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PACKAGE LEAFLET: INFORMATION FOR THE USER SERETIDE® 125 EVOHALER®

(salmeterol xinafoate / fluticasone propionate)

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

This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.

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 symptoms and 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 Seretide is and what it is used for

2.    What you need to know before you use Seretide

3.    How to use Seretide

4.    Possible side effects

5.    How to store Seretide

6.    Contents of the pack and other information

1. What Seretide is and what it is used for

Seretide contains two medicines, salmeterol and fluticasone propionate:

•    Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours.

•    Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

The doctor has prescribed this medicine to help prevent breathing problems such as asthma.

You must use Seretide every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.

Seretide helps to stop breathlessness and wheeziness coming on. However Seretide should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever' (‘rescue') inhaler, such as salbutamol. You should always have your fast-acting ‘rescue' inhaler with you.

2. What you need to know before you use Seretide

Do not take Seretide if:

You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient norflurane (HFA 134a).

Warnings and precautions

Your doctor will supervise your treatment more closely if you have medical conditions such as:

•    Heart disease, including an irregular or fast heart beat

•    Overactive thyroid gland

•    High blood pressure

•    Diabetes mellitus (Seretide may increase your blood sugar)

•    Low potassium in your blood

•    Tuberculosis (TB) now, or in the past, or other lung infections

If you have ever had any of these conditions, tell your doctor before you use Seretide.

Other medicines and Seretide

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines for asthma or any medicines obtained without a prescription. This is because Seretide may not be suitable to be taken with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to

use Seretide:

•    p blockers (such as atenolol, propranolol and sotalol). p blockers are mostly used for high blood pressure or other heart conditions.

•    Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with Seretide, including irregular heart beats, or may make side effects worse.

•    Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.

•    Diuretics, also known as 'water tablets' used to treat high blood pressure.

•    Other bronchodilators (such as salbutamol).

•    Xanthine medicines. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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

Seretide is not likely to affect your ability to drive or use machines.

Always use this medicine exactly as your doctor or pharmacist has told

you. Check with your doctor or pharmacist if you are not sure.

•    Use your Seretide every day, until your doctor advises you to stop. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure.

•    Do not stop taking Seretide or reduce the dose of Seretide without talking to your doctor first

•    Seretide should be inhaled through the mouth into the lungs.

Adults and adolescents aged 12 years and over

•    Seretide 50 Evohaler - 2 puffs twice a day

• Seretide 125 Evohaler - 2 puffs twice a day

• Seretide 250 Evohaler - 2 puffs twice a day

Children 4 to 12 years of age

• Seretide 50 Evohaler - 2 puffs twice a day

•    Seretide is not recommended for use in children below 4 years of age.

Your symptoms may become well controlled using Seretide twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

•    once at night - if you have night-time symptoms

•    once in the morning - if you have daytime symptoms.

It is very important to follow your doctor's instructions on how many puffs to take and how often to take your medicine.

If you are using Seretide 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, you should continue to take Seretide but do not increase the number of puffs you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.

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 Seretide Evohaler properly or as prescribed may mean that it will not help your asthma as it should.

•    The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.

•    There is a counter on the back of the Evohaler which tells you how many doses are left. Each time you press the canister, a puff of medicine is released and the counter will count down by one.

•    Take care not to drop the inhaler as this may cause the counter to count down.

Testing your inhaler

1.    When using your inhaler for the first time, test that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.

2.    To make sure that it works, shake it well, point the mouthpiece away from you and press the canister to release a puff into the air. Repeat these steps, shaking the inhaler before releasing each puff, until the counter reads 120. If you have not used your inhaler for a week or more, release two puffs of medicine into the air.

Using your inhaler

It is important to start to breathe as slowly as possible just before using your inhaler.

1.    Stand or sit upright when using your inhaler.

2.    Remove the mouthpiece cover (as shown in the first picture). Check inside and outside to make sure that the mouthpiece is clean and free of loose objects.

3.

4.

5.

6.

7.    Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable.

8.    Wait about half a minute between taking each puff of medicine and then repeat steps 3 to 7.

9.    Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help to stop you getting thrush and becoming hoarse.

10.    After use always replace the mouthpiece cover straight away to keep out dust. When the mouthpiece cover is fitted correctly it will 'click' into position. If it does not 'click' into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.

Do not rush steps 4, 5, 6 and 7. It is important that you breathe in as slowly as possible just before using your inhaler. You should use your inhaler whilst standing in front of a mirror for the first few times. If you see "mist" coming from the top of your inhaler or the sides of your mouth, you should start again from step 3.

As with all inhalers, caregivers should ensure that children prescribed Seretide Evohaler use correct inhalation technique, as described above.

If you or your child find it difficult to use the Evohaler, either your doctor or other healthcare provider may recommend using a spacer device such as the Volumatic® or AeroChamber Plus® with your inhaler. Your doctor, nurse, pharmacist or other healthcare provider should show you how to use the spacer device with your inhaler and how to care for your spacer device and will answer any questions you may have. It is important that if you are using a spacer device with your inhaler that you do not stop using it without talking to your doctor or nurse first. It is also important that you do not change the type of spacer device that you use without talking to your doctor. If you stop using a spacer device or change the type of spacer device that you use your doctor may need to change the dose of medicine required to control your asthma. Always talk to your doctor before making any changes to your asthma treatment.