca group
of companies.
S748 LEAFLET Pulmicort 20150506

S748 LEAFLET Budesonide 20150506

PACKAGE LEAFLET: INFORMATION FOR THE USER

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
Budesonide Suspension unless your doctor tells you to.

Your medicine is known as Budesonide 1mg Suspension for
Nebulisation but will be referred to as Budesonide Suspension
throughout the following leaflet.



If you get pregnant while using Budesonide Suspension, do not
stop using Budesonide Suspension but talk to your doctor
immediately.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Driving and using machines

BUDESONIDE 1mg SUSPENSION FOR NEBULISATION
(budesonide)



Keep this leaflet. You may need to read it again.

Budesonide Suspension is not likely to affect you being able to
drive or use any tools or machines.



If you have any further questions, ask your doctor or
pharmacist.

3. HOW TO USE BUDESONIDE SUSPENSION



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.





Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.

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 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 Budesonide
Suspension.



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 Budesonide Suspension every day, even if you
have no asthma symptoms at the time.

What is in this leaflet:
1. What Budesonide Suspension is and what it is used for
2. What you need to know before you use Budesonide Suspension
3. How to use Budesonide Suspension
4. Possible side effects
5. How to store Budesonide Suspension
6. Contents of the pack and other information

How much to take
1. WHAT BUDESONIDE SUSPENSION IS AND WHAT IT IS
USED FOR
Budesonide Suspension contains 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.


Budesonide Suspension is 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
BUDESONIDE SUSPENSION

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 lower doses
(0.5 mg 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.
Instructions for using Budesonide Suspension

Do not use Budesonide Suspension:

1. Break off a Respule from the strip. Leave the rest in the foil
envelope.



2. Shake the Respule gently.

If you are allergic to budesonide or any of the other ingredients
of this medicine (listed in section 6).

3. Hold upright. Twist off the top of the Respule to open.

Warnings and precautions

4. Place the open end of the Respule firmly inside the nebuliser
cup. Squeeze slowly to put the liquid in the cup.

Talk to your doctor or pharmacist before using Budesonide
Suspension, tell your doctor or pharmacist if:

5. Throw the empty Respule away. Put the top back on the
nebuliser cup.



You have a lung infection.

6. Connect one end of the cup to the face mask or mouthpiece.



You have a cold or chest infection.

7. Connect the other end of the cup to the air pump.



You have liver problems.

8. Gently shake the cup.

Other medicines and Budesonide Suspension

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.

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
Budesonide Suspension can affect the way some medicines work
and some medicines can have an effect on Budesonide
Suspension.

10. You will know when your treatment is complete because the
fine mist will stop coming out of your mask or mouthpiece.

In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:

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.



Steroid medicines.



Medicines to treat fungal infections (such as itraconazole and
ketoconazole).

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.



HIV protease inhibitors (such as ritonavir and nelfinavir).

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.

Important information about your asthma symptoms

Reporting of side effects

If you feel you are getting breathless or wheezy while using
Budesonide Suspension, you should continue to use Budesonide
Suspension but go to see your doctor as soon as possible, as you
may need additional treatment.

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.

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

These signs could mean that your condition is not being properly
controlled and you may need different or additional treatment
immediately.



Do not store above 30°C.



Opened vials should be used within 12 hours. Vials should be
kept in the foil envelope and outer carton to protect from light
and used within 3 months of opening the envelope. Note: It is
best to mark the opening date on the foil envelope to help you
remember.



Do not use Budesonide Suspension after the expiry date
printed on the carton and foil envelope.



If your doctor decides to stop the treatment return the
Budesonide Suspension to the pharmacist for safe disposal.
Only keep them if your doctor tells you to.



If the suspension becomes discoloured or shows any other
signs of deterioration, you should consult your pharmacist who
will tell you what to do.



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 protect
the environment.

5. HOW TO STORE BUDESONIDE SUSPENSION

If you use more Budesonide Suspension 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 Budesonide Suspension than you should, contact your doctor
or pharmacist for advice.
If you forget to use Budesonide Suspension
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Budesonide Suspension contains

If either of the following happen to you, stop using Budesonide
Suspension and talk to your doctor immediately:



Each single dose unit Respule contains 1mg budesonide in 2ml
of white to off-white suspension for nebulisation





The suspension also contains disodium edetate, sodium
chloride, polysorbate 80, citric acid anhydrous, sodium citrate
and purified water.

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 (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.



Loss of voice.





The suspension is made into a fine mist in a nebuliser and is
inhaled.



The pack contains 4 foil envelopes each containing five 2ml unit
doses Respule equal to twenty 2ml unit doses.

Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca AB, S-151 85
Södertälje, Sweden.
POM

PL No: 19488/0748

Bruising of the skin.



What Budesonide Suspension looks like and contents of the
pack

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.

Leaflet revision date: 6 May 2015
S748 LEAFLET Budesonide 20150506

Expand Transcript

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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