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Package Leaflet: Information for the User

(salbutamol sulphate)

Adults and adolescents aged 12 years and over

Your medicine is available as Ventolin 100 Micrograms Evohaler but will be referred to as
Ventolin Evohaler 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 about your illness or your medicine, ask your doctor,
nurse 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, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

Your doctor may have told you to take more than this as an emergency treatment if your
wheezing or breathing gets very bad. It is very important that you keep to your doctor's
instructions as to how many puffs to take and how often to use your inhaler.

Testing your inhaler

Ventolin Evohaler is used to treat breathing problems in people with asthma and similar
conditions. This includes relieving and preventing asthma brought on by exercise or other
“triggers”. These are things, which bring on asthma symptoms in some people. Common
triggers include house dust, pollen, cats, dogs and cigarette smoke.
Ventolin Evohaler contains a propellant called HFA 134a. This is less harmful to the environment
than older inhalers. Older inhalers may taste differently to Ventolin Evohaler. This will make no
difference to how your medicine works.

When using the 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.


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 5 days or
more, shake it well and release two puffs of medicine into the air.

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

you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed
in section 6).
you unexpectedly go into early labour (premature labour) or threatened abortion.

Talk to your doctor, nurse or pharmacist before taking Ventolin Evohaler if:
• your asthma is active (for example you have frequent symptoms or flare ups or limited
physical ability). Your doctor may start or increase a medicine to control your asthma such
as an inhaled corticosteroid.
• you have high blood pressure
• you have an overactive thyroid gland
• you have a history of heart problems such as an irregular or fast heartbeat or angina.
• you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma.
• you are taking water tablets (diuretics), sometimes used to treat high blood pressure or a
heart condition.


Using your inhaler


Warnings and precautions

To help identify that the inhaler is Ventolin, there is an embossed letter V on the plastic
Ventolin Evohaler produces a fine mist, which you inhale through your mouth into your
lungs. Your doctor, nurse or pharmacist should show you how to use your inhaler. If you are
not sure ask your doctor, nurse or pharmacist.
Each Evohaler canister provides 200 puffs.

Do not use your inhaler more often than the doctor told you to. Tell your doctor if your medicine
does not seem to be working as well as usual, as your chest problem may be getting worse and
you may need a different medicine.


Do not use Ventolin Evohaler if:

to relieve asthma - One puff. Two puffs if required.
to prevent asthma - One puff 10-15 minutes before exercise or exposure to a “trigger”. Two
puffs if required.
for regular treatment - Two puffs up to 4 times a day.
the maximum dose is 8 puffs in a 24 hour period.

Instructions for use

Ventolin Evohaler contains a medicine called salbutamol. This belongs to a group of medicines
called fast acting bronchodilators.
• Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to
get in and out.
• They help to relieve chest tightness, wheezing and cough.


to relieve asthma - One or two puffs.
to prevent asthma - Two puffs 10-15 minutes before exercise or exposure to a “trigger”.
for regular treatment - Two puffs up to 4 times a day.
the maximum dose is 8 puffs in a 24 hour period.

Children under 12 years of age

What is in this leaflet:
1. What Ventolin Evohaler is and what it is used for
2. What you need to know before you use Ventolin Evohaler
3. How to use Ventolin Evohaler
4. Possible side effects
5. How to store Ventolin Evohaler
6. Contents of the pack and other information


Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or
pharmacist if you are not sure.


Stand or sit upright when using your inhaler.


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.


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.


Hold the inhaler upright with your thumb on the base, below the
mouthpiece. Breathe out as far as is comfortable. Do not breathe in
again yet.


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


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.

Other medicines and Ventolin Evohaler

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take other
medicines, including medicines obtained without a prescription. This includes herbal medicines.
Remember to take this medicine with you if you have to go to hospital.
In particular tell your doctor, nurse or pharmacist if you are taking:
• medicines for an irregular or fast heartbeat
• other medicines for your asthma.

Ventolin Evohaler with food and drink

You can take Ventolin Evohaler at any time of day, with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

Driving and using machines

Ventolin is not likely to affect you being able to drive or use any tools or machines.

Page 1 of 2

Asthma Control Test™

The Asthma Control Test is one way to quickly assess your asthma control, giving you a simple
score out of 25.
Your healthcare professional may ask you additional questions during a consultation.
Are you in control of your asthma? Or is your asthma in control of you? Here’s how to
find out
Step 1: Read each question below carefully, circle your score and write it in the box.
Step 2: Add up each of your five scores to get your total Asthma Control Test TM score.
Step 3: Use the score guide to learn how well you are controlling your asthma.




During the past 4 weeks, how often did your asthma prevent you from
getting as much done at work, school or home?
All of the time
1 Most of
2 Some of
3 A little
the time
the time
of the
During the past 4 weeks, how often have you had shortness of breath?
More than
1 Once a
2 3-6
3 1-2
once a day
times a
times a
During the past 4 weeks, how often did your asthma symptoms
(wheezing, coughing, chest tightness, shortness of breath) wake you up
at night or earlier than usual in the morning?
4 or more
1 2-3
2 Once a
3 Once or
times a week
nights a

None of
the time
Not at



Not at


Turn over for Questions 4 and 5.

Page 1 of 2


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.

Uncommon (may affect up to 1 in 100 people)

mouth and throat irritation
muscle cramps.

Rare (may affect up to 1 in 1,000 people)


If your doctor has told you to take two puffs, wait about half a minute before you take
another puff by repeating steps 3 to 7.

Very rare (may affect up to 1 in 10,000 people)

After use always replace the mouthpiece cover straight away to keep out dust. Replace the
cover by firmly pushing and clicking into position.

The following side effects can also happen but the frequency of these are not

Practise 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 think this medicine is not working well enough for you

If your medicine does not seem to be working as well as usual, talk to your doctor as soon as
Your chest problem may be getting worse and you may need a different medicine. Do not take
extra doses of Ventolin Evohaler unless your doctor tells you to.

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 metal canister from the plastic casing of the inhaler and remove the mouthpiece
• Rinse the plastic casing thoroughly under warm running water.
• Dry the plastic casing thoroughly inside and out.
• Replace the metal canister into the plastic casing and put on mouthpiece cover.
Do not put the metal canister in water.

If you take more Ventolin Evohaler than you should

If you take more than you should, talk to a doctor as soon as possible.
The following effects may happen:
• your heart beating faster than usual
• you feel shaky
• hyperactivity
These effects usually wear off in a few hours.




Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from frost and light.
If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in
your hands for a few minutes before use. Never use anything else to warm it up.
• Do not pierce. Do not puncture, break or burn, even when apparently empty.
• Do not use Ventolin Evohaler after the expiry date, which is stated on the label and carton
after ‘EXP’. The expiry date refers to the last day of that month.
• If you are told to stop taking this medicine return any unused Ventolin Evohaler to your
pharmacist to be destroyed.
• If your inhaler fails to work properly or you notice any other signs of deterioration, you
should seek the advice of your pharmacist.
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 protect the

If you forget a dose, take it as soon as you remember it.
However, if it is time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

The active substance is salbutamol sulphate.
The other ingredient is CFC-free propellant norflurane (HFA 134a).
Each actuation contains 100 micrograms of salbutamol (as salbutamol sulphate)

What Ventolin Evohaler looks like and contents of the pack

If you stop taking Ventolin Evohaler

Ventolin Evohaler consists of a pressurised metered dose inhaler with a blue plastic device and a
dark blue dust cap.

Do not stop taking Ventolin Evohaler without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor, nurse or

Each container provides 200 actuations.



If your breathing or wheezing gets worse straight after taking this medicine, stop
using it immediately, and tell your doctor as soon as possible.

Manufactured by:
Glaxo Wellcome Production, Zone Industrielle no. 2, 23 Rue Lavoisier, 27000 Evreux, France.
GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189, 60-322 Poznan, Poland
Glaxo Wellcome S.A., Avda de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The
following side effects may happen with this medicine:
Allergic Reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop taking Ventolin Evohaler and see a doctor straight away.
Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which
may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR .

Talk to your doctor as soon as possible if:


What Ventolin Evohaler contains

If you forget to take Ventolin Evohaler

chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if
this occurs. Do not stop using this medicine unless told to do so.

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:
By reporting side effects you can help provide more information on the safety of this medicine.

Older children or people with weak hands may find it easier to hold the inhaler with both hands.
Put the two forefingers on top of the inhaler and both thumbs on the bottom below the
mouthpiece. If this does not help, a special device called a Haleraid® may make it easier. Your
doctor, nurse or pharmacist will be able to advise you.


changes in sleep patterns and changes in behaviour, such as restlessness and excitability.

Reporting of side effects

Young children may need help and their parents may need to operate the inhaler for them.
Encourage the child to breathe out and operate the inhaler just after the child starts to breathe
in. Practise the technique together. You may find the Volumatic® spacer device, with a face
mask, or the Babyhaler® device useful if you have to give Ventolin Evohaler to a baby or a child
under 5 – speak to your doctor if you think you might need one of these.

a low level of potassium in your blood
increased blood flow to your extremities (peripheral dilatation).

PL No: 08929/0560

you feel your heart is beating faster or stronger than usual (palpitations). This is usually
harmless, and usually stops after you have used the medicine for a while
you may feel your heartbeat is uneven or it gives an extra beat
these may affect up to 1 in 10 people.


Ventolin™ and Evohaler™ are trademarks of the GlaxoSmithKline Group of Companies.
Leaflet revision date: 24.02.16

If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this
medicine unless told to do so.

Tell your doctor if you have any of the following side effects which may also happen with
this medicine:
Common (may affect up to 1 in 10 people)

feeling shaky

Page 2 of 2



During the past 4 weeks, how often have you used your reliever
inhaler (usually blue)?
3 or more
1 1-2 times
2 2-3 times
3 Once a
times a
a day
a week
week or
How would you rate your asthma control during the past 4 weeks?
1 Poorly
2 Somewhat 3 Well
Total Score

What does your score mean?

Not at all




Score: 25 - WELL DONE
• Your asthma appears to
have been UNDER
CONTROL over the last 4
• However, if you are
experiencing any problems
with your asthma, you
should see your doctor,
nurse or pharmacist.

Page 2 of 2

Score: 20 to 24 - ON
• Your asthma appears to
have been REASONABLY
the past 4 weeks.
• However, if you are
experiencing symptoms
your doctor, nurse or
pharmacist may be able to
help you.

Score: less than 20 - OFF
• Your asthma may NOT
during the past
4 weeks.
• Your doctor, nurse or
pharmacist can
recommend an asthma
action plan to help
improve your asthma

Expand Transcript

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.