Skip to Content

FORMOTEROL FUMARATE DIHYDRATE 6 MICROGRAMS DRY POWDER INHALER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
®
®

Oxis 6 Turbohaler

(formoterol fumarate dihydrate)
Powder for Inhalation. 6 micrograms/actuation.
Read all of this leaflet carefully before you start
If any of the above applies to you, or if you are not sure,
taking this medicine because it contains important
talk to your doctor or pharmacist before using Oxis
information for you.
Turbohaler.
Keep this leaflet. You may need to read it again.
Also tell your doctor or pharmacist if you are going to
If you have any further questions, ask your doctor or
have a general anaesthetic for an operation or for dental
pharmacist.
work.
This medicine has been prescribed for you only. Do
The addition of anticholinergics (such as tiotropium or
not pass it on to others. It may harm them, even if
ipratropium bromide) to the treatment with Oxis
their signs of illness are the same as yours.
Turbohaler, can help to open your airways even more.
If you get any side effects, talk to your doctor or
Pregnancy and breast-feeding
pharmacist. This includes any possible side effects
If you are pregnant or breast-feeding, think you may
not listed in this leaflet. See section 4.
be pregnant, or are planning to have a baby, ask
®
®
The name of your medicine is Oxis 6 Turbohaler but
your doctor for advice before taking this medicine will be referred to as Oxis Turbohaler or Turbohaler
do not use Oxis Turbohaler unless your doctor tells
throughout this leaflet.
you to.
If you get pregnant while using Oxis Turbohaler, do
What is in this leaflet:
not stop using Oxis Turbohaler but talk to your
1. What Oxis Turbohaler is and what it is used for
doctor immediately.
2. What you need to know before you use Oxis
Turbohaler
Driving and using machines
3. How to use Oxis Turbohaler
Oxis Turbohaler is not likely to affect you being able to
4. Possible side effects
drive or use any tools or machines.
5. How to store Oxis Turbohaler
Oxis Turbohaler contains lactose
6. Contents of the pack and other information
Oxis Turbohaler contains lactose, which is a type of
sugar. If you have been told by your doctor that you
1. What Oxis Turbohaler is and what it is used
have an intolerance to some sugars, talk to your doctor
for
before using this medicine. The amount of lactose in this
Oxis Turbohaler is an inhaler. It contains a medicine
medicine does not normally cause problems in people
called formoterol. This belongs to a group of medicines
who are lactose intolerant.
called ‘long-acting beta-agonists’ or ‘bronchodilators’.
The excipient lactose contains small amounts of milk
It works by relaxing the muscles in your airways. This
proteins, which may cause allergic reactions.
helps you to breathe more easily. It starts to work within
1 to 3 minutes and the effects last up to 12 hours.
3. How to use Oxis Turbohaler
Your doctor has prescribed this medicine to treat
Always use this medicine exactly as your doctor or
asthma or chronic obstructive pulmonary disease
pharmacist has told you. Check with your doctor or
(COPD).
pharmacist if you are not sure.
Asthma
Do not increase the dose of Oxis Turbohaler
Oxis Turbohaler is used to treat asthma in adults,
prescribed by your doctor without talking to your
adolescents and children 6 years and older. For asthma,
doctor first.
your doctor will prescribe two asthma inhalers: Oxis
If you are using Oxis Turbohaler regularly for
Turbohaler and a separate ‘corticosteroid’ inhaler.
asthma or COPD you should continue to use your
These should be used together.
medicine, even if you have no symptoms.
Oxis Turbohaler is used to help prevent asthma
Important information about your asthma or COPD
symptoms from happening.
symptoms
Some people also use Oxis Turbohaler when they
If you feel you are getting breathless or wheezy while
need extra doses for relief of asthma symptoms, to
using Oxis Turbohaler, you should continue to use Oxis
make it easier to breathe again.
Turbohaler but go to see your doctor as soon as
Oxis Turbohaler can also be used before exercise to
possible, as you may need additional treatment.
prevent asthma symptoms caused by exercise.
Contact your doctor immediately if:
Chronic obstructive pulmonary disease (COPD)
Your breathing is getting worse or you often wake
Oxis Turbohaler can also be used to treat the symptoms
up at night with asthma.
of COPD in adults. COPD is a long-term disease of the
You start getting chest tightness.
airways in the lungs, which is often caused by cigarette
You are not getting relief from your current dose.
smoking.
You need to take more than your usual dose for
more than two days in a week.
2. What you need to know before you use Oxis
You need to use your Turbohaler more often than
Turbohaler
usual before exercise.
Do not use Oxis Turbohaler:
These signs could mean that your asthma or COPD is
If you are allergic (hypersensitive) to formoterol, or
not being properly controlled and you may need different
any of the other ingredients of this medicine (listed
or additional treatment immediately.
in section 6).
Asthma
Warnings and Precautions
Oxis Turbohaler should not be used in children under 6
Talk to your doctor or pharmacist before using
years of age.
Oxis Turbohaler if:
Adults (18 years and above)
You are diabetic. You may need some additional
The recommended dose is 1 or 2 inhalations, once
blood sugar tests while you are using Oxis
or twice a day.
Turbohaler.
Your doctor may increase this to 4 inhalations, once
You have high blood pressure or you have ever had
or twice a day.
a heart problem.
Some people also use Oxis Turbohaler as a ‘reliever
You have problems with your thyroid gland.
inhaler’. If you get asthma symptoms, the usual
You have low levels of potassium in your blood.
dose is 1 or 2 inhalations when they happen.
Your doctor may take blood samples to check the
A total daily dose of more than 8 inhalations is not
levels of potassium in your blood.
normally needed. This includes the inhalations that
You have severe liver problems such as liver
you take every day, when you get asthma
cirrhosis.
symptoms and before exercise. However, your
If you are not sure if any of the above apply to you, talk
doctor may allow you to take up to 12 inhalations a
to your doctor or pharmacist before using Oxis
day. Do not use more than 12 inhalations in total in
Turbohaler.
24 hours.
Other medicines and Oxis Turbohaler
Do not take more than 6 inhalations at any one time.
Tell your doctor or pharmacist if you are taking, have
Children and adolescents (6 to 17 years)
recently taken or might take any other medicines. This
The recommended dose is 2 inhalations, once or
includes medicines that you buy without a prescription
twice a day.
and herbal medicines. This is because Oxis Turbohaler
Some children also use Oxis Turbohaler as a
can affect the way some medicines work and some
‘reliever inhaler’. If your child gets asthma
medicines can have an effect on Oxis Turbohaler.
symptoms, the usual dose is 1 or 2 inhalations when
In particular, tell your doctor or pharmacist if you are
they happen.
taking any of the following medicines:
A total daily dose of more than 4 inhalations is not
Beta-blocker medicines (such as atenolol or
normally needed. This includes the inhalations that
propranolol for high blood pressure), including
your child takes every day, when they get asthma
eyedrops (such as timolol for glaucoma).
symptoms and before exercise. However, your
Medicines for a fast or uneven heart beat (such as
doctor may allow your child to take up to 8
quinidine).
inhalations a day. Your child should not use more
Medicines like digoxin, often used to treat heart
than 8 inhalations in total in 24 hours.
failure.
Your child should not have more than 2 inhalations
Diuretics, also known as ‘water tablets’ (such as
at any one time.
furosemide). These are used to treat high blood
Your doctor (or asthma nurse) will help you to manage
pressure.
your asthma. Once your asthma is well controlled your
Steroid medicines that you take by mouth (such as
doctor may consider it appropriate to gradually reduce
prednisolone).
the dose of Oxis Turbohaler.
Xanthine medicines (such as theophylline or
Asthma caused by exercise
aminophylline). These are often used to treat
If you or your child have asthma symptoms caused by
asthma.
exercise, your doctor may advise you or your child to
Erythromycin (used to treat infections).
use Oxis Turbohaler before exercise as well. Oxis
Anti-histamines (such as terfenadine).
Turbohaler should not be used in children under 6 years
Other substances that dilate the airways
of age.
(bronchodilators, such as salbutamol).
Adults (18 years and above)
Ephedrine (used to treat asthma or as a
decongestant).
The recommended dose is 2 inhalations before
exercise.
Tricyclic anti-depressants (such as amitriptyline).
.

.

.

.

.

.

.

A total daily dose of more than 8 inhalations is not
normally needed. This includes the inhalations that
you take every day, when you get asthma
symptoms and before exercise. However, your
doctor may allow you to take up to 12 inhalations a
day. Do not use more than 12 inhalations in total in
24 hours.
Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
The recommended dose is 1 or 2 inhalations before
exercise.
A total daily dose of more than 4 inhalations is not
normally needed. This includes the inhalations that
your child takes every day, when they get asthma
symptoms and before exercise. However, your
doctor may allow your child to take up to 8
inhalations a day. Your child should not use more
than 8 inhalations in total in 24 hours.
Your child should not have more than 2 inhalations
at any one time.
.

Chronic obstructive pulmonary disease (COPD)
Only to be used by adults (aged 18 years and
above).
The recommended dose is 2 inhalations once or
twice a day.
Your doctor may advise you to take extra doses for
relief of your COPD symptoms.
You should not have more than 8 inhalations a day.
Do not take more than 4 inhalations at any one time.
Preparing your new Oxis Turbohaler Inhaler
Before using your new
Oxis Turbohaler for the first
time, you need to prepare it for
use as follows.
Unscrew the white cover
and lift it off. You may hear
a rattling sound.
Hold your Oxis Turbohaler
upright with the turquoise
grip at the bottom.
Turn the turquoise grip as
far as it will go in one
direction. Then turn it as far
as it will go in the other
direction (it does not matter
which way you turn it first).
You should hear a click
sound.
Do this again, turning the turquoise grip in both
directions.
Your Oxis Turbohaler is now ready for use.
1.

How to take an inhalation
Every time you need to take an inhalation, follow the
instructions below.
1. Unscrew the white cover and lift it off. You may
hear a rattling sound.
2. Hold your Turbohaler upright with the turquoise
grip at the bottom.
3. Do not hold the mouthpiece when you load your
Turbohaler. To load your Turbohaler with a dose,
turn the turquoise grip as far as it will go in one
direction. Then turn it as far as it will go in the
other direction (it does not matter which way you
turn it first). You should hear a click sound. Your
Turbohaler is now loaded and ready to use. Only
load your Turbohaler when you need to use it.
4. Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable). Do
not breathe out through your Turbohaler.
5. Place the mouthpiece
gently between your teeth.
Close your lips. Breathe in
as deeply and as hard as
you can through your
mouth. Do not chew or bite
on the mouthpiece.
6. Remove your Turbohaler from your mouth.
Then breathe out gently. The amount of
medicine that is inhaled is very small. This means
you may not be able to taste it after inhalation. If
you have followed the instructions, you can still be
confident that you have inhaled the dose and the
medicine is now in your lungs.
7. If you are to take a second inhalation, repeat
steps 2 to 6.
8. Replace the cover tightly after use.
Do not try to remove or twist the mouthpiece. It is
fixed to your Turbohaler and must not be taken off. Do
not use your Turbohaler if it has been damaged or if
the mouthpiece has come apart from your Turbohaler.
As with all inhalers, caregivers should ensure that
children prescribed Oxis Turbohaler use correct
inhalation technique, as described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a
dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
The Turbohaler contains 60 doses (inhalations). The
dose indicator tells you how many doses are left in
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.
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.
.

.

.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If the following happens to you, stop using Oxis
Turbohaler and talk to your doctor immediately:
Bronchospasm (tightening of the muscles in the
airways which causes sudden wheezing) after
inhaling your medicine. This happens very rarely,
may affect up to 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Palpitations (awareness of your heart beating),
trembling or shaking. If these effects occur, they are
usually mild and usually disappear as you continue
to use Oxis Turbohaler.
Headache.
Uncommon (may affect up to 1 in 100 people)
Feeling restless or agitated.
Disturbed sleep.
Fast heart beat.
Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
Uneven heart beat.
Nausea (feeling sick).
Low level of potassium in your blood.
Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
Chest pain or tightness in the chest (angina
pectoris).
An increase in the amount of sugar (glucose) in your
blood.
Taste changes, such as an unpleasant taste in the
mouth.
Changes in your blood pressure.
Feeling dizzy.
Reporting of side effects
If you get any side effects, talk to your doctor 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 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. Contents of the pack and other 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.
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®
POM
PL No: 18799/1978
Leaflet date: 29.07.2015
Oxis and Turbohaler are trade marks of the
AstraZeneca group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Formoterol Fumarate dihydrate 6 dry powder inhaler
Powder for Inhalation. 6 micrograms/actuation.
Read all of this leaflet carefully before you start
If any of the above applies to you, or if you are not sure,
taking this medicine because it contains important
talk to your doctor or pharmacist before using
information for you.
Formoterol inhaler.
Keep this leaflet. You may need to read it again.
Also tell your doctor or pharmacist if you are going to
If you have any further questions, ask your doctor or
have a general anaesthetic for an operation or for dental
pharmacist.
work.
This medicine has been prescribed for you only. Do
The addition of anticholinergics (such as tiotropium or
not pass it on to others. It may harm them, even if
ipratropium bromide) to the treatment with Formoterol
their signs of illness are the same as yours.
inhaler, can help to open your airways even more.
If you get any side effects, talk to your doctor or
Pregnancy and breast-feeding
pharmacist. This includes any possible side effects
If you are pregnant or breast-feeding, think you may
not listed in this leaflet. See section 4.
be pregnant, or are planning to have a baby, ask
The name of your medicine is Formoterol Fumarate
your doctor for advice before taking this medicine dihydrate 6 inhaler but will be referred to as Formoterol
do not use Formoterol inhaler unless your doctor
inhaler or inhaler throughout this leaflet.
tells you to.
If you get pregnant while using Formoterol inhaler,
What is in this leaflet:
do not stop using Formoterol inhaler but talk to your
1. What Formoterol inhaler is and what it is used for
doctor immediately.
2. What you need to know before you use Formoterol
inhaler
Driving and using machines
3. How to use Formoterol inhaler
Formoterol inhaler is not likely to affect you being able to
4. Possible side effects
drive or use any tools or machines.
5. How to store Formoterol inhaler
Formoterol inhaler contains lactose
6. Contents of the pack and other information
Formoterol inhaler contains lactose, which is a type of
sugar. If you have been told by your doctor that you
1. What Formoterol inhaler is and what it is used
have an intolerance to some sugars, talk to your doctor
for
before using this medicine. The amount of lactose in this
Formoterol inhaler is an inhaler. It contains a medicine
medicine does not normally cause problems in people
called formoterol. This belongs to a group of medicines
who are lactose intolerant.
called ‘long-acting beta-agonists’ or ‘bronchodilators’.
The excipient lactose contains small amounts of milk
It works by relaxing the muscles in your airways. This
proteins, which may cause allergic reactions.
helps you to breathe more easily. It starts to work within
1 to 3 minutes and the effects last up to 12 hours.
3. How to use Formoterol inhaler
Your doctor has prescribed this medicine to treat
Always use this medicine exactly as your doctor or
asthma or chronic obstructive pulmonary disease
pharmacist has told you. Check with your doctor or
(COPD).
pharmacist if you are not sure.
Asthma
Do not increase the dose of Formoterol inhaler
Formoterol inhaler is used to treat asthma in adults,
prescribed by your doctor without talking to your
adolescents and children 6 years and older. For asthma,
doctor first.
your doctor will prescribe two asthma inhalers:
If you are using Formoterol inhaler regularly for
Formoterol inhaler and a separate ‘corticosteroid’
asthma or COPD you should continue to use your
inhaler.
medicine, even if you have no symptoms.
These should be used together.
Important information about your asthma or COPD
Formoterol inhaler is used to help prevent asthma
symptoms
symptoms from happening.
If you feel you are getting breathless or wheezy while
Some people also use Formoterol inhaler when they
using Formoterol inhaler, you should continue to use
need extra doses for relief of asthma symptoms, to
Formoterol inhaler but go to see your doctor as soon as
make it easier to breathe again.
possible, as you may need additional treatment.
Formoterol inhaler can also be used before exercise
Contact your doctor immediately if:
to prevent asthma symptoms caused by exercise.
Your breathing is getting worse or you often wake
Chronic obstructive pulmonary disease (COPD)
up at night with asthma.
Formoterol inhaler can also be used to treat the
You start getting chest tightness.
symptoms of COPD in adults. COPD is a long-term
You are not getting relief from your current dose.
disease of the airways in the lungs, which is often
You need to take more than your usual dose for
caused by cigarette smoking.
more than two days in a week.
You need to use your Inhaler more often than usual
2. What you need to know before you use
before exercise.
Formoterol inhaler
These
signs could mean that your asthma or COPD is
Do not use Formoterol inhaler:
not being properly controlled and you may need different
If you are allergic (hypersensitive) to formoterol, or
or additional treatment immediately.
any of the other ingredients of this medicine (listed
Asthma
in section 6).
Formoterol inhaler should not be used in children under
Warnings and Precautions
6 years of age.
Talk to your doctor or pharmacist before using
Adults (18 years and above)
Formoterol inhaler if:
The recommended dose is 1 or 2 inhalations, once
You are diabetic. You may need some additional
or twice a day.
blood sugar tests while you are using Formoterol
Your doctor may increase this to 4 inhalations, once
inhaler.
or twice a day.
You have high blood pressure or you have ever had
a heart problem.
Some people also use Formoterol inhaler as a
‘reliever inhaler’. If you get asthma symptoms, the
You have problems with your thyroid gland.
usual dose is 1 or 2 inhalations when they happen.
You have low levels of potassium in your blood.
A total daily dose of more than 8 inhalations is not
Your doctor may take blood samples to check the
normally needed. This includes the inhalations that
levels of potassium in your blood.
you take every day, when you get asthma
You have severe liver problems such as liver
symptoms and before exercise. However, your
cirrhosis.
doctor may allow you to take up to 12 inhalations a
If you are not sure if any of the above apply to you, talk
day. Do not use more than 12 inhalations in total in
to your doctor or pharmacist before using Formoterol
24 hours.
inhaler.
Do not take more than 6 inhalations at any one time.
Other medicines and Formoterol inhaler
Children and adolescents (6 to 17 years)
Tell your doctor or pharmacist if you are taking, have
The recommended dose is 2 inhalations, once or
recently taken or might take any other medicines. This
twice a day.
includes medicines that you buy without a prescription
Some children also use Formoterol inhaler as a
and herbal medicines. This is because Formoterol
‘reliever inhaler’. If your child gets asthma
inhaler can affect the way some medicines work and
symptoms, the usual dose is 1 or 2 inhalations when
some medicines can have an effect on Formoterol
they happen.
inhaler.
A total daily dose of more than 4 inhalations is not
In particular, tell your doctor or pharmacist if you are
normally needed. This includes the inhalations that
taking any of the following medicines:
your child takes every day, when they get asthma
Beta-blocker medicines (such as atenolol or
symptoms and before exercise. However, your
propranolol for high blood pressure), including
doctor may allow your child to take up to 8
eyedrops (such as timolol for glaucoma).
inhalations a day. Your child should not use more
Medicines for a fast or uneven heart beat (such as
than 8 inhalations in total in 24 hours.
quinidine).
Your child should not have more than 2 inhalations
Medicines like digoxin, often used to treat heart
at any one time.
failure.
Your doctor (or asthma nurse) will help you to manage
Diuretics, also known as ‘water tablets’ (such as
your asthma. Once your asthma is well controlled your
furosemide). These are used to treat high blood
doctor may consider it appropriate to gradually reduce
pressure.
the dose of Formoterol inhaler.
Steroid medicines that you take by mouth (such as
Asthma caused by exercise
prednisolone).
If you or your child have asthma symptoms caused by
Xanthine medicines (such as theophylline or
exercise, your doctor may advise you or your child to
aminophylline). These are often used to treat
use Formoterol inhaler before exercise as well.
asthma.
Formoterol inhaler should not be used in children under
Erythromycin (used to treat infections).
6 years of age.
Anti-histamines (such as terfenadine).
Adults (18 years and above)
Other substances that dilate the airways
(bronchodilators, such as salbutamol).
The recommended dose is 2 inhalations before
Ephedrine (used to treat asthma or as a
exercise
decongestant).
Tricyclic anti-depressants (such as amitriptyline).
.

.

.

A total daily dose of more than 8 inhalations is not
normally needed. This includes the inhalations that
you take every day, when you get asthma
symptoms and before exercise. However, your
doctor may allow you to take up to 12 inhalations a
day. Do not use more than 12 inhalations in total in
24 hours.
Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
The recommended dose is 1 or 2 inhalations before
exercise.
A total daily dose of more than 4 inhalations is not
normally needed. This includes the inhalations that
your child takes every day, when they get asthma
symptoms and before exercise. However, your
doctor may allow your child to take up to 8
inhalations a day. Your child should not use more
than 8 inhalations in total in 24 hours.
Your child should not have more than 2 inhalations
at any one time.
Chronic obstructive pulmonary disease (COPD)
Only to be used by adults (aged 18 years and
above).
The recommended dose is 2 inhalations once or
twice a day.
Your doctor may advise you to take extra doses for
relief of your COPD symptoms.
You should not have more than 8 inhalations a day.
Do not take more than 4 inhalations at any one time.
Preparing your new Formoterol inhaler Inhaler
Before using your new
Formoterol inhaler 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
inhaler 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 inhaler is now ready for use.
1.

How to take an inhalation
Every time you need to take an inhalation, follow the
instructions below.
1. Unscrew the white cover and lift it off. You may
hear a rattling sound.
2. Hold your Inhaler upright with the turquoise grip
at the bottom.
3. Do not hold the mouthpiece when you load your
Inhaler. To load your Inhaler 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 Inhaler
is now loaded and ready to use. Only load your
Inhaler when you need to use it.
4. Hold your Inhaler away from your mouth. Breathe
out gently (as far as is comfortable). Do not
breathe out through your Inhaler.
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 Inhaler 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 Inhaler and must not be taken off. Do not
use your Inhaler if it has been damaged or if the
mouthpiece has come apart from your Inhaler.
As with all inhalers, caregivers should ensure that
children prescribed Formoterol inhaler use correct
inhalation technique, as described above.
Cleaning your Inhaler
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 Inhaler
The Inhaler contains 60 doses (inhalations). The
dose indicator tells you how many doses are left in
the Inhaler.
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
Inhaler.

Note:
The grip will still twist and ‘click’ even when your
Inhaler is empty.

The sound that you hear as you shake your Inhaler
is produced by a drying agent and not the medicine.
Therefore the sound does not tell you how much
medicine is left in your Inhaler.
If you load your Formoterol inhaler more than once
by mistake before taking your dose, you will still only
receive one dose. However, the dose indicator will
register all the loaded doses.
..

If you use more Formoterol inhaler than you should
If you use more Formoterol inhaler 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 inhaler
If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for your next
dose, skip the missed dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop using Formoterol inhaler
Do not stop using Formoterol inhaler without talking to
your doctor.
If you have any further questions on using your Inhaler,
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 inhaler and talk to your doctor
immediately:
Bronchospasm (tightening of the muscles in the
airways which causes sudden wheezing) after
inhaling your medicine. This happens very rarely,
may affect up to 1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Palpitations (awareness of your heart beating),
trembling or shaking. If these effects occur, they are
usually mild and usually disappear as you continue
to use Formoterol inhaler.
Headache.
Uncommon (may affect up to 1 in 100 people)
Feeling restless or agitated.
Disturbed sleep.
Fast heart beat.
Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
Uneven heart beat.
Nausea (feeling sick).
Low level of potassium in your blood.
Allergic reactions such as rash, itching and
bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
Chest pain or tightness in the chest (angina
pectoris).
An increase in the amount of sugar (glucose) in your
blood.
Taste changes, such as an unpleasant taste in the
mouth.
Changes in your blood pressure.
Feeling dizzy.
Reporting of side effects
If you get any side effects, talk to your doctor 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 inhaler
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 inhaler after the expiry date
printed on the carton or on the side of your Inhaler.
The expiry date refers to the last day of that month.
Always be sure to dispose of your used Inhaler
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. Contents of the pack and other information
What Formoterol inhaler 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 inhaler looks like and contents of
the pack
Formoterol inhaler is an inhaler containing your
medicine. The Inhaler 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 Inhaler contains 60 actuations.
Manufactured by: AstraZeneca AB, S-151 85
Södertälje, Sweden.
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 dry powder inhaler
PL No: 18799/1978
POM
Leaflet date: 29.07.2015

Expand view ⇕

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.

Hide