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.aov.uk/vellowcard.

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 Accuhaler unless your doctor tells you to.

Q Contents of the pack and other information Your medicine

Each blister contains 200 micrograms of salbutamol sulphate. Also contains lactose

What is in your medicine

Ventolin Accuhaler is a plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 200 micrograms of the active ingredient salbutamol (as sulphate) and lactose which acts as the ‘carrier’. The blisters protect the powder for inhalation from the effects of the atmosphere. The device has a counter which tells you the number of blisters remaining. It counts down from 60 to 0. To show when the last five blisters have been reached the numbers appear in red. When the counter shows 0 your inhaler is empty and should be disposed of.

Manufacturer and Licence Holder

Ventolin Accuhaler is manufactured by Glaxo Wellcome Production Zone Industrielle, No 2, 23 Rue Lavoisier, 27000 Evreux, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 ORE.

EXPIRY DATE

Do not use this medicine after the expiry date shown on the label or carton label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.

STORING YOUR MEDICINE

*    KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

*    Do not store above 30°C. Store in the original packaging.

Ventolin & Accuhaler are registered trademarks of the GlaxoSmithKline Group of Companies.

Leaflet revision date: 23/08/16

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Ventolin®200 micrograms Accuhaler®

(salbutamol sulphate)

Patient Information 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, 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 medicine is called Ventolin 200 micrograms Accuhaler, throughout the rest of this leaflet it will be referred to as Ventolin Accuhaler.

Q What Ventolin Accuhaler is and what it is used for

Ventolin Accuhaler 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 Accuhaler 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.

Q What you need to know before you use Ventolin Accuhaler Do not use Ventolin Accuhaler 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

Accuhaler 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.

Other medicines and Ventolin Accuhaler

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 heartbeat

•    other medicines for your asthma.

Ventolin Accuhaler with food and drink

You can use Ventolin Accuhaler 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 Accuhaler contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Q How to use Ventolin Accuhaler

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 Ventolin Accuhaler properly or as prescribed may mean that it will not help your asthma as it should.

•    The Ventolin Accuhaler device holds blisters containing Ventolin as a powder

•    There is a counter on top of the Ventolin Accuhaler 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 Ventolin 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 Ventolin 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 Ventolin Accuhaler away from your mouth, breathe out as far as is comfortable.

Do not breathe into your Ventolin Accuhaler.

Do not breath in again yet.

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

Breathe out slowly.

5    To close the Ventolin Accuhaler, slide the thumb grip back towards you, as far as it will go. 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.

Cleaning your inhaler

Wipe the mouthpiece of the Accuhaler with a dry

tissue to clean it.

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.

If you forget to use Ventolin Accuhaler

•    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 Accuhaler

Do not stop using Ventolin Accuhaler without talking to your doctor.

If you have any further questions on the use of this medicine, ask

your doctor, nurse or pharmacist.

Q 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.

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 heartbeat is uneven or it gives an extra beat

•    these may affect up to 1 in 10 people.

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

•    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).

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

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

Ref: 1119/230816/1 /B

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.aov.uk/vellowcard.

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 Accuhaler unless your doctor tells you to.

Q How to store Salbutamol Accuhaler EXPIRY DATE

Do not use this medicine after the expiry date shown on the label or carton label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.

STORING YOUR MEDICINE

*    KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

*    Do not store above 30°C. Store in the original packaging.

Q Contents of the pack and other information Your medicine

Each blister contains 200 micrograms of salbutamol sulphate. Also contains lactose

What is in your medicine

Salbutamol Accuhaler is a plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 200 micrograms of the active ingredient salbutamol (as sulphate) and lactose which acts as the ‘carrier’. The blisters protect the powder for inhalation from the effects of the atmosphere. The device has a counter which tells you the number of blisters remaining. It counts down from 60 to 0. To show when the last five blisters have been reached the numbers appear in red. When the counter shows 0 your inhaler is empty and should be disposed of.

Manufacturer and Licence Holder

Salbutamol Accuhaler is manufactured by Glaxo Wellcome Production Zone Industrielle, No 2, 23 Rue Lavoisier, 27000 Evreux, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 ORE.

PL Number:

Accuhaler is registered trademarks of the GlaxoSmithKline Group of Companies.

Leaflet revision date: 23/08/16

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Salbutamol 200 micrograms Accuhaler®

(salbutamol sulphate)

Patient Information 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, 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 medicine is called Salbutamol 200 micrograms Accuhaler, throughout the rest of this leaflet it will be referred to as Salbutamol Accuhaler.

Q What Salbutamol Accuhaler is and what it is used for

Salbutamol Accuhaler 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 Accuhaler 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.

Q What you need to know before you use Salbutamol Accuhaler

Do not use Salbutamol Accuhaler 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.

What is in this leaflet:

Q What Salbutamol Accuhaler is and what it is used for Q What you need to know before you use Salbutamol Accuhaler Q How to use Salbutamol Accuhaler Q Possible side effects Q How to store Salbutamol Accuhaler Q Contents of the pack and other information

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Sulbutamol Accuhaler 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.

Other medicines and Salbutamol Accuhaler

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 heartbeat

•    other medicines for your asthma.

Salbutamol Accuhaler with food and drink

You can use salbutamol Accuhaler 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.

Accuhaler contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Q How to use Salbutamol Accuhaler

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 Accuhaler properly or as prescribed may mean that it will not help your asthma as it should.

•    The Salbutamol Accuhaler device holds blisters containing Salbutamol as a powder

• There is a counter on top of the Salbutamol Accuhaler 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 Salbutamol 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 Salbutamol 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 Salbutamol Accuhaler away from your mouth, breathe out as far as is comfortable.

Do not breathe into your Salbutamol Accuhaler.

Do not breath in again yet.

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

5    To close the Salbutamol 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

Cleaning your inhaler

Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

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.

If you forget to use Salbutamol Accuhaler

•    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 Accuhaler

Do not stop using Salbutamol Accuhaler without talking to your doctor.

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

Q 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.

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 heartbeat is uneven or it gives an extra beat

•    these may affect up to 1 in 10 people.

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

•    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).

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

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

Ref:1119/230816/2/B