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Serevent Accuhaler

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Document: leaflet MAH BRAND_PLPI 16369-1629 change

1. What Serevent Accuhaler is and what it is used for


2. What you need to know before you use Serevent Accuhaler


PACKAGE LEAFLET: INFORMATION FOR THE USER Serevent® Accuhaler® 50 micrograms (salmeterol xinafoate)

This product is available in the above name but will be referred to as Serevent throughout the remainder of this leaflet.

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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 yours.

•    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    What you 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

•    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.

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 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. 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.

•    Once your 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 may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent may increase your blood sugar) or heart disease, including an irregular or fast heartbeat.

Other medicines and Serevent

•    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 may not be suitable to be taken with other medicines.

•    Inform your doctor before using Serevent 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, including irregular heart beats, or may make 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. T ell 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 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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

3. How to use Serevent Accuhaler

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Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not 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 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

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   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 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.