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P S04048    I

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxis Turbohaler 6 micrograms per dose Inhalation Powder

(Formoterol fumarate dihydrate)

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.

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

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

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).

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.

3. How to use Oxis 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 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 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 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    ^Mouth

and lift it off. You may hear a    _{I d}

rattling sound.    ⁿ

•    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.