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OXIS TURBOHALER 12 MICROGRAMS

Active substance(s): EFORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE / FORMOTEROL FUMARATE DIHYDRATE

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Pregnancy and breast-feeding

PACKAGE LEAFLET: INFORMATION FOR THE USER
®



®

Oxis Turbohaler 12 micrograms Inhalation Powder
(formoterol fumarate)



Your medicine is available using the above name but will be referred to as Oxis Turbohaler throughout
this leaflet.

Driving and using machines

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

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.

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.


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.




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.

WHAT OXIS TURBOHALER IS AND WHAT IT IS USED FOR

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.

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).

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 is used to treat asthma in adults, adolescents and children aged 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)

Asthma

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

Adults (18 years and above)






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.

WHAT YOU NEED TO KNOW BEFORE YOU USE OXIS TURBOHALER



Do not use Oxis Turbohaler:


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

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’.

2.

If you are pregnant, or breast-feeding, 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.

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

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)



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.





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.

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

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.

Adults (18 years and above)



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).



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)






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.

Page 1 of 2

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

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.


4.

Mouthpiece

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

Indicator



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 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.

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)

Grip



POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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)

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.

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

2.

Hold your Turbohaler upright with the turquoise 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.

How to take an inhalation

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.







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 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.







6.

Uneven heart beat.
Nausea (feeling sick).
Low level of potassium in your blood.
Allergic reactions such as rash, itching and bronchospasm.

HOW TO STORE OXIS TURBOHALER

Keep out of the sight and reach of children.
Do not store above 30°C.
Keep the cap screwed tightly onto your Turbohaler when you are not using it.
Do not use a damaged Turbohaler.
Do not use Oxis Turbohaler after the expiry date printed on the label. The expiry date refers to the
last day of that month.
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.
If the Turbohaler become discoloured or show signs of deterioration, you should seek the advice of
your pharmacist.
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.

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.

6.

8.

Replace the cover tightly after use.

What Oxis Turbohaler contains



CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is formoterol fumarate dihydrate.

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.

Each dose contains 12 micrograms of formoterol fumarate dihydrate of which you can inhale 9
micrograms.

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

Oxis Turbohaler also contains lactose monohydrate.

Cleaning your Turbohaler

Oxis Turbohaler is a multi dose, inspiratory flow driven, dry powder inhaler, consisting of a dark
turquoise turning grip and a white cover. It has a Braille code on the base. The turbohaler consists of a
mouthpiece, inhaler body and an indicator.

What Oxis Turbohaler looks like and contents of the pack

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 Oxis Turbohaler




The inhalation powder is white in colour.

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, shown in the diagram below in
grey, there are approximately 20 doses left. When the red mark reaches the bottom of the
indicator window, shown in the diagram below in grey, you must start using your new Turbohaler.

Each Oxis Turbohaler contains 60 actuations.

Manufacturer

Manufactured by: AstraZeneca AB, S-151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0550

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.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call: 01302 365000
and ask for the Regulatory Department.
Please be ready to give the following information:
Product name
Oxis Turbohaler 12 microgram Inhalation Powder
Reference number
08929/0550

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




POM

Leaflet revision and issue date: 11.05.15
Oxis® and Turbohaler® are registered trademarks of the AstraZeneca group of companies.

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.
Page 2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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