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FORMOTEROL FUMARATE 6 MICROGRAM TURBOHALER

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OXIS® TURBOHALER® 6 MICROGRAMS
(formoterol fumarate dihydrate)
This product is available in the above name and strength but will be
referred to as Oxis Turbohaler throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Oxis Turbohaler is and what it is used for
2. Before you use Oxis Turbohaler
3. How to use Oxis Turbohaler
4. Possible side effects
5. How to store Oxis Turbohaler
6. Further 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.

The excipient lactose contains small amounts of milk proteins, which may
cause allergic reactions.
3. How to use Oxis Turbohaler




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.

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

Adults (18 years and above)
 The usual 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.

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.

Children and adolescents (6 to 17 years)
 The usual 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.

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.

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.

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.
Pregnancy and breast-feeding
 If you are pregnant, or planning to get pregnant, talk to your doctor
before using Oxis Turbohaler - 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 breast-feeding, talk to your doctor before using Oxis
Turbohaler.
Driving and using machines
Oxis Turbohaler is not likely to affect you being able to drive or use any
tools or machines.
Important information about some of the ingredients of Oxis
Turbohaler
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.

Always use Oxis Turbohaler exactly as your doctor, nurse or
pharmacist has told you. Ask one of them for advice 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.

Adults (18 years and above)
 The usual 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 usual 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 usual 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 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.
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. It is not
possible to overload your Turbohaler even if
you turn the grip several times. 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.

5. How to store Oxis Turbohaler
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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store below 30°C. Replace cap properly after use.
Do not use after the expiry date printed on the inhaler label or carton.
If your doctor tells you to stop using your medicine, take any unused
medicine to your pharmacist for safe disposal. Only keep your medicine
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 you notice any signs of deterioration you should return your Oxis
Turbohaler to your pharmacist who will tell you what to do.

6. Further information
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. The other ingredient is lactose
monohydrate (which contains milk proteins).
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 contains 60
doses and has a white body with a turquoise turning grip.
Manufacturer
Oxis Turbohaler 6 is manufactured by AstraZeneca AB, Sodertalje,
Sweden. Procured from within the EU. Product Licence holder: G-Pharma
Limited, Dakota Avenue, Salford. M50 2PU.

8. Replace the cover tightly after use.

PL 16369/0421

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.

Oxis® Turbohaler®

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 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 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.
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.
If any of the side effects get serious or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

POM
29/01/2014

Oxis and Turbohaler are registered trademarks of AstraZeneca AB.

Expand Transcript

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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