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BUDESONIDE RESPULES 0.5 MG NEBULISER SUSPENSION

Active substance(s): BUDESONIDE

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Pulmicort® Respules® 0.5 mg
nebuliser suspension

2663
23.03.15[2]

(budesonide)
PATIENT INFORMATION 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.
This medicine is available using the above name but will be referred to as
Pulmicort Respules throughout this leaflet. Also available in 1 mg strength.
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.
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).
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
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 doses of 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 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 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.
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 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.
- 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.
5. HOW TO STORE PULMICORT RESPULES
Keep in a safe place, out of the sight and reach of children.
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.
If only some of the suspension is used, the remaining suspension in the
Respule should be thrown away immediately.
Do not store above 30oC. Do not freeze. Store in an upright position.
Respules should be kept in the original foil envelope to protect them from
light
Do not use Pulmicort Respules after the expiry date printed on the carton
and foil envelope.
If your doctor tells you to stop taking this medicine, return any unused
Respules to your pharmacist for safe disposal. Only keep the tablets if your
doctor tells you to.
If your Respules become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pulmicort Respules contain
Pulmicort Respules contain budesonide in the form of a nebuliser
suspension.
Each 2 ml Respule contains 0.5 mg of the active ingredient, budesonide.
Each ml of nebuliser suspension contains 0.25 mg budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate
80, anhydrous citric acid, sodium citrate and water for injections.
What Pulmicort Respules look like and the contents of the pack
Each Pulmicort Respule contains 2 ml of a white to off-white nebuliser
suspension (made into a fine mist for inhalation).
The Pulmicort Respules are packed in strips of 5 inside a foil envelope; each
carton contains 5 Respules or 20 Respules.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Pulmicort Respules are manufactured by AstraZeneca AB, S-15185,
Sodertalje, Sweden and is procured from within in the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2663

Leaflet revision and issue date (Ref) 23.03.15[2]
Pulmicort and Respules are trademarks of AstraZeneca AB.

Budesonide Respules® 0.5 mg
nebuliser suspension

2663
23.03.15[2]

PATIENT INFORMATION 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.
This medicine is available using the above name but will be referred to as
Budesonide Respules throughout this leaflet. Also available in 1 mg
strength.
What is in this leaflet
1. What Budesonide Respules are and what they are used for
2. What you need to know before you use Budesonide Respules
3. How to use Budesonide Respules
4. Possible side effects
5. How to store Budesonide Respules
6. Contents of the pack and other information
1. WHAT BUDESONIDE RESPULES ARE AND WHAT THEY ARE USED
FOR
Budesonide 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.
- Budesonide 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 BUDESONIDE
RESPULES
Do not use Budesonide 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 Budesonide 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 Budesonide 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 Budesonide
Respules can affect the way some medicines work and some medicines
can have an effect on Budesonide 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, 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 Respules unless your doctor
tells you to.
- If you get pregnant while using Budesonide Respules, do not stop using
Budesonide Respules but talk to your doctor immediately.
Driving and using machines
Budesonide Respules are not likely to affect you being able to drive or use
any tools or machines.

3. HOW TO USE BUDESONIDE 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 Budesonide 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
Budesonide 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 doses of 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 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 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 Budesonide
Respules, you should continue to use Budesonide 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 Budesonide 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 Budesonide
Respules than you should, contact your doctor or pharmacist for advice.
If you forget to use Budesonide 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 Budesonide
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 (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 Budesonide.
- 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.
5. HOW TO STORE BUDESONIDE RESPULES
Keep in a safe place, out of the sight and reach of children.
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.
If only some of the suspension is used, the remaining suspension in the
Respule should be thrown away immediately.
Do not store above 30oC. Do not freeze. Store in an upright position.
Respules should be kept in the original foil envelope to protect them from
light
Do not use Budesonide Respules after the expiry date printed on the carton
and foil envelope.
If your doctor tells you to stop taking this medicine, return any unused
Respules to your pharmacist for safe disposal. Only keep the tablets if your
doctor tells you to.
If your Respules become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Budesonide Respules contain
Budesonide Respules contain budesonide in the form of a nebuliser
suspension.
Each 2 ml Respule contains 0.5 mg of the active ingredient, budesonide.
Each ml of nebuliser suspension contains 0.25 mg budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate
80, anhydrous citric acid, sodium citrate and water for injections.
What Budesonide Respules look like and the contents of the pack
Each Budesonide Respule contains 2 ml of a white to off-white nebuliser
suspension (made into a fine mist for inhalation).
The Budesonide Respules are packed in strips of 5 inside a foil envelope;
each carton contains 5 Respules or 20 Respules.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Budesonide Respules are manufactured by AstraZeneca AB, S-15185,
Sodertalje, Sweden and is procured from within in the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2663

Leaflet revision and issue date (Ref) 23.03.15[2]
Respules is a trademark of AstraZeneca AB.

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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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