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UK PIL DATED MAY 2013 REPORTING OF SIDE EFFECTS

4. Possible side effects

Like all medicines, Oxis Turbohaler 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, affecting less than 1 in 10,000 people.

Other possible side effects:

Common (affects less than 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 (affects less than 1 in 100 people)

•    Feeling restless or agitated.

•    Disturbed sleep.

•    Fast heart beat.

•    Muscle cramps.

Rare (affects less than 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 (affects less than 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, 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.

5. How to store Oxis Turbohaler

Do not store your Turbohaler above 30°C. Replace the cover of your Turbohaler properly after use.

Do not use after the expiry date printed on the turbohaler or carton label.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use a damaged Turbohaler.

If your doctor tells you to stop using the Turbohaler, please take it back to the pharmacist for safe disposal. Only keep the Turbohaler if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.

If the Turbohaler fails to work properly or shows visible signs of deterioration, you should seek the advice of your pharmacist before using it.

6. Further information

The active substance is formoterol fumarate, dihydrate. Each dose contains 12 micrograms of formoterol fumarate dihydrate of which you can inhale 9 micrograms.

Oxis 12 Turbohaler is a metered dose dry powder inhaler with a dark-greenish blue turning grip and white cover. On the bottom of the turning grip, Braille '5' is embossed.

The contents are white to off white rounded granules.

Oxis Turbohaler also contains lactose monohydrate (which contains milk proteins).

Oxis Turbohaler contains 60 actuations or puffs.

PL No: 6464/1899 Oxis 12 Turbohaler

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

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. Before you use Oxis Turbohaler

Do not use Oxis Turbohaler if:

•    You are allergic (hypersensitive) to formoterol, or the other ingredient, lactose (which contains small amounts of milk proteins).

Take special care with Oxis Turbohaler

Before you use Oxis Turbohaler, tell your doctor or pharmacist 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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.

WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 usual 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 usual 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 usual 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.

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When to start using a new Turbohaler

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

•    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 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 ora 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. 672-4181E

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WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.