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FORMOTEROL FUMARATE DIHYDRATE 6 MICROGRAMS TURBOHALER

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

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Ref: 1262/191216/1/F

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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE OXIS TURBOHALER

• KEEP OUT OF THE SIGHT AND REACH OF

PATIENT INFORMATION LEAFLET
®

OXIS ® 6 TURBOHALER, INHALATION POWDER
(formoterol fumarate dihydrate)

CHILDREN.

• Do not store above 30°C.
• When not in use, Keep container/cap tightly
closed.

• Do not use Oxis Turbohaler after the expiry date
printed on the carton or on the side of your
Turbohaler. The expiry date refers to the last
day of that month.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines that no longer
required. This will help the enviroment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Oxis Turbohaler contains:
The active substance is formoterol fumarate
dihydrate. Each dose contains 6 micrograms of
formoterol fumarate dihydrate of which you can
inhale 4.5 micrograms.
Your medicine also contains the following inactive
ingredient: lactose monohydrate.
What Oxis Turbohaler looks like and contents
of the pack
Oxis Turbohaler 6 is an inhaler containing your
medicine. The inhalation powder is white in colour.
Each Turbohaler has a white body and white
screw cap, with a light turquoise grip.
Each Oxis Turbohaler contains 60 doses.
Manufacturer and Licence Holder
Your medicine is manufactured by AstraZeneca
AB, S-151 85 Sodertalje, Sweden and are
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1262

Oxis & Turbohaler are registered trademarks of
AstraZeneca AB.
Revision date: 19/12/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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.
Your medicine is called Oxis 6 Turbohaler
Inhalation Powder but will be referred to as Oxis
Turbohaler throughout this leaflet.

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.

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

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.

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
smoking. YOU
2. WHAT
YOUcaused
NEED by
TOcigarette
KNOW BEFORE
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).

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 breastfeeding, 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

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.

• 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.

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.
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.

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
theTurbohaler.
• 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.

7. If you are to take a second inhalation, repeat
steps 2 to 6.
8. Replace the cover tightly after use.

Ref: 1262/191216/1/B

Ref: 1262/191216/2/F

• 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.
If you stop using Formoterol Fumarate
Dihydrate Turbohaler
Do not stop using Formoterol Fumarate Dihydrate
Turbohaler without talking to your doctor.
If you have any further questions on using your
Turbohaler, ask your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If the following happens to you, stop using
Formoterol Fumarate Dihydrate Turbohaler and
talk to your doctor immediately:
• Bronchospasm (tightening of the muscles in the
airways which causes sudden wheezing) after
inhaling your medicine. This happens very
rarely, 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE FUMARATE DIHYDRATE
TURBOHALER

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

• Do not store above 30°C.
• When not in use, Keep container/cap tightly
closed.

• Do not use Formoterol Fumarate Dihydrate
Turbohaler after the expiry date printed on the
carton or on the side of your Turbohaler. The
expiry date refers to the last day of that month.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines that no longer
required. This will help the enviroment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Formoterol Fumarate Dihydrate
Turbohaler contains:
The active substance is formoterol fumarate
dihydrate. Each dose contains 6 micrograms of
formoterol fumarate dihydrate of which you can
inhale 4.5 micrograms.
Your medicine also contains the following inactive
ingredient: lactose monohydrate.
What Formoterol Fumarate Dihydrate
Turbohaler looks like and contents of the pack
Formoterol Fumarate Dihydrate Turbohaler 6 is an
inhaler containing your medicine. The inhalation
powder is white in colour. Each Turbohaler has a
white body and white screw cap, with a light
turquoise grip.
Each Formoterol Fumarate Dihydrate Turbohaler
contains 60 doses.
Manufacturer and Licence Holder
Your medicine is manufactured by AstraZeneca
AB, S-151 85 Sodertalje, Sweden and are
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1262

Turbohaler is a registered trademark of
AstraZeneca AB.
Revision date: 19/12/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

FORMOTEROL FUMARATE DIHYDRATE
®
6 MICROGRAMS TURBOHALER INHALATION POWDER
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.
Your medicine is called Formoterol Fumarate
Dihydrate 6 micrograms Turbohaler Inhalation
Powder but will be referred to as Formoterol
Fumarate Dihydrate 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
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 Turbohaler 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 Turbohaler and a separate
‘corticosteroid’ inhaler. These should be used
together.
• Formoterol Fumarate Dihydrate Turbohaler is
used to help prevent asthma symptoms from
happening.
• Some people also use Formoterol Fumarate
Dihydrate Turbohaler when they need extra
doses for relief of asthma symptoms, to make it
easier to breathe again.
• Formoterol Fumarate Dihydrate Turbohaler can
also be used before exercise to prevent asthma
symptoms caused by exercise.

Chronic obstructive pulmonary disease
(COPD)
Formoterol Fumarate Dihydrate Turbohaler can
also be used to treat the symptoms of COPD in
adults. COPD is a 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).

• You need to use your Turbohaler more often

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.

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.

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 breastfeeding, 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.

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 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 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 Formoterol Fumarate
Dihydrate 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 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 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 Formoterol Fumarate
Dihydrate Turbohaler
Before using your new
Formoterol Fumarate
Dihydrate Turbohaler for
the first time, you need
to prepare it for use as
follows.
• Unscrew the white
cover and lift it off.
You may hear a
rattling sound.
• Hold your Formoterol
Fumarate Dihydrate
Turbohaler upright
with the turquoise
grip at the bottom.
• Turn the turquoise
grip as far as it will
go in one direction.
Then turn it as far as it
will go in the other
direction (it does not
matter which way you
turn it first). You should
hear a click sound.
• Do this again, turning
the turquoise grip in both directions.
• Your Formoterol Fumarate Dihydrate Turbohaler is
now ready for use.
How to take an inhalation
Every time you need to take an inhalation, follow
the instructions below.
1. Unscrew the white cover and lift it off. 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 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
theTurbohaler.
• 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.

Ref: 1262/191216/2/B

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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