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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 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 12 microgram 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 betaagonists’ 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, 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 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.
Grip
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.

Other possible side effects:
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.

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. Replace cover properly after use.
Do not use Oxis 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.
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 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 dose contains 12 micrograms of formoterol fumarate
dihydrate
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.
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 18799/1979
Leaflet date: 15.09.2016

POM

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

Package Leaflet: Information for the user

Formoterol fumarate dihydrate 12 microgram 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 12
microgram 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 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, 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 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.

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 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.

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

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 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 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 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).
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 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 and Inhaler label after ‘Exp’.
The expiry date refers to the last day of that month.
Always be sure to dispose of your used Inhaler 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 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 dose contains 12 micrograms of
Formoterol fumarate dihydrate
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 12 microgram dry powder inhaler
PL 18799/1979
POM
Leaflet date: 15.09.2016

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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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