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FORMOTEROL 12 MICROGRAM TURBOHALER

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S1019 LEAFLET Oxis 20140115

PACKAGE LEAFLET: INFORMATION FOR THE USER

OXIS TURBOHALER 12
(formoterol fumarate dihydrate)
This medicine is known as Oxis Turbohaler 12 but will be referred to
as Oxis Turbohaler in this leaflet.
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.

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

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

6. Further information

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.

1. WHAT OXIS TURBOHALER IS AND WHAT IT IS USED FOR

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

4. Possible side effects
5. How to store Oxis Turbohaler

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).

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.

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).

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.

Take special care with Oxis Turbohaler

Adults (18 years and above)

Before you use Oxis Turbohaler, tell your doctor or pharmacist if:




The usual dose is 1 inhalation, once or twice a day.

You are diabetic. You may need some additional blood sugar
tests while you are using Oxis Turbohaler.





Your doctor may increase this to 2 inhalations, once or twice a
day.

You have high blood pressure or you have ever had a heart
problem.





You have problems with your thyroid gland.

Some people also use Oxis Turbohaler as a ‘reliever inhaler’. If
you get asthma symptoms, the usual dose is 1 inhalation when
they happen.



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.

A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 6 inhalations a day. Do
not use more than 6 inhalations in total in 24 hours.

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.

 Do not take more than 3 inhalations at any one time.
Children and adolescents (6 to 17 years)


The usual dose is 1 inhalation once or twice a day.



Some children also use Oxis Turbohaler as a ‘reliever inhaler’.
If your child gets asthma symptoms, the usual dose is 1
inhalation when they happen.



A total daily dose of more than 2 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take up
to 4 inhalations a day. Your child should not use more than 4
inhalations in total in 24 hours.



Your child should not have more than 1 inhalation at any one
time.

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.

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 1 inhalation before exercise.



A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 6 inhalations a day. Do
not use more than 6 inhalations in total in 24 hours.



Do not take more than 3 inhalations at any one time.

Children and adolescents (6 to 17 years)

If you forget to use Oxis Turbohaler



The usual dose is 1 inhalation before exercise.





A total daily dose of more than 2 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take up
to 4 inhalations a day. Your child should not use more than 4
inhalations in total in 24 hours.

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.



Your child should not have more than 1 inhalation 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.

Chronic obstructive pulmonary disease (COPD)


Only to be used by adults (aged 18 years and above).

4. POSSIBLE SIDE EFFECTS



The usual dose is 1 inhalation once or twice a day.



Your doctor may advise you to take extra doses for relief of
your COPD symptoms.

Like all medicines, Oxis Turbohaler can cause side effects,
although not everybody gets them.



You should not have more than 4 inhalations a day.



Do not take more than 2 inhalations at any one time.

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.

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

Other possible side effects:



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 first). You
should hear a click sound.




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.

Do this again, turning the turquoise grip in
both directions.



Muscle cramps.

Your Oxis Turbohaler is now ready for use.



Uneven heart beat.



Nausea (feeling sick).



Low level of potassium in your blood.

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.

Rare (affects less than 1 in 1,000 people)

 Allergic reactions such as rash, itching and bronchospasm.
Very rare (affects less than 1 in 10,000 people)

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



Chest pain or tightness in the chest (angina pectoris).



An increase in the amount of sugar (glucose) in your blood.

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.



Taste changes, such as an unpleasant taste in the mouth.



Changes in your blood pressure.



Feeling dizzy.

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.

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE OXIS TURBOHALER


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Keep container tightly closed.



Do not use after the expiry date printed on the carton or device
label.



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 turbohaler does not work properly, you should seek the
advice of your pharmacist who will tell you what to do.

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

6. FURTHER INFORMATION
What Oxis Turbohaler contains

When to start using a new Turbohaler


The Turbohaler contains 60 doses (inhalations). The dose
indicator tells you how many doses are left in the Turbohaler.



When you first see a red mark at the edge of the indicator
window, there are approximately 20 doses left. When the red
mark reaches the bottom of the indicator window, you must
start using your new Turbohaler.

Note:


The grip will still twist and ‘click’ even when your Turbohaler is
empty.



The sound that you hear as you shake your Turbohaler is
produced by a drying agent and not the medicine. Therefore the
sound does not tell you how much medicine is left in your
Turbohaler.



The active substance is formoterol fumarate dihydrate. Each
dose contains 12 micrograms of formoterol fumarate dihydrate
of which you can inhale 9 micrograms.



Wipe the outside of the mouthpiece once a week with a dry tissue.
Do not use water or liquids.

The inhaler also includes lactose monohydrate.

 Each Oxis Turbohaler contains 60 actuations.
What Oxis Turbohaler looks like and contents of the pack
Oxis Turbohaler is a metered dose, inspiratory flow driven, dry
powder inhaler, consisting of a dark turquoise greenish-blue turning
grip and white cover. On the bottom of the turning grip a braille
code for identification of formoterol is embossed, which works by
breathing in (inhaling) through the mouthpiece.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Oxis Turbohalers are manufactured by AstraZeneca Produtos
Farmaceuticos, Lda. Rua Humberto Madeira, 7 Valejas, Barcerena
2745-663 Portugal.
And
Astra Zeneca AB, 151 85 Sodertalje, Sweden.
POM

PL 19488/1019 Oxis Turbohaler 12

If you use more Oxis Turbohaler than you should

Leaflet revision date: 15 January 2014

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.

Oxis is a registered trade mark of AstraZeneca AB, Sweden.
S1019 LEAFLET Oxis 20140115

S1019 LEAFLET Formoterol 20140115

PACKAGE LEAFLET: INFORMATION FOR THE USER

FORMOTEROL 12 microgram TURBOHALER
(formoterol fumarate dihydrate)
This medicine is known as Formoterol 12 microgram Turbohaler but
will be referred to as Formoterol Turbohaler in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

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 have any further questions, ask your doctor or
pharmacist.

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.





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 you get pregnant while using Formoterol Turbohaler, do not
stop using Formoterol Turbohaler but talk to your doctor
immediately.





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.

If you are breast-feeding, talk to your doctor before using
Formoterol Turbohaler.



Keep this leaflet. You may need to read it again.



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

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’.

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


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.

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.

Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).



If you are using Formoterol Turbohaler regularly for asthma or
COPD you should continue to use your medicine, even if you
have no symptoms.

Asthma
For asthma, your doctor will prescribe two asthma inhalers:
Formoterol Turbohaler and a separate ‘corticosteroid’ inhaler.
These should be used together.

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.



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.

Contact your doctor immediately if:


Your breathing is getting worse or you often wake up at night
with asthma.

Formoterol Turbohaler can also be used before exercise to
prevent asthma symptoms caused by exercise.



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.



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 problems with your thyroid gland.



You have severe liver problems such as liver cirrhosis.



The usual dose is 1 inhalation, once or twice a day.



Your doctor may increase this to 2 inhalations, once or twice a
day.



Some people also use Formoterol Turbohaler as a ‘reliever
inhaler’. If you get asthma symptoms, the usual dose is 1
inhalation when they happen.



A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 6 inhalations a day. Do
not use more than 6 inhalations in total in 24 hours.

You have low levels of potassium in your blood. Your doctor
may take blood samples to check the levels of potassium in
your blood.



Formoterol Turbohaler should not be used in children under 6 years
of age.
Adults (18 years and above)

You have high blood pressure or you have ever had a heart
problem.



These signs could mean that your asthma or COPD is not being
properly controlled and you may need different or additional
treatment immediately.
Asthma

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.

 Do not take more than 3 inhalations at any one time.
Children and adolescents (6 to 17 years)


The usual dose is 1 inhalation 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 inhalation when they happen.



A total daily dose of more than 2 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take up
to 4 inhalations a day. Your child should not use more than 4
inhalations in total in 24 hours.



Your child should not have more than 1 inhalation at any one
time.

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.

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.



Erythromycin (used to treat infections).

Adults (18 years and above)



Anti-histamines (such as terfenadine).



The usual dose is 1 inhalation before exercise.



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).

A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 6 inhalations a day. Do
not use more than 6 inhalations in total in 24 hours.



Do not take more than 3 inhalations at any one time.

If any of the above applies to you, or if you are not sure, talk to your
doctor or pharmacist before using Formoterol Turbohaler.

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

Children and adolescents (6 to 17 years)

If you forget to use Formoterol Turbohaler



The usual dose is 1 inhalation before exercise.





A total daily dose of more than 2 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take up
to 4 inhalations a day. Your child should not use more than 4
inhalations in total in 24 hours.

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.



Your child should not have more than 1 inhalation at any one
time.

Chronic obstructive pulmonary disease (COPD)

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.



Only to be used by adults (aged 18 years and above).



The usual dose is 1 inhalation once or twice a day.



Your doctor may advise you to take extra doses for relief of
your COPD symptoms.



You should not have more than 4 inhalations a day.



If the following happens to you, stop using Formoterol
Turbohaler and talk to your doctor immediately:

Do not take more than 2 inhalations at any one time.



4. POSSIBLE SIDE EFFECTS
Like all medicines, Formoterol Turbohaler can cause side effects,
although not everybody gets them.

Preparing your new Formoterol Turbohaler

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.

Before using your new Formoterol Turbohaler for the first time,
you need to prepare it for use as
follows:

Other possible side effects:



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 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.

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).

How to take an inhalation



Low level of potassium in your blood.

Every time you need to take an inhalation, follow the instructions
below.



Allergic reactions such as rash, itching and bronchospasm.

1. Unscrew the white cover and lift it off.
2. Hold your Turbohaler upright with the turquoise grip at the
bottom.



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.

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.

Very rare (affects less than 1 in 10,000 people)

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.
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. Keep container tightly closed.



Do not use after the expiry date printed on the carton or device
label.



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.

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.

If the turbohaler does not work properly, you should seek the
advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

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.

What Formoterol Turbohaler contains
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a dry tissue.
Do not use water or liquids.
When to start using a new Turbohaler



The Turbohaler contains 60 doses (inhalations). The dose
indicator tells you how many doses are left in the Turbohaler.
When you first see a red mark at the edge of the indicator
window, there are approximately 20 doses left. When the red
mark reaches the bottom of the indicator window, you must
start using your new Turbohaler.

Note:


The grip will still twist and ‘click’ even when your Turbohaler is
empty.



The sound that you hear as you shake your Turbohaler is
produced by a drying agent and not the medicine. Therefore the
sound does not tell you how much medicine is left in your
Turbohaler.



The active substance is formoterol fumarate dihydrate. Each
dose contains 12 micrograms of formoterol fumarate dihydrate
of which you can inhale 9 micrograms.



The inhaler also includes lactose monohydrate.



Each Formoterol Turbohaler contains 60 actuations.

What Formoterol Turbohaler looks like and contents of the
pack
Formoterol Turbohaler is a metered dose, inspiratory flow driven,
dry powder inhaler, consisting of a dark turquoise greenish-blue
turning grip and white cover. On the bottom of the turning grip a
braille code for identification of formoterol is embossed, which
works by breathing in (inhaling) through the mouthpiece.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Formoterol Turbohalers are manufactured by AstraZeneca
Produtos Farmaceuticos, Lda. Rua Humberto Madeira, 7 Valejas,
Barcerena 2745-663 Portugal.
And
Astra Zeneca AB, 151 85 Sodertalje, Sweden.

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.

POM

PL 19488/1019

Leaflet revision date: 15 January 2014
S1019 LEAFLET Formoterol 20140115

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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