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BUDESONIDE SINGLE-DOSE UNIT 0.5MG NEBULISER SUSPENSION

Active substance(s): BUDESONIDE / BUDESONIDE / BUDESONIDE

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Package leaflet: Information for the user

Pulmicort® Respules® 0.5mg, nebuliser suspension
(budesonide)
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.
The name of your medicine is Pulmicort Respules 0.5mg, nebuliser suspension, 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
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 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.

Croup
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
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, 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: 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 out of the sight and reach of children.
Do not store above 30°C. Do not freeze. Store in an upright position. Store in the original pack in order 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.
If only 1ml of suspension is used, the remaining suspension is not sterile and should be discarded immediately.
If the nebulising suspension shows any signs of discoloration, 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 ingredient is budesonide. Each 2ml Respule contains 0.5mg budesonide.
Each ml of nebuliser suspension contains 0.25mg budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and water for injections.
What Pulmicort Respules looks like and the contents of the pack
Sterile nebuliser suspension. Clear, colourless liquid in a plastic single dose unit.
Pulmicort Respules are available in packs containing 4 foil pouches with each pouch containing 5 single-dose vials of 2ml.
Each carton contains 20 respules.
Manufactured by: AstraZeneca AB – Forskargatan 18 – SE - 151 85, Sodertalje, Sweden. OR AstraZeneca Pty Ltd -10-14 Khartoum Road North Ryde NSW 2113, Australia.
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® Respules® 0.5mg, nebuliser suspension; PL 18799/2353
Leaflet date: 21.06.2017

POM

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the leaflet in a format suitable for you.

Package leaflet: Information for the user

Budesonide single-dose unit 0.5mg, nebuliser suspension
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.
The name of your medicine is Budesonide single-dose unit 0.5mg, nebuliser suspension, but will be referred to as Budesonide single-dose units or
single-dose units throughout this leaflet.
What is in this leaflet
1. What Budesonide single-dose units are and what they are used for
2. What you need to know before you use Budesonide single-dose units
3. How to use Budesonide single-dose units
4. Possible side effects
5. How to store Budesonide single-dose units
6. Contents of the pack and other information

1. What Budesonide single-dose units are and what they are used for
Budesonide single-dose units 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 single-dose units are used to treat asthma. They are also used to treat croup in infants and children.
A single-dose unit 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 single-dose units
Do not use Budesonide single-dose units:
 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 single-dose units, 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 Budesonide single-dose units
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 single-dose units can affect the way some medicines work and some
medicines can have an effect on Budesonide single-dose units 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 Budesonide single-dose units unless your doctor tells you to.
 If you get pregnant while using Budesonide single-dose units, do not stop using Budesonide single-dose units but talk to your doctor
immediately.
Driving and using machines
Budesonide single-dose units are not likely to affect you being able to drive or use any tools or machines.

3. How to use Budesonide single-dose units



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 single-dose unit 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 single-dose units.



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 single-dose units 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 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.

Croup
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 Budesonide single-dose units
1. Break off a single-dose unit from the strip. Leave the rest in the foil envelope.
2. Shake the single-dose unit gently.
3. Hold upright. Twist off the top of the single-dose unit to open.
4. Place the open end of the single-dose unit firmly inside the nebuliser cup. Squeeze slowly to put the liquid in the cup.
5. Throw the empty single-dose unit 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
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 single-dose units, you should continue to use Budesonide single-dose
units 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 single-dose units 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 single-dose units than you should, contact your doctor or pharmacist for advice.
If you forget to use Budesonide single-dose units
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 single-dose units 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 Budesonide.
 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: 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 single-dose units









Keep out of the sight and reach of children.
Do not store above 30°C. Do not freeze. Store in an upright position. Store in the original pack in order to protect from light.
Once a foil envelope has been opened, the single-dose units 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 1ml of suspension is used, the remaining suspension is not sterile and should be discarded immediately.
If the nebulising suspension shows any signs of discoloration, seek the advice of your pharmacist.
Do not use the single-dose units 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 Budesonide single-dose units contains
The active ingredient is budesonide. Each 2ml single-dose unit contains 0.5mg budesonide.
Each ml of nebuliser suspension contains 0.25mg budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and water for injections.
What Budesonide single-dose units looks like and the contents of the pack
Sterile nebuliser suspension. Clear, colourless liquid in a plastic single dose unit.
Budesonide single-dose units are available in packs containing 4 foil pouches with each pouch containing 5 single-dose vials of 2ml.
Each carton contains 20 single-dose units.
Manufactured by: AstraZeneca AB – Forskargatan 18 – SE - 151 85, Sodertalje, Sweden. OR AstraZeneca Pty Ltd -10-14 Khartoum Road North Ryde NSW 2113, Australia.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Budesonide single-dose unit 0.5mg, nebuliser suspension; PL 18799/2353
Leaflet date: 21.06.2017

POM

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the leaflet in a format suitable for you.

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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