Skip to Content

UK Edition. Click here for US version.

SEREVENT 25MICROGRAMS EVOHALER

Active substance(s): SALMETEROL / SALMETEROL XINAFOATE MICRONISED

View full screen / Print PDF » Download PDF ⇩
Transcript
CUSTOMER: Waymade
PRODUCT:
CODE:

Serevent 25mcg Evohaler
6464/2561E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

17/10/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 17/10/14

£‹„µ†æ
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED APRIL 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

SEREVENT® 25 micrograms EVOHALER®
(Salmeterol Xinafoate)
Patient Information Leaflet

6. Contents of the pack and other information
What Serevent Evohaler contains

Each metered actuation contains 25 micrograms of the active ingredient salmeterol (as xinafoate), in
a pressurised inhalation, suspension form.

There are 120 puffs in each canister.

The other ingredient is norflurane (HFA 134a).
What Serevent Evohaler looks like and contents of the pack

A pressurised inhalation white suspension in a metered dose inhaler with a dark green plastic body
and a light green removable cap.
Marketing Authorisation Holder and Manufacturer
POM

PL No: 6464/2561

This product is manufactured by Glaxo Wellcome Production, 23, Rue Lavoisier, 2, Evreux, 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.) 17.10.2014
Serevent and Evohaler are registered trademarks of the Glaxo Wellcome Group

This product is known as the above name but will be referred to throughout this leaflet as Serevent or Serevent
Evohaler.
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
4. Possible side effects
5. How to store Serevent Evohaler
6. Contents of the pack and other information

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).
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
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.
Pg 2 !

WARNING!

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.

&2v2[ª
‘¢>§ƒ(

[v>ƒÌ

WARNING!

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.

CUSTOMER: Waymade
PRODUCT:
CODE:

Serevent 25mcg Evohaler
6464/2561E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

17/10/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 17/10/14

£‹„µ†æ
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED APRIL 2014
REPORTING OF SIDE EFFECTS

Pg 2

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 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.
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 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.

Pg 3

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 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
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.
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).
Other side effects are listed below:

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 two puffs into the
air. If you have not used the inhaler for a week or more, also release
two puffs of medicine into the air.

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

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

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

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.

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)

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.

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

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

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

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.

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.

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.
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 inhaler fails to work properly, or shows any other signs of deterioration, you should ask your doctor or
pharmacist for advice. He/she will tell you what to do.

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

Pg 4 !

Pg 3 !

WARNING!

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.

&2v2[ª
‘¢>§ƒ(

[v>ƒÌ

WARNING!

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.

Expand view ⇕

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.

Hide