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FORMOTEROL FUMARATE DIHYDRATE 6 MICROGRAMS POWDER INHALER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxis® Turbohaler® 6 micrograms Inhalation Powder
(formoterol fumarate)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

Pregnancy and breast-feeding
 If you are pregnant, or breast-feeding, think you may be
pregnant, or are planning to have a baby, ask your doctor for
advice before taking this medicine - do not use Oxis Turbohaler
unless your doctor tells you to.
 If you get pregnant while using Oxis Turbohaler, do not stop
using Oxis Turbohaler but talk to your doctor immediately.

The name of your medicine is Oxis® Turbohaler® 6 micrograms
Inhalation Powder, but it will be referred as Oxis Turbohaler
throughout the leaflet.

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.

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.

1. What Oxis Turbohaler is and what it is used for
What

Oxis Turbohaler is and what it is used f

Oxis Turbohaler is an inhaler. It contains a medicine called
formoterol. This belongs to a group of medicines called ‘long-acting
beta-agonists’ or ‘bronchodilators’.
It works by relaxing the muscles in your airways. This helps you to
breathe more easily. It starts to work within 1 to 3 minutes and the
effects last up to 12 hours.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
Asthma
Oxis Turbohaler is used to treat asthma in adults, adolescents and
children aged 6 years and older.
For asthma, your doctor will prescribe two asthma inhalers:
Oxis Turbohaler and a separate ‘corticosteroid’ inhaler.
These should be used together.
 Oxis Turbohaler is used to help prevent asthma symptoms from
happening.
 Some people also use Oxis Turbohaler when they need extra
doses for relief of asthma symptoms, to make it easier to
breathe again.
 Oxis Turbohaler can also be used before exercise to prevent
asthma symptoms caused by exercise.
Chronic obstructive pulmonary disease (COPD)
Oxis Turbohaler can also be used to treat the symptoms of COPD in
adults. COPD is a long-term disease of the airways in the lungs,
which is often caused by cigarette smoking.
2. B

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.

Driving and using machines
Oxis Turbohaler is not likely to affect you being able to drive or use
any tools or machines.

The excipient lactose contains small amounts of milk proteins, which
may cause allergic reactions.

3. How to use Oxis Turbohaler

3. How to use Oxis Turbohaler
 Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
 Do not increase the dose of Oxis Turbohaler prescribed by your
doctor without talking to your doctor first.
 If you are using Oxis Turbohaler regularly for asthma or COPD
you should continue to use your medicine, even if you have no
symptoms.
Important information about your asthma or COPD symptoms
If you feel you are getting breathless or wheezy while using Oxis
Turbohaler, you should continue to use Oxis Turbohaler but go to
see your doctor as soon as possible, as you may need additional
treatment.
Contact your doctor immediately if:
 Your breathing is getting worse or you often wake up at
night with asthma.
 You start getting chest tightness.
 You are not getting relief from your current dose.
 You need to take more than your usual dose for more than two
days in a week.
 You need to use your Turbohaler more often than usual before
exercise.
These signs could mean that your asthma or COPD is not being
properly controlled and you may need different or additional
treatment immediately.
Asthma
Oxis Turbohaler should not be used in children under 6 years of age.
Adults (18 years and above)
 The recommended dose is 1 or 2 inhalations, once or twice a
day.
 Your doctor may increase this to 4 inhalations, once or twice a
day.
 Some people also use Oxis Turbohaler as a ‘reliever inhaler’. If
you get asthma symptoms, the usual dose is 1 or 2 inhalations
when they happen.
 A total daily dose of more than 8 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 12 inhalations a day. Do
not use more than 12 inhalations in total in 24 hours.
 Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
 The recommended dose is 2 inhalations, once or twice a day.
 Some children also use Oxis Turbohaler as a ‘reliever inhaler’. If
your child gets asthma symptoms, the usual dose is 1 or 2
inhalations when they happen.
 A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes every
day, when they get asthma symptoms and before exercise.
However, your doctor may allow your child to take up to 8
inhalations a day. Your child should not use more than 8
inhalations in total in 24 hours.
 Your child should not have more than 2 inhalations at any one
time.
Your doctor (or asthma nurse) will help you to manage your asthma.
Once your asthma is well controlled your doctor may consider it
appropriate to gradually reduce the dose of Oxis Turbohaler.

Asthma caused by exercise
If you or your child have asthma symptoms caused by exercise, your
doctor may advise you or your child to use Oxis Turbohaler before
exercise as well. Oxis Turbohaler should not be used in children
under 6 years of age.
Adults (18 years and above)
 The recommended dose is 2 inhalations before exercise.
 A total daily dose of more than 8 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 12 inhalations a day. Do
not use more than 12 inhalations in total in 24 hours.
 Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
 The recommended dose is 1 or 2 inhalations before exercise.
 A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes every
day, when they get asthma symptoms and before exercise.
However, your doctor may allow your child to take up to 8
inhalations a day. Your child should not use more than 8
inhalations in total in 24 hours.
 Your child should not have more than 2 inhalations at any one
time.

Chronic obstructive pulmonary disease (COPD)






Only to be used by adults (aged 18 years and above).
The recommended dose is 2 inhalations once or twice a day.
Your doctor may advise you to take extra doses for relief of your
COPD symptoms.
You should not have more than 8 inhalations a day.
Do not take more than 4 inhalations at any one time.

Preparing your new Oxis Turbohaler
Before using your new
Mouthpiece
Oxis Turbohaler for the first time, you
need to prepare it for use as follows.
Indicator
 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.



Grip

How to take an inhalation
Every time you need to take an inhalation, follow the instructions
below.
 Unscrew the white cover and lift it off. You may hear a rattling
sound.


Hold your Turbohaler upright with the turquoise grip at the
bottom.



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 dose indicator tells you how many
doses are left in the Turbohaler, starting
with 60 doses when it is full.

The dose indicator is marked in intervals of
10 doses. Therefore, it does not show every
dose. When you first see a red mark at the
edge of the indicator window, there are
approximately 20 doses left. For the last
10 doses, the background of the dose
indicator is red. When the ‘0’ on the red
background has reached the middle of the
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.
P


 4. Possible
e effects 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 to1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)
 Palpitations (awareness of your heart beating), trembling or
shaking. If these effects occur, they are usually mild and usually
disappear as you continue to use Oxis Turbohaler.
 Headache.
Uncommon (may affect up to 1 in 100 people)
 Feeling restless or agitated.
 Disturbed sleep.
 Fast heart beat.
 Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
 Uneven heart beat.
 Nausea (feeling sick).
 Low level of potassium in your blood.
 Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
 Chest pain or tightness in the chest (angina pectoris).
 An increase in the amount of sugar (glucose) in your blood.
 Taste changes, such as an unpleasant taste in the mouth.
 Changes in your blood pressure.
 Feeling dizzy.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine
5. H

5. How to store Oxis Turbohaler












Keep out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Keep the container/cap tightly closed.
Do not use Formoterol fumarate dihydrate Inhaler after the
expiry date printed on the carton or on the side of your Inhaler.
The expiry date refers to the last day of that month.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to protect
the environment.
ther information
Fu

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.
The other ingredient is lactose monohydrate (which contains milk
proteins).
What Oxis Turbohaler looks like and contents of the pack
Oxis Turbohaler is an inhaler containing your medicine.
The inhalation powder is white in colour. Each Turbohaler contains
60 doses and has a white body with a turquoise turning grip.
Manufactured by: AstraZeneca AB, SE-151 85 Sodertalje,
Sweden.
or
AstraZeneca GmbH, Wedel, Germany.
or
AstraZeneca UK Ltd., Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading
Estate, SL1 4NL, UK

Oxis® Turbohaler® 6 micrograms
Inhalation Powder
PL: - 39352/0091

POM

Oxis® and Turbohaler® are registered trademarks of the AstraZeneca
group of companies.
Leaflet date: 20/05/2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

Formoterol fumarate dihydrate 6 micrograms Powder Inhaler
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Formoterol Fumarate dihydrate
6 micrograms Powder Inhaler, but it will be referred as Formoterol
fumarate dihydrate Inhaler throughout the 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.

1.

What Formoterol fumarate dihydrate Inhaler is and

What what
Formoterol
fumarate
it is used
fordihydrate Inhaler is and what it is used f
Formoterol fumarate dihydrate Inhaler is an inhaler. It contains a
medicine called Formoterol fumarate. 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. B

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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines that you
buy without a prescription and herbal medicines. This is because
Formoterol fumarate dihydrate Inhaler can affect the way some
medicines work and some medicines can have an effect on
Formoterol fumarate dihydrate Inhaler.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:
 Beta-blocker medicines (such as atenolol or propranolol for high
blood pressure), including eyedrops (such as timolol for
glaucoma).
 Medicines for a fast or uneven heart beat (such as quinidine).
 Medicines like digoxin, often used to treat heart failure.
 Diuretics, also known as ‘water tablets’ (such as furosemide).
These are used to treat high blood pressure.
 Steroid medicines that you take by mouth (such as
prednisolone).
 Xanthine medicines (such as theophylline or aminophylline).
These are often used to treat asthma.
 Erythromycin (used to treat infections).
 Anti-histamines (such as terfenadine).
 Other substances that dilate the airways (bronchodilators, such
as salbutamol).
 Ephedrine (used to treat asthma or as a decongestant).
 Tricyclic anti-depressants (such as amitriptyline).
If any of the above applies to you, or if you are not sure, talk to your
doctor or pharmacist before using Formoterol fumarate dihydrate
Inhaler.

Also tell your doctor or pharmacist if you are going to have a general
anaesthetic for an operation or for dental work.
The addition of anticholinergics (such as tiotropium or ipratropium
bromide) to the treatment with Formoterol fumarate dihydrate
Inhaler, can help to open your airways even more.
Pregnancy and breast-feeding
 If you are pregnant, or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine - do not use Formoterol
fumarate dihydrate Inhaler unless your doctor tells you to.
 If you get pregnant while using Formoterol fumarate dihydrate
Inhaler, do not stop using Formoterol fumarate dihydrate Inhaler
but talk to your doctor immediately.
Driving and using machines
Formoterol fumarate dihydrate Inhaler is not likely to affect you being
able to drive or use any tools or machines.
Formoterol fumarate dihydrate Inhaler contains lactose
Formoterol fumarate dihydrate Inhaler contains lactose, which is a
type of sugar.
If you have been told by your doctor that you have an intolerance to
some sugars, talk to your doctor before using this medicine. The
amount of lactose in this medicine does not normally cause
problems in people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins, which
may cause allergic reactions.

3.

How to use Formoterol fumarate dihydrate Inhaler

3. How to use Formoterol fumarate Turbohale



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 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 Inhaler should not be used in children
under 6 years of age.
Adults (18 years and above)
 The recommended dose is 1 or 2 inhalations, once or twice a
day.
 Your doctor may increase this to 4 inhalations, once or twice a
day.
 Some people also use Formoterol fumarate dihydrate Inhaler as
a ‘reliever inhaler’. If you get asthma symptoms, the usual dose
is 1 or 2 inhalations when they happen.
 A total daily dose of more than 8 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 12 inhalations a day. Do
not use more than 12 inhalations in total in 24 hours.
 Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
 The recommended dose is 2 inhalations, once or twice a day.
 Some children also use Formoterol fumarate dihydrate Inhaler
as a ‘reliever inhaler’. If your child gets asthma symptoms, the
usual dose is 1 or 2 inhalations when they happen.
 A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes every
day, when they get asthma symptoms and before exercise.
However, your doctor may allow your child to take up to 8
inhalations a day. Your child should not use more than 8
inhalations in total in 24 hours.
 Your child should not have more than 2 inhalations at any one
time.
Your doctor (or asthma nurse) will help you to manage your asthma.
Once your asthma is well controlled your doctor may consider it
appropriate to gradually reduce the dose of 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 Formoterol fumarate
dihydrate Inhaler before exercise as well. Formoterol fumarate
dihydrate Inhaler should not be used in children under 6 years of
age.
Adults (18 years and above)
 The recommended dose is 2 inhalations before exercise.
 A total daily dose of more than 8 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 12 inhalations a day. Do
not use more than 12 inhalations in total in 24 hours.
 Do not take more than 6 inhalations at any one time.

Children and adolescents (6 to 17 years)
 The recommended dose is 1 or 2 inhalations before exercise.
 A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes every
day, when they get asthma symptoms and before exercise.
However, your doctor may allow your child to take up to 8
inhalations a day. Your child should not use more than 8
inhalations in total in 24 hours.
 Your child should not have more than 2 inhalations at any one
time

Chronic obstructive pulmonary disease (COPD)






Only to be used by adults (aged 18 years and above).
The recommended dose is 2 inhalations once or twice a day.
Your doctor may advise you to take extra doses for relief of your
COPD symptoms.
You should not have more than 8 inhalations a day.
Do not take more than 4 inhalations at any one time.

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.

If you forget to use Formoterol fumarate dihydrate Inhaler
 If you forget to take a dose, take it as soon as you remember.
However, if it is nearly time for your next dose, skip the missed
dose.
 Do not take a double dose to make up for a forgotten dose.
If you stop using Formoterol fumarate dihydrate Inhaler
Do not stop using Formoterol fumarate dihydrate Inhaler without
talking to your doctor.
If you have any further questions on using your Turbohaler, ask your
doctor, nurse or pharmacist.
1. P
2.4. Possible side effects
e effects

Mouthpiece
Indicator



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



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.

Grip

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. It is not possible to overload your Turbohaler
even if you turn the grip several times. 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.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If the following happens to you, stop using Formoterol fumarate
dihydrate Inhaler and talk to your doctor immediately:
 Bronchospasm (tightening of the muscles in the airways
which causes sudden wheezing) after inhaling your
medicine. This happens very rarely, may affect up to 1 in 10,000
people.

Other possible side effects:
Common (may affect up to 1 in 10 people)
 Palpitations (awareness of your heart beating), trembling or
shaking. If these effects occur, they are usually mild and usually
disappear as you continue to use Formoterol fumarate dihydrate
Inhaler.
 Headache.
Uncommon (may affect up to 1 in 100 people)
 Feeling restless or agitated.
 Disturbed sleep.
 Fast heart beat.
 Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
 Uneven heart beat.
 Nausea (feeling sick).
 Low level of potassium in your blood.
 Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
 Chest pain or tightness in the chest (angina pectoris).
 An increase in the amount of sugar (glucose) in your blood.
 Taste changes, such as an unpleasant taste in the mouth.
 Changes in your blood pressure.
 Feeling dizzy.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine
5. H

5. How to store Formoterol fumarate dihydrate Inhaler

e O Tu





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 Inhaler 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 dose indicator tells you how many
doses are left in the Turbohaler, starting
with 60 doses when it is full.

The dose indicator is marked in intervals of
10 doses. Therefore, it does not show every
dose. When you first see a red mark at the
edge of the indicator window, there are
approximately 20 doses left. For the last
10 doses, the background of the dose
indicator is red. When the ‘0’ on the red
background has reached the middle of the
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 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.




Keep out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Keep the container/cap tightly closed.
Do not use Formoterol fumarate dihydrate Inhaler after the
expiry date printed on the carton or on the side of your Inhaler.
The expiry date refers to the last day of that month.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to protect
the environment.

3.6. Contents
Fu
of the pack and other information
What Formoterol fumarate dihydrate Inhaler 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. The other ingredient is lactose
monohydrate (which contains milk proteins).
What Formoterol fumarate dihydrate Inhaler looks like and
contents of the pack
Formoterol fumarate dihydrate Inhaler is an inhaler containing your
medicine.
The inhalation powder is white in colour. Each inhaler contains
60 doses and has a white body with a turquoise turning grip.
Manufactured by: AstraZeneca AB, SE-151 85 Sodertalje, Sweden.
or
AstraZeneca GmbH, Wedel, Germany.
or
AstraZeneca UK Ltd., Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading
Estate, SL1 4NL, UK

Formoterol fumarate dihydrate 6 micrograms
Powder Inhaler
POM
PL 39352/0091
Leaflet date: 20/05/2016

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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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