PULMICORT RESPULES 0.5MG
Active substance: BUDESONIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PS01911
Pulmicort Respules 0.5mg, 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. 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 5. How to store Pulmicort Respules 6. 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.
Pulmicort Respules 0.5mg, Nebuliser Suspension
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 2days. However, it can take up to 4weeks 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 12years is 1mg to 2mg (milligrams), twice a day. Children under 12years are usually prescribed a lower dose of 0.5mg to 1mg, twice a day. Croup The usual dose for infants and children is 2mg a day. This may be given all in one go, or 1mg may be given followed by another 1mg 30minutes 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.
365662-A01 04-02-13 PS01911 AZL022A 7496 Pulmicort 0.5mg/2ml Leaflet: Patient UK RY
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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 pharmacists 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 1in 1,000people. Sudden wheezing after inhaling your medicine. This happens very rarely, affecting less than 1in 10,000people. Other possible side effects: Common (affects less than 1in 10people) 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 (affects less than 1in 1,000people) 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. 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 reach and sight of children. Once a foil envelope has been opened, the Respules inside should be used within 3months. 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 30C. Do not freeze. Store in an upright position. 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 0.5mg contain The active substance is budesonide. Each Pulmicort Respule 0.5mg contains 0.5mg of the active ingredient, budesonide. The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and water for injections. What Pulmicort Respules 0.5mg look like and the contents of the pack Each Respule contains 2millilitres (ml) of sterile solution. The solution must be nebulised (made into a fine mist) before it can be breathed in. Pulmicort Respules 0.5mg are packed in strips of 5inside a foil envelope. Each carton contains 20Respules. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Pulmicort Respules 0.5mg is held by AstraZeneca UK Ltd, 600Capability Green, Luton, LU13LU, UK. Pulmicort Respules 0.5mg are manufactured by AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK102NA, UK.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Pulmicort Respules 0.5mg Reference number 17901/0160 This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: January 2013 Pulmicort and Respules are trade marks of the AstraZeneca group of companies. AstraZeneca 2013 RSP 130001
365662-A01 04-02-13 PS01911 AZL022A 7496 Pulmicort 0.5mg/2ml Leaflet: Patient UK RY
Black
PS01911
Pulmicort Respules 0.5mg, 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. 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 5. How to store Pulmicort Respules 6. 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.
Pulmicort Respules 0.5mg, Nebuliser Suspension
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 2days. However, it can take up to 4weeks 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 12years is 1mg to 2mg (milligrams), twice a day. Children under 12years are usually prescribed a lower dose of 0.5mg to 1mg, twice a day. Croup The usual dose for infants and children is 2mg a day. This may be given all in one go, or 1mg may be given followed by another 1mg 30minutes 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.
365662-A01 04-02-13 PS01911 AZL022A 7496 Pulmicort 0.5mg/2ml Leaflet: Patient UK RY
Black
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 pharmacists 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 1in 1,000people. Sudden wheezing after inhaling your medicine. This happens very rarely, affecting less than 1in 10,000people. Other possible side effects: Common (affects less than 1in 10people) 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 (affects less than 1in 1,000people) 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. 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 reach and sight of children. Once a foil envelope has been opened, the Respules inside should be used within 3months. 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 30C. Do not freeze. Store in an upright position. 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 0.5mg contain The active substance is budesonide. Each Pulmicort Respule 0.5mg contains 0.5mg of the active ingredient, budesonide. The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and water for injections. What Pulmicort Respules 0.5mg look like and the contents of the pack Each Respule contains 2millilitres (ml) of sterile solution. The solution must be nebulised (made into a fine mist) before it can be breathed in. Pulmicort Respules 0.5mg are packed in strips of 5inside a foil envelope. Each carton contains 20Respules. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Pulmicort Respules 0.5mg is held by AstraZeneca UK Ltd, 600Capability Green, Luton, LU13LU, UK. Pulmicort Respules 0.5mg are manufactured by AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK102NA, UK.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Pulmicort Respules 0.5mg Reference number 17901/0160 This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: January 2013 Pulmicort and Respules are trade marks of the AstraZeneca group of companies. AstraZeneca 2013 RSP 130001
365662-A01 04-02-13 PS01911 AZL022A 7496 Pulmicort 0.5mg/2ml Leaflet: Patient UK RY
Black
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
