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FORMOTEROL FUMARATE TURBOHALER 6 MICROGRAMS INHALATION POWDER

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxis® Turbohaler® 6 micrograms Inhalation Powder
(formoterol fumarate dihydrate)
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.
The name of your medicine is Oxis® Turbohaler® 6 micrograms
Inhalation Powder, but it will be referred as Oxis Turbohaler
throughout the leaflet.
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.




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

3. How to use Oxis 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.

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.




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.

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.

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.
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.

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.
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.
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 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)






4. Possible side effects

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.

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.

Preparing your new Oxis Turbohaler Inhaler
Before using your new
Mouthpiece
Oxis Turbohaler for the first time, you
need to prepare it for use as follows.
Indicator
 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.



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



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.

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.



Other possible side effects:

Your Oxis Turbohaler is now ready for use.

Grip

Uncommon (affects less than 1 in 100 people)
 Feeling restless or agitated.
 Disturbed sleep.
 Fast heart beat.
 Muscle cramps.

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.

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.
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

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.

5. How to store Oxis Turbohaler






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.
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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not use a damaged inhaler. Replace the cover properly after
use.
Keep the container 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 wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are
no longer required. This will help to protect the environment.
4. ther information
6. Further Information

What Oxis Turbohaler contains
Each dose contains 6 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk
proteins).
What Oxis Turbohaler looks like and contents of the pack
Oxis Turbohaler 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.
Manufactured by: AstraZeneca AB, 000S-151 85 Sodertalje,
Sweden.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading
Estate, SL1 4NL.
Oxis® Turbohaler® 6 micrograms Inhalation Powder
PL: - 39352/0091

POM

Oxis® and Turbohaler® are registered trademarks of the AstraZeneca
group of companies.
Leaflet date: 05.11.2013
RED
RED
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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Formoterol fumarate Turbohaler® 6 micrograms Inhalation Powder
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.
The name of your medicine is Formoterol Fumarate Turbohaler®
6 micrograms Inhalation Powder, but it will be referred as Formoterol
fumarate Turbohaler throughout the leaflet.
In this leaflet:
1. What Formoterol fumarate Turbohaler is and what it is used for
2. Before you use Formoterol fumarate Turbohaler
3. How to use Formoterol fumarate Turbohaler
4. Possible side effects
5. How to store Formoterol fumarate Turbohaler
6. Further information
1.

1. What Formoterol fumarate Turbohaler is and what
it is used for

What Formoterol fumarate Turbohaler is and what it is used f

Formoterol fumarate Turbohaler is an inhaler. It contains a medicine
called Formoterol fumarate. 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:
Formoterol fumarate Turbohaler and a separate ‘corticosteroid’
inhaler.
These should be used together.
 Formoterol fumarate Turbohaler is used to help prevent asthma
symptoms from happening.
 Some people also use Formoterol fumarate Turbohaler when
they need extra doses for relief of asthma symptoms, to make it
easier to breathe again.
 Formoterol fumarate Turbohaler can also be used before exercise
to prevent asthma symptoms caused by exercise.
Chronic obstructive pulmonary disease (COPD)
Formoterol fumarate 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
.B

2. Before you use Formoterol fumarate
Turbohaler
Do not use Formoterol fumarate Turbohaler if:
 You are allergic (hypersensitive) to Formoterol fumarate, or the
other ingredient, lactose (which contains small amounts of milk
proteins).
Take special care with Formoterol fumarate Turbohaler
Before you use Formoterol fumarate Turbohaler, tell your doctor or
pharmacist if:
 You are diabetic. You may need some additional blood sugar
tests while you are using Formoterol fumarate 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 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
Formoterol fumarate Turbohaler can affect the way some medicines
work and some medicines can have an effect on Formoterol fumarate
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 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 Formoterol fumarate 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 Formoterol fumarate Turbohaler - do not use
Formoterol fumarate Turbohaler unless your doctor tells you to.
 If you get pregnant while using Formoterol fumarate Turbohaler,
do not stop using Formoterol fumarate Turbohaler but talk to your
doctor immediately.
 If you are breast-feeding, talk to your doctor before using
Formoterol fumarate Turbohaler.
Driving and using machines
Formoterol fumarate 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
Formoterol fumarate Turbohaler
Formoterol fumarate 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 Turbohaler




Always use Formoterol fumarate 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 Formoterol fumarate Turbohaler
prescribed by your doctor without talking to your doctor first.
If you are using Formoterol fumarate 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 Turbohaler, you should continue to use
Formoterol fumarate 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 Turbohaler should not be used in children under
6 years of age.
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 Formoterol fumarate 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 usual dose is 2 inhalations, once or twice a day.
 Some children also use Formoterol fumarate 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 Formoterol fumarate
Turbohaler before exercise as well. Formoterol fumarate Turbohaler
should not be used in children under 6 years of age.
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.

4. Possible side effects

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
Mouthpiece
Oxis Turbohaler for the first time, you
need to prepare it for use as follows.
Indicator
 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.

Grip

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.
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.
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.

Like all medicines, Formoterol fumarate Turbohaler can cause side
effects, although not everybody gets them.
If the following happens to you, stop using Formoterol fumarate
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 Formoterol fumarate
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.
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

e O Tu
5. How to store Formoterol Turbohaler







KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not use a damaged inhaler. Replace the cover properly after
use.
Keep the container tightly closed.
Do not use Formoterol fumarate 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 wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are
no longer required. This will help to protect the environment.

6. Further Information
What Formoterol fumarate Turbohaler contains
Each dose contains 6 micrograms of Formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk
proteins).
What Formoterol fumarate Turbohaler looks like and contents of
the pack
Formoterol fumarate Turbohaler 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.
Manufactured by: AstraZeneca AB, 000S-151 85 Sodertalje,
Sweden.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading
Estate, SL1 4NL.
Formoterol fumarate Turbohaler® 6 micrograms Inhalation
Powder
PL 39352/0091
POM
Turbohaler® is a registered trademark of the AstraZeneca group of
companies.

RED
RED
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 Formoterol fumarate Turbohaler than you
should
If you use more Formoterol fumarate 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 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 Formoterol fumarate Turbohaler
Do not stop using Formoterol fumarate Turbohaler without talking to
your doctor.
If you have any further questions on using your Turbohaler, ask your
doctor, nurse or pharmacist.

Leaflet date: 05.11.2013

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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