• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or asthma nurse.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

Easyhaler Salbutamol is a “reliever” inhaler. The active ingredient is salbutamol, an asthma medicine, which opens up the airways. Salbutamol has a quick effect and a short duration of action (4 to 6 hours).

Salbutamol is used to relieve symptoms of asthma and other asthma-like conditions such as chest tightness, wheezing and coughing in adults and children aged 4 years and over. It is also used for prevention of asthma symptoms brought on by exercise or a known allergen exposure that cannot be avoided.

• if you are allergic to salbutamol or the other ingredient of this medicine (listed in section 6), which is lactose (which contains small amounts of milk protein)
• if you unexpectedly go into early labour (premature labour) or threatened abortion

Talk to your doctor, nurse or pharmacist before using Easyhaler Salbutamol if you have any of the following:

• any diseases affecting the heart or blood vessels
• any infection in your lungs
• overactivity of the thyroid gland
• low levels of potassium in your blood
• diabetes
• hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, you should not take this medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular it is important to tell your doctor if you are currently taking any of the following medicines:

• medicines for your breathing problems for example theophylline or aminophylline (xanthines)
• corticosteroids
• beta-blockers for your blood pressure e.g. propranolol
• medicines for depression
• water tablets (diuretics) and other medicines for heart problems

If you already use “preventor” medication e.g. inhaled corticosteroid, it is important to continue using it regularly, even if you feel better.

Easyhaler Salbutamol should not be used if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, unless you are advised to do so by your doctor. Ask your doctor or pharmacist for advice before taking this medicine.

Easyhaler Salbutamol will normally not affect your ability to drive or operate machinery (no formal studies have been carried out).

However, if you experience side effects such as dizziness, increased or uneven heart rate, muscle cramps or muscle pain or if you feel a bit shaky, your ability to drive or operate machinery may be affected.

Lactose contains small amounts of milk proteins, which may cause allergic reaction. If you have been told that you do not tolerate certain kinds of sugars, contact your doctor before taking this medicine. The amount of lactose in Easyhaler Salbutamol (less than 10 mg per dose) does not normally cause problems in lactose intolerant people.

If you have taken more puffs than recommended, you should contact your doctor immediately.

You may notice that your heart is beating faster than usual and that you feel shaky. These effects usually wear off in a few hours.

If you forget to take a dose do not worry. Take your next dose when it is due or if you become wheezy. Do not take a double dose to make up for a forgotten dose.

• itching, rash or reddened skin
• swelling of the eye lids, lips, face or throat
• low blood pressure or collapse
• increase in wheezing and shortness of breath immediately after dosing.

Common side effects (may affect up to 1 in 10 people)

• feeling a bit shaky
• increased or uneven heart rate
• increased blood flow to your extremities

Uncommon side effects (may affect up to 1 in 100 people)

• headache.

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

• cough, mouth and throat irritation (these may be prevented by rinsing the mouth with water and spitting it out after inhalation)
• decrease in the level of potassium in your blood
• muscle cramps
• restlessness, dizziness, behavioural difficulties.

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

• angina (chest pain), heart attack (myocardial ischemia).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is salbutamol sulfate
• The other ingredient is lactose (which contains milk protein).

White or almost white inhalation powder.

Easyhaler multidose powder inhaler contains 200 doses (puffs).

Packages:

200 doses in plastic multidose powder inhaler

200 doses in plastic multidose powder inhaler and protective cover

A protective cover is also available separately.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Step 1: SHAKE

• Remove the dustcap
• Shake the inhaler 3 to 5 times holding it in the upright position

SHAKE x 3-5

Important points to remember

• It is important to keep the inhaler in the upright position
• If you accidentally click while you shake the inhaler, empty the powder from the mouthpiece as shown below

Step 2: CLICK

• Keep holding the inhaler upright between your forefinger and thumb
• Press down until you hear a click, and let the inhaler click back again. This releases a dose
• Only click down once

CLICK x 1

Important points to remember

• The inhaler will not click if the dustcap is still on
• Only click down once
• If you accidentally click more than once, empty the powder from the mouthpiece, see below
• Click to release dose before you inhale, not at the same time
• Keep the inhaler upright when you click it and when you inhale the dose. If you tip it, the powder could fall out before you are able to inhale it

Step 3: INHALE

• Keep holding the inhaler upright
• Breathe out normally
• Place the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece
• Take a strong and deep breath in
• Take the inhaler out of your mouth, hold breath for at least 5 seconds, then breathe out normally.

INHALE

Important points to remember

• Make sure the whole mouthpiece is well inside your mouth, so that the medication gets into your lungs
• Make sure your lips make a good seal around the mouthpiece
• Do not breathe out into the inhaler. This is important: it could clog up the inhaler. If you breathed out into the inhaler, empty the powder from mouthpiece, see below

If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.

After you have used the inhaler:

• Put the dust cap back on the mouthpiece. It stops the inhaler going off by accident.

If you click the inhaler by accident, or if you might have clicked it more than once, or if you breathe out into it, empty the mouthpiece.

• Tap the mouthpiece to empty the powder onto a table top, or the palm of your hand.
• Then start again with steps Shake-Click-Inhale.

Keep your inhaler dry and clean. If necessary you may wipe the mouthpiece of your inhaler with a dry cloth or tissue. Do not use water: the powder in the Easyhaler is sensitive to moisture.

You may use a protective cover with your inhaler. This helps to improve durability of the product. When you first insert your inhaler in the protective cover make sure the dustcap is on the inhaler as this stops it going off by accident. You can use the inhaler without removing it from the protective cover.

Follow the same instructions as above, 1. Shake – 2. Click – 3. Inhale.

Remember to:

• Keep the inhaler in the upright position when clicking it
• Replace the dustcap after taking the dose as this stops the inhaler going off by accident.

The dose counter shows the number of remaining doses. The counter turns after every 5th click. When the dose counter starts turning red, there are 20 doses left.

If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the counter reaches 0 (zero), you need to replace the Easyhaler.

If you use the protective cover, you can keep it and insert your new inhaler into it.

• 1. Shake – 2. Click – 3. Inhale.
• Do not get your inhaler wet, protect it from moisture.

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