Ventolin Evohaler 100 micrograms

• 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.

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

• 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.

Ventolin Evohaler should be used as required rather than regularly.

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, such as breathlessness that makes speaking, eating or sleeping difficult, cough, wheezing, tight chest or limited physical ability), you should tell your doctor right away who 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.

Your inhaler does not have a dose counter. Your inhaler contains enough medicine for 200 puffs only (whether inhaled and/or released into the air for testing) and it contains a propellant gas to deliver the medicine. However, after 200 puffs, your inhaler can continue to spray the gas but without the right dose of salbutamol, so you cannot be sure you will receive any medicine after using 200 puffs. Methods of telling that the inhaler is empty like shaking it, weighing it, or floating it in water, are not reliable. You should consider recording the number of puffs used. You could also consider keeping a back-up inhaler. If you are using more than one inhaler, it is recommended to keep track of the number of puffs used for each inhaler separately.

• If your inhaler fails to give relief for a duration of at least 3 hours, check with your doctor as soon as possible.
• Tell your doctor as soon as possible if your asthma gets worse or if this medicine does not provide as much relief from your asthma as before.

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.

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

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.

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

• to relieve asthma symptoms/ attack - One or two puffs.
• to prevent asthma symptoms/ attack - Two puffs 10-15 minutes before exercise or exposure to a “trigger”.
• for regular treatment (along with regular asthma anti-inflammatory medicine - inhaled corticosteroid) - One or two puffs.

• The maximum dose is 800 micrograms (two puffs up to four times in a 24 hour period).

• to relieve asthma symptoms/ attack - One puff. Two puffs if required.
• to prevent asthma symptoms/ attack - One puff 10-15 minutes before exercise or exposure to a “trigger”. Two puffs if required.
• for regular treatment (along with regular asthma anti-inflammatory medicine - inhaled corticosteroid) - One or two puffs.

• The maximum dose is 800 micrograms (two puffs up to four times in a 24 hour period).

The inhaler does not have a dose counter, you can consider recording the number of puffs you are taking. If you are using more than one inhaler, it is recommended to keep track of the number of doses for each inhaler separately.

• 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 as soon as possible if your medicine does not seem to be working as well as usual (for example you need higher doses to relieve your breathing problems or your inhaler fails to give relief for at least 3 hours) as your chest problem may be getting worse and you may need a different medicine.

If you use Ventolin Evohaler more than twice a week to treat your asthma symptoms, not including preventive use before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can have serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a medicine against inflammation of your lungs daily, e.g., “inhaled corticosteroid”, it is important to continue using it regularly, even if you feel better.

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.

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.

Your leaflet has a picture in this location, showing the inhaler held in one hand and the mouthpiece cover being removed from the inhaler by gently squeezing the sides of the mouthpiece cover with the thumb and forefinger of the other hand.

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.

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.
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.

Your leaflet has a picture in this location, showing the inhaler held in one hand between the thumb and forefinger with an arrow to indicate that the inhaler is being shaken to remove any loose objects and to ensure 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.

Your leaflet has a picture in this location, showing a person preparing to use the inhaler. The person is holding the inhaler in an upright position, with their forefinger on the top of the metal canister and the thumb holding the base of the inhaler, next to its mouthpiece. Arrows pointing away from the persons mouth indicate the person is breathing out.

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

Your leaflet has a picture in this location, showing a person placing the mouthpiece of the inhaler into their mouth between their teeth, with their lips closed around the mouthpiece. The person is holding the inhaler in an upright position, with their forefinger on the top of the metal canister and the thumb holding the base of the inhaler, next to its mouthpiece.

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.

Your leaflet has a picture in this location, showing a person breathing in through their mouth while pressing down on the top of the metal canister. An arrow pointing downward shows the direction the canister is being pressed.

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.

Your leaflet has a picture in this location, showing a person holding their breath after they have inhaled the dose from the inhaler. The person is holding the inhaler in their hand, away from their face.

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, your doctor, nurse or pharmacist will be able to advise you.

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 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 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.

Do not stop taking Ventolin Evohaler without talking to your doctor.

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 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.

• The active substance is salbutamol sulfate.
• The other ingredient is HFA 134a.

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 18 g of HFC 134a (also referred as HFA 134a) corresponding to 0.0257 tonne CO₂ equivalent (global warming potential GWP = 1 430).

Ventolin Evohaler comprises an aluminium alloy can sealed with a metering valve, actuator and dust cap.

Each canister contains 200 doses (whether inhaled and/or released into the air for testing) of 100 micrograms of salbutamol (as salbutamol sulfate).