Ventolin 100 Micrograms Evohaler

Leaflet

VENTOLIN™ 100 MICROGRAMS EVOHALER™

_(salbutamol sulphate)_

Package Leaflet: Information for the User

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.

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

1. WHAT VENTOLIN EVOHALER IS AND WHAT IT IS USED FOR

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.

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.

3. HOW TO USE VENTOLIN EVOHALER

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

Adults and adolescents aged 12 years and over

• 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

• 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

• To help identify that the inhaler is Ventolin, there is an embossed letter V on the plastic case.

• 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.

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

1. 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.

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

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN EVOHALER Do not use Ventolin Evohaler 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.

Using your inhaler

It is important to start to breathe 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.

Warnings and precautions

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.

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.

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. Do not breathe in again yet.

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

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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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.

Q1	During the past 4 weeks, how often did your asthma prevent you from getting as much done at work, school or home?								Score:
Q1	All of the time	1	Most of the time	2	Some of the time	3	A little of the time	4	None of the time	5
Q2	During the past 4 weeks, how often have you had shortness of breath?								Score:
Q2	More than once a day	1	Once a day	2	3-6 times a week	3	1-2 times a week	4	Not at all	5
Q3	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?								Score:
Q3	4 or more times a week	1	2-3 nights a week	2	Once a week	3	Once or twice	4	Not at all	5

Turn over for Questions 4 and 5.

POM

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. 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.

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

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.

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.

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.

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 cover.

• 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.

If you forget to take Ventolin Evohaler

• 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 taking Ventolin Evohaler

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 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 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 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.

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 Evohaler unless your doctor tells you to.

5. HOW TO STORE VENTOLIN EVOHALER

• 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 environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ventolin Evohaler contains

• 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

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

Each container provides 200 actuations.

Manufacturer

Manufactured by:

Glaxo Wellcome Production, Zone Industrielle no. 2, 23 Rue Lavoisier, 27000 Evreux, France. or

GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189, 60-322 Poznan, Poland or

Glaxo Wellcome S.A., Avda de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.

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 .

PL No: 08929/0560

Ventolin™ and Evohaler™ are trademarks of the GlaxoSmithKline Group of Companies.

Leaflet revision date: 24.02.16

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Q4	During the past 4 weeks, how often have you used your reliever inhaler (usually blue)?								Score:
Q4	3 or more times a day	1	1-2 times a day	2	2-3 times a week	3	Once a week or less	4	Not at all	5
Q5	How would you rate your asthma control during the						past 4 weeks?		Score:
Q5	Not controlled	1	Poorly controlled	2	Somewhat controlled	3	Well controlled	4	Completely controlled	5

Total Score

What does your score mean?

Score: 25 - WELL DONE

• Your asthma appears to have been UNDER CONTROL over the last 4 weeks.

• However, if you are experiencing any problems with your asthma, you should see your doctor, nurse or pharmacist.

Score: 20 to 24 - ON TARGET

• Your asthma appears to have been REASONABLY WELL CONTROLLED during 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 TARGET

• Your asthma may NOT HAVE BEEN CONTROLLED during the past

4 weeks.

• Your doctor, nurse or pharmacist can recommend an asthma action plan to help improve your asthma control.

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