FLIXOTIDE NEBULES 0.5MG/2ML
Active substance: FLUTICASONE PROPIONATE MICRONISED
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Package Leaflet: Information for the user
FlixotideTM NebulesTM 0.5mg/2ml
(fluticasone propionate)
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, nurse 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. The name of your medicine is Flixotide Nebules 0.5mg/2ml but will be referred to as Flixotide or Flixotide Nebules throughout this leaflet. In this leaflet: 1 What Flixotide is and what it is used for 2 Before you use Flixotide 3 How to use Flixotide 4 Possible side effects 5 How to store Flixotide 6 Further information 1 What Flixotide is and what it is used for Flixotide Nebules contain a medicine called fluticasone propionate. Fluticasone propionate belongs to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs. Flixotide works by reducing swelling and irritation in the lungs. It has what is called an anti-inflammatory action. Flixotide help to prevent asthma attacks in people who need regular treatment. This is why they are sometimes called preventers. They need to be used regularly, every day. Flixotide will not help treat sudden asthma attacks where you feel breathless. A different medicine is used for treating sudden attacks (called a reliever). If you have more than one medicine, be careful not to confuse them.
Driving and using machines Flixotide is not likely to affect you being able to drive or use any tools or machines.
3
How to use Flixotide
Flixotide Nebules come in two different strengths. Your doctor will have decided which strength you need. Always use Flixotide exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure. Using this medicine Do not inject or swallow the liquid. Flixotide Nebules should only be inhaled using your jet nebuliser. Using Flixotide Nebules with ultrasonic nebulisers is not generally recommended. The jet nebuliser produces a fine mist which you breathe in through a mouthpiece or face mask. Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them. Each small plastic container (Nebule) contains some liquid. The liquid is put into a nebuliser. This makes a fine mist for you to breathe in through a face mask or mouthpiece. Use of a mouthpiece prevents the medicine affecting the skin of your face, which may occur if you use a face mask over a long period of time. If you prefer to use a face mask, or you are using a face mask for your child, then you must protect the skin on your (or your childs) face with a barrier cream or wash your (or your childs) face thoroughly after treatment. Use your nebuliser in a well-ventilated room as some of the mist will be released into the air and may be breathed in by others. It takes a few days for this medicine to work and it is very important that you use it regularly. The usual starting dose is 0.5 to 2.0 mg (500 to 2000 micrograms) twice a day. Flixotide Nebules 0.5 mg/2 ml provides you with a dose of 500 micrograms. Flixotide Nebules 2.0 mg/2 ml provides you with a dose of 2000 micrograms.
Adults and Children over 16 years of age
Children (4 to 16 years of age) The usual starting dose is 1 mg (1000 micrograms) twice a day. It is recommended that children being treated with steroids, including Flixotide Nebules have their height checked regularly by their doctor. If you are using high doses of an inhaled steroid for a long time you may sometimes need extra steroids for example during stressful circumstances such as a road traffic accident or before an operation. Your doctor may decide to give you extra steroid medicines during this time. Patients who have been on high doses of steroids, including Flixotide Nebules for a long time, must not stop taking their medicine suddenly without talking to their doctor. Suddenly stopping treatment can make you feel unwell and may cause symptoms such as vomiting, drowsiness, nausea, headache, tiredness, loss of appetite, low blood sugar level and fitting. Using your Nebules
2
Before you use Flixotide
Do not use Flixotide if you are allergic (hypersensitive) to: fluticasone propionate any of the other ingredients of Flixotide (listed in Section 6). Do not use Flixotide if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Flixotide. Take special care with Flixotide Check with your doctor, nurse or pharmacist before taking your medicine if: you have ever been treated for tuberculosis (TB). you are using Flixotide at the same time as taking steroid tablets. Also if you have just finished taking steroid tablets. In both cases, you should carry a steroid warning card until your doctor tells you not to carry one. If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Flixotide. Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this medicine with you if you have to go into hospital. In particular tell your doctor or pharmacist if you are taking any of the following: a type of antiviral medicine known as a protease inhibitor (such as ritonavir) medicines used to treat fungal infections (such as ketoconazole). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Flixotide. Using Flixotide with food and drink You can use Flixotide at any time of day, with or without food. Pregnancy and breast-feeding Talk to your doctor before using this medicine if you are pregnant, might become pregnant or are breast-feeding.
1 2
the Nebules are in a foil pack. Do not open the pack until you need to use them hold the top of the Nebule you have just removed. Twist the body to open it
3
put the open end of the Nebule into the nebuliser bowl and squeeze slowly to empty the content
The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD): Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems Bruising. Very rare (affects less than 1 in 10,000 people) sleeping problems or feeling worried, over-excited and irritable. These effects are more likely to occur in children joint pains indigestion level of sugar (glucose) in your blood may be increased. the way steroids are produced by your body may be affected when using Flixotide. This is more likely to happen if you use high doses for a long period of time. This can cause: - children and young people to grow more slowly - something called Cushings syndrome. This happens when you have too much steroid in your body and it can cause thinning of your bones and eye problems (such as cataracts and glaucoma which is high pressure in the eye). Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms. Although the frequency is not known, the following side effects may also occur: depression, feeling restless or nervous. These effects are more likely to occur in children Talk to your doctor as soon as possible if: after 7 days of using Flixotide your shortness of breath or wheezing does not get better, or gets worse. you or your child is on high doses of inhaled steroid and become unwell with vague symptoms such as tummy ache, sickness, diarrhoea, headache or drowsiness. This can happen during an infection such as a viral infection or stomach upset. It is important that your steroid is not stopped suddenly as this could make your asthma worse and could also cause problems with the bodys hormones.
4 5
assemble the nebuliser and use it as directed repeat steps 2 to 4 to make up the dose needed if necessary
Diluting your Nebules Do not dilute the contents of a Nebule unless you are told to by your doctor if your doctor has told you to dilute the solution, empty the contents of the Nebule into the nebuliser bowl add the amount of sterile sodium chloride 0.9% solution your doctor has told you to use put the top on the nebuliser bowl and shake gently to mix the contents. If dilution is necessary then only sterile sodium chloride 0.9% solution should be used. After use use a fresh Nebule for each dose. Only open a new one when you are ready to use it. If there is any liquid left over, throw it away. Do not save it to use again throw away any solution remaining in the nebuliser bowl clean your nebuliser in the recommended way. If you use more Flixotide than you should If you use more than you were told, talk to your doctor as soon as possible. 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 forget to use Flixotide Take the next dose when it is due. Do not take a double dose to make up for the forgotten dose.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
5
How to store Flixotide
Keep out of the sight and reach of children. Do not store above 30C. Keep container in the outer carton. Protect from frost. Store upright. The blister pack should be opened immediately before use. Opened Nebules should be refrigerated and used within 12 hours of opening. Do not leave suspension in your nebuliser once you have finished a treatment. If you are told to stop taking this medicine, return any Flixotide Nebules to your pharmacist to be destroyed. If your medicine shows any signs of deterioration or discolouration, you should seek the advice of your pharmacist.
If you stop using Flixotide Do not stop treatment even if you feel better unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4
Possible side effects
Like all medicines, Flixotide can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop using this medicine and talk to your doctor straight away. You may need urgent medical treatment. allergic reactions (affects less than 1 in 100 people) the signs include skin rashes, redness, itching or weals like nettle rash or hives severe allergic reactions (affects less than 1 in 10,000 people) - the signs include swelling of your face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed and collapse your breathing or wheezing gets worse straight after using your inhaler. Other side effects include: Very common (affects more than 1 in 10 people) thrush in the mouth and throat Common (affects less than 1 in 10 people) sore tongue or throat hoarseness of voice Problems with your mouth and throat can be reduced by doing certain things straight after inhaling your dose. These are brushing your teeth, rinsing your mouth or gargling with water and spitting it out. Tell your doctor if you have these problems with your mouth or throat, but do not stop treatment unless you are told to.
6
Further information
What Flixotide contains Flixotide Nebules contain a liquid, which is nebulised (turned into a mist) in a nebuliser and then inhaled. Each Nebule contains suspension for inhalation containing 0.5mg of the active ingredient fluticasone propionate in 2ml of normal saline. Other ingredients are polysorbate 20, sorbitan monolaurate, monosodium phosphate dihydrate, dibasic sodium phosphate anhydrous, sodium chloride and water for injection. What Flixotide looks like and contents of the pack The 2ml opaque, plastic ampoules with a twist-off tab, containing whitish, opaque freely dispersed suspension are sealed in individual foil blisters. Each carton contains 10 Nebules individually packed in foil blisters. Manufactured by: GlaxoSmithKline Australia Pty Ltd, Australia. Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Flixotide
TM
Nebules
TM
0.5mg/2ml - PL No: 18799/0769
POM
Leaflet date: 13.09.2012 Flixotide, Nebules and Nebule are trademarks of the GlaxoSmithKline group of companies.
FlixotideTM NebulesTM 0.5mg/2ml
(fluticasone propionate)
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, nurse 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. The name of your medicine is Flixotide Nebules 0.5mg/2ml but will be referred to as Flixotide or Flixotide Nebules throughout this leaflet. In this leaflet: 1 What Flixotide is and what it is used for 2 Before you use Flixotide 3 How to use Flixotide 4 Possible side effects 5 How to store Flixotide 6 Further information 1 What Flixotide is and what it is used for Flixotide Nebules contain a medicine called fluticasone propionate. Fluticasone propionate belongs to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs. Flixotide works by reducing swelling and irritation in the lungs. It has what is called an anti-inflammatory action. Flixotide help to prevent asthma attacks in people who need regular treatment. This is why they are sometimes called preventers. They need to be used regularly, every day. Flixotide will not help treat sudden asthma attacks where you feel breathless. A different medicine is used for treating sudden attacks (called a reliever). If you have more than one medicine, be careful not to confuse them.
Driving and using machines Flixotide is not likely to affect you being able to drive or use any tools or machines.
3
How to use Flixotide
Flixotide Nebules come in two different strengths. Your doctor will have decided which strength you need. Always use Flixotide exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure. Using this medicine Do not inject or swallow the liquid. Flixotide Nebules should only be inhaled using your jet nebuliser. Using Flixotide Nebules with ultrasonic nebulisers is not generally recommended. The jet nebuliser produces a fine mist which you breathe in through a mouthpiece or face mask. Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them. Each small plastic container (Nebule) contains some liquid. The liquid is put into a nebuliser. This makes a fine mist for you to breathe in through a face mask or mouthpiece. Use of a mouthpiece prevents the medicine affecting the skin of your face, which may occur if you use a face mask over a long period of time. If you prefer to use a face mask, or you are using a face mask for your child, then you must protect the skin on your (or your childs) face with a barrier cream or wash your (or your childs) face thoroughly after treatment. Use your nebuliser in a well-ventilated room as some of the mist will be released into the air and may be breathed in by others. It takes a few days for this medicine to work and it is very important that you use it regularly. The usual starting dose is 0.5 to 2.0 mg (500 to 2000 micrograms) twice a day. Flixotide Nebules 0.5 mg/2 ml provides you with a dose of 500 micrograms. Flixotide Nebules 2.0 mg/2 ml provides you with a dose of 2000 micrograms.
Adults and Children over 16 years of age
Children (4 to 16 years of age) The usual starting dose is 1 mg (1000 micrograms) twice a day. It is recommended that children being treated with steroids, including Flixotide Nebules have their height checked regularly by their doctor. If you are using high doses of an inhaled steroid for a long time you may sometimes need extra steroids for example during stressful circumstances such as a road traffic accident or before an operation. Your doctor may decide to give you extra steroid medicines during this time. Patients who have been on high doses of steroids, including Flixotide Nebules for a long time, must not stop taking their medicine suddenly without talking to their doctor. Suddenly stopping treatment can make you feel unwell and may cause symptoms such as vomiting, drowsiness, nausea, headache, tiredness, loss of appetite, low blood sugar level and fitting. Using your Nebules
2
Before you use Flixotide
Do not use Flixotide if you are allergic (hypersensitive) to: fluticasone propionate any of the other ingredients of Flixotide (listed in Section 6). Do not use Flixotide if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Flixotide. Take special care with Flixotide Check with your doctor, nurse or pharmacist before taking your medicine if: you have ever been treated for tuberculosis (TB). you are using Flixotide at the same time as taking steroid tablets. Also if you have just finished taking steroid tablets. In both cases, you should carry a steroid warning card until your doctor tells you not to carry one. If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Flixotide. Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this medicine with you if you have to go into hospital. In particular tell your doctor or pharmacist if you are taking any of the following: a type of antiviral medicine known as a protease inhibitor (such as ritonavir) medicines used to treat fungal infections (such as ketoconazole). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Flixotide. Using Flixotide with food and drink You can use Flixotide at any time of day, with or without food. Pregnancy and breast-feeding Talk to your doctor before using this medicine if you are pregnant, might become pregnant or are breast-feeding.
1 2
the Nebules are in a foil pack. Do not open the pack until you need to use them hold the top of the Nebule you have just removed. Twist the body to open it
3
put the open end of the Nebule into the nebuliser bowl and squeeze slowly to empty the content
The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD): Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems Bruising. Very rare (affects less than 1 in 10,000 people) sleeping problems or feeling worried, over-excited and irritable. These effects are more likely to occur in children joint pains indigestion level of sugar (glucose) in your blood may be increased. the way steroids are produced by your body may be affected when using Flixotide. This is more likely to happen if you use high doses for a long period of time. This can cause: - children and young people to grow more slowly - something called Cushings syndrome. This happens when you have too much steroid in your body and it can cause thinning of your bones and eye problems (such as cataracts and glaucoma which is high pressure in the eye). Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms. Although the frequency is not known, the following side effects may also occur: depression, feeling restless or nervous. These effects are more likely to occur in children Talk to your doctor as soon as possible if: after 7 days of using Flixotide your shortness of breath or wheezing does not get better, or gets worse. you or your child is on high doses of inhaled steroid and become unwell with vague symptoms such as tummy ache, sickness, diarrhoea, headache or drowsiness. This can happen during an infection such as a viral infection or stomach upset. It is important that your steroid is not stopped suddenly as this could make your asthma worse and could also cause problems with the bodys hormones.
4 5
assemble the nebuliser and use it as directed repeat steps 2 to 4 to make up the dose needed if necessary
Diluting your Nebules Do not dilute the contents of a Nebule unless you are told to by your doctor if your doctor has told you to dilute the solution, empty the contents of the Nebule into the nebuliser bowl add the amount of sterile sodium chloride 0.9% solution your doctor has told you to use put the top on the nebuliser bowl and shake gently to mix the contents. If dilution is necessary then only sterile sodium chloride 0.9% solution should be used. After use use a fresh Nebule for each dose. Only open a new one when you are ready to use it. If there is any liquid left over, throw it away. Do not save it to use again throw away any solution remaining in the nebuliser bowl clean your nebuliser in the recommended way. If you use more Flixotide than you should If you use more than you were told, talk to your doctor as soon as possible. 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 forget to use Flixotide Take the next dose when it is due. Do not take a double dose to make up for the forgotten dose.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
5
How to store Flixotide
Keep out of the sight and reach of children. Do not store above 30C. Keep container in the outer carton. Protect from frost. Store upright. The blister pack should be opened immediately before use. Opened Nebules should be refrigerated and used within 12 hours of opening. Do not leave suspension in your nebuliser once you have finished a treatment. If you are told to stop taking this medicine, return any Flixotide Nebules to your pharmacist to be destroyed. If your medicine shows any signs of deterioration or discolouration, you should seek the advice of your pharmacist.
If you stop using Flixotide Do not stop treatment even if you feel better unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4
Possible side effects
Like all medicines, Flixotide can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop using this medicine and talk to your doctor straight away. You may need urgent medical treatment. allergic reactions (affects less than 1 in 100 people) the signs include skin rashes, redness, itching or weals like nettle rash or hives severe allergic reactions (affects less than 1 in 10,000 people) - the signs include swelling of your face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed and collapse your breathing or wheezing gets worse straight after using your inhaler. Other side effects include: Very common (affects more than 1 in 10 people) thrush in the mouth and throat Common (affects less than 1 in 10 people) sore tongue or throat hoarseness of voice Problems with your mouth and throat can be reduced by doing certain things straight after inhaling your dose. These are brushing your teeth, rinsing your mouth or gargling with water and spitting it out. Tell your doctor if you have these problems with your mouth or throat, but do not stop treatment unless you are told to.
6
Further information
What Flixotide contains Flixotide Nebules contain a liquid, which is nebulised (turned into a mist) in a nebuliser and then inhaled. Each Nebule contains suspension for inhalation containing 0.5mg of the active ingredient fluticasone propionate in 2ml of normal saline. Other ingredients are polysorbate 20, sorbitan monolaurate, monosodium phosphate dihydrate, dibasic sodium phosphate anhydrous, sodium chloride and water for injection. What Flixotide looks like and contents of the pack The 2ml opaque, plastic ampoules with a twist-off tab, containing whitish, opaque freely dispersed suspension are sealed in individual foil blisters. Each carton contains 10 Nebules individually packed in foil blisters. Manufactured by: GlaxoSmithKline Australia Pty Ltd, Australia. Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Flixotide
TM
Nebules
TM
0.5mg/2ml - PL No: 18799/0769
POM
Leaflet date: 13.09.2012 Flixotide, Nebules and Nebule are trademarks of the GlaxoSmithKline group of companies.
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.
