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SEREVENT 25 MICROGRAMS EVOHALER

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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 Evohaler is and what it is used for
2. What you need to know before you use Serevent Evohaler
3. How to use Serevent Evohaler

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. 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.
• 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. 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 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.

02/06/14

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 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 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.

TVT CHECKED

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.
TO UK PIL DATED NOVEMBER 2013
REPORTING OF SIDE EFFECTS

6464/2363F
CODE:

DATE OF PROOF:

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.

DATE:

DT

DATE:

Q.A.
APPROVED:
04-1957

ARTWORKER:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 02/06/14

Leaflet Flat Size = 180 x 429

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1. WHAT SEREVENT EVOHALER IS AND WHAT IT IS USED FOR
• 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 and a steroid inhaler to use together.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SEREVENT EVOHALER
Do not take Serevent Evohaler if:
you are allergic (hypersensitive) to salmeterol or to the other ingredient norflurane (HFA 134a).

PRE-PRESS NO.:

Serevent evohaler
PRODUCT:

CUSTOMER: Waymade

4. Possible side effects
5. How to store Serevent Evohaler
6. Contents of the pack and other information

Children with Asthma

In children aged 4 to 12 the usual dose is 2 puffs 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 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.
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. 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.

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.

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

WARNING!

This product is known as the above name but will be referred to throughout this leaflet as Serevent Evohaler.
27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

(Salmeterol Xinafoate)
Patient Information Leaflet

WARNING!

SEREVENT® 25 micrograms EVOHALER®

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

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.

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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 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.

PROOF HISTORY:
v.1 - waymade - 02/06/14

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.

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

Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent. 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 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).

TO UK PIL DATED NOVEMBER 2013
REPORTING OF SIDE EFFECTS

CODE:

6464/2363F

TVT CHECKED

02/06/14
DATE OF PROOF:

DATE:

DT

04-1957
PRE-PRESS NO.:

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)

Serevent evohaler

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:

CUSTOMER: Waymade

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

ARTWORKER:

Q.A.
APPROVED:

Other side effects are listed below:

Very rare (affects less than 1 person in 10,000):
• Breathing difficulties or wheezing that gets worse straight after taking Serevent Evohaler. If this happens stop using your
Serevent Evohaler. 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). If you have diabetes, more frequent blood sugar
monitoring and possibly adjustment 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
If you 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 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 above 30°C.
• Keep container in the outer carton.
• The metal canister contains a pressurised liquid. Do not pierce or burn even when empty.
• Do not use Serevent Evohaler after the expiry date which is stated on the label and carton. The expiry date refers to the last day of
the month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the environment.
• If your doctor tells you to stop using this medicine or when you need to dispose of them, please take them back to your pharmacist
for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or show signs of
deterioration, you should seek advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Serevent Evohaler contains
• Each actuation provides 25 micrograms of the active ingredient salmeterol (as xinafoate).
• There are 120 metered actuations (puffs) in each canister.
• The other ingredient is norflurane (HFA 134a).
What Serevent Evohaler looks like and contents of the pack
• An aerosol metered dose inhaler with a dark green plastic body and a light green removable cap.
Marketing Authorisation Holder and Manufacturer
POM

PL No: 6464/2363

This product is manufactured by Glaxo Wellcome Production, 100, route de Versailles, 78163 Marly le Roi Cedex, France and
procured from within the EU and repackaged by the Product Licence holder who is:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 02.06.2014
Serevent and Evohaler are registered trademarks of the Glaxo Wellcome Group

WARNING!

4. POSSIBLE SIDE EFFECTS
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.

DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 180 x 429

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

WARNING!

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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