Serevent 50 Micrograms Accuhaler
Assessed against UK PIL dated February 2013
Mouthpiece
Outer Case
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By Kanagasabaic at 11:22 am, Aug 23, 13
SEREVENT ™ 50 MICROGRAMS ACCUHALER™
_(salmeterol xinafoate)_
PATIENT INFORMATION LEAFLET
Your medicine is available using the name Serevent 50 micrograms Accuhaler, but will be referred to as Serevent Accuhaler throughout this leaflet.
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Thumbgrip
Lever
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.
Mock-up
• 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 Accuhaler 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.
Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant or breast-feeding, talk to your doctor before taking
Serevent Accuhaler. Your doctor will assess whether you can take Serevent Accuhaler 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.
Warning:
This medicine contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this product.
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 Accuhaler every day, until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
Serevent Accuhaler is for inhalation by mouth only.
2.
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
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 Accuhaler 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 Accuhaler
and a steroid inhaler to use together.
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
monohydrate.
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.
• Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Serevent Accuhaler.
• 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 Accuhaler.
• 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.
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 Accuhaler 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 Accuhaler as a powder.
• There is a counter on top of the Serevent Accuhaler which tells you how many doses are left. 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. 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.
3. Hold the Serevent Accuhaler away from your mouth, breathe out as far as is comfortable. Do not breathe into your Serevent Accuhaler.
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.
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.
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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.
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.
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 Accuhaler to control your asthma or COPD. These are the side effects reported by people taking Serevent Accuhaler.
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 Accuhaler, 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 Accuhaler 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 Accuhaler, 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 Accuhaler 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
• Keep out of the sight and reach of children.
• Do not store above 30°C. Store in the original package.
• Do not use Serevent Accuhaler after the expiry date which is stated on the label and carton.
• If your doctor tells you to stop using the inhaler, please take it back to your pharmacist for safe disposal. Only keep the inhaler if your doctor tells you to.
• If your inhaler fails to work properly or you notice any other signs of deterioration you should ask your doctor or pharmacist for advice.
• 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.
6. FURTHER INFORMATION
What Serevent Accuhaler contains
The active substance is salmeterol. Each blister contains powder for inhalation providing 50 micrograms of salmeterol (as the xinafoate).
The other ingredient is lactose monohydrate (which contains milk proteins).
What Serevent Accuhaler looks like and contents of the pack
Serevent Accuhaler is a two-tone green and turquoise colour, circular device in moulded plastic containing white inhalation powder in foil strips and with a dose counter indicating the number of doses remaining.
The Accuhaler contains a foil strip with 60 blisters.
The foil protects the powder for inhalation from the effects of atmosphere.
Each dose is pre-dispensed.
The device is packed in a carton which holds one accuhaler containing 60 blisters providing 60 actuations.
Manufacturer
Serevent Accuhaler is manufactured by: Glaxo Welcome Production, Zone Industrielle No. 2,
23 Rue Lavoisier, Evereux, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0320
Leaflet issue and revision date (Ref): 21.06.13
Serevent™ and Accuhaler™ are trademarks of GlaxoSmithKline group of companies.
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302 552940 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name: Serevent 50 micrograms Accuhaler
Reference number: 21828/0320
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