Read all of this leaflet carefully before you start taking 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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1    What Serevent Accuhaler is and what it is used for

2    Whatyou need to know before you use Serevent Accuhaler

3    How to use Serevent Accuhaler

4    Possible side effects

5    How to store Serevent Accuhaler

6    Contents of the pack and other information

1 What Serevent Accuhaler is and what it is used for

•    Serevent Accuhaler contains themedicine 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 byasthma.Taking Serevent Accuhaler regularly will help preventasthma 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 notwork onceyou are breathless or wheezy. If that happens, you need to use a fast-acting 'reliever' medicine, such as salbutamol.

•    Serevent is supplied toyouinan 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.

2 What you need to know 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 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 morewheezy,your chest feels tight more often or you may need to use more of your fast-acting 'reliever' medicine.

If anyof these happen, do notincreaseyour number of puffs of Serevent.

Your chest condition may be getting worse and you could become seriously ill. See you doctor as you may need a change in asthma treatment.

•    Onceyour asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Serevent.

•    If you have been prescribed Serevent 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 maywantto check your health regularly ifyou have an overactive thyroid gland, diabetes mellitus (Sereventmayincreaseyour blood sugar) or heart disease, including an irregular or fast heartbeat.

Other medicines and Serevent

•    Tell your doctor ifyou 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 may not be

suitable to be taken with other medicines.

•    Inform your doctor before using Serevent ifyou are currently being treated for any fungal infectionswith medicines containing ketoconazole or itraconazole, or ifyou are being treated for HIVwith ritonavir.These medicinesmayincrease the risk ofyou experiencing side effects with Serevent, including irregular heartbeats, or maymake side-effects worse.

•    Beta-blockers should be avoided when taking Serevent, 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.Tell your doctor ifyou are taking beta-blockers or have recently been prescribed beta-blockers as they may reduce or abolish the effects of salmeterol.

•    Serevent can reduce the amount of potassium in your blood. If this happens you may notice an uneven heartbeat, muscleweakness orcramp.Thisismore likely to happen ifyou take Sereventwith some medicines used to treat high blood presssure (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. Ifyou have any concerns discuss them with your doctor.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, think you maybe pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking thismedicine.

Driving and using machines

The possible side effects associated with Serevent are unlikely to affect your ability to drive or use machines.

Serevent Accuhaler

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou arenot sure.

•    If you are being treated for asthma, you should always be given both a Serevent 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 12the usual dose is 1 puff twice a day.

•    Serevent is notrecommended for use in children below4 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 showyou how to use your inhaler. They should check howyou use it from timeto time.

Not using the Serevent Accuhaler properly or as prescribed may mean thatitwill nothelpyour asthmaor 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 howmany doses are left. It counts down toO.Thenumbers5to 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

ITo open your SereventAccuhaler, 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 dick, this will open a small hole in the mouthpiece.

2 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.

I

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 SereventAccuhaler awayfrom your mouth, breathe out as far as is comfortable. Do not breathe into your SereventAccuhaler.

4 Put the mouthpiece to your lips; breathe in steadily and deeply through the SereventAccuhaler, 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.

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 SereventAccuhaler, slide the thumbgrip back towards you, as far asitwill 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 than you should

It is important to use the inhaler as instructed. Ifyou 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, muscleweakness and aching joints. If you forget to use Serevent

Do not take a double dose to make up for a missed dose. Just take your next dose at the usual time.

Ifyou have any further questions on the use of thismedicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, thismedicine 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. Youmay be verywheezy and cough.

You may also notice itching and swelling (usually of the face, lips, tongue or throat). Ifyou get these effects or they happen suddenly after using Serevent, tell your doctor straight away. Allergic reactions to Serevent 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 ifyou 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 ismore likely to happen ifyou 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)

Very rare (affects less than 1 person in 10,000):

•    Breathing difficulties or wheezing that gets worse straight after taking Serevent. 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

•    Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). Ifyou have diabetes, more frequent blood sugar monitoring and possibly ad|ustment of your usual diabetic treatment may be required

•    Sore mouth or throat

•    Feeling sick (nausea)

•    Aching, swollen joints, or chest pain

Reporting of side effects

Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Serevent Accuhaler

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 30°C.

•    Do not use Serevent after the expiry date which is stated on the label and carton.

Do not throw awaymedicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Serevent Accuhaler contains

•    The active substance is50 micrograms salmeterol xinafoate

•    The other ingredient is lactose (which contains milk proteins).

What Serevent Accuhaler looks like and contents of the pack

•    The Serevent Accuhaler contains a foil strip. The foil protects the powder for inhalation from the effects of the atmosphere.

•    Eachdoseispre-dispensed.

•    The devices are packed in cartonswhich hold one Accuhaler containing 60 inhalations

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Glaxo Wellcome UK Ltd Stockley Park West Uxbridge

Middlesex UB11 1BT Manufacturer:

Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier 27000 Evreux France

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name    Serevent Accuhaler

Reference number    10949/0214

This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 03/2014.

Accuhaler and Serevent are registered trademarks of the GlaxoSmithKline group of companies

© 2014 GlaxoSmithKline group of companies

GlaxoSmithKline

Thic PDF has boon uorifioH ncinn Pit^tnn flR - POP ic PDF/Y-la rnmnliant