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FORMOTEROL FUMARATE DIHYDRATE 12 MICROGRAMS DRY POWDER INHALER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®
®

Oxis 12 Turbohaler

(formoterol fumarate dihydrate)
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.
The name of your medicine is Oxis® 12 Turbohaler® but
will be referred to as Oxis Turbohaler or Turbohaler
throughout this leaflet.
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. 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
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)
Oxis Turbohaler can also be used to treat the symptoms
of COPD in adults. COPD is a long-term disease of the
airways in the lungs, which is often caused by cigarette
smoking.

2. What you need to know before you use Oxis
Turbohaler
Do not use Oxis Turbohaler:
If you are allergic (hypersensitive) to formoterol, or
any of the other ingredients of this medicine (listed
in section 6).
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.
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before using Oxis
Turbohaler.
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.
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 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.
Driving and using machines
Oxis Turbohaler is not likely to affect you being able to
drive or use any tools or machines.
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. 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
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.
Adults (18 years and above)
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)
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.
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 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)
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.
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.
1.

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. You may
hear a rattling sound.
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.
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.
As with all inhalers, caregivers should ensure that
children prescribed Oxis Turbohaler use correct
inhalation technique, as described above.
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 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.

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, this medicine 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,
may affect up to 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 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 (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)
Uneven heart beat.
Nausea (feeling sick).
Low level of potassium in your blood.
Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
Chest pain or tightness in the chest (angina
pectoris).
An increase in the amount of sugar (glucose) in your
blood.
Taste changes, such as an unpleasant taste in the
mouth.
Changes in your blood pressure.
Feeling dizzy.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Oxis Turbohaler
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
which is stated on the carton label or on the side of
your Turbohaler after ‘Exp’. The expiry date refers to
the last day of that month.
Always be sure to dispose of your used Turbohaler
responsibly, since some of the medicine will remain
inside it. 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. Contents of the pack and other 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 POM
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.
Oxis® 12 Turbohaler® PL No: 18799/1979
Leaflet date: 24.08.2015
Oxis and Turbohaler are trade marks of the
AstraZeneca group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Formoterol fumarate dihydrate 12micrograms dry powder inhaler
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.
The name of your medicine is Formoterol fumarate
dihydrate 12micrograms dry powder inhaler but will be
referred to Formoterol fumarate dihydrate inhaler or inhaler
throughout this leaflet.
What is in this leaflet:
1. What Formoterol fumarate dihydrate inhaler is and what
it is used for
2. What you need to know before you use Formoterol
fumarate dihydrate inhaler
3. How to use Formoterol fumarate dihydrate inhaler
4. Possible side effects
5. How to store Formoterol fumarate dihydrate inhaler
6. Contents of the pack and other information

1. What Formoterol fumarate dihydrate inhaler is
and what it is used for
Formoterol fumarate dihydrate inhaler 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
Formoterol fumarate dihydrate inhaler is used to treat
asthma in adults, adolescents and children aged 6 years
and older. For asthma, your doctor will prescribe two
asthma inhalers: Formoterol fumarate dihydrate inhaler and
a separate ‘corticosteroid’ inhaler.
These should be used together.
Formoterol fumarate dihydrate inhaler is used to help
prevent asthma symptoms from happening.
Some people also use Formoterol fumarate dihydrate
inhaler when they need extra doses for relief of asthma
symptoms, to make it easier to breathe again.
Formoterol fumarate dihydrate inhaler can also be used
before exercise to prevent asthma symptoms caused by
exercise.
Chronic obstructive pulmonary disease (COPD)
Formoterol fumarate dihydrate inhaler 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. What you need to know before you use
Formoterol fumarate dihydrate inhaler
Do not use Formoterol fumarate dihydrate inhaler:
If you are allergic (hypersensitive) to formoterol or any
of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using
Formoterol fumarate dihydrate inhaler if:
You are diabetic. You may need some additional blood
sugar tests while you are using Formoterol fumarate
dihydrate inhaler.
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 inhaler .
Other medicines and Formoterol fumarate dihydrate
inhaler
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 Formoterol fumarate
dihydrate inhaler can affect the way some medicines work
and some medicines can have an effect on Formoterol
fumarate dihydrate inhaler.
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 inhaler.
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 inhaler, can help to open your airways
even more.
Pregnancy and breast-feeding
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 Formoterol fumarate dihydrate inhaler unless your
doctor tells you to.
If you get pregnant while using Formoterol fumarate
dihydrate inhaler, do not stop using Formoterol
fumarate dihydrate inhaler but talk to your doctor
immediately.
Driving and using machines
Formoterol fumarate dihydrate inhaler is not likely to affect
you being able to drive or use any tools or machines.
Formoterol fumarate dihydrate inhaler contains lactose
Formoterol fumarate dihydrate inhaler 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
inhaler
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 Formoterol fumarate
dihydrate inhaler prescribed by your doctor without
talking to your doctor first.
If you are using Formoterol fumarate dihydrate inhaler
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 inhaler, you should continue
to use Formoterol fumarate dihydrate inhaler 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 inhaler 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 inhaler should not be used in
children under 6 years of age.
Adults (18 years and above)
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 Formoterol fumarate dihydrate
inhaler 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 recommended dose is 1 inhalation once or twice a
day.
Some children also use Formoterol fumarate dihydrate
inhaler 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 inhaler.
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 inhaler before exercise as
well.
Formoterol fumarate dihydrate inhaler should not be used in
children under 6 years of age.
Adults (18 years and above)
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)
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 Formoterol fumarate dihydrate
inhaler
Before using your new
Formoterol fumarate dihydrate
inhaler 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 inhaler
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 inhaler is now
ready for use.
1.

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. You may
hear a rattling sound.
2. Hold your inhaler upright with the turquoise grip
at the bottom.
3. Do not hold the mouthpiece when you load your
Inhaler. To load your Inhaler 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 inhaler
is now loaded and ready to use. Only load your
inhaler when you need to use it.
4. Hold your inhaler away from your mouth. Breathe
out gently (as far as is comfortable). Do not
breathe out through your inhaler.
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 inhaler 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 inhaler and must not be taken off. Do not
use your inhaler if it has been damaged or if the
mouthpiece has come apart from your Inhaler.
As with all inhalers, caregivers should ensure that children
prescribed Formoterol fumarate dihydrate inhaler use
correct inhalation technique, as described above.
Cleaning your inhaler
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 Inhaler
The Inhaler contains 60 doses (inhalations). The dose
indicator tells you how many doses are left in the
Inhaler.
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 Inhaler.

Note:
The grip will still twist and ‘click’ even when your Inhaler
is empty.

The sound that you hear as you shake your Inhaler is
produced by a drying agent and not the medicine.
Therefore the sound does not tell you how much
medicine is left in your Inhaler.
If you load your Formoterol fumarate Dihydrate Inhaler
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.
If you use more Formoterol fumarate dihydrate inhaler
than you should
If you use more Formoterol fumarate dihydrate inhaler 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
inhaler
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 inhaler
Do not stop using Formoterol fumarate dihydrate inhaler
without talking to your doctor.
If you have any further questions on using your Inhaler, ask
your doctor, nurse or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If the following happens to you, stop using Formoterol
fumarate dihydrate inhaler 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, may affect up to 1
in 10,000 people.
Other possible side effects:
Common (may affect up to 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 inhaler.
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)
Uneven heart beat.
Nausea (feeling sick).
Low level of potassium in your blood.
Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
Chest pain or tightness in the chest (angina pectoris).
An increase in the amount of sugar (glucose) in your
blood.
Taste changes, such as an unpleasant taste in the
mouth.
Changes in your blood pressure.
Feeling dizzy.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Formoterol fumarate dihydrate
inhaler
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 inhaler after
the expiry date which is stated on the carton label or on
the side of your inhaler after ‘Exp’. The expiry date
refers to the last day of that month.
Always be sure to dispose of your used Turbohaler
responsibly, since some of the medicine will remain
inside it. 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. Contents of the pack and other information
What Formoterol fumarate dihydrate inhaler 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 Formoterol fumarate dihydrate inhaler looks like
and contents of the pack
Formoterol fumarate dihydrate inhaler is an inhaler
containing your medicine. The inhaler 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 Inhaler contains 60 actuations.
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 12micrograms dry
powder inhaler; PL No: 18799/1979
Leaflet date: 24.08.2015
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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