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BUDESONIDE 1MG/2ML NEBULISER SUSPENSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PULMICORT ® 1mg/2ml NEBULISER SUSPENSION
(budesonide)
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.
The name of your medicine is Pulmicort 1mg/2ml Nebuliser Suspension but will be referred to as
Pulmicort Respules or Respules throughout this leaflet.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Pulmicort Respules are and what they are used for
Before you use Pulmicort Respules
How to use Pulmicort Respules
Possible side effects
How to store Pulmicort Respules
Further 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. 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).
 HIV protease inhibitors (such as ritonavir and nelfinavir).
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.

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.




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.

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 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.

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 Respules.

 Mild sore throat, coughing and a hoarse voice.
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.

 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:






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.
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 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 carton and foil, and out of
direct sunlight.

 Do not use Pulmicort Respules after the expiry date printed on the carton and foil envelope.
6. Further information
What Pulmicort Respules contain
Each 2ml Respule contains 1mg of budesonide. They also contain disodium edetate, sodium
chloride, polysorbate 80, citric acid anhydrous, sodium citrate and water purified.
What Pulmicort Respules look like and the contents of the pack
Each Repsule contains 2ml of a suspension to be nebulised (made into a fine mist for inhalation).
The Respules are packed in strips of 5 inside a foil envelope. Each carton contains 20 Respules.
Manufactured by: Astra Pharmaceutical Production AB, Sodertalje, Sweden.
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® 1mg/2ml Nebuliser Suspension, PL No: 18799/0553
Leaflet date: 30.01.2013
Pulmicort and Respules are trade marks of the AstraZeneca group of companies.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

BUDESONIDE 1mg/2ml NEBULISER SUSPENSION
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.
The name of your medicine is Budesonide 1mg/2ml Nebuliser Suspension but will be referred to
as Budesonide Respules or Respules throughout this leaflet.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Budesonide Respules are and what they are used for
Before you use Budesonide Respules
How to use Budesonide Respules
Possible side effects
How to store Budesonide Respules
Further 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. 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).
 HIV protease inhibitors (such as ritonavir and nelfinavir).
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 Budesonide Respules.
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 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.



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.

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 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.

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 Budesonide Respules.

 Mild sore throat, coughing and a hoarse voice.
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.

 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:






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.
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 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 Budesonide Respules in their original carton and foil, and out
of direct sunlight.

 Do not use Budesonide Respules after the expiry date printed on the carton and foil envelope.
6. Further information
What Budesonide Respules contain
Each 2ml Respule contains 1mg of budesonide. They also contain disodium edetate, sodium
chloride, polysorbate 80, citric acid anhydrous, sodium citrate and water purified.
What Budesonide Respules look like and the contents of the pack
Each Repsule contains 2ml of a suspension to be nebulised (made into a fine mist for inhalation).
The Respules are packed in strips of 5 inside a foil envelope. Each carton contains 20 Respules.
Manufactured by: Astra Pharmaceutical Production AB, Sodertalje, Sweden.
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 1mg/2ml Nebuliser Suspension, PL No: 18799/0553
Leaflet date: 30.01.2013

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

PULMICORT ® 1mg/2ml NEBULISER SUSPENSION
(budesonide)
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.
The name of your medicine is Pulmicort 1mg/2ml Nebuliser Suspension but will be referred to as
Pulmicort Respules or Respules throughout this leaflet.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Pulmicort Respules are and what they are used for
Before you use Pulmicort Respules
How to use Pulmicort Respules
Possible side effects
How to store Pulmicort Respules
Further 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. 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).
 HIV protease inhibitors (such as ritonavir and nelfinavir).
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.

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.




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.

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 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.

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 Respules.

 Mild sore throat, coughing and a hoarse voice.
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.

 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:






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.
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 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 carton and foil, and out of
direct sunlight.

 Do not use Pulmicort Respules after the expiry date printed on the carton and foil envelope.
6. Further information
What Pulmicort Respules contain
Each 2ml Respule contains 1mg of budesonide. They also contain disodium edetate, sodium
chloride, polysorbate 80, citric acid anhydrous, sodium citrate and water purified.
What Pulmicort Respules look like and the contents of the pack
Each Repsule contains 2ml of a suspension to be nebulised (made into a fine mist for inhalation).
The Respules are packed in strips of 5 inside a foil envelope. Each carton contains 20 Respules.
Manufactured by: Astra Pharmaceutical Production AB, Sodertalje, Sweden.
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® 1mg/2ml Nebuliser Suspension, PL No: 18799/0553
Leaflet date: 30.01.2013
Pulmicort and Respules are trade marks of the AstraZeneca group of companies.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

BUDESONIDE 1mg/2ml NEBULISER SUSPENSION
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.
The name of your medicine is Budesonide 1mg/2ml Nebuliser Suspension but will be referred to
as Budesonide Respules or Respules throughout this leaflet.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Budesonide Respules are and what they are used for
Before you use Budesonide Respules
How to use Budesonide Respules
Possible side effects
How to store Budesonide Respules
Further 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. 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).
 HIV protease inhibitors (such as ritonavir and nelfinavir).
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 Budesonide Respules.
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 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.



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.

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 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.

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 Budesonide Respules.

 Mild sore throat, coughing and a hoarse voice.
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.

 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:






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.
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 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 Budesonide Respules in their original carton and foil, and out
of direct sunlight.

 Do not use Budesonide Respules after the expiry date printed on the carton and foil envelope.
6. Further information
What Budesonide Respules contain
Each 2ml Respule contains 1mg of budesonide. They also contain disodium edetate, sodium
chloride, polysorbate 80, citric acid anhydrous, sodium citrate and water purified.
What Budesonide Respules look like and the contents of the pack
Each Repsule contains 2ml of a suspension to be nebulised (made into a fine mist for inhalation).
The Respules are packed in strips of 5 inside a foil envelope. Each carton contains 20 Respules.
Manufactured by: Astra Pharmaceutical Production AB, Sodertalje, Sweden.
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 1mg/2ml Nebuliser Suspension, PL No: 18799/0553
Leaflet date: 30.01.2013

POM

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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