Before use:

This inhaler has a different feel and taste to CFC inhalers you may have used before.

If this is a new device or if you have not used it for 2 weeks or more, it must be tested before use by releasing 4 puffs into the air in the following way:

1.    Take the cover off from the mouthpiece, by pulling down on the lip at the back (fig. 1).

2.    Shake the inhaler vigorously. Point the mouthpiece away from you so that the puffs of medicine will go into the air. Hold the inhaler upright and push the lever up so that it stays up (fig. 2).

3.    Then, to release a puff, push the dose release slide on the bottom of the device in the direction indicated by the arrow on it (fig. 3).

4.    To release the next puff you need to return the lever to its down position (fig. 4) and follow steps 2 and 3 again. Steps 2 and 3 should be repeated until a total of 4 puffs have been released. After releasing the fourth puff, return the lever to its down position, to be ready to take a puff of your medicine.

REG0068388

Version 5.4

Approved

^,ved

Page 1 of 3

DO NOT USE THE DOSE RELEASE SLIDE TO TAKE YOUR MEDICINE, THE AUTOHALER DEVICE WILL AUTOMATICALLY RELEASE A DOSE WHEN YOU BEGIN TO BREATHE IN FROM THE MOUTHPIECE

The instructions for taking a puff are given over the page.

How to use your Airomir® Autohaler® device

1.    Take the cover off from the mouthpiece, by pulling down on the lip at the back.

2.    Shake the inhaler vigorously. Hold your Autohaler device upright as shown. Push the lever up so that it stays up. Continue to hold your Autohaler device upright, making sure that your hand is not blocking the air vent (marked by X in fig. 2) at the bottom of the device.

3.    Breathe out as far as is comfortable and then immediately place the mouthpiece in your mouth and close your lips around it.

4.    Breathe in slowly and deeply through the mouthpiece. Do not stop breathing in when you hear the slight click and feel the puff in your mouth as it is important that you carry on breathing in after the puff is released.

5.    Hold your breath for 10 seconds and then breathe out slowly.

6.    The lever must be lowered to the down position immediately after each puff whilst holding the Autohaler device upright. If your doctor has prescribed more than one puff, repeat steps 2-6. After use, replace the cover on the mouthpiece.

Cleaning instructions

For normal hygiene, the mouthpiece of your Autohaler device should be cleaned weekly with a clean, dry tissue or cloth.

CAUTION: Do not push a drying cloth or anything else into any part of the device since it may cause damage to its operating parts. Do not take the device apart.

How to tell when your device is empty

When the device is completely empty you will not feel or hear any propellant being discharged.

Further questions

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

4. Possible side effects

Like all medicines, Airomir Autohaler device can cause side effects, although not everybody gets them.

If, immediately after inhaling a puff, your asthma worsens, do not use Airomir Autohaler device again and contact your doctor straight away.

If the following happens, stop using Airomir Autohaler device and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives, and a fall in blood pressure. You might collapse in very rare circumstances).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Common: may affect up to 1 in 10 people

•    Feeling tense

•    Headache

•    Dizziness

•    Mild tremor (shaking) especially of the hands.

Uncommon: may affect up to 1 in 100 people

•    Muscle pain.

Rare: may affect up to 1 in 1,000 people

•    Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm

•    Sleep disturbances and sensing things that are not real have been reported especially in children

•    Faster heart beat

•    Abnormal heart beat

•    Widening of blood vessels

•    Throat irritation

•    Feeling sick

•    Vomiting

•    A dry, sore mouth

•    Mouth irritation

•    Muscle cramps.

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

•    Difficulty in sleeping

•    Difficulty in breathing or wheezing

•    Irregular heart beat, especially when used with beta-blockers

•    Chest pain

•    Itching skin.

Not known: frequency cannot be estimated from the available data

•    Restriction of blood supply to the heart.

Using Airomir Autohaler may rarely lead to a build up of lactic acid or low potassium levels in your blood. Your doctor may wish you to have regular blood tests to check your blood potassium levels.

Although it is not known exactly how often this happens, some people may experience chest pain (due to heart problems such as angina). Tell your doctor as soon as possible if you develop these symptoms whilst receiving treatment with Airomir, but do not stop taking this medicine unless told to do so.

If any of the side effects continue for more than a few days, get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

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 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.

5.    How to store Airomir Autohaler device

Keep this medicine out of the sight and reach of children.

Store this inhaler below 30°C. Avoid storage in direct sunlight or heat. Protect from frost.

The metal canister is pressurised. Do not attempt to puncture it or burn it, even when empty.

Do not use Airomir Autohaler device after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

Airomir Autohaler device does not contain CFC’s; instead, the inhaler contains a hydrofluoroalkane (HFA-134a) as an inactive ingredient. Chlorofluorocarbons (CFC’s) have been shown to damage the ozone layer in the atmosphere. HFA’s have been developed as a replacement for CFC’s because they do not damage the ozone layer.

What Airomir Autohaler device contains:

•    The active ingredient is salbutamol.

Each puff contains salbutamol sulfate equivalent to salbutamol 100 micrograms.

•    The other ingredients are oleic acid, ethanol, propellant HFA-134a. Propellant HFA-134a is a new propellant which has been developed to replace chlorofluorocarbons (CFCs). This inhaler does not contain CFC propellants.

What Airomir Autohaler device looks like and contents of the pack:

•    The Airomir Autohaler device is a breath actuated pressurised inhalation suspension.

•    The inhaler contains 200 puffs.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG,

United Kingdom.

Airomir Autohaler devices are made by 3M Health Care Limited, Loughborough, Leicestershire LE11 1EP, England.

This leaflet was last revised: January 2016 PL 00289/1411

TQHZD®

87783-E

620613162

Autohaler is a trademark of 3M and used under license

REG0068388

Version 5.4

Appro'

Page 2 of 3

This is a representation of an electronic record that was signed electronically and this

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE