Pulmicort Respules 0.5mg Nebuliser Suspension
Variation 0010: Labels updated - prompted by renewal
Variation 0012: To correct the generic name to 'Budesonide Respule 0.5mg nebuliser suspension', with consequential changes to the labels and leaflet. No other changes approved
|
Previously assessed against the UK PIL dated Oct 2014 |
‘HE USER |
Pregnancy, breast-feeding and f |
ertility | |
|
Pulmicort® Respules® 0.5mg |
• If you are pregnant or breast-fe |
By BeeharryN at |
J |
nebuliser suspension
(budesonide)
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
Your medicine is known as Pulmicort Respules 0.5mg nebuliser using Pulmicort Respules but talk to your doctor immediately.
suspension but will be referred to as Pulmicort Respules throughout the following leaflet.
Driving and using machines
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.
What is in this leaflet
1. What Pulmicort Respules are and what they are used for
2. What you need to know before you use Pulmicort Respules
3. How to use Pulmicort Respules
4. Possible side effects
5. How to store Pulmicort Respules
6. Contents of the pack and other information
1. WHAT PULMICORT RESPULES ARE AND WHAT THEY ARE USED FOR
Pulmicort Respules contain a medicine called budesonide. This belongs to a group of medicines called ‘corticosteroids'. It works by reducing and preventing swelling and inflammation in your lungs.
• Pulmicort Respules are used to treat asthma. They are also used to treat croup in infants and children.
• A Respule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face mask or mouthpiece.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PULMICORT RESPULES
Do not use Pulmicort Respules:
• If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Pulmicort Respules, tell your doctor or pharmacist if:
• You have a lung infection.
• You have a cold or chest infection.
• You have liver problems.
Other medicines and Pulmicort Respules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Pulmicort Respules can affect the way some medicines work and some medicines can have an effect on Pulmicort Respules.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Steroid medicines.
• Medicines to treat fungal infections (such as itraconazole and ketoconazole).
• HIV protease inhibitors (such as ritonavir and nelfinavir).
Pulmicort Respules are not likely to affect you being able to drive or use any tools or machines.
3. HOW TO USE PULMICORT RESPULES
• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The solution in a Respule must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section ‘How much to take'.
Note: Do not use an ultrasonic nebuliser with Pulmicort Respules.
• Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to have its full effect. It is important to use Pulmicort Respules every day, even if you have no asthma symptoms at the time.
How much to take
Asthma
Your doctor will tell you how much to take. This will depend on how severe your asthma is. Your doctor may lower your dose as your asthma improves.
• The recommended starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a day.
• Children under 12 years are usually prescribed a lower dose of
0.5 mg to 1 mg, twice a day.
Croup
The recommended dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be given followed by another 1 mg 30 minutes later.
Instructions for using Pulmicort Respules
1. Break off a Respule from the strip. Leave the rest in the foil envelope.
2. Shake the Respule gently.
3. Hold upright. Twist off the top of the Respule to open.
4. Place the open end of the Respule firmly inside the nebuliser cup. Squeeze slowly to put the liquid in the cup.
5. Throw the empty Respule away. Put the top back on the nebuliser cup.
6. Connect one end of the cup to the face mask or mouthpiece.
7. Connect the other end of the cup to the air pump.
8. Gently shake the cup.
9. Turn on the nebuliser and breathe in the mist calmly and deeply using the face mask or mouthpiece. If you are using a 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.
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.
Rare (may affect up to 1 in 1,000 people)
• Rash on the face after using the face mask. You can stop this from happening by washing your face after using the face mask.
• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children.
• Bruising of the skin.
• Loss of voice.
• Hoarse voice (in children).
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
• changes in bone mineral density (thinning of the bones).
• cataract (clouding of the lens in the eye).
• glaucoma (increased pressure in the eye).
• a slowing of the rate of growth of children and adolescents (rare).
• an effect on the adrenal gland (a small gland next to the kidney) (rare).
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PULMICORT RESPULES
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not freeze.
• If only 1ml of suspension is used, the remaining suspension is not sterile and should be discarded immediately.
• Respules should be kept in the foil envelope and outer carton to protect from light and used within 3 months of opening the envelope. Note: It is best to mark the opening date on the foil envelope to help you remember.
• Do not use Pulmicort Respules after the expiry date printed on the carton and foil envelope.
• If your doctor decides to stop the treatment return the Pulmicort Respules to the pharmacist for safe disposal. Only keep them if your doctor tells you to.
• If the suspension becomes discoloured or shows any other signs of deterioration, you should consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pulmicort Respules contain
• Each 2ml Respule contains 0.5mg of the active ingredient budesonide as a suspension (0.25mg/ml).
• Pulmicort Respules also contain the following: disodium edetate, sodium chloride, polysorbate 80, citric acid anhydrous, sodium citrate and water for injection.
What Pulmicort Respules look like and contents of the pack
• Pulmicort Respules is a clear nebuliser suspension packed in 2ml unit dose plastic twist top vials. The suspension is made into a fine mist in a nebuliser and is inhaled.
• The unit doses are packed in strips of 5 inside a foil envelope, each carton contains 20 unit doses.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden.
| POM | PL 19488/0747
Leaflet revision date: 10 August 2015
Pulmicort and Respules are trade marks of the AstraZeneca group of companies.
S747 LEAFLET Pulmicort 20150810
S747 LEAFLET Budesonide 20150810
PACKAGE LEAFLET: INFORMATION FOR THE USER Budesonide Respule 0.5mg nebuliser suspension
Your medicine is known as Budesonide Respule 0.5mg nebuliser
suspension but will be referred to as Budesonide Suspension
throughout the following leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Budesonide Suspension is and what it is used for
2. What you need to know before you use Budesonide Suspension
3. How to use Budesonide Suspension
4. Possible side effects
5. How to store Budesonide Suspension
6. Contents of the pack and other information
1. WHAT BUDESONIDE SUSPENSION IS AND WHAT IT IS USED FOR
Budesonide Suspension contains a medicine called budesonide. This belongs to a group of medicines called ‘corticosteroids'. It works by reducing and preventing swelling and inflammation in your lungs.
• Budesonide Suspension is used to treat asthma. It is also used to treat croup in infants and children.
• A Respule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face mask or mouthpiece.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUDESONIDE SUSPENSION
Do not use Budesonide Suspension:
• 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 Suspension, tell your doctor or pharmacist if:
• You have a lung infection.
• You have a cold or chest infection.
• You have liver problems.
Other medicines and Budesonide Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Budesonide Suspension can affect the way some medicines work and some medicines can have an effect on Budesonide Suspension.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Steroid medicines.
• Medicines to treat fungal infections (such as itraconazole and ketoconazole).
• HIV protease inhibitors (such as ritonavir and nelfinavir).
Pregnancy, breast-feeding and fertility
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine - do not use Budesonide Suspension unless your doctor tells you to.
• If you get pregnant while using Budesonide Suspension, do not stop using Budesonide Suspension but talk to your doctor immediately.
Driving and using machines
Budesonide Suspension is not likely to affect you being able to
drive or use any tools or machines.
3. HOW TO USE BUDESONIDE SUSPENSION
• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The solution in a Respule must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section ‘How much to take'.
Note: Do not use an ultrasonic nebuliser with Budesonide Suspension.
• Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to have its full effect. It is important to use Budesonide Suspension every day, even if you have no asthma symptoms at the time.
How much to take Asthma
Your doctor will tell you how much to take. This will depend on how severe your asthma is. Your doctor may lower your dose as your asthma improves.
• The recommended starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a day.
• Children under 12 years are usually prescribed a lower dose of
0.5 mg to 1 mg, twice a day.
Croup
The recommended dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be given followed by another 1 mg 30 minutes later.
Instructions for using Budesonide Suspension
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.
If you feel you are getting breathless or wheezy while using Budesonide Suspension, you should continue to use Budesonide Suspension but go to see your doctor as soon as possible, as you may need additional treatment.
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 Suspension than you should
It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice. If you use more Budesonide Suspension than you should, contact your doctor or pharmacist for advice.
If you forget to use Budesonide Suspension
If you forget to take a dose, skip the missed dose and take the next dose as usual.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If either of the following happen to you, stop using Budesonide Suspension 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.
Rare (may affect up to 1 in 1,000 people)
• Rash on the face after using the face mask. You can stop this from happening by washing your face after using the face mask.
• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children.
• Bruising of the skin.
• Loss of voice.
• Hoarse voice (in children).
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
• changes in bone mineral density (thinning of the bones).
• cataract (clouding of the lens in the eye).
• glaucoma (increased pressure in the eye).
• a slowing of the rate of growth of children and adolescents (rare).
• an effect on the adrenal gland (a small gland next to the kidney) (rare).
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BUDESONIDE SUSPENSION
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not freeze.
• If only 1ml of suspension is used, the remaining suspension is not sterile and should be discarded immediately.
• Respules should be kept in the foil envelope and outer carton to protect from light and used within 3 months of opening the envelope. Note: It is best to mark the opening date on the foil envelope to help you remember.
• Do not use Budesonide Suspension after the expiry date printed on the carton and foil envelope.
• If your doctor decides to stop the treatment return the Budesonide Suspension to the pharmacist for safe disposal. Only keep them if your doctor tells you to.
• If the suspension becomes discoloured or shows any other signs of deterioration, you should consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Budesonide Suspension contain
• Each 2ml Respule contains 0.5mg of the active ingredient budesonide as a suspension (0.25mg/ml).
• Budesonide Suspension also contain the following: disodium edetate, sodium chloride, polysorbate 80, citric acid anhydrous, sodium citrate and water for injection.
What Budesonide Suspension looks like and contents of the
pack
• Budesonide Suspension is a clear nebuliser suspension packed in 2ml unit dose plastic twist top vials. The suspension is made into a fine mist in a nebuliser and is inhaled.
• The unit doses are packed in strips of 5 inside a foil envelope, each carton contains 20 unit doses.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden.
I POM I PL 19488/0747
Leaflet revision date: 10 August 2015
S747 LEAFLET Budesonide 20150810