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FORMOTEROL FUMARATE DIHYDRATE 6 MICROGRAM TURBOHALER

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

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Add/Amend to correct part of the manufacturer
address from "S-151 85" to "SE-151 85".

By Aneela Mahmood at 4:33 pm, Jun 06, 2017

S1819 LEAFLET Oxis 20170530

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mock up

®

OXIS 6 TURBOHALER
(formoterol fumarate)

®

This medicine is known as Oxis 6 Turbohaler but will be referred to
as Oxis Turbohaler in this leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.


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



If you have any further questions, ask your doctor or
pharmacist.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet

The addition of anticholinergics (such as tiotropium or ipratropium
bromide) to the treatment with Oxis Turbohaler, can help to open
your airways even more.
Pregnancy, breast-feeding and fertility


If you are pregnant or breastfeeding, think you may be
pregnant, or are planning to have a baby, ask your doctor for
advice before taking this medicine - do not use Oxis Turbohaler
unless your doctor tells you to.



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

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

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.

6. Contents of the pack and other information



Do not increase the dose of Oxis Turbohaler prescribed by your
doctor without talking to your doctor first.

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



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

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’.

Important information about your asthma or COPD symptoms

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.

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.

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

Contact your doctor immediately if:

Asthma
Oxis Turbohaler is used to treat asthma in adults, adolescents and
children 6 years and older. For asthma, your doctor will prescribe
two asthma inhalers: Oxis Turbohaler and a separate
‘corticosteroid’ inhaler. These should be used together.


Oxis Turbohaler is used to help prevent asthma symptoms from
happening.



Some people also use Oxis Turbohaler when they need extra
doses for relief of asthma symptoms, to make it easier to
breathe again.



Oxis Turbohaler can also be used before exercise to prevent
asthma symptoms caused by exercise.
Chronic obstructive pulmonary disease (COPD)
Oxis Turbohaler can also be used to treat the symptoms of COPD
in adults. COPD is a long-term disease of the airways in the lungs,
which is often caused by cigarette smoking.



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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXIS
TURBOHALER



Your doctor may increase this to 4 inhalations, once or twice a
day.

Do not use Oxis Turbohaler:



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.



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.



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

You have problems with your thyroid gland.





The recommended dose is 2 inhalations, once or twice a day.

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





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.

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 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 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:

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



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.

Adults (18 years and above)



Steroid medicines that you take by mouth (such as
prednisolone).



The recommended dose is 2 inhalations before exercise.





Xanthine medicines (such as theophylline or aminophylline).
These are often used to treat asthma.



Erythromycin (used to treat infections).

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.



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 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.

 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.

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.

Chronic obstructive pulmonary disease (COPD)

4. POSSIBLE SIDE EFFECTS



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



The recommended dose is 2 inhalations once or twice a day.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



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

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



You should not have more than 8 inhalations a day.





Do not take more than 4 inhalations at any one time.

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:
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.






Common (may affect up to 1 in 10 people)


Unscrew the white cover and
lift it off. You may hear a
rattling sound.

Trembling or shaking. If these effects occur, they are usually
mild and usually disappear as you continue to use Oxis
Turbohaler.



Headache.

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



Feeling dizzy.



Nausea (feeling sick).



Muscle cramps.

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.

Uncommon (may affect up to 1 in 100 people)


Palpitations (awareness of your heart beating). If this effect
occurs, it is usually mild and usually disappear as you continue
to use Oxis Turbohaler.



Disturbed sleep.



Fast heart beat.



Allergic reactions such as rash, itching and bronchospasm.



Low level of potassium in your blood.



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



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

1. Unscrew the white cover and lift it off. You may hear a rattling
sound.



Changes in your blood pressure.



Uneven heart beat.

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



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



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.

3. Do not hold the mouthpiece when you load your Turbohaler. To
load your Turbohaler with a dose, turn the turquoise grip as far
as it will go in one direction. Then turn it as far as it will go in the
other direction (it does not matter which way you turn it first).
You should hear a click sound. Your Turbohaler is now loaded
and ready to use. Only load your Turbohaler when you need to
use it.
4. Hold your Turbohaler away from your mouth. Breathe out gently
(as far as is comfortable). Do not breathe out through your
Turbohaler.

Rare (may affect up to 1 in 1,000 people)


Feeling restless or agitated.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

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.

By reporting side effects you can help provide more information on
the safety of this medicine.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.



This medicinal product does not require any special storage
conditions.



When not in use, Oxis Turbohaler should be stored with the
cover tightened.



Do not use this medicine after the expiry date which is stated 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. Do not throw
away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.

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

5. HOW TO STORE OXIS TURBOHALER

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Oxis Turbohaler contains


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

The active substance is formoterol fumarate dihydrate.
Each dose contains 6 micrograms of formoterol fumarate
dihydrate of which you can inhale 4.5 micrograms.


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.

The other ingredient is lactose monohydrate (which contains
milk proteins). See section 2 Oxis Turbohaler contains lactose.
What Oxis Turbohaler looks like and contents of the pack


A multi-dose, dry powder inhaler made of plastic materials. The
inhaler is white with a dose counter and has a light greenishblue turning grip. On the bottom of the turning grip Braille ‘5’ is
embossed. The contents are white to off-white rounded
granules.



Oxis Turbohaler is available in packs of 60 doses (1 Inhaler).

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.

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.

Manufacturer
This product is manufactured by AstraZeneca AB, SE-151 85
Sodertalje, Sweden.
POM

PL 19488/1819

Leaflet revision date: 30 May 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Oxis and Turbohaler are a registered trade mark of AstraZeneca
AB, Sweden.
S1819 LEAFLET Oxis 20170530

S1819 LEAFLET Formoterol 20170530

PACKAGE LEAFLET: INFORMATION FOR THE USER

FORMOTEROL FUMARATE DIHYDRATE 6 microgram
TURBOHALER
This medicine is known as Formoterol Fumarate Dihydrate 6
microgram Turbohaler but will be referred to as Formoterol
Turbohaler in this leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

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, breast-feeding and fertility


If you are pregnant or breastfeeding, think you may be
pregnant, or are planning to have a baby, ask your doctor for
advice before taking this medicine - do not use Formoterol
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.



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.

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



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.

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.

What is in this leaflet
1. What Formoterol Turbohaler is and what it is used for
2. What you need to know before you use Formoterol Turbohaler
3. How to use Formoterol Turbohaler

Driving and using machines

Formoterol Turbohaler contains lactose

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

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

3. HOW TO USE FORMOTEROL TURBOHALER

6. Contents of the pack and other information



Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.

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



Do not increase the dose of Formoterol Turbohaler prescribed
by your doctor without talking to your doctor first.

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.

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

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

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.

Asthma

Contact your doctor immediately if:

Formoterol Turbohaler is used to treat asthma in adults,
adolescents and children 6 years and older. For asthma, your
doctor will prescribe two asthma inhalers: Formoterol Turbohaler
and a separate ‘corticosteroid’ inhaler. These should be used
together.



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.



Formoterol Turbohaler is used to help prevent asthma
symptoms from happening.



You need to take more than your usual dose for more than two
days in a week.



Some people also use Formoterol Turbohaler when they need
extra doses for relief of asthma symptoms, to make it easier to
breathe again.



You need to use your Turbohaler more often than usual before
exercise.



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

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

Chronic obstructive pulmonary disease (COPD)

Asthma

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.

Formoterol Turbohaler should not be used in children under 6 years
of age.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
FORMOTEROL TURBOHALER

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 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 use Formoterol Turbohaler:


If you are allergic (hypersensitive) to formoterol, or any of the
other ingredients of this medicine (listed in section 6).

Warnings and Precautions
Talk to your doctor or pharmacist before using Formoterol
Turbohaler 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.



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

You have problems with your thyroid gland.





The recommended dose is 2 inhalations, once or twice a day.

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





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.

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 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 are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Formoterol Turbohaler.
Other medicines and Formoterol Turbohaler
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines that you
buy without a prescription and herbal medicines. This is because
Formoterol 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).

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 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.

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.

Chronic obstructive pulmonary disease (COPD)


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



The recommended dose is 2 inhalations once or twice a day.



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



You should not have more than 8 inhalations a day.



Do not take more than 4 inhalations at any one time.

Preparing your new Formoterol 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.

If you have any further questions on using your Turbohaler, ask
your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If the following happens to you, stop using Formoterol
Turbohaler and talk to your doctor immediately:


Bronchospasm (tightening of the muscles in the airways which
causes sudden wheezing) after inhaling your medicine. This
happens very rarely, may affect up to 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)


Trembling or shaking. If these effects occur, they are usually
mild and usually disappear as you continue to use Formoterol
Turbohaler.



Headache.



Feeling dizzy.



Nausea (feeling sick).



Muscle cramps.

Uncommon (may affect up to 1 in 100 people)


Your Formoterol Turbohaler is now ready
for use.
How to take an inhalation

Palpitations (awareness of your heart beating). If this effect
occurs, it is usually mild and usually disappear as you continue
to use Formoterol Turbohaler.



Disturbed sleep.



Fast heart beat.

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. You may hear a rattling
sound.



Low level of potassium in your blood.



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

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



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



Changes in your blood pressure.

3. Do not hold the mouthpiece when you load your Turbohaler. To
load your Turbohaler with a dose, turn the turquoise grip as far
as it will go in one direction. Then turn it as far as it will go in the
other direction (it does not matter which way you turn it first).
You should hear a click sound. Your Turbohaler is now loaded
and ready to use. Only load your Turbohaler when you need to
use it.



Uneven heart beat.



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

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



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.

Rare (may affect up to 1 in 1,000 people)


Feeling restless or agitated.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly 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.



This medicinal product does not require any special storage
conditions.



When not in use, Formoterol Turbohaler should be stored with
the cover tightened.

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.

Do not use this medicine after the expiry date which is stated 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. Do not throw
away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.

7. If you are to take a second inhalation, repeat steps 2 to 6.

As with all inhalers, caregivers should ensure that children
prescribed Formoterol 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Formoterol 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). See section 2 Formoterol Turbohaler contains
lactose.

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 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.

What Formoterol Turbohaler looks like and contents of the
pack


A multi-dose, dry powder inhaler made of plastic materials. The
inhaler is white with a dose counter and has a light greenishblue turning grip. On the bottom of the turning grip Braille ‘5’ is
embossed. The contents are white to off-white rounded
granules.



Formoterol Turbohaler is available in packs of 60 doses (1
Inhaler).

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 AB,
SE-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.
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.

POM

PL 19488/1819

Leaflet revision date: 30 May 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
S1819 LEAFLET Formoterol 20170530

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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