SEREVENT ACCUHALER
Active substance: SALMETEROL XINAFOATE
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Assessed against UK PIL dated June 2011
Serevent Accuhaler
(salmeterol xinafoate)
By kanagasabaic at 11:45 am, Jan 28, 2013
Mock-up
This product is available using either of the above names but will be referred to as Serevent Accuhaler throughout the following leaflet. Package Leaflet: Information for the User
Counter
Full
Outer Case
Empty 0
Thumbgrip
60
Beta-blockers should be avoided when taking Serevent Accuhaler, unless your doctor tells you to take them. Beta-blockers, including atenolol, propranolol and sotalol, are mostly used for high blood pressure or other heart conditions. Please tell your doctor if you are taking beta-blockers or have recently been prescribed beta-blockers as they may reduce or abolish the effects of salmeterol. Serevent Accuhaler can reduce the amount of potassium in your blood. If this happens you may notice an uneven heartbeat, muscle weakness or cramp. This is more likely to happen if you take Serevent with some medicines used to treat high blood pressure (diuretics water tablets) and other medicines used to treat breathing problems such as theophylline or steroids. Your doctor may ask for you to have blood tests to check the amount of potassium in your blood. If you have any concerns discuss them with your doctor.
Mouthpiece Lever
Pregnancy and breast-feeding If you are pregnant, planning to get pregnant or breast-feeding, talk to your doctor before taking Serevent. Your doctor will assess whether you can take Serevent during this time. Driving and using machines The possible side effects associated with Serevent Accuhaler are unlikely to affect your ability to drive or use machines.
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Serevent Accuhaler is and what it is used for 2. Before you use Serevent Accuhaler 3. How to use Serevent Accuhaler 4. Possible side effects 5. How to store Serevent Accuhaler 6. Further information
3. HOW TO USE SEREVENT ACCUHALER
If you are being treated for asthma, you should always be given both a Serevent Accuhaler and a steroid inhaler to use together. Use Serevent every day, until your doctor advises you to stop. You will start to feel your medicine working within the first day of use.
Serevent is for inhalation by mouth only. Adults and adolescents aged 12 years and older with Asthma The usual starting dose is 1 puff twice a day. For people with more severe asthma, your doctor may increase your dose to 2 puffs twice a day. Children with Asthma In children aged 4 to 12 the usual dose is 1 puff twice a day. Serevent is not recommended for use in children below 4 years of age. Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis and emphysema The usual starting dose is 1 puff twice a day. Not applicable for children and adolescents. Instructions for use Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Serevent Accuhaler properly or as prescribed may mean that it will not help your asthma or COPD as it should. The Serevent Accuhaler device holds blisters containing Serevent as a powder. There is a counter on top of the Serevent Accuhaler which tells you how many doses are leaflet. It counts down to 0. the numbers 5 to 0 will appear in red to warn you when there are only a few doses left. Once the counter shows 0, your inhaler is empty. Using your inhaler
1. WHAT SEREVENT ACCUHALER IS AND WHAT IT IS USED FOR
Serevent Accuhaler contains the medicine salmeterol. It is a long-acting bronchodilator. It helps the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects are usually felt within 10 to 20 minutes and last for 12 hours or more. The doctor has prescribed it to help prevent breathing problems. These could be caused by asthma. Taking Serevent Accuhaler regularly will help prevent asthma attacks. This also includes asthma brought on by exercise or at night. Taking Serevent Accuhaler regularly will also help prevent breathing problems caused by other chest illnesses such as Chronic Obstructive Pulmonary Disease (COPD). Serevent Accuhaler helps to stop breathlessness and wheezing coming on. It does not work once you are breathless or wheezy. If that happens, you need to use a fast acting reliever medicine, such as salbutamol. Serevent is supplied to you in an inhaler called the Accuhaler. You breathe the medicine directly into your lungs. If you are being treated for asthma, you should always be given both a Serevent and a steroid inhaler to use together.
1 To open your
Serevent Accuhaler, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go. You will hear a click. This will open a small hole in the mouthpiece. Hold your Serevent Accuhaler with the mouthpiece towards you. You can hold it in either your right or left hand. Slide the lever away from you as far as it will go. You will hear a click. This places a dose of your medicine in the mouthpiece. Every time the lever is pushed back a blister is opened inside and the powder made ready for you to inhale. Do not play with the lever as this opens the blisters and wastes medicine.
4 Put the
mouthpiece to your lips; breathe in steadily and deeply through the Serevent Accuhaler, not through your nose. Remove the Serevent Accuhaler from your mouth. Hold your breath for about 10 seconds or for as long as is comfortable. Breathe out slowly.
2. BEFORE YOU USE SEREVENT ACCUHALER
Do not take Serevent Accuhaler if: you are allergic (hypersensitive) to salmeterol xinafoate, or to the other ingredient lactose. Take special care with Serevent Accuhaler If you are using Serevent Accuhaler for asthma your doctor will want to regularly check your symptoms. If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast acting reliever medicine. If any of these happen, do not increase your number of puffs of Serevent Accuhaler. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need a change in asthma treatment. If you have been prescribed Serevent Accuhaler for your asthma, continue to use any other asthma medication you are already taking. These could include a steroid inhaler or steroid tablets. Continue taking the same doses as before, unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop taking your steroid inhaler (or any steroid tablets) when you start using Serevent. Your doctor may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent Accuhaler may increase your blood sugar) or heart disease, including an irregular or fast heartbeat. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines. This includes those for asthma or any other medicines obtained without a prescription. This is because Serevent Accuhaler may not be suitable to be taken with other medicines. Please inform your doctor before using Serevent Accuhaler if you are currently being treated for any fungal infections with medicines containing ketoconazole or itraconazole, or if you are being treated for HIV with ritonavir. These medicines may increase the risk of you experiencing side effects with Serevent Accuhaler, including irregular heart beats, or may make side effects worse.
2
5 Afterwards rinse your mouth with water and spit it out. This may help to stop you getting thrush and being hoarse. 6 To close the
Serevent Accuhaler, slide the thumbgrip back towards you, as far as it will go. You will hear a click. The lever will return to its original position and is reset. Your Serevent Accuhaler is now ready for you to use again.
3 Hold the Serevent Accuhaler
away from your mouth, breathe out as far as is comfortable. Do not breathe into your Serevent Accuhaler.
Cleaning your inhaler Wipe the mouthpiece of the Serevent Accuhaler with a dry tissue to clean it. If you use more Serevent Accuhaler than you should It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky and/or dizzy. You may also have a headache, muscle weakness and aching joints. If you forget to use Serevent Accuhaler If you forget to use your Serevent Accuhaler, take your next dose when it is due. Do not take a double dose to replace the one you forgot. If you have any further questions on the use of this product, ask your doctor or pharmacist.
6. FURTHER INFORMATION
What is a Serevent Accuhaler inhaler? The name of your medicine is Serevent Accuhaler. Each blister contains 50 micrograms of the active ingredient salmeterol (as xinafoate), and lactose which acts as a carrier. What Serevent Accuhaler looks like and contents of the pack Your Accuhaler is a moulded plastic inhaler device containing a foil strip with 20 or 60 regularly spaced blisters. The blisters protect the powder for inhalation from the effects of the atmosphere. The inhaler device has a counter which tells you the number of blisters remaining. It counts down from 60 to 0. To show when the last five blisters have been reached, the numbers appear in red. When the counter shows 0, your inhaler is empty and should be disposed of. Serevent Accuhaler is packed in cartons which hold one Accuhaler containing 20 or 60 inhalations. Who makes your medicine? This product is manufactured by Glaxo Wellcome Production, 27000 EvreuxFrance. It is procured from within the EU by the Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and repackaged by OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR. POM PL No: 13826/0965 Serevent Accuhaler Leaflet revision date (ref): 09/11/2012 Serevent and Accuhaler are Trade Marks of GlaxoSmithKline Group of Companies.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Serevent Accuhaler can cause side effects, although not everybody gets them. To reduce the chances of side effects, your doctor will prescribe the lowest dose of Serevent to control your asthma or COPD. These are the side effects reported by people taking Serevent. Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent Accuhaler. You may be very wheezy and cough. You may also notice itching and swelling (usually of the face, lips, tongue or throat). If you get these effects or they happen suddenly after using Serevent, tell your doctor straight away. Allergic reactions to Serevent Accuhaler are very rare (they affect less than 1 person in 10,000). Other side effects are listed below: Common (affects less than 1 person in 10): Muscle cramps Feeling shaky; fast or uneven heartbeat (palpitations), headache, shaking hands (tremor). Tremors are more likely if you are taking more than one puff twice daily. These side effects do not last long and happen less as treatment with Serevent continues. Uncommon (affects less than 1 person in 100): Rash Very fast heart rate (tachycardia). This is more likely to happen if you are taking more than one puff twice daily Feeling nervous. Rare (affects less than 1 person in 1,000): Feeling dizzy Being unable to sleep or finding sleep difficult A reduction in the amount of potassium in your blood (you may get an uneven heartbeat, muscle weakness, cramp). The following side effects have been reported when using Serevent, but it is not known how often they occur: Breathing difficulties or wheezing that gets worse straight after taking Serevent Accuhaler. If this happens stop using your Serevent Accuhaler. Use your fast-acting reliever inhaler to help your breathing and tell your doctor straight away Uneven heartbeat or your heart gives an extra beat (arrhythmias). If this happens do not stop using Serevent but tell your doctor Sore mouth or throat High blood sugar Feeling sick (nausea) Aching, swollen joints, or chest pain. 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 SEREVENT ACCUHALER
Do not store above 30C. Store in a dry place. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton or Accuhaler label. If your doctor tells you to stop using the Accuhaler, please take it back to the pharmacist for safe disposal. Only keep the Accuhaler if your doctor tells you to. If your Accuhaler fails to work properly or you notice any other signs of deterioration, you should seek the advice of your pharmacist. 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 to protect the environment.
Serevent Accuhaler
(salmeterol xinafoate)
By kanagasabaic at 11:45 am, Jan 28, 2013
Mock-up
This product is available using either of the above names but will be referred to as Serevent Accuhaler throughout the following leaflet. Package Leaflet: Information for the User
Counter
Full
Outer Case
Empty 0
Thumbgrip
60
Beta-blockers should be avoided when taking Serevent Accuhaler, unless your doctor tells you to take them. Beta-blockers, including atenolol, propranolol and sotalol, are mostly used for high blood pressure or other heart conditions. Please tell your doctor if you are taking beta-blockers or have recently been prescribed beta-blockers as they may reduce or abolish the effects of salmeterol. Serevent Accuhaler can reduce the amount of potassium in your blood. If this happens you may notice an uneven heartbeat, muscle weakness or cramp. This is more likely to happen if you take Serevent with some medicines used to treat high blood pressure (diuretics water tablets) and other medicines used to treat breathing problems such as theophylline or steroids. Your doctor may ask for you to have blood tests to check the amount of potassium in your blood. If you have any concerns discuss them with your doctor.
Mouthpiece Lever
Pregnancy and breast-feeding If you are pregnant, planning to get pregnant or breast-feeding, talk to your doctor before taking Serevent. Your doctor will assess whether you can take Serevent during this time. Driving and using machines The possible side effects associated with Serevent Accuhaler are unlikely to affect your ability to drive or use machines.
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Serevent Accuhaler is and what it is used for 2. Before you use Serevent Accuhaler 3. How to use Serevent Accuhaler 4. Possible side effects 5. How to store Serevent Accuhaler 6. Further information
3. HOW TO USE SEREVENT ACCUHALER
If you are being treated for asthma, you should always be given both a Serevent Accuhaler and a steroid inhaler to use together. Use Serevent every day, until your doctor advises you to stop. You will start to feel your medicine working within the first day of use.
Serevent is for inhalation by mouth only. Adults and adolescents aged 12 years and older with Asthma The usual starting dose is 1 puff twice a day. For people with more severe asthma, your doctor may increase your dose to 2 puffs twice a day. Children with Asthma In children aged 4 to 12 the usual dose is 1 puff twice a day. Serevent is not recommended for use in children below 4 years of age. Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis and emphysema The usual starting dose is 1 puff twice a day. Not applicable for children and adolescents. Instructions for use Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Serevent Accuhaler properly or as prescribed may mean that it will not help your asthma or COPD as it should. The Serevent Accuhaler device holds blisters containing Serevent as a powder. There is a counter on top of the Serevent Accuhaler which tells you how many doses are leaflet. It counts down to 0. the numbers 5 to 0 will appear in red to warn you when there are only a few doses left. Once the counter shows 0, your inhaler is empty. Using your inhaler
1. WHAT SEREVENT ACCUHALER IS AND WHAT IT IS USED FOR
Serevent Accuhaler contains the medicine salmeterol. It is a long-acting bronchodilator. It helps the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects are usually felt within 10 to 20 minutes and last for 12 hours or more. The doctor has prescribed it to help prevent breathing problems. These could be caused by asthma. Taking Serevent Accuhaler regularly will help prevent asthma attacks. This also includes asthma brought on by exercise or at night. Taking Serevent Accuhaler regularly will also help prevent breathing problems caused by other chest illnesses such as Chronic Obstructive Pulmonary Disease (COPD). Serevent Accuhaler helps to stop breathlessness and wheezing coming on. It does not work once you are breathless or wheezy. If that happens, you need to use a fast acting reliever medicine, such as salbutamol. Serevent is supplied to you in an inhaler called the Accuhaler. You breathe the medicine directly into your lungs. If you are being treated for asthma, you should always be given both a Serevent and a steroid inhaler to use together.
1 To open your
Serevent Accuhaler, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go. You will hear a click. This will open a small hole in the mouthpiece. Hold your Serevent Accuhaler with the mouthpiece towards you. You can hold it in either your right or left hand. Slide the lever away from you as far as it will go. You will hear a click. This places a dose of your medicine in the mouthpiece. Every time the lever is pushed back a blister is opened inside and the powder made ready for you to inhale. Do not play with the lever as this opens the blisters and wastes medicine.
4 Put the
mouthpiece to your lips; breathe in steadily and deeply through the Serevent Accuhaler, not through your nose. Remove the Serevent Accuhaler from your mouth. Hold your breath for about 10 seconds or for as long as is comfortable. Breathe out slowly.
2. BEFORE YOU USE SEREVENT ACCUHALER
Do not take Serevent Accuhaler if: you are allergic (hypersensitive) to salmeterol xinafoate, or to the other ingredient lactose. Take special care with Serevent Accuhaler If you are using Serevent Accuhaler for asthma your doctor will want to regularly check your symptoms. If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast acting reliever medicine. If any of these happen, do not increase your number of puffs of Serevent Accuhaler. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need a change in asthma treatment. If you have been prescribed Serevent Accuhaler for your asthma, continue to use any other asthma medication you are already taking. These could include a steroid inhaler or steroid tablets. Continue taking the same doses as before, unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop taking your steroid inhaler (or any steroid tablets) when you start using Serevent. Your doctor may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent Accuhaler may increase your blood sugar) or heart disease, including an irregular or fast heartbeat. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines. This includes those for asthma or any other medicines obtained without a prescription. This is because Serevent Accuhaler may not be suitable to be taken with other medicines. Please inform your doctor before using Serevent Accuhaler if you are currently being treated for any fungal infections with medicines containing ketoconazole or itraconazole, or if you are being treated for HIV with ritonavir. These medicines may increase the risk of you experiencing side effects with Serevent Accuhaler, including irregular heart beats, or may make side effects worse.
2
5 Afterwards rinse your mouth with water and spit it out. This may help to stop you getting thrush and being hoarse. 6 To close the
Serevent Accuhaler, slide the thumbgrip back towards you, as far as it will go. You will hear a click. The lever will return to its original position and is reset. Your Serevent Accuhaler is now ready for you to use again.
3 Hold the Serevent Accuhaler
away from your mouth, breathe out as far as is comfortable. Do not breathe into your Serevent Accuhaler.
Cleaning your inhaler Wipe the mouthpiece of the Serevent Accuhaler with a dry tissue to clean it. If you use more Serevent Accuhaler than you should It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky and/or dizzy. You may also have a headache, muscle weakness and aching joints. If you forget to use Serevent Accuhaler If you forget to use your Serevent Accuhaler, take your next dose when it is due. Do not take a double dose to replace the one you forgot. If you have any further questions on the use of this product, ask your doctor or pharmacist.
6. FURTHER INFORMATION
What is a Serevent Accuhaler inhaler? The name of your medicine is Serevent Accuhaler. Each blister contains 50 micrograms of the active ingredient salmeterol (as xinafoate), and lactose which acts as a carrier. What Serevent Accuhaler looks like and contents of the pack Your Accuhaler is a moulded plastic inhaler device containing a foil strip with 20 or 60 regularly spaced blisters. The blisters protect the powder for inhalation from the effects of the atmosphere. The inhaler device has a counter which tells you the number of blisters remaining. It counts down from 60 to 0. To show when the last five blisters have been reached, the numbers appear in red. When the counter shows 0, your inhaler is empty and should be disposed of. Serevent Accuhaler is packed in cartons which hold one Accuhaler containing 20 or 60 inhalations. Who makes your medicine? This product is manufactured by Glaxo Wellcome Production, 27000 EvreuxFrance. It is procured from within the EU by the Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and repackaged by OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR. POM PL No: 13826/0965 Serevent Accuhaler Leaflet revision date (ref): 09/11/2012 Serevent and Accuhaler are Trade Marks of GlaxoSmithKline Group of Companies.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Serevent Accuhaler can cause side effects, although not everybody gets them. To reduce the chances of side effects, your doctor will prescribe the lowest dose of Serevent to control your asthma or COPD. These are the side effects reported by people taking Serevent. Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent Accuhaler. You may be very wheezy and cough. You may also notice itching and swelling (usually of the face, lips, tongue or throat). If you get these effects or they happen suddenly after using Serevent, tell your doctor straight away. Allergic reactions to Serevent Accuhaler are very rare (they affect less than 1 person in 10,000). Other side effects are listed below: Common (affects less than 1 person in 10): Muscle cramps Feeling shaky; fast or uneven heartbeat (palpitations), headache, shaking hands (tremor). Tremors are more likely if you are taking more than one puff twice daily. These side effects do not last long and happen less as treatment with Serevent continues. Uncommon (affects less than 1 person in 100): Rash Very fast heart rate (tachycardia). This is more likely to happen if you are taking more than one puff twice daily Feeling nervous. Rare (affects less than 1 person in 1,000): Feeling dizzy Being unable to sleep or finding sleep difficult A reduction in the amount of potassium in your blood (you may get an uneven heartbeat, muscle weakness, cramp). The following side effects have been reported when using Serevent, but it is not known how often they occur: Breathing difficulties or wheezing that gets worse straight after taking Serevent Accuhaler. If this happens stop using your Serevent Accuhaler. Use your fast-acting reliever inhaler to help your breathing and tell your doctor straight away Uneven heartbeat or your heart gives an extra beat (arrhythmias). If this happens do not stop using Serevent but tell your doctor Sore mouth or throat High blood sugar Feeling sick (nausea) Aching, swollen joints, or chest pain. 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 SEREVENT ACCUHALER
Do not store above 30C. Store in a dry place. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton or Accuhaler label. If your doctor tells you to stop using the Accuhaler, please take it back to the pharmacist for safe disposal. Only keep the Accuhaler if your doctor tells you to. If your Accuhaler fails to work properly or you notice any other signs of deterioration, you should seek the advice of your pharmacist. 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 to protect the environment.
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.
