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OXIS 12 TURBOHALER/ FORMOTEROL FUMARATE DIHYDRATE 12 TURBOHALER

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®
®

OXIS 12microgram TURBOHALER
(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 12microgram Turbohaler
but will be referred to as Oxis Turbohaler or Turbohaler
throughout this 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

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

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.

3. How to use 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.

2. Before you use Oxis Turbohaler

These signs could mean that your asthma or COPD is not
being properly controlled and you may need different or
additional treatment immediately.

Do not use Oxis Turbohaler if:
You are allergic (hypersensitive) to formoterol, or the
other ingredient, lactose (which contains small amounts
of milk proteins).

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

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.

Adults (18 years and above)
The usual 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)
The usual 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.
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.
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.
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.
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.

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.
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
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use a damaged inhaler. Replace cover properly
after use.
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.
If the medicine shows any signs of deterioration, do not
use it and take it to your doctor or pharmacist.
6. Further information
What Oxis Turbohaler contains
The active substance is formoterol fumarate dihydrate. Each
dose contains 12 micrograms of formoterol fumarate
dihydrate of which you can inhale 9 micrograms.
Also contains 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
turbohaler is a multi-dose, dry powder inhaler made of white
plastic body with cap and turquoise turn grip. The base of
the turn grip is marked ‘5’ in Braille for identification of
Formoterol.
Each Turbohaler contains 60 actuations.
Manufactured by: AstraZeneca AB, S-151 85 Södertälje,
Sweden.

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.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Oxis 12 Turbohaler
PL No: 18799/1979

POM

Leaflet date: 24.02.2014
Oxis and Turbohaler are trademarks of the AstraZeneca
group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

FORMOTEROL FUMARATE DIHYDRATE 12microgram TURBOHALER
(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 Formoterol Fumarate
dihydrate 12microgram Turbohaler but will be referred to as
Formoterol Fumarate dihydrate Turbohaler or Turbohaler
throughout this leaflet.
In this leaflet:
1. What Formoterol Fumarate dihydrate Turbohaler is and
what it is used for
2. Before you use Formoterol Fumarate dihydrate
Turbohaler
3. How to use Formoterol Fumarate dihydrate Turbohaler
4. Possible side effects
5. How to store Formoterol Fumarate dihydrate Turbohaler
6. Further information

1. What Formoterol Fumarate dihydrate Turbohaler
is and what it is used for
Formoterol Fumarate dihydrate 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:
Formoterol Fumarate dihydrate Turbohaler and a separate
‘corticosteroid’ inhaler.
These should be used together.
Formoterol Fumarate dihydrate Turbohaler is used to
help prevent asthma symptoms from happening.
Some people also use Formoterol Fumarate dihydrate
Turbohaler when they need extra doses for relief of
asthma symptoms, to make it easier to breathe again.
Formoterol Fumarate dihydrate Turbohaler can also be
used before exercise to prevent asthma symptoms
caused by exercise.
Chronic obstructive pulmonary disease (COPD)
Formoterol Fumarate dihydrate Turbohaler can also be used
to treat the symptoms of COPD in adults. COPD is a longterm disease of the airways in the lungs, which is often
caused by cigarette smoking.

2. Before you use Formoterol Fumarate dihydrate
Turbohaler
Do not use Formoterol Fumarate dihydrate Turbohaler
if:
You are allergic (hypersensitive) to formoterol, or the
other ingredient, lactose (which contains small amounts
of milk proteins).
Take special care with Formoterol Fumarate dihydrate
Turbohaler
Before you use Formoterol Fumarate dihydrate Turbohaler,
tell your doctor or pharmacist if:
You are diabetic. You may need some additional blood
sugar tests while you are using Formoterol Fumarate
dihydrate 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
dihydrate 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 dihydrate
Turbohaler can affect the way some medicines work and
some medicines can have an effect on Formoterol Fumarate
dihydrate 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 dihydrate 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 dihydrate 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 dihydrate
Turbohaler - do not use Formoterol Fumarate dihydrate
Turbohaler unless your doctor tells you to.
If you get pregnant while using Formoterol Fumarate
dihydrate Turbohaler, do not stop using Formoterol
Fumarate dihydrate Turbohaler but talk to your doctor
immediately.
If you are breast-feeding, talk to your doctor before
using Formoterol Fumarate dihydrate Turbohaler.
Driving and using machines
Formoterol Fumarate dihydrate 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 dihydrate Turbohaler
Formoterol Fumarate dihydrate 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 dihydrate
Turbohaler
Always use Formoterol Fumarate dihydrate 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
dihydrate Turbohaler prescribed by your doctor without
talking to your doctor first.
If you are using Formoterol Fumarate dihydrate
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 dihydrate Turbohaler, you should
continue to use Formoterol Fumarate dihydrate 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 dihydrate Turbohaler should not be
used in children under 6 years of age.
Adults (18 years and above)
The usual 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 Formoterol Fumarate dihydrate
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)
The usual dose is 1 inhalation once or twice a day.
Some children also use Formoterol Fumarate dihydrate
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
Formoterol Fumarate dihydrate 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 dihydrate Turbohaler before exercise
as well. Formoterol Fumarate dihydrate 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.
Preparing your new Formoterol Fumarate dihydrate
Turbohaler
Before using your new Formoterol Fumarate dihydrate
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 Formoterol Fumarate dihydrate 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 Formoterol Fumarate dihydrate 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.
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.

If you use more Formoterol Fumarate dihydrate
Turbohaler than you should
If you use more Formoterol Fumarate dihydrate 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 dihydrate
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 dihydrate
Turbohaler
Do not stop using Formoterol Fumarate dihydrate
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, Formoterol Fumarate dehydrate
Turbohaler can cause side effects, although not everybody
gets them.
If the following happens to you, stop using Formoterol
Fumarate dihydrate 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 dihydrate 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. How to store Formoterol Fumarate dihydrate
Turbohaler
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use a damaged inhaler. Replace cover properly
after use.
Do not use Formoterol Fumarate dihydrate 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.
If the medicine shows any signs of deterioration, do not
use it and take it to your doctor or pharmacist.
6. Further information
What Formoterol Fumarate dihydrate Turbohaler
contains
The active substance is formoterol fumarate dihydrate. Each
dose contains 12micrograms of formoterol fumarate
dihydrate of which you can inhale 9micrograms.
Also contains lactose monohydrate (which contains milk
proteins).
What Formoterol Fumarate dihydrate Turbohaler looks
like and contents of the pack
Formoterol Fumarate dihydrate Turbohaler is an inhaler
containing your medicine. The turbohaler is a multi-dose, dry
powder inhaler made of white plastic body with cap and
turquoise turn grip. The base of the turn grip is marked ‘5’ in
Braille for identification of Formoterol.
Each Turbohaler contains 60 actuations.

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.

Manufactured by: AstraZeneca AB, S-151 85 Södertälje,
Sweden.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Formoterol Fumarate dihydrate 12 Turbohaler
PL No: 18799/1979
Leaflet date: 24.02.2014

POM

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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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