PULMICORT RESPULES 1 MG NEBULISER SUSPENSION

Active substance: BUDESONIDE

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Transcript
Ref: 1303/190912/1/F

®

®

Pulmicort Respules 1mg nebuliser suspension
(budesonide)
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Pulmicort Respules 1mg nebuliser suspension and
will be referred to as Pulmicort Respules throughout this leaflet.
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

3

How to use Pulmicort Respules

* 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’.
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.

5 How to store Pulmicort Respules
6 Further information

* 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.

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

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 information).
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 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).
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
Respules.

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

Croup
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
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 oulet 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
If 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 forget to use Pulmicort Respules
If you forget to take a dose, skip the missed dose and take the next dose as
usual.

Ref: 1303/190912/1/B

®

®

Pulmicort Respules 1mg nebuliser suspension
(budesonide)
Patient Information Leaflet (continued)
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, 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.

6

Further information

What Pulmicort Respules 1 mg contain
The active substance is budesonide. Each 2ml respule contains 1 mg of the
active ingredient, budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80,
citric acid, sodium citrate and water for injection.
What Pulmicort Respules 1 mg look like and the contents of the pack
Each Respule contains 2 millilitres (ml) of clear, colourless solution.
The solution must be nebulised (made into a fine mist) before it can be
breathed in.
Pulmicort Respules 1 mg are packed in strips of 5 inside a foil envelope.
Each carton contains 20 Respules.

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.

Manufacturer and Licence Holder
Pulmicort Respule are manufactured by AstraZeneca AB, S-151 85,
Sodertalje, Sweden and are procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

Rare (affects less than 1 in 1,000 people)

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

* Rash on the face after using the face mask. You can stop this from
happening by washing your face after using the face mask.

* Feeling restless or nervous.
* Depression.
* Changes in behaviour.
* 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
* an effect on the adrenal gland (a small gland next to the kidney).
These effects are much less likely to happen with inhaled corticosteroids
than with corticosteroid tablets.
Frequency not known, but may also occur:
* Sleeping problems, depression or feeling worried, restless, nervous,
over-excited or irritable. These effects are more likely to occur in children.
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 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 30°C. Store Pulmicort Respules in their original
packaging and protect from light.
Do not use Pulmicort Respules after the expiry date printed on the carton
and foil envelope.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

POM

PL 15184/1303

Pulmicort Respule 1 mg nebuliser suspension

Pulmicort and Respules are registered trademarks of AstraZeneca AB.
Revision date: 19/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1303/190912/2/F

®

Budesonide Respules 1mg nebuliser suspension
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Budesonide Respules 1mg nebuliser suspension and
will be referred to as Budesonide Respules throughout this leaflet.
In this leaflet:
1 What Budesonide Respules are and what they are used for
2 Before you use Budesonide Respules
3 How to use Budesonide Respules
4 Possible side effects

3

How to use Budesonide Respules

* Always use Budesonide 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’.
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.

5 How to store Budesonide Respules
6 Further information

* 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.

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

Before you use Budesonide Respules

Do not use Budesonide Respules if:
* You are allergic (hypersensitive) to budesonide or any of the other
ingredients of Budesonide Respules (listed in Section 6: Further information).
Take special care with Budesonide Respules
Before you use Budesonide 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 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).
Pregnancy and breast-feeding
* If you are pregnant, or planning to get pregnant, talk to your doctor before
using Budesonide Respules - 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.
* If you are breast-feeding, talk to your doctor before using Pulmicort
Respules.
Driving and using machines
Budesonide Respules are not likely to affect you being able to drive or use
any tools or machines.

Croup
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 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 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 oulet 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
If 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 forget to use Budesonide Respules
If you forget to take a dose, skip the missed dose and take the next dose as
usual.

Ref: 1303/190912/2/B

®

Budesonide Respules 1mg nebuliser suspension
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines, Budesonide Respules 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, 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.

6

Further information

What Budesonide Respules 1 mg contain
The active substance is budesonide. Each 2ml respule contains 1 mg of the
active ingredient, budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80,
citric acid, sodium citrate and water for injection.
What Budesonide Respules 1 mg look like and the contents of the pack
Each Respule contains 2 millilitres (ml) of clear, colourless solution.
The solution must be nebulised (made into a fine mist) before it can be
breathed in.
Budesonide Respules 1 mg are packed in strips of 5 inside a foil envelope.
Each carton contains 20 Respules.

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.

Manufacturer and Licence Holder
Budesonide Respules are manufactured by AstraZeneca AB, S-151 85,
Sodertalje, Sweden and are procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

Rare (affects less than 1 in 1,000 people)

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

* Rash on the face after using the face mask. You can stop this from
happening by washing your face after using the face mask.

* Feeling restless or nervous.
* Depression.
* Changes in behaviour.
* 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
* an effect on the adrenal gland (a small gland next to the kidney).
These effects are much less likely to happen with inhaled corticosteroids
than with corticosteroid tablets.
Frequency not known, but may also occur:
* Sleeping problems, depression or feeling worried, restless, nervous,
over-excited or irritable. These effects are more likely to occur in children.
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 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 30°C. Store Pulmicort Respules in their original
packaging and protect from light.
Do not use Budesonide Respules after the expiry date printed on the
carton and foil envelope.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

POM

PL 15184/1303

Budesonide Respules
1 mg nebuliser suspension

Respules are registered trademarks of AstraZeneca AB.
Revision date: 19/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1303/190912/3/F

®

®

Pulmicort Respules 1mg nebuliser suspension
(budesonide)
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Pulmicort Respules 1mg nebuliser suspension and
will be referred to as Pulmicort Respules throughout this leaflet.
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

3

How to use Pulmicort Respules

* 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’.
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.

5 How to store Pulmicort Respules
6 Further information

* 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.

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

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 information).
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 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).
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
Respules.

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

Croup
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
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 oulet 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
If 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 forget to use Pulmicort Respules
If you forget to take a dose, skip the missed dose and take the next dose as
usual.

Ref: 1303/190912/3/B

®

®

Pulmicort Respules 1mg nebuliser suspension
(budesonide)
Patient Information Leaflet (continued)
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, 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.

6

Further information

What Pulmicort Respules 1 mg contain
The active substance is budesonide. Each 2ml respule contains 1 mg of the
active ingredient, budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80,
citric acid, sodium citrate and water for injection.
What Pulmicort Respules 1 mg look like and the contents of the pack
Each Respule contains 2 millilitres (ml) of clear, colourless solution.
The solution must be nebulised (made into a fine mist) before it can be
breathed in.
Pulmicort Respules 1 mg are packed in strips of 5 inside a foil envelope.
Each carton contains 20 Respules.
Manufacturer and Licence Holder
Pulmicort Respules are manufactured by AstraZeneca Pty Ltd -10-14
Khartoum Road, North Ryde, NSW 2113, Australia and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

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.
* Feeling restless or nervous.
* Depression.
* Changes in behaviour.
* 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
* an effect on the adrenal gland (a small gland next to the kidney).
These effects are much less likely to happen with inhaled corticosteroids
than with corticosteroid tablets.
Frequency not known, but may also occur:
* Sleeping problems, depression or feeling worried, restless, nervous,
over-excited or irritable. These effects are more likely to occur in children.
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 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 30°C. Store Pulmicort Respules in their original
packaging and protect from light.
Do not use Pulmicort Respules after the expiry date printed on the carton
and foil envelope.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1303

Pulmicort Respule 1 mg nebuliser suspension

Pulmicort and Respules are registered trademarks of AstraZeneca AB.
Revision date: 19/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1302/190912/4/F

®

Budesonide Respules 1mg nebuliser suspension
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Budesonide Respules 1 mg nebuliser suspension
and will be referred to as Budesonide Respules throughout this leaflet.
In this leaflet:
1 What Budesonide Respules are and what they are used for
2 Before you use Budesonide Respules
3 How to use Budesonide Respules
4 Possible side effects

3

How to use Budesonide Respules

* Always use Budesonide 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’.
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.

5 How to store Budesonide Respules
6 Further information

* 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.

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

Before you use Budesonide Respules

Do not use Budesonide Respules if:
* You are allergic (hypersensitive) to budesonide or any of the other
ingredients of Budesonide Respules (listed in Section 6: Further information).
Take special care with Budesonide Respules
Before you use Budesonide 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 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).
Pregnancy and breast-feeding
* If you are pregnant, or planning to get pregnant, talk to your doctor before
using Budesonide Respules - 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.
* If you are breast-feeding, talk to your doctor before using Pulmicort
Respules.
Driving and using machines
Budesonide Respules are not likely to affect you being able to drive or use
any tools or machines.

Croup
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 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 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 oulet 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
If 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 forget to use Budesonide Respules
If you forget to take a dose, skip the missed dose and take the next dose as
usual.

Ref: 1302/190912/4/B

®

Budesonide Respules 1 mg nebuliser suspension
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines, Budesonide Respules 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, 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.

6

Further information

What Budesonide Respules 1 mg contain
The active substance is budesonide. Each 2ml respule contains 1 mg of the
active ingredient, budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80,
citric acid, sodium citrate and water for injection.
What Budesonide Respules 1 mg look like and the contents of the pack
Each Respule contains 2 millilitres (ml) of clear, colourless solution.
The solution must be nebulised (made into a fine mist) before it can be
breathed in.
Budesonide Respules 1 mg are packed in strips of 5 inside a foil envelope.
Each carton contains 20 Respules.
Manufacturer and Licence Holder
Budesonide Respules are manufactured by AstraZeneca Pty Ltd -10-14
Khartoum Road, North Ryde, NSW 2113, Australia and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

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.
* Feeling restless or nervous.
* Depression.
* Changes in behaviour.
* 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
* an effect on the adrenal gland (a small gland next to the kidney).
These effects are much less likely to happen with inhaled corticosteroids
than with corticosteroid tablets.
Frequency not known, but may also occur:
* Sleeping problems, depression or feeling worried, restless, nervous,
over-excited or irritable. These effects are more likely to occur in children.
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 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 30°C. Store Pulmicort Respules in their original
packaging and protect from light.
Do not use Budesonide Respules after the expiry date printed on the
carton and foil envelope.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1302

Budesonide Respules 1 mg
nebuliser suspension

Respules are registered trademarks of AstraZeneca AB.
Revision date: 19/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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