1 What Serevent Evohaler is and what it is used for

What Serevent Evohaler contains

•    Each metered actuation contains 25 micrograms of the active ingredient salmeterol

(as xinafoate).

•    There are 120 metered actuations in each canister.

•    The other ingredient is norflurane (FIFA 134a).

What Serevent Evohaler looks like and contents of the pack

Pressurised inhalation suspension, white to off white suspension sealed in an aluminium canister in a green actuator. The actuator has a light green cap and a V shaped ridged area on the base.

Manufacturer:

Manufactured by Glaxo Wellcome Production, 23 Rue Lavoisier, 27000 Evreux, France and procured from within the EU by the Product Licence Holder Polyfarma Ltd and repackaged by Kent Pharmaceuticals Ltd both at Repton Road, Measham, DE12 7DT, UK.

POM

Serevent 25 micrograms Evohaler PL No: 17211/1101

Leaflet revision and issue date: 05.06.2014

Evohaler®, Serevent®, Haleraid® and Volumatic® are trademarks of the GlaxoSmithKline group of companies

•    Serevent Evohaler 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 Evohaler regularly will help prevent asthma attacks. This also includes asthma brought on by exercise or at night.

•    Taking Serevent Evohaler regularly will also help prevent breathing problems caused by other chest illnesses such as Chronic Obstructive Pulmonary Disease (COPD).

•    Serevent Evohaler 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 Evohaler is supplied to you in an inhaler. You breathe the medicine directly into your lungs.

•    Serevent Evohaler contains norflurane. This is less harmful to the environment than older inhalers. Older inhalers may taste differently to Serevent Evohaler. This will make no difference to how your medicine works.

If you are being treated for asthma, you should always be given both a Serevent

Evohaler and a steroid inhaler to use together.

2 What you need to know before you use Serevent Evohaler

Product: Serevent 25 microgram Evohaler

PLPI: 17211/1101

Dimensions: 210mm x 400mm

Colours: Black

Item Code: SER2003F/E

Proof: 2

Do not take Serevent Evohaler if:

you are allergic (hypersensitive) to salmeterol or to the other ingredient norflurane (HFA

134a).

Take special care with Serevent Evohaler

•    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 Evohaler. 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 Evohaler.

•    If you have been prescribed Serevent Evohaler 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 Evohaler.

•    Your doctor may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus (Serevent Evohaler 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 Evohaler may not be suitable to be taken with other medicines.

•    Inform your doctor before using Serevent Evohaler 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 Evohaler, including irregular heart beats, or may make side-effects worse.

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

• Serevent Evohaler 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 Evohaler with some medicines used to treat high blood pressure (diuretics) 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 Evohaler are unlikely to affect your ability to drive or use machines.

5 Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.

6 Breathe in through your mouth. Just after starting to breathe in, press down on the top of the canister to release a puff of medicine. Do this while still breathing in steadily and deeply.

3 How to use Serevent Evohaler

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 Evohaler and a steroid inhaler to use together.

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

•    You will start to feel your medicine working within the first day of use.

Serevent Evohaler is for inhalation by mouth only.

Adults and adolescents aged 12 years and older with Asthma

•    The usual starting dose is 2 puffs twice a day.

•    For people with more severe asthma, your doctor may increase your dose to 4 puffs twice a day.

Children with Asthma

•    In children aged 4 to 12 the usual dose is 2 puffs twice a day.

•    Serevent Evohaler 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 2 puffs 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 inhaler properly or as prescribed, may mean that the medicine will not help your asthma or COPD as it should.

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

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

9 After use always replace the mouthpiece cover immediately to keep out dust. Replace the cover by firmly pushing and snapping the cap into position.

7 Hold your breath, take the i nhaler 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.

Practice in front of a mirror for the first few times.

If you see a ‘mist' coming from the top of your inhaler or the sides of your mouth you should start again.

If you or your child find it difficult to use Serevent Evohaler, it may be used with other devices to make its use easier e.g. a Haleraid™ or Volumatic™ spacer device. Serevent is also available in an alternative device. Talk to your doctor, nurse or pharmacist for further advice.

Testing your inhaler

IWhen 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. If you have not used the inhaler for a week or more, release one puff of medicine into the air.

Using your inhaler

It is important to start to breathe in 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 objects.

Cleaning your inhaler

To stop your inhaler blocking up, 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.

Do not put the metal canister in water.

If you use more Serevent 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 and/or dizzy. You may also have a headache, muscle weakness and aching joints.

If you forget to use Serevent Evohaler

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

3 Shake the inhaler 4 or 5 times to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.

A Hold the inhaler upright with your thumb ⁴ on the base, below the mouthpiece. Breathe out as far as is comfortable.

Like all medicines, this medicine 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 Evohaler to control your asthma or COPD. These are the side effects reported by people taking Serevent Evohaler.

Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent 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 Serevent Evohaler, tell your doctor straight away. Allergic reactions to Serevent Evohaler 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 two puffs twice daily. These side effects do not last long and happen less as treatment with Serevent Evohaler 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 two puffs twice daily

•    Feeling nervous

Product: Serevent 25 microgram Evohaler

PLPI: 17211/1101

Dimensions: 210mm x 400mm

Colours: Black

Item Code: SER2003F/E

Proof: 2