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OXIS TURBOHALER 12MICROGRAMS PER DOSE INHALATION POWDER

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

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®

Package Leaflet: Information for the user
®

Oxis Turbohaler 12 micrograms per dose inhalation powder
(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 Turbohaler 12 micrograms per
dose inhalation powder 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 Indicator
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.
Keep container tightly closed.
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 actuation contains 12 micrograms of formoterol fumarate
dehydrate.
Oxis Turbohaler also includes lactose monohydrate.
What Oxis Turbohaler looks like and contents of the pack
Oxis Turbohaler is an inhaler containing your medicine. The inhalation
powder is white. The Turbohaler is a multi dose container made of
white plastic body with a turquoise screw cap.
Each Turbohaler contains 60 doses.
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® Turbohaler® 12 micrograms per dose inhalation powder
PL 18799/2276
POM
Leaflet date: 15.09.2016
Oxis and Turbohaler are trade marks of the AstraZeneca group of
companies.

Package Leaflet: Information for the user

Formoterol fumarate dihydrate
12 micrograms per dose inhalation powder Turbohaler
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 micrograms per dose inhalation powder Turbohaler but will be
referred to as Formoterol fumarate dihydrate Turbohaler or
Turbohaler throughout this leaflet.
What is in this leaflet
1. What Formoterol fumarate dihydrate Turbohaler is and what it is
used for
2. What you need to know before you use Formoterol fumarate
dihydrate Turbohaler
3. How to use Formoterol fumarate dihydrate Turbohaler
4. Possible side effects
5. How to store Formoterol fumarate dihydrate Turbohaler
6. Contents of the pack and other information

1. What Formoterol fumarate dihydrate Turbohaler is and
what it is used for
Formoterol fumarate dihydrate Turbohaler is an Turbohaler. 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 Turbohaler is used to treat asthma in
adults, adolescents and children aged 6 years and older. For asthma,
your doctor will prescribe two asthma Turbohalers: Formoterol
fumarate dihydrate Turbohaler and a separate ‘corticosteroid’
Turbohaler. These should be used together.
Formoterol fumarate dihydrate Turbohaler is used to help prevent
asthma symptoms from happening.
Some people also use Formoterol fumarate dihydrate Turbohaler
when they need extra doses for relief of asthma symptoms, to
make it easier to breathe again.
Formoterol fumarate dihydrate Turbohaler can also be used
before exercise to prevent asthma symptoms caused by exercise.
Chronic obstructive pulmonary disease (COPD)
Formoterol fumarate dihydrate Turbohaler can also be used to treat
the symptoms of COPD in adults. COPD is a 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 Turbohaler
Do not use Formoterol fumarate dihydrate 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 Formoterol fumarate
dihydrate Turbohaler if
You are diabetic. You may need some additional blood sugar
tests while you are using Formoterol fumarate dihydrate
Turbohaler.
You have high blood pressure or you have ever had a heart
problem.
You have problems with your thyroid gland.
You have low levels of potassium in your blood. Your doctor may
take blood samples to check the levels of potassium in your
blood.
You have severe liver problems such as liver cirrhosis.
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before using Formoterol fumarate dihydrate Turbohaler.
Other medicines and Formoterol fumarate dihydrate 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
Formoterol fumarate dihydrate Turbohaler can affect the way some
medicines work and some medicines can have an effect on
Formoterol fumarate dihydrate Turbohaler.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
Beta-blocker medicines (such as atenolol or propranolol for high
blood pressure), including eyedrops (such as timolol for
glaucoma).
Medicines for a fast or uneven heart beat (such as quinidine).
Medicines like digoxin, often used to treat heart failure.
Diuretics, also known as ‘water tablets’ (such as furosemide).
These are used to treat high blood pressure.
Steroid medicines that you take by mouth (such as prednisolone).
Xanthine medicines (such as theophylline or aminophylline).
These are often used to treat asthma.
Erythromycin (used to treat infections).
Anti-histamines (such as terfenadine).
Other substances that dilate the airways (bronchodilators, such
as salbutamol).
Ephedrine (used to treat asthma or as a decongestant).
Tricyclic anti-depressants (such as amitriptyline).
If any of the above applies to you, or if you are not sure, talk to your
doctor or pharmacist before using Formoterol fumarate dihydrate
Turbohaler.
Also tell your doctor or pharmacist if you are going to have a general
anaesthetic for an operation or for dental work.
The addition of anticholinergics (such as tiotropium or
ipratropium bromide) to the treatment with Formoterol fumarate
dihydrate Turbohaler, can help to open your airways even more.

Pregnancy, 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
Turbohaler unless your doctor tells you to.
If you get pregnant while using Formoterol fumarate dihydrate
Turbohaler, do not stop using Formoterol fumarate dihydrate
Turbohaler but talk to your doctor immediately.
Driving and using machines
Formoterol fumarate dihydrate Turbohaler is not likely to affect you
being able to drive or use any tools or machines.
Formoterol fumarate dihydrate Turbohaler contains lactose
Formoterol fumarate dihydrate Turbohaler contains lactose, which is a
type of sugar. If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before using this
medicine. The amount of lactose in this medicine does not normally
cause problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins, which
may cause allergic reactions.

3. How to use Formoterol fumarate dihydrate Turbohaler
Always use 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
Turbohaler prescribed by your doctor without talking to your
doctor first.
If you are using Formoterol fumarate dihydrate Turbohaler
regularly for asthma or COPD you should continue to use your
medicine, even if you have no symptoms.
Important information about your asthma or COPD symptoms
If you feel you are getting breathless or wheezy while using
Formoterol fumarate dihydrate Turbohaler, you should continue to
use Formoterol fumarate dihydrate Turbohaler but go to see your
doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
Your breathing is getting worse or you often wake up at night with
asthma.
You start getting chest tightness.
You are not getting relief from your current dose.
You need to take more than your usual dose for more than two
days in a week.
You need to use your Turbohaler more often than usual before
exercise.
These signs could mean that your asthma or COPD is not being
properly controlled and you may need different or additional treatment
immediately.
Asthma
Formoterol fumarate dihydrate Turbohaler should not be used in
children under 6 years of age.
Adults (18 years and above)
The 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 Turbohaler
as a ‘reliever Turbohaler’. 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
Turbohaler as a ‘reliever Turbohaler’. If your child gets asthma
symptoms, the usual dose is 1 inhalation when they happen.
A total daily dose of more than 2 inhalations is not normally
needed. This includes the inhalations that your child takes every
day, when they get asthma symptoms and before exercise.
However, your doctor may allow your child to take up to 4
inhalations a day. Your child should not use more than 4
inhalations in total in 24 hours.
Your child should not have more than 1 inhalation at any one
time.
Your doctor (or asthma nurse) will help you to manage your asthma.
Once your asthma is well controlled your doctor may consider it
appropriate to gradually reduce the dose of Formoterol fumarate
dihydrate Turbohaler.
Asthma caused by exercise
If you or your child have asthma symptoms caused by exercise, your
doctor may advise you or your child to use Formoterol fumarate
dihydrate Turbohaler before exercise as well. Formoterol fumarate
dihydrate Turbohaler should not be used in children under 6 years of
age.
Adults (18 years and above)
The 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 Turbohaler
Do not stop using Formoterol fumarate dihydrate Turbohaler without
talking to your doctor.

Preparing your new Formoterol fumarate dihydrate Turbohaler
Before using your new
Mouthpiece
Formoterol fumarate dihydrate
Turbohaler for the first time, Indicator
you need to prepare it for use
as follows:
Unscrew the white cover
and lift it off. You may hear
Grip
a rattling sound.
Hold your Formoterol
fumarate dihydrate
Turbohaler upright with the
turquoise grip at the
bottom.
Turn the turquoise grip as
far as it will go in one
direction. Then turn it as far
as it will go in the other
direction (it does not matter
which way you turn first).
You should hear a click
sound.
Do this again, turning the turquoise grip in both
directions.
Your Formoterol fumarate dihydrate Turbohaler is
now ready for use.

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 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 Turbohalers, caregivers should ensure that children
prescribed Formoterol fumarate dihydrate 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 have any further questions on using your Turbohaler, ask your
doctor, nurse or pharmacist.

4. Possible side effects

If the following happens to you, stop using Formoterol fumarate
dihydrate Turbohaler and talk to your doctor immediately:
Bronchospasm (tightening of the muscles in the airways which
causes sudden wheezing) after inhaling your medicine. This
happens very rarely, 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 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 Formoterol fumarate dihydrate 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 Formoterol fumarate dihydrate Turbohaler
Keep out of the sight and reach of children.
Do not store above 30°C.
Keep container tightly closed.
Do not use a damaged Turbohaler. Replace cover properly after
use.
Do not use Formoterol fumarate dihydrate 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 Formoterol fumarate dihydrate Turbohaler contains
The active ingredient in Formoterol fumarate dihydrate Turbohaler is
formoterol fumarate dihydrate.
Each actuation contains 12 micrograms of formoterol fumarate
dihydrate of which you can inhale 9 micrograms.
Formoterol fumarate dihydrate Turbohaler also includes lactose
monohydrate.
What Formoterol fumarate dihydrate Turbohaler looks like and
contents of the pack
Formoterol fumarate dihydrate Turbohaler is Turbohaler containing
your medicine. The inhalation powder is white. The Turbohaler is a
multi dose container made of white plastic body with a turquoise
screw cap.
Each Turbohaler contains 60 doses.
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,
POM
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Formoterol fumarate dihydrate 12 micrograms per dose
inhalation powder Turbohaler; PL 18799/2276
Leaflet date: 15.09.2016

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 Formoterol fumarate dihydrate 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 Formoterol fumarate dihydrate Turbohaler than
you should
If you use more Formoterol fumarate dihydrate Turbohaler than you
should, contact your doctor or pharmacist for advice immediately. The
following effects may happen: trembling, headache or a rapid heart
beat.
If you forget to use Formoterol fumarate dihydrate Turbohaler
If you forget to take a dose, take it as soon as you remember.
However, if it is nearly time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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