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FORMOTEROL FUMARATE DIHYDRATE 6 MICROGRAMS DRY POWDER INHALER

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

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Package Leaflet: Information for the user
®
®

Oxis 6 Turbohaler

(formoterol fumarate dihydrate)
Read all of this leaflet carefully before you start using
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 6 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 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, breast-feeding and fertility
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 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 recommended 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 recommended 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 recommended dose is 1 or 2 inhalations before
exercise.

A total daily dose of more than 4 inhalations is not
normally needed. This includes the inhalations that
your child takes every day, when they get asthma
symptoms and before exercise. However, your doctor
may allow your child to take up to 8 inhalations a day.
Your child should not use more than 8 inhalations in
total in 24 hours.
Your child should not have more than 2 inhalations at
any one time.
Chronic obstructive pulmonary disease (COPD)
Only to be used by adults (aged 18 years and above).
The recommended dose is 2 inhalations once or twice
a day.
Your doctor may advise you to take extra doses for
relief of your COPD symptoms.
You should not have more than 8 inhalations a day.
Do not take more than 4 inhalations at any one time.
Preparing your new Oxis Turbohaler Inhaler
Before using your new
Oxis Turbohaler for the first
time, you need to prepare it for
use as follows.
Unscrew the white cover
and lift it off. You may hear
a rattling sound.
Hold your Oxis Turbohaler
upright with the turquoise
grip at the bottom.
Turn the turquoise grip as
far as it will go in one
direction. Then turn it as far
as it will go in the other
direction (it does not matter
which way you turn it first).
You should hear a click
sound.
Do this again, turning the turquoise
grip in both directions.
Your Oxis Turbohaler is now ready for use.
How to take an inhalation
Every time you need to take an inhalation, follow the
instructions below.
1. Unscrew the white cover and lift it off. You may
hear a rattling sound.
2. Hold your Turbohaler upright with the turquoise
grip at the bottom.
1.

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.

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)
Trembling or shaking. If these effects occur, they are
usually mild and usually disappear as you continue to
use Oxis Turbohaler.
Headache.
Feeling dizzy.
Nausea (feeling sick).
Muscle cramps.
Uncommon (may affect up to 1 in 100 people)
Palpitations (awareness of your heart beating). If this
effect occurs, it is usually mild and usually disappear
as you continue to use Oxis Turbohaler.
Disturbed sleep.
Fast heart beat.
Allergic reactions such as rash, itching and
bronchospasm.
Low level of potassium in your blood.
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.
Uneven heart beat.
Chest pain or tightness in the chest (angina pectoris).
Rare (may affect up to 1 in 1,000 people)
Feeling restless or agitated.
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. If the inhaler becomes
damaged, seek the advice of your pharmacist.
Replace cover properly after use.
Do not use the Turbohaler after the expiry date which
is stated on the carton and Turbohaler label after
‘Exp’. 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 no longer required. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Oxis Turbohaler contains
The active ingredient in Oxis Turbohaler is formoterol
fumarate dihydrate.
Each actuation contains 6 micrograms of the active
ingredient 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 turbohaler is a multi-dose, dry powder inhaler made of
white plastic body with a 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.
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® 6 Turbohaler®

PL 18799/1978

Leaflet date: 17.08.2016
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.

POM

Oxis and Turbohaler are trade marks of the AstraZeneca
group of companies.

Package Leaflet: Information for the user

Formoterol fumarate dihydrate 6 micrograms dry powder inhaler
Read all of this leaflet carefully before you start using 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
6 micrograms dry powder inhaler but will be referred to as
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 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, breast-feeding and fertility
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 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 dihydrate inhaler
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 recommended dose is 2 inhalations, 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 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 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 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 recommended dose is 1 or 2 inhalations before exercise.
A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take
up to 8 inhalations a day. Your child should not use more than
8 inhalations in total in 24 hours.
Your child should not have more than 2 inhalations at any one
time.

Chronic obstructive pulmonary disease (COPD)
Only to be used by adults (aged 18 years and above).
The recommended 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.

If you stop using Formoterol fumarate dihydrate inhaler
Do not stop using Formoterol fumarate dihydrate inhaler without
talking to your doctor.

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 it 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.
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.

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

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.

Rare (may affect up to 1 in 1,000 people)
Feeling restless or agitated.

1.

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.

If you have any further questions on using your Inhaler, ask your
doctor, nurse or pharmacist.
4. Possible side effects

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)
Trembling or shaking. If these effects occur, they are usually
mild and usually disappear as you continue to use Formoterol
fumarate dihydrate inhaler.
Headache.
Feeling dizzy.
Nausea (feeling sick).
Muscle cramps.
Uncommon (may affect up to 1 in 100 people)
Palpitations (awareness of your heart beating). If this effect
occurs, it is usually mild and usually disappear as you
continue to use Formoterol fumarate dihydrate inhaler.
Disturbed sleep.
Fast heart beat.
Allergic reactions such as rash, itching and bronchospasm.
Low level of potassium in your blood.
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.
Uneven heart beat.
Chest pain or tightness in the chest (angina pectoris).

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. If the Inhaler becomes
damaged, seek the advice of your pharmacist.
Replace cover properly after use.
Do not use the Inhaler after the expiry date which is stated on
the carton and Inhaler label after ‘Exp’. 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 no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Formoterol fumarate dihydrate inhaler contains
The active ingredient in Formoterol fumarate dihydrate inhaler is
formoterol fumarate dihydrate.
Each actuation contains 6 micrograms of the active ingredient
formoterol fumarate dihydrate.
The other ingredient is 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 a 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 6 micrograms dry powder
inhaler;
POM
PL 18799/1978

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.

Leaflet date: 17.08.2016

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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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