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Document: leaflet MAH BRAND_PLPI 15184-1262 change

• leaflet MAH BRAND_PLPI 15184-0620
• leaflet MAH BRAND_PLPI 15184-1262
• leaflet MAH BRAND_PLPI 18799-1978
• leaflet MAH BRAND_PLPI 18799-2604

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Like all medicines, this medicine can cause side

effects, although not everybody gets them.

If the following happens to you, stop using

Oxis Turbohaler and talk to your doctor

immediately:

•    Bronchospasm (tightening of the muscles in the airways which causes sudden wheezing) after inhaling your medicine. This happens very rarely, may affect up to 1 in 10,000 people.

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Oxis Turbohaler.

•    Headache.

Uncommon (may affect up to 1 in 100 people)

•    Feeling restless or agitated.

•    Disturbed sleep.

•    Fast heart beat.

•    Muscle cramps.

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

•    Uneven heart beat.

•    Nausea (feeling sick).

•    Low level of potassium in your blood.

•    Allergic reactions such as rash, itching and bronchospasm.

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

•    Chest pain or tightness in the chest (angina pectoris).

•    An increase in the amount of sugar (glucose) in your blood.

•    Taste changes, such as an unpleasant taste in the mouth.

•    Changes in your blood pressure.

•    Feeling dizzy.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 30°C.

•    When not in use, Keep container/cap tightly closed.

•    Do not use Oxis Turbohaler after the expiry date printed on the carton or on the side of your Turbohaler. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines that no longer required. This will help the enviroment.

What Oxis Turbohaler contains:

The active substance is formoterol fumarate dihydrate. Each dose contains 6 micrograms of formoterol fumarate dihydrate of which you can inhale 4.5 micrograms.

Your medicine also contains the following inactive ingredient: lactose monohydrate.

What Oxis Turbohaler looks like and contents of the pack

Oxis Turbohaler 6 is an inhaler containing your medicine. The inhalation powder is white in colour. Each Turbohaler has a white body and white screw cap, with a light turquoise grip.

Each Oxis Turbohaler contains 60 doses.

Manufacturer and Licence Holder

Your medicine is manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden and are 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 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

PL 15184/1262

Oxis & Turbohaler are registered trademarks of AstraZeneca AB.

Revision date: 21/10/15

Blind or partially sighted?

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

Tel: 01527 505414 for help.

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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Oxis 6 Turbohaler

Inhalation Powder but will be referred to as Oxis

Turbohaler throughout this leaflet.

What is in this leaflet:

1.    What Oxis Turbohaler is and what it is used for

2.    What you need to know before you use Oxis Turbohaler

3.    How to use Oxis Turbohaler

4.    Possible side effects

5.    How to store Oxis Turbohaler

6.    Contents of the pack and other information

Oxis Turbohaler is an inhaler. It contains a medicine called formoterol. This belongs to a group of medicines called ‘long-acting beta-agonists' or ‘bronchodilators'.

It works by relaxing the muscles in your airways. This helps you to breathe more easily. It starts to work within 1 to 3 minutes and the effects last up to 12 hours.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

Oxis Turbohaler is used to treat asthma in adults, adolescents and children 6 years and older. For asthma, your doctor will prescribe two asthma inhalers: Oxis Turbohaler and a separate ‘corticosteroid' inhaler. These should be used together.

•    Oxis Turbohaler is used to help prevent asthma symptoms from happening.

•    Some people also use Oxis Turbohaler when they need extra doses for relief of asthma symptoms, to make it easier to breathe again.

•    Oxis Turbohaler can also be used before exercise to prevent asthma symptoms caused by exercise.

Chronic obstructive pulmonary disease (COPD)

Oxis Turbohaler can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXIS TURBOHALER

Do not use Oxis Turbohaler:

•    If you are allergic (hypersensitive) to formoterol, or any of the other ingredients of this medicine (listed in section 6).

Ref: 1262/211015/1/F

Warnings and Precautions

Talk to your doctor or pharmacist before using Oxis Turbohaler if:

•    You are diabetic. You may need some additional blood sugar tests while you are using Oxis Turbohaler.

•    You have high blood pressure or you have ever had a heart problem.

•    You have problems with your thyroid gland.

•    You have low levels of potassium in your blood. Your doctor may take blood samples to check the levels of potassium in your blood.

•    You have severe liver problems such as liver cirrhosis.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Oxis Turbohaler.

Other medicines and Oxis Turbohaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Oxis Turbohaler can affect the way some medicines work and some medicines can have an effect on Oxis Turbohaler.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).

•    Medicines for a fast or uneven heart beat (such as quinidine).

•    Medicines like digoxin, often used to treat heart failure.

•    Diuretics, also known as ‘water tablets' (such as furosemide). These are used to treat high blood pressure.

•    Steroid medicines that you take by mouth (such as prednisolone).

•    Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.

•    Erythromycin (used to treat infections).

•    Anti-histamines (such as terfenadine).

•    Other substances that dilate the airways (bronchodilators, such as salbutamol).

•    Ephedrine (used to treat asthma or as a decongestant).

•    Tricyclic anti-depressants (such as amitriptyline). If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Oxis Turbohaler.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment with Oxis Turbohaler, can help to open your airways even more.

Pregnancy and breast-feeding

•    If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine - do not use Oxis Turbohaler unless your doctor tells you to.

•    If you get pregnant while using Oxis Turbohaler, do not stop using Oxis Turbohaler but talk to your doctor immediately.

Driving and using machines

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

Oxis Turbohaler contains lactose

Oxis Turbohaler contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

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

•    Do not increase the dose of Oxis Turbohaler prescribed by your doctor without talking to your doctor first.

•    If you are using Oxis Turbohaler regularly for asthma or COPD you should continue to use your medicine, even if you have no symptoms.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Oxis Turbohaler, you should continue to use Oxis Turbohaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

•    Your breathing is getting worse or you often wake up at night with asthma.

•    You start getting chest tightness.

•    You are not getting relief from your current dose.

•    You need to take more than your usual dose for more than two days in a week.

•    You need to use your Turbohaler more often than usual before exercise.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Asthma

Oxis Turbohaler should not be used in children under 6 years of age.

Adults (18 years and above)

•    The recommended dose is 1 or 2 inhalations, once or twice a day.

•    Your doctor may increase this to 4 inhalations, once or twice a day.

•    Some people also use Oxis Turbohaler as a ‘reliever inhaler'. If you get asthma symptoms, the usual dose is 1 or 2 inhalations when they happen.

•    A total daily dose of more than 8 inhalations is not normally needed. This includes the inhalations that you take every day, when you get asthma symptoms and before exercise. However, your doctor may allow you to

take up to 12 inhalations a day. Do not use more than 12 inhalations in total in 24 hours.

•    Do not take more than 6 inhalations at any one time.

Children and adolescents (6 to 17 years)

•    The recommended dose is 2 inhalations, once or twice a day.

•    Some children also use Oxis Turbohaler as a ‘reliever inhaler'. If your child gets asthma symptoms, the usual dose is 1 or 2 inhalations when they happen.

•    A total daily dose of more than 4 inhalations is not normally needed. This includes the inhalations that your child takes every day, when they get asthma symptoms and before exercise. However, your doctor may allow your child to take up to 8 inhalations a day. Your child should not use more than 8 inhalations in total in 24 hours.

•    Your child should not have more than 2 inhalations at any one time.

Your doctor (or asthma nurse) will help you to manage your asthma. Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Oxis Turbohaler.

Asthma caused by exercise

If you or your child have asthma symptoms caused by exercise, your doctor may advise you or your child to use Oxis Turbohaler before exercise as well. Oxis Turbohaler should not be used in children under 6 years of age.

Adults (18 years and above)

•    The recommended dose is 2 inhalations before exercise.

•    A total daily dose of more than 8 inhalations is not normally needed. This includes the inhalations that you take every day, when you get asthma symptoms and before exercise. However, your doctor may allow you to

take up to 12 inhalations a day. Do not use more than 12 inhalations in total in 24 hours.

•    Do not take more than 6 inhalations at any one time.

Children and adolescents (6 to 17 years)

•    The recommended dose is 1 or 2 inhalations before exercise.

•    A total daily dose of more than 4 inhalations is not normally needed. This includes the inhalations that your child takes every day, when they get asthma symptoms and before exercise. However, your doctor may allow your child to take up to 8 inhalations a day. Your child should not use more than 8 inhalations in total in 24 hours.

•    Your child should not have more than 2 inhalations at any one time.

Chronic obstructive pulmonary disease

(COPD)

•    Only to be used by adults (aged 18 years and above).

•    The recommended dose is 1 inhalation once or twice a day.

•    Your doctor may advise you to take extra doses for relief of your COPD symptoms.

•    You should not have more than 4 inhalations a day.

•    Do not take more than 2 inhalations at any one time.

Preparing your new Oxis Turbohaler Inhaler

Before using your new Oxis Turbohaler for the first

time, you need to prepare it for use as follows.

•    Unscrew the white cover and lift it off.

You may hear a rattling sound.

•    Hold your Oxis Turbohaler upright with the turquoise grip at the bottom.

•    Turn the turquoise grip as far as it will go in one direction.

Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound.

•    Do this again, turning the turquoise grip in both directions.

•    Your Oxis Turbohaler is now ready for use.

How to take an inhalation

Every time you need to take an inhalation,

follow the instructions below.

1.    Unscrew the white cover and lift it off. You may hear a rattling sound.

2.    Hold your Turbohaler upright with the turquiose grip at the bottom.

3 Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, turn the turquoise grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. Your Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.

4.    Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Turbohaler.

5.    Place the mouthpiece gently between your teeth. Close your lips.

Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

6.    Remove your Turbohaler from your mouth. Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.

7.    If you are to take a second inhalation, repeat steps 2 to 6.

8.    Replace the cover tightly after use.

Do not try to remove or twist the mouthpiece. It is fixed to your Turbohaler and must not be taken off. Do not use your Turbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.

As with all inhalers, caregivers should ensure that children prescribed Oxis Turbohaler use correct inhalation technique, as described above.

Cleaning your Turbohaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new Turbohaler

•    The Turbohaler contains 60 doses (inhalations). The dose indicator tells you how many doses are left in theTurbohaler.

•    When you first see a red mark at the edge of the indicator window, there are approximately 20 doses left. When the red mark reaches the bottom of the indicator window, you must start using your new Turbohaler.

Note:

•    The grip will still twist and ‘click' even when your Turbohaler is empty.

•    The sound that you hear as you shake your Turbohaler is produced by a drying agent and not the medicine. Therefore the sound does not tell you how much medicine is left in your Turbohaler.

•    If you load your Oxis Turbohaler more than once by mistake before taking your dose, you will still only receive one dose. However, the dose indicator will register all the loaded doses.

If you use more Oxis Turbohaler than you should

If you use more Oxis Turbohaler than you should, contact your doctor or pharmacist for advice immediately. The following effects may happen: trembling, headache or a rapid heart beat.

If you forget to use Oxis Turbohaler

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

•    Do not take a double dose to make up for a forgotten dose.

If you stop using Oxis Turbohaler

Do not stop using Oxis Turbohaler without talking to your doctor.

If you have any further questions on using your Turbohaler, ask your doctor, nurse or pharmacist.

If you stop using Formoterol Fumarate Dihydrate Turbohaler

Do not stop using Formoterol Fumarate Dihydrate Turbohaler without talking to your doctor.

If you have any further questions on using your Turbohaler, ask your doctor, nurse or pharmacist.

Like all medicines, Formoterol Fumarate Dihydrate Turbohaler can cause side effects, although not everybody gets them.

If the following happens to you, stop using Fumarate Dihydrate Turbohaler and talk to your doctor immediately:

•    Bronchospasm (tightening of the muscles in the airways which causes sudden wheezing) after inhaling your medicine. This happens very rarely, may affect up to 1 in 10,000 people.

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Oxis Turbohaler.

•    Headache.

Uncommon (may affect up to 1 in 100 people)

•    Feeling restless or agitated.

•    Disturbed sleep.

•    Fast heart beat.

•    Muscle cramps.

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

•    Uneven heart beat.

•    Nausea (feeling sick).

•    Low level of potassium in your blood.

•    Allergic reactions such as rash, itching and bronchospasm.

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

•    Chest pain or tightness in the chest (angina pectoris).

•    An increase in the amount of sugar (glucose) in your blood.

•    Taste changes, such as an unpleasant taste in the mouth.

•    Changes in your blood pressure.

•    Feeling dizzy.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE FORMOTEROL FUMARATE DIHYDRATE TURBOHALER

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 30°C.

•    When not in use, Keep container/cap tightly closed.

•    Do not use Formoterol Fumarate Dihydrate Turbohaler after the expiry date printed on the carton or on the side of your Turbohaler. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines that no longer required. This will help the enviroment.

What Formoterol Fumarate Dihydrate Turbohaler contains:

The active substance is formoterol fumarate dihydrate. Each dose contains 6 micrograms of formoterol fumarate dihydrate of which you can inhale 4.5 micrograms.

Your medicine also contains the following inactive ingredient: lactose monohydrate.

What Formoterol Fumarate Dihydrate Turbohaler looks like and contents of the pack

Formoterol Fumarate Dihydrate Turbohaler 6 is an inhaler containing your medicine. The inhalation powder is white in colour. Each Turbohaler has a white body and white screw cap, with a light turquoise grip.

Each Formoterol Fumarate Dihydrate Turbohaler contains 60 doses.

Manufacturer and Licence Holder

Your medicine is manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden and are 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 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

PL 15184/1262

Revision date: 21/10/15

Blind or partially sighted?

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

Tel: 01527 505414 for help.

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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Formoterol Fumarate Dihydrate 6mcg Turbohaler Inhalation Powder but will be referred to as Formoterol Fumarate Dihydrate Turbohaler throughout this leaflet.

What is in this leaflet:

1.    What Formoterol Fumarate Dihydrate Turbohaler is and what it is used for

2.    What you need to know before you use Oxis Turbohaler

3.    How to use Formoterol Fumarate Dihydrate Turbohaler

4.    Possible side effects

5.    How to store Formoterol Fumarate Dihydrate Turbohaler

6.    Contents of the pack and other information

Formoterol Fumarate Dihydrate Turbohaler is an inhaler. It contains a medicine called formoterol. This belongs to a group of medicines called ‘long-acting beta-agonists' or ‘bronchodilators'.

It works by relaxing the muscles in your airways. This helps you to breathe more easily. It starts to work within 1 to 3 minutes and the effects last up to 12 hours.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

Formoterol Fumarate Dihydrate Turbohaler is used to treat asthma in adults, adolescents and children 6 years and older. For asthma, your doctor will prescribe two asthma inhalers: Formoterol Fumarate Dihydrate Turbohaler and a separate ‘corticosteroid' inhaler. These should be used together.

•    Formoterol Fumarate Dihydrate Turbohaler is used to help prevent asthma symptoms from happening.

•    Some people also use Formoterol Fumarate Dihydrate Turbohaler when they need extra doses for relief of asthma symptoms, to make it easier to breathe again.

•    Formoterol Fumarate Dihydrate Turbohaler can also be used before exercise to prevent asthma symptoms caused by exercise.

Ref: 1262/211015/2/F

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FORMOTEROL FUMARATE DIHYDRATE TURBOHALER

Do not use Formoterol Fumarate Dihydrate Turbohaler:

•    If you are allergic (hypersensitive) to formoterol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before using Formoterol Fumarate Dihydrate Turbohaler if:

•    You are diabetic. You may need some additional blood sugar tests while you are using Formoterol Fumarate Dihydrate Turbohaler.

•    You have high blood pressure or you have ever had a heart problem.

•    You have problems with your thyroid gland.

•    You have low levels of potassium in your blood. Your doctor may take blood samples to check the levels of potassium in your blood.

•    You have severe liver problems such as liver cirrhosis.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Formoterol Fumarate Dihydrate Turbohaler.

Other medicines and Formoterol Fumarate Dihydrate Turbohaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Formoterol Fumarate Dihydrate Turbohaler can affect the way some medicines work and some medicines can have an effect on Formoterol Fumarate Dihydrate Turbohaler.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).

•    Medicines for a fast or uneven heart beat (such as quinidine).

•    Medicines like digoxin, often used to treat heart failure.

•    Diuretics, also known as ‘water tablets' (such as furosemide). These are used to treat high blood pressure.

•    Steroid medicines that you take by mouth (such as prednisolone).

•    Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.

•    Erythromycin (used to treat infections).

•    Anti-histamines (such as terfenadine).

•    Other substances that dilate the airways (bronchodilators, such as salbutamol).

•    Ephedrine (used to treat asthma or as a decongestant).

•    Tricyclic anti-depressants (such as amitriptyline). If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Formoterol Fumarate Dihydrate Turbohaler.

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment with Formoterol Fumarate Dihydrate Turbohaler, can help to open your airways even more.

Pregnancy and breast-feeding

•    If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine - do not use Formoterol Fumarate Dihydrate Turbohaler unless your doctor tells you to.

•    If you get pregnant while using Formoterol Fumarate Dihydrate Turbohaler, do not stop using Formoterol Fumarate Dihydrate Turbohaler but talk to your doctor immediately.

Driving and using machines

Formoterol Fumarate Dihydrate Turbohaler is not likely to affect you being able to drive or use any tools or machines.

Formoterol Fumarate Dihydrate Turbohaler contains lactose

Formoterol Fumarate Dihydrate Turbohaler contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. HOW TO USE FORMOTEROL FUMARATE DIHYDRATE TURBOHALER

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

•    Do not increase the dose of Formoterol Fumarate Dihydrate Turbohaler prescribed by your doctor without talking to your doctor first.

•    If you are using Formoterol Fumarate Dihydrate Turbohaler regularly for asthma or COPD you should continue to use your medicine, even if you have no symptoms.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Formoterol Fumarate Dihydrate Turbohaler, you should continue to use Formoterol Fumarate Dihydrate Turbohaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

•    Your breathing is getting worse or you often wake up at night with asthma.

•    You start getting chest tightness.

•    You are not getting relief from your current dose.

•    You need to take more than your usual dose for more than two days in a week.

•    You need to use your Turbohaler more often than usual before exercise.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Asthma

Formoterol Fumarate Dihydrate Turbohaler should not be used in children under 6 years of age.

Adults (18 years and above)

•    The recommended dose is 1 inhalation, once or twice a day.

•    Your doctor may increase this to 2 inhalations, once or twice a day.

•    Some people also use Oxis Turbohaler as a ‘reliever inhaler'. If you get asthma symptoms, the usual dose is 1 inhalation when they happen.

•    A total daily dose of more than 4 inhalations is not normally needed. This includes the inhalations that you take every day, when you get asthma symptoms and before exercise. However, your doctor may allow you to take up to 6 inhalations a day. Do not use more than

6 inhalations in total in 24 hours.

•    Do not take more than 3 inhalations at any one time.

Children and adolescents (6 to 17 years)

•    The recommended dose is 1 inhalation once or twice a day.

•    Some children also use Oxis Turbohaler as a ‘reliever inhaler'. If your child gets asthma symptoms, the usual dose is 1 inhalation when they happen.

•    A total daily dose of more than 2 inhalations is not normally needed. This includes the inhalations that your child takes every day, when they get asthma symptoms and before exercise. However, your doctor may allow

your child to take up to 4 inhalations a day. Your child should not use more than 4 inhalations in total in 24 hours.

•    Your child should not have more than 1 inhalation at any one time.

Your doctor (or asthma nurse) will help you to manage your asthma. Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Oxis Turbohaler.

Asthma caused by exercise

If you or your child have asthma symptoms caused by exercise, your doctor may advise you or your child to use Oxis Turbohaler before exercise as well. Oxis Turbohaler should not be used in children under 6 years of age.

Adults (18 years and above)

•    The recommended dose is 1 inhalation before exercise.

•    A total daily dose of more than 4 inhalations is not normally needed. This includes the inhalations that you take every day, when you get asthma symptoms and before exercise. However, your doctor may allow you to take up to 6 inhalations a day. Do not use more than

6 inhalations in total in 24 hours.

•    Do not take more than 3 inhalations at any one time.

Children and adolescents (6 to 17 years)

•    The recommended dose is 1 inhalation before exercise.

•    A total daily dose of more than 2 inhalations is not normally needed. This includes the inhalations that your child takes every day, when they get asthma symptoms and before exercise. However, your doctor may allow

your child to take up to 4 inhalations a day. Your child should not use more than 4 inhalations in total in 24 hours.

•    Your child should not have more than 1 inhalation at any one time.

Chronic obstructive pulmonary disease (COPD)

•    Only to be used by adults (aged 18 years and above)

•    The recommended dose is 2 inhalations once or twice a day.

•    Your doctor may advise you to take extra doses for relief of your COPD symptoms

•    You should not have more than 8 inhalations a day.

•    Do not take more than 4 inhalations at any one time.

Preparing your new Formoterol Fumarate Dihydrate Turbohaler Inhaler Before using your new Formoterol Fumarate Turbohaler for the first time, you need to prepare it for use as follows.

•    Unscrew the white cover and lift it off.

You may hear a rattling sound.

•    Hold your Oxis Turbohaler upright with the turquoise grip at the bottom.

•    Turn the turquoise grip as far as it will go in one direction.

Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound.

•    Do this again, turning the turquoise grip in both directions.

•    Your Oxis Turbohaler is now ready for use.

How to take an inhalation

Every time you need to take an inhalation,

follow the instructions below.

1.    Unscrew the white cover and lift it off. You may hear a rattling sound.

2.    Hold your Turbohaler upright with the light turquiose grip at the bottom.

3.    Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, turn the turquoise grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. Your Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.

4.    Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Turbohaler.

5. Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

Ref: 1262/211015/2/B

6.    Remove your Turbohaler from your mouth. Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.

7.    If you are to take a second inhalation, repeat steps 2 to 6.

8.    Replace the cover tightly after use.

Do not try to remove or twist the mouthpiece. It is fixed to your Turbohaler and must not be taken off. Do not use your Turbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.

As with all inhalers, caregivers should ensure that children

prescribed Formoterol Fumarate Dihydrate Turbohaler use correct inhalation technique, as described above.

Cleaning your Turbohaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new Turbohaler

•    The Turbohaler contains 60 doses (inhalations). The dose indicator tells you how many doses are left in theTurbohaler.

•    When you first see a red mark at the edge of the indicator window, there are approximately 20 doses left. When the red mark reaches the bottom of the indicator window, you must start using your new Turbohaler.

Note:

•    The grip will still twist and ‘click' even when your Turbohaler is empty.

•    The sound that you hear as you shake your Turbohaler is produced by a drying agent and not the medicine. Therefore the sound does not tell you how much medicine is left in your Turbohaler.

•    If you load your Oxis Turbohaler more than once by mistake before taking your dose, you will still only receive one dose. However, the dose indicator will register all the loaded doses.

If you use more Formoterol Fumarate Dihydrate Turbohaler than you should

If you use more Formoterol Fumarate Dihydrate Turbohaler than you should, contact your doctor or pharmacist for advice immediately. The following effects may happen: trembling, headache or a rapid heart beat.

If you forget to use Formoterol Fumarate Dihydrate Turbohaler

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

•    Do not take a double dose to make up for a forgotten dose.