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OXIS 6 TURBOHALER/ FORMOTEROL FUMARATE DIHYDRATE 6 TURBOHALER

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OXIS 6 TURBOHALER
(formoterol fumarate dihydrate)
Powder for Inhalation. 6micrograms/actuation.
Read all of this leaflet carefully before you start
taking this medicine.
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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
The name of your medicine is Oxis 6 Turbohaler but will
be referred to as Oxis Turbohaler or Turbohaler
throughout this leaflet.
In this leaflet:
1. What Oxis Turbohaler is and what it is used for
2. Before you use Oxis Turbohaler
3. How to use Oxis Turbohaler
4. Possible side effects
5. How to store Oxis Turbohaler
6. Further information

1. What Oxis Turbohaler is and what it is used
for
Oxis Turbohaler is an inhaler. It contains a medicine
called formoterol. This belongs to a group of medicines
called ‘long-acting beta-agonists’ or ‘bronchodilators’.
It works by relaxing the muscles in your airways. This
helps you to breathe more easily. It starts to work within
1 to 3 minutes and the effects last up to 12 hours.
Your doctor has prescribed this medicine to treat
asthma or chronic obstructive pulmonary disease
(COPD).
Asthma
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. Before you use Oxis Turbohaler
Do not use Oxis Turbohaler if:
You are allergic (hypersensitive) to formoterol, or
the other ingredient, lactose (which contains small
amounts of milk proteins).
Take special care with Oxis Turbohaler
Before you use Oxis Turbohaler, tell your doctor or
pharmacist 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.
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 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 and breast-feeding
If you are pregnant, or planning to get pregnant, talk
to your doctor before using Oxis Turbohaler - 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.
If you are breast-feeding, talk to your doctor before
using Oxis Turbohaler.
Driving and using machines
Oxis Turbohaler is not likely to affect you being able to
drive or use any tools or machines.
Important information about some of the ingredients
of Oxis Turbohaler
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 Oxis Turbohaler exactly as your doctor,
nurse or pharmacist has told you. Ask one of them
for advice 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 usual 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 usual 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 usual 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 usual 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.

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.

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

If you stop using 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.

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.
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.
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.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a
dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
The Turbohaler contains 60 doses (inhalations). The
dose indicator tells you how many doses are left in
the Turbohaler.
When you first see a red mark at the edge of the
indicator window, there are approximately 20 doses
left. When the red mark reaches the bottom of the
indicator window, you must start using your new
Turbohaler.

If you forget to use Oxis Turbohaler
If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for your next
dose, skip the missed dose.
Do not take a double dose to make up for a
forgotten dose.

4. Possible side effects
Like all medicines, Oxis Turbohaler 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,
affecting less than 1 in 10,000 people.
Other possible side effects:
Common (affects less than 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 (affects less than 1 in 100 people)
Feeling restless or agitated.
Disturbed sleep.
Fast heart beat.
Muscle cramps.
Rare (affects less than 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 (affects less than 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. How to store Oxis Turbohaler
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use a damaged inhaler. Replace cover
properly after use.
Do not use Oxis Turbohaler after the expiry date
printed on the carton or on the side of your
Turbohaler. 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 that are no
longer required. This will help to protect the
environment.
If the medicine shows any signs of deterioration, do
not use it and take it to your doctor or pharmacist.
6. Further information
What Oxis Turbohaler contains
The active substance is formoterol fumarate dihydrate.
Each actuation contains 6 micrograms of active
ingredient formoterol fumarate dihydrate.
Also contains lactose monohydrate (which contains milk
proteins).
What Oxis Turbohaler looks like and contents of the
pack
Oxis Turbohaler is an inhaler containing your medicine.
The turbohaler is a multi-dose, dry powder inhaler made
of white plastic body with a cap and turquoise turn grip.
The base of the turn grip is marked ‘5’ in Braille for
identification of Formoterol.
Each Turbohaler contains 60 actuations.
Manufactured by: AstraZeneca AB, S-151 85
Södertälje, Sweden.

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.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
OXIS 6 TURBOHALER PL No: 18799/1978
Leaflet date: 17.04.2014
Oxis and Turbohaler are trade marks of the
AstraZeneca group of companies.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Formoterol Fumarate dihydrate 6 Turbohaler
Powder for Inhalation. 6micrograms/actuation.
Read all of this leaflet carefully before you start
taking this medicine.
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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
The name of your medicine is Formoterol Fumarate
dihydrate 6 Turbohaler but will be referred to as
Formoterol Turbohaler or Turbohaler throughout this
leaflet.
In this leaflet:
1. What Formoterol Turbohaler is and what it is used for
2. Before you use Formoterol Turbohaler
3. How to use Formoterol Turbohaler
4. Possible side effects
5. How to store Formoterol Turbohaler
6. Further information

1. What Formoterol Turbohaler is and what it is
used for
Formoterol 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
For asthma, your doctor will prescribe two asthma
inhalers: Formoterol Turbohaler and a separate
‘corticosteroid’ inhaler.
These should be used together.
Formoterol Turbohaler is used to help prevent
asthma symptoms from happening.
Some people also use Formoterol Turbohaler when
they need extra doses for relief of asthma
symptoms, to make it easier to breathe again.
Formoterol Turbohaler can also be used before
exercise to prevent asthma symptoms caused by
exercise.
Chronic obstructive pulmonary disease (COPD)
Formoterol 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. Before you use Formoterol Turbohaler
Do not use Formoterol Turbohaler if:
You are allergic (hypersensitive) to formoterol, or
the other ingredient, lactose (which contains small
amounts of milk proteins).
Take special care with Formoterol Turbohaler
Before you use Formoterol Turbohaler, tell your doctor
or pharmacist if:
You are diabetic. You may need some additional
blood sugar tests while you are using Formoterol
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
Turbohaler.
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 Turbohaler can
affect the way some medicines work and some
medicines can have an effect on Formoterol 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 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
Turbohaler, can help to open your airways even more.
Pregnancy and breast-feeding
If you are pregnant, or planning to get pregnant, talk
to your doctor before using Formoterol Turbohaler do not use Formoterol Turbohaler unless your
doctor tells you to.
If you get pregnant while using Formoterol
Turbohaler, do not stop using Formoterol Turbohaler
but talk to your doctor immediately.
If you are breast-feeding, talk to your doctor before
using Formoterol Turbohaler.
Driving and using machines
Formoterol Turbohaler is not likely to affect you being
able to drive or use any tools or machines.
Important information about some of the ingredients
of Formoterol Turbohaler
Formoterol 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 Turbohaler
Always use Formoterol Turbohaler exactly as your
doctor, nurse or pharmacist has told you. Ask one of
them for advice if you are not sure.
Do not increase the dose of Formoterol Turbohaler
prescribed by your doctor without talking to your
doctor first.
If you are using Formoterol 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 Turbohaler, you should continue to
use Formoterol 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 Turbohaler should not be used in children
under 6 years of age.
Adults (18 years and above)
The usual 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 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 usual dose is 2 inhalations, once or twice a day.
Some children also use Formoterol 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 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 Turbohaler before exercise as well.
Formoterol Turbohaler should not be used in children
under 6 years of age.
Adults (18 years and above)
The usual 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 usual 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 usual 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 Turbohaler Inhaler
Before using your new
Formoterol 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
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 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.
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.
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.
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 use more Formoterol Turbohaler than you
should
If you use more Formoterol 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 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 Turbohaler
Do not stop using Formoterol 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, Formoterol Turbohaler can cause
side effects, although not everybody gets them.
If the following happens to you, stop using
Formoterol 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,
affecting less than 1 in 10,000 people.
Other possible side effects:
Common (affects less than 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 Turbohaler.
Headache.
Uncommon (affects less than 1 in 100 people)
Feeling restless or agitated.
Disturbed sleep.
Fast heart beat.
Muscle cramps.
Rare (affects less than 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 (affects less than 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. How to store Formoterol Turbohaler
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use a damaged inhaler. Replace cover
properly after use.
Do not use Formoterol 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.
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 that are no
longer required. This will help to protect the
environment.
If the medicine shows any signs of deterioration, do
not use it and take it to your doctor or pharmacist.
6. Further information
What Formoterol Turbohaler contains
The active substance is formoterol fumarate dihydrate.
Each actuation contains 6 micrograms of active
ingredient formoterol fumarate dihydrate.
Also contains lactose monohydrate (which contains milk
proteins).
What Formoterol Turbohaler looks like and contents
of the pack
Formoterol Turbohaler is an inhaler containing your
medicine. The turbohaler is a multi-dose, dry powder
inhaler made of white plastic body with a cap and
turquoise turn grip. The base of the turn grip is marked
‘5’ in Braille for identification of Formoterol.
Each Turbohaler contains 60 actuations.
Manufactured by: AstraZeneca AB, S-151 85
Södertälje, Sweden.

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.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Formoterol Fumarate dihydrate 6 Turbohaler
PL No: 18799/1978
Leaflet date: 17.04.2014

POM

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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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