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SALBUTAMOL 200 MICROGRAMS ACCUHALER

Active substance(s): SALBUTAMOL / SALBUTAMOL SULFATE / SALBUTAMOL / SALBUTAMOL

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Counter
Full Empty
Outer case

60

Mouthpiece
Lever

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, 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.
The name of your medicine is Ventolin® 200 micrograms Accuhaler®
but will be referred to as Ventolin or Accuhaler throughout this
leaflet.

(salbutamol sulphate)

Ventolin® 200 micrograms Accuhaler®

Package Leaflet: Information for the User

What you need to know before you use
Ventolin

3

How to use Ventolin

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

0

Thumbgrip

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

1

2

What Ventolin is and what it is used for

Ventolin 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.
Ventolin 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.

Do not use Ventolin if:
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.
you have a severe milk-protein allergy.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Ventolin 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
heart beat 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.
Other medicines and Ventolin
Tell your doctor, nurse or pharmacist if you are taking, have recently
taken or might take any 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 heart beat
other medicines for your asthma.
Ventolin with food and drink
You can use Ventolin 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
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.
Ventolin contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

Adults, adolescents aged 12 years and over and children 4 to
11 years of age
to relieve asthma - One inhalation (200 micrograms).
to prevent asthma - One inhalation (200 micrograms) 10 to 15
minutes before exercise or exposure to a ‘trigger’.
the maximum dose is one inhalation (200 micrograms) four
times a day.
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 Ventolin properly or as prescribed may
mean that it will not help your asthma as it should.
The Ventolin device holds blisters containing Ventolin as a
powder.
There is a counter on top of the Ventolin which tells you how
many doses are left. It counts down to 0. The numbers 5 to 0
will appear in red to warn you when there are only a few doses
left. Once the counter shows 0, your inhaler is empty.
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.
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 blisters to take and how often to use your inhaler.

Using your inhaler

1

To open your Accuhaler, hold
the outer case in one hand
and put the thumb of your other
hand on the thumbgrip. Push your
thumb away from you as far as it
will go. You will hear a click. This
will open a small hole in the
mouthpiece.

2

Hold your Accuhaler with the
mouthpiece towards you.
You can hold it in either your right
or left hand. Slide the lever away
from you as far as it will go. You
will hear a click. This places a
dose of your medicine in the
mouthpiece.
Every time the lever is pushed back a blister is opened
inside and the powder made ready for you to inhale. Do
not play with the lever as this opens the blisters and
wastes medicine.

3

Hold the Accuhaler away from your mouth, breathe out
as far as is comfortable. Do not breathe into your
Ventolin. Do not breath in again yet.

Put the mouthpiece to your
lips; breathe in steadily and
deeply through the Accuhaler,
with your mouth, not through your
nose.
Remove the Accuhaler from
your mouth.
Hold your breath for about 10
seconds or for as long as is
comfortable.
Breathe out slowly.

4

5

To close the Accuhaler, slide
the thumbgrip back towards
you, as far as it will go. You will
hear a click. The lever will return to
its original position and is reset.
Your Accuhaler is now ready for
you to use again.

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

4

Possible side effects

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

If you use more Ventolin than you should
If you use 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.

The following side effects can also happen but the frequency
of these are not known:
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.
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.
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 possible. Your chest problem may be
getting worse and you may need a different medicine. Do not take
extra doses of Ventolin unless your doctor tells you to.

5

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.

Common (may affect up to 1 in 10 people)
feeling shaky
headache.
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)
a low level of potassium in your blood
increased blood flow to your extremities (peripheral dilatation).

How to store Ventolin
Keep out of the sight and reach of children.
Do not store above 30°C. Do not freeze.
Store in the original package in order to protect from light.
Do not use Ventolin after the expiry date which is stated on the
carton and accuhaler label. The expiry date refers to the last
day of that 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.

Talk to your doctor as soon as possible if:
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 heart beat is uneven or it gives an extra beat
these may affect up to 1 in 10 people.

Tell your doctor if you have any of the following side effects, which
may also happen with this medicine:
Cleaning your inhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

Very rare (may affect up to 1 in 10,000 people)
changes in sleep patterns and changes in behaviour, such as
restlessness and excitability.

6

Contents of the pack and other information

What Ventolin contains
The active ingredient in Ventolin is salbutamol (as the sulphate).
Each dose contains powder for inhalation providing
200 micrograms salbutamol (as the sulphate).
The other ingredient is lactose.
What Ventolin looks like and contents of the pack
The powder for inhalation is contained in blister strips and within a
two-tone blue, circular device which has a mouthpiece and dose
counter indicating 60 doses.
Each device is packed in cartons which hold: 1 Accuhaler each
containing 60 blisters.

Manufactured by: Glaxo Wellcome Production, Zone Industrielle
No.2., 23 rue Lavoisier, la Madeleine, 27000 Evreux, France.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Ventolin® 200 micrograms Accuhaler®;
PL 18799/2934
Leaflet date: 07.07.2016

POM

Counter
Full Empty
Outer case

60

Mouthpiece
Lever

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, 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.
The name of your medicine is Salbutamol 200 micrograms
Accuhaler but will be referred to as Salbutamol or Accuhaler
throughout this leaflet.

(salbutamol sulphate)

Salbutamol 200 micrograms Accuhaler

Package Leaflet: Information for the User

What you need to know before you use
Salbutamol

0

Thumbgrip

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

1

2

What Salbutamol is and what it is used for

Salbutamol 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.
Salbutamol 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.

Do not use Salbutamol if:
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.
you have a severe milk-protein allergy.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Salbutamol 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
heart beat 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.
Other medicines and Salbutamol
Tell your doctor, nurse or pharmacist if you are taking, have recently
taken or might take any 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 heart beat
other medicines for your asthma.
Salbutamol with food and drink
You can use Salbutamol 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
planning to have a baby, ask your doctor, nurse or pharmacist for
advice before taking this medicine.
Driving and using machines
Salbutamol is not likely to affect you being able to drive or use any
tools or machines.
Salbutamol contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

3

How to use Salbutamol

Always use this medicine exactly as your doctor has told you.
Check with your doctor, nurse or pharmacist if you are not sure.
Adults, adolescents aged 12 years and over and children 4 to
11 years of age
to relieve asthma - One inhalation (200 micrograms).
to prevent asthma - One inhalation (200 micrograms) 10 to 15
minutes before exercise or exposure to a ‘trigger’.
the maximum dose is one inhalation (200 micrograms) four
times a day.
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 Salbutamol properly or as prescribed may
mean that it will not help your asthma as it should.
The Salbutamol device holds blisters containing Salbutamol as
a powder.
There is a counter on top of the Salbutamol which tells you how
many doses are left. It counts down to 0. The numbers 5 to 0
will appear in red to warn you when there are only a few doses
left. Once the counter shows 0, your inhaler is empty.
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.
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 blisters to take and how often to use your inhaler.

Using your inhaler

1

To open your Accuhaler, hold
the outer case in one hand
and put the thumb of your other
hand on the thumbgrip. Push your
thumb away from you as far as it
will go. You will hear a click. This
will open a small hole in the
mouthpiece.

2

Hold your Accuhaler with the
mouthpiece towards you.
You can hold it in either your right
or left hand. Slide the lever away
from you as far as it will go. You
will hear a click. This places a
dose of your medicine in the
mouthpiece.
Every time the lever is pushed back a blister is opened
inside and the powder made ready for you to inhale. Do
not play with the lever as this opens the blisters and
wastes medicine.

3

Hold the Accuhaler away from your mouth, breathe out
as far as is comfortable. Do not breathe into your
Salbutamol. Do not breath in again yet.

Put the mouthpiece to your
lips; breathe in steadily and
deeply through the Accuhaler,
with your mouth, not through your
nose.
Remove the Accuhaler from
your mouth.
Hold your breath for about 10
seconds or for as long as is
comfortable.
Breathe out slowly.

4

5

To close the Accuhaler, slide
the thumbgrip back towards
you, as far as it will go. You will
hear a click. The lever will return to
its original position and is reset.
Your Accuhaler is now ready for
you to use again.

If you forget to use Salbutamol
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.
If you stop using Salbutamol
Do not stop using Salbutamol without talking to your doctor.
If you have any further questions on the use of this medicine, ask
your doctor, nurse or pharmacist.

4

Possible side effects

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

If you use more Salbutamol than you should
If you use 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.

The following side effects can also happen but the frequency
of these are not known:
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.
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.
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 possible. Your chest problem may be
getting worse and you may need a different medicine. Do not take
extra doses of Salbutamol unless your doctor tells you to.

5

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.

Common (may affect up to 1 in 10 people)
feeling shaky
headache.
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)
a low level of potassium in your blood
increased blood flow to your extremities (peripheral dilatation).

How to store Salbutamol
Keep out of the sight and reach of children.
Do not store above 30°C. Do not freeze.
Store in the original package in order to protect from light.
Do not use Salbutamol after the expiry date which is stated on
the carton and accuhaler label. The expiry date refers to the last
day of that 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.

Talk to your doctor as soon as possible if:
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 heart beat is uneven or it gives an extra beat
these may affect up to 1 in 10 people.

Tell your doctor if you have any of the following side effects, which
may also happen with this medicine:
Cleaning your inhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

Very rare (may affect up to 1 in 10,000 people)
changes in sleep patterns and changes in behaviour, such as
restlessness and excitability.

6

Contents of the pack and other information

What Salbutamol contains
The active ingredient in Salbutamol is salbutamol (as the sulphate).
Each dose contains powder for inhalation providing
200 micrograms salbutamol (as the sulphate).
The other ingredient is lactose.
What Salbutamol looks like and contents of the pack
The powder for inhalation is contained in blister strips and within a
two-tone blue, circular device which has a mouthpiece and dose
counter indicating 60 doses.
Each device is packed in cartons which hold: 1 Accuhaler each
containing 60 blisters.

Manufactured by: Glaxo Wellcome Production, Zone Industrielle
No.2., 23 rue Lavoisier, la Madeleine, 27000 Evreux, France.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Salbutamol 200 micrograms Accuhaler;
PL 18799/2934
Leaflet date: 07.07.2016

POM

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.

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