Package Leaflet: Information for the User

Seretide® 25/250 Evohaler® Seretide® 25/250 CFC Free Inhaler

(salmeterol xinafoate, fluticasone propionate)

This product can be known by either of the above names but will be referred to as Seretide Evohaler throughout this leaflet.

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 Seretide Evohaler is and what it is used for

2.    Before you use Seretide Evohaler

3.    How to use Seretide Evohaler

4.    Possible side effects

5.    How to store Seretide Evohaler

6.    Further information

1. What Seretide Evohaler is and what it is used for

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

Seretide Evohaler helps to stop breathlessness and wheeziness coming on. It does not work once you are breathless or wheezy. If that happens you need to use a fast acting ‘reliever’ medication, such as salbutamol.

2. Before you use Seretide Evohaler

Do not take Seretide Evohaler if:

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

Take special care with Seretide Evohaler

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

•    heart disease, including an irregular or fast heartbeat

•    overactive thyroid gland

•    high blood pressure

•    diabetes mellitus (Seretide Evohaler may increase your blood sugar)

•    low potassium in your blood

•    Tuberculosis (TB) now, or in the past.

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

Taking other medicines

Please 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 Evohaler 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 Evohaler:

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

•    Antiviral and antifungal medicines (such as ritonavir, ketoconazole and itraconazole). 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 Evohaler, 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.

Pregnancy and breast-feeding

If you are pregnant, planning to get pregnant, or breast-feeding, talk to your doctor before taking Seretide Evohaler. Your doctor will assess whether you can take Seretide Evohaler during this time.

Driving and using machines

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

3. How to use Seretide Evohaler

•    Use your Seretide Evohaler every day, until your doctor advises you to stop.

•    Always use Seretide Evohaler exactly as your doctor has told you. Don't exceed the recommended dose. Check with your doctor or pharmacist if you're not sure.

Adults and adolescents aged 12 years and over

•    Seretide Evohaler: 2 puffs twice a day

•    Seretide 250 Evohaler is not recommended for children below 12 years of age.

Your symptoms may become well controlled using Seretide Evohaler twice a day. If so, your doctor may decide to reduce your dose to once daily. 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 inhalations to take and how often to take your medicine.

If you are using Seretide Evohaler 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 Evohaler 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 Seretide 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.

If you or your child find it difficult to use Seretide Evohaler, either the VolumatiCjM or Aerochamber Plus _TM spacer device may be used. Before starting to use a spacer device for the first time or if you need to change your make of spacer device, talk to your doctor, nurse or pharmacist. A special device called a Haleraid _TM may also make it easier.

You should get a replacement when the counter shows the number 020.

Stop using the inhaler when the counter shows 000 as any puffs left in the device may not be enough to give you a full dose. Never try to alter the numbers on the counter or detach the counter from the metal canister.

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Cleaning your inhaler

To stop your inhaler blocking, it is important to clean it at least once a week.

To clean your inhaler:

•    Remove the mouthpiece cover.

•    Do not remove the metal canister from the plastic casing at any time.

•    Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

•    Replace the mouthpiece cover. It will ‘click' into place when fitted correctly. 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 put the metal canister in water.

If you use more Seretide Evohaler 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. You may also have a headache, muscle weakness and aching joints.

If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seretide Evohaler may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Seretide Evohaler

If you forget to use your inhaler, take your next dose when it is due.

Do not take a double dose to replace the one you forgot.

If you stop using Seretide Evohaler

It is very important that you take your Seretide Evohaler every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Seretide Evohaler. This could make your breathing problem worse and very rarely side effects could occur.

These include:

•    Stomach pain

•    Tiredness and loss of appetite

•    Sickness and diarrhoea

•    Weight loss

•    Headache or drowsiness

•    Low levels of potassium in your blood

•    Low blood pressure and seizures

Very rarely, if you get an infection or at times of extreme stress (such as after a serious accident or if you have surgery), you may get similar side effects.

To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids (like prednisolone).

If you have any further questions on using your inhaler, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Seretide Evohaler can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Seretide Evohaler to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse after using Seretide Evohaler. 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 if they happen suddenly after using Seretide Evohaler, tell your doctor straight away. Allergic reactions to Seretide Evohaler are uncommon (they affect less than 1 person in 100).

Other side effects are listed below:

Very Common (affects more than 1 person in 10)

•    Headache - this usually gets better as treatment continues.

•    Increased number of colds have been reported in patients with COPD.

Common (affects less than 1 person in 10)

•    Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue and hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help.

Your doctor may prescribe an antifungal medication to treat the thrush.

•    Aching, swollen joints and muscle pain.

•    Muscle cramps.

The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

•    Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems.

•    Throat irritation. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help.

•    Bruising and fractures.

•    Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).

•    A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp).

Uncommon (affects less than 1 person in 100)

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

•    Cloudy lens in the eye.

•    Very fast heartbeat (tachycardia).

•    Feeling shaky and fast or uneven heart beat (palpitations) - these are usually harmless and get less as treatment continues.

•    Chest pain.

•    Feeling worried (this effect mainly occurs in children).

•    Disturbed sleep.

•    Rash.

Rare (affects less than 1 person in 1000)

•    Breathing difficulties or wheezing that get worse straight after taking Seretide. If this happens stop using your Seretide Evohaler. Use your fast acting ‘reliever' inhaler to help your breathing and tell your doctor straight away.

•    Seretide Evohaler may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:

-    Slowing of growth in children and adolescents

-    Thinning of the bones

-    Glaucoma

-    Weight gain

-    Rounded (moon shaped) face (Cushing's Syndrome).

Your doctor will check you regularly for any of these side effects and make

sure you are taking the lowest dose of Seretide Evohaler to control your

asthma.

•    Behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).

•    Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Seretide Evohaler unless they tell you to stop.

Frequency not known, but may also occur:

•    Depression or aggression. These effects are more likely to occur in children. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Seretide Evohaler

•    Keep out of the sight and reach of children.

•    Straight after use, replace the mouthpiece cover firmly and click it into position. Do not use excessive force.

•    Do not store your Seretide Evohaler above 25°C.

•    Do not store Seretide Evohaler in a cold place, as your medicine may not work as well.

•    Do not use after the expiry date printed on the carton and the canister label.

•    The expiry date refers to the last day of that month

•    The metal canister contains a pressurized liquid. Do not puncture, break or burn it even when apparently empty.

If your Evohaler shows any signs of deterioration, consult your doctor or

pharmacist who will tell you what to do.

Medicines should not be disposed of via waste water 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 Seretide Evohaler contains

•    Each metered dose or puff contains 25 micrograms salmeterol (as the xinafoate) and 250 micrograms of fluticasone propionate.

•    The other ingredient is a CFC-free propellant, Norflurane (HFA 134a).

What Seretide Evohaler looks like and the contents of the pack

•    Seretide Evohaler is a metered dose aerosol canister contained in a plastic inhaler device with a dark purple removable cap, fitted with a dosage counter.

•    Each canister provides 120 puffs or metered doses of a pressurised inhalation suspension.

Manufacturer

This product is manufactured by Glaxo Wellcome Production, Zone Industrielle

N°2, 23 Rue Lavoisier, 27000 Evreux, France. Procured from within the EU

and repackaged by Mediwin Limited, Product Licence Holder: Mediport Limited

13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, BN17 7PA,

United Kingdom.

POM PL No: 18980/0642

SERETIDE, EVOHALER, HALERAID AND VOLUMATIC ARE TRADEMARKS OF THE GLAXOSMITHKLINE GROUP OF COMPANIES.

AEROCHAMBER PLUS IS A TRADEMARK OF TRUDELL MEDICAL INTERNATIONAL.

Date of leaflet preparation: 10/12/2013