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FORADIL 12 MICROGRAM INHALATION CAPSULES

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

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Patient Information Leaflet



Foradil® 12microgram
Inhalation Capsules
(formoterol fumarate)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
 Keep this leaflet. You may need to read
it again.
 If you have any further questions, ask
your doctor or pharmacist.
 This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
 If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet (see section 4).
The name of your medicine is Foradil
12microgram Inhalation Capsules but will be
referred to as Foradil throughout this leaflet.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Foradil is and what it is used for
Before you take Foradil
How to take Foradil
Possible side effects
How to store Foradil
Contents of the pack and other
information

1. What Foradil is and what it is
used for
The Foradil pack includes a blister pack of
capsules containing the medicine and an
inhaler device for taking the medicine. The
capsules are for inhalation use only.
Instructions for using the inhaler are given
later on in the leaflet.
The active ingredient in this medicine is
formoterol fumarate dihydrate.
Formoterol fumarate dihydrate is one of a
group of medicines called long‑acting
bronchodilators. It makes breathing easier
by relaxing muscle spasms in the air
passages of the lungs.



Foradil is used to treat asthma in people
who are already taking inhaled steroids
but still have symptoms such as
wheezing and breathlessness. Taking
Foradil regularly together with inhaled
steroids will help to prevent breathing
problems
Foradil is also used to treat breathing
problems in patients with chronic
obstructive pulmonary disease (COPD)







2. Before you take Foradil
Do not take Foradil if:
 you are allergic to formoterol fumarate
dihydrate or any of the other ingredients
of this medicine (listed in section 6).




Foradil is not suitable for children under six
years of age.
Talk to your doctor or pharmacist before
taking Foradil if you:
 are taking any other asthma medicine
 suffer from any heart problems
 have high blood pressure
 have an overactive thyroid gland
 have an aneurysm (area where an artery
is swollen because the wall of the artery
is weak)
 have a heart disorder such as abnormal
electrical signal called 'prolongation of
QT interval'
 are diabetic
 have pheochromocytoma (a tumor of the
adrenal gland that can affect
blood pressure)
Other medicines and Foradil
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, particularly:
 Medicines for heart conditions including
irregular heart beats, angina and heart
failure
 Medicines for high blood pressure
 Beta blockers (either as tablets or eye
drops)
 Water tablets (diuretics)
 Medicines for depression, for example,
monoamine oxidase inhibitors (MAOIs)
or tricyclics
 Anti-histamines or cold remedies
(including any bought from the chemist)



Medicines called ‘steroids’. Your doctor
will know which these are
Sympathomimetic agents, which are
adrenaline-like medicines used to treat
asthma and nasal congestion
Phenothiazines, which are a group of
medicines which control mental
disorders such as schizophrenia, mania,
psychotic conditions and anxiety
Xanthines, for example theophylline or
aminophylline, which are a class of
medicines used to treat asthma and
chronic obstructive airways diseases
Macrolides (for example Erythromycin)
used to treat bacterial infections
Anaesthetics like Halogenated
hydrocarbons (for example Halothane).
These drugs are used to produce
anaesthesia during surgery
Anticholinergic drugs (for example
Ipratropium bromide) used to treat
gastrointestinal disorders and
genitourinary disorders

Other special warnings










You must not use Foradil to treat a
sudden asthma attack. Your doctor will
have given you another inhaler (a
‘reliever’) for this
It is very important to keep using your
other asthma medicines, (inhaled
steroids known as a ‘preventer’),
regularly. DO NOT stop using them or
change the dose when you start using
Foradil
If you feel that you are getting breathless
or wheezy while you are using Foradil,
you should continue to use it, but go to
see your doctor as soon as possible in
case you need another medicine
Treatment with Foradil may lead to your
blood level of potassium becoming too
low. This may make you more
susceptible to abnormal heart rhythm.
Therefore, your doctor may monitor your
blood level of potassium, especially if
you have severe asthma
Treatment with Foradil may lead to
increased sugar levels in the blood.
Therefore, you might need to monitor
your blood sugar levels if you are
diabetic

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.

For the treatment of COPD (Chronic
Obstructive Pulmonary Disease)

Driving and using machines
In some patients, Foradil has been reported
to cause dizziness. If you feel dizzy, do
not drive or operate machinery.

Children under 18
 Not applicable

Foradil contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to take Foradil

Adults and the elderly
 The usual dose is 1 puff in the morning
and evening

The effects of this medicine will normally last
for 12 hours. If you do get attacks of
wheezing between doses, do not take extra
doses of Foradil. Your doctor will have
prescribed another medicine for this
purpose. If you are not sure about this,
check with your doctor.
Do not stop or reduce the dose of
Foradil or any other medicine for your
breathing just because you feel better,
without talking to your doctor first. It is
very important to use these medicines
regularly
Do not increase your dose of Foradil
without talking to your doctor first
If you feel sick or very shaky or if you
have an unusually fast heart beat, your
Foradil dose may be too high. Tell your
doctor as soon as possible

3. Take one of today's
capsules out of the
blister strip. Place it
in the capsuleshaped
compartment in the
base of the inhaler.
It is important that
you remove the
capsule from the
blister pack only
immediately
before you use it.

How to use the capsules with the
inhaler device
A child should be shown how to use the
inhaler correctly and should only use it with
the help of an adult.

4. Twist the
mouthpiece to the
closed position until
it clicks.



Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
Foradil capsules must only be used with the
inhaler provided. You must not try to inhale
them using another inhaler. Also, do not put
other types of capsules into the inhaler
supplied with Foradil.
Do not swallow the capsules. The
contents of the capsule must be inhaled
using the inhaler provided.
For the treatment of asthma
Adults and the elderly
 The usual dose is 1 puff (1 capsule=
1 puff) morning and evening
 The usual dose for more severe cases is
2 puffs (2 capsules) morning and
evening
 You should not take more than 4
capsules in a day
Children aged 6 and over
 The usual dose is 1 puff (1 capsule=1
puff) morning and evening
 A child should not take more than 2
capsules in a day.
When you have asthma you must also be
taking an inhaled steroid at the same
time as Foradil.

2. Hold the base of
the inhaler firmly
and turn the
mouthpiece in the
direction of the
arrow on the bottom
of the mouthpiece
to open.




Cap

Mouthpiece

Capsule
Compartment

Base

1. Pull off the cap.

5. Keeping the inhaler
upright, firmly
squeeze the two
blue buttons once
only. This will
pierce the capsule.
Release the
buttons.
Although the
capsule is now
pierced, the powder
will not be released
until you inhale it.

6. Breathe out fully.

7. Place the
mouthpiece in your
mouth and tilt your
head slightly
backwards. Close
your lips around the
mouthpiece and
breathe in as
quickly and as
deeply as you can.
As you breathe in,
you will inhale the
medicine into your
lungs.
You should hear the capsule spinning in the
inhaler. If you do not hear this whirring
noise, the capsule may be stuck in the
compartment. If this occurs, open the inhaler
and loosen the capsule by prising it out of
the compartment. Do not try to loosen the
capsule by repeatedly pressing the buttons.
8. If you have heard the whirring noise,
hold your breath for as long as you
comfortably can while taking the inhaler
out of your mouth. Then breathe
normally. Open the inhaler to see if any
powder is still in the capsule. If there is
still powder in the capsule repeat steps
6 to 8.
9. After use, tip out the empty capsule and
close the mouthpiece.
10. Replace the cap.
11. If you need to clean the inhaler, wipe the
mouthpiece and capsule compartment
with a dry cloth or a clean soft brush.

Very occasionally, very small pieces of the
capsule shell can get in the mouth. If
this happens, you may be able to feel these
pieces on your tongue. The capsule
shell is made of gelatin which is harmless to
humans, and will soften or dissolve
in the mouth and be swallowed. The
chances of this happening will be increased
if the capsule is pierced many times
(Step 5); hence it is recommended that you
do this only once for each capsule.
If you forget to take Foradil
If you miss a dose, take it as soon as you
remember. Then go on as before. Do not
double the dose to make up for the forgotten
dose.
What if you take too much?
If you, or anyone else, accidentally takes too
much, tell your doctor or your nearest
hospital casualty department immediately.
Take your medicine pack with you so
that people can see what you have taken.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Some side effects can be serious
Stop using Foradil and tell your doctor
straight away if you notice:
 Bronchospasm with wheezing or
coughing and difficulty in breathing. This
may affect up to 1 in 100 people
 An allergic reaction such as if you feel
faint (you might have low blood
pressure), have a rash, or experience
itching or facial swelling. This may affect
up to 1 in 1,000 people
 If you feel you have muscle weakness,
muscle spasms or an abnormal heart
rhythm (these could mean you have a
low blood potassium level). This may
affect up to 1 in 1,000 people
 If you feel you have an irregular heart
beat or a fast heart beat. This may affect
up to 1 in 1,000 people
 If you feel a crushing chest pain
(symptoms of angina pectoris). This may
affect up to 1 in 10,000 people.

The side effects listed below have also
been reported.
Common (may affect up to 1 in 10
people)
Headache, tremor, palpitations.
Uncommon (may affect up to 1 in 100
people)
Agitation, anxiety, feeling nervous,
difficulties with sleeping, dizziness, fast
heart beat, throat irritation, dry mouth,
muscle cramps, muscle pain, worsening of
asthma.
Rare (may affect up to 1 in 1,000 people)
Nausea
Very rare side effects (may affect up to
1 in 10,000 people)
Distorted sense of taste, swelling of hands,
ankles or feet, variations in blood pressure.
Excessive thirst, frequent urination and
tiredness over an extended period of time (a
possible indication of high blood sugar).
Not known (frequency cannot be
estimated from the available data)
Headache and dizziness (symptoms of high
blood pressure), cough and rash.
Some of these effects may wear off as you
get used to the medicine.
If any of the symptoms become
troublesome, or if you notice anything
else not mentioned here, please go and
see your doctor. He/she may want to give
you a different medicine.
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 any side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting any side effects, you can help
provide more information on the safety of
this medicine.

5. How to store Foradil
KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN.
Do not take the capsules after the expiry
date which is stated on the carton and
blister label after 'Exp'. The expiry date
refers to the last day of that month.
Do not store above 25°C. Protect from
moisture and heat.
Do not take the capsules out of the blister
pack until you need them. Return any
unused medicine to your pharmacist.
If the capsules becomes discoloured or
show any signs of deterioration, seek the
advice of your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine to your pharmacist for safe
disposal. Only keep this medicine if your
doctor tells you to.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
The active ingredient in this medicine is
formoterol. (as formoterol fumarate
dihydrate) This is the new name for
eformoterol. The ingredient itself has not
changed. Foradil comes as capsules
containing a dry powder for inhalation.
Each capsule contains 12 micrograms of
formoterol fumarate dihydrate. This is one of
a group of medicines called bronchodilators.
The gelatin capsules also contain lactose.
Foradil comes as a clear capsules marked
with ‘CG’ and ‘FXF’ in black ink containing
white dry powder for inhalation. They come
with a light blue and white inhaler device.
The dry powder is inhaled into the lungs
using the inhaler provided in the pack.
Foradil comes in blister packs of 60
inhalation capsules with inhaler.

Manufactured by: Novartis Farma S.p.A,
Via Provinciale Schito 131,
Torre Annunziata NA, Italy.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Foradil® 12microgram Inhalation
Capsules; PL 18799/1227
Leaflet date: 09.01.2017

POM

Foradil is a registered trademark of Novartis
Pharmaceuticals UK Limited.
Blind or partially sighted?
Is this leaflet hard to see or Read?
Call 0208 515 3763 to obtain the leaflet in a
format suitable for you.

Patient Information Leaflet

Formoterol Fumarate
Dihydrate 12microgram
Dry Powder Capsules for
Inhalation
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
 Keep this leaflet. You may need to read
it again.
 If you have any further questions, ask
your doctor or pharmacist.
 This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
 If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet (see section 4).
The name of your medicine is Formoterol
Fumarate Dihydrate 12microgram Dry
Powder Capsules for Inhalation but will be
referred to as Formoterol fumarate
throughout this leaflet.
What is in this leaflet:
1. What Formoterol fumarate is and what it
is used for
2. Before you take Formoterol fumarate
3. How to take Formoterol fumarate
4. Possible side effects
5. How to store Formoterol fumarate
6. Contents of the pack and other
information

1. What Formoterol fumarate is
and what it is used for
The Formoterol fumarate pack includes a
blister pack of capsules containing the
medicine and an inhaler device for taking
the medicine. The capsules are for
inhalation use only.
Instructions for using the inhaler are given
later on in the leaflet.

The active ingredient in this medicine is
formoterol fumarate dihydrate. Formoterol
fumarate dihydrate is one of a group of
medicines called long‑acting
bronchodilators. It makes breathing easier
by relaxing muscle spasms in the air
passages of the lungs.

Formoterol fumarate is used to treat
asthma in people who are already taking
inhaled steroids but still have symptoms
such as wheezing and breathlessness.
Taking Formoterol fumarate regularly
together with inhaled steroids will help to
prevent breathing problems


Formoterol fumarate is also used to treat
breathing problems in patients with
chronic obstructive pulmonary disease
(COPD)

2. Before you take Formoterol
fumarate
Do not take Formoterol fumarate if:
 you are allergic to formoterol fumarate
dihydrate or any of the other ingredients
of this medicine (listed in section 6).















Formoterol fumarate is not suitable for
children under six years of age.
Talk to your doctor or pharmacist before
taking Formoterol fumarate if you:
 are taking any other asthma medicine
 suffer from any heart problems
 have high blood pressure
 have an overactive thyroid gland
 have an aneurysm (area where an artery
is swollen because the wall of the artery
is weak)
 have a heart disorder such as abnormal
electrical signal called 'prolongation of
QT interval'
 are diabetic
 have pheochromocytoma (a tumor of the
adrenal gland that can affect
blood pressure)
Other medicines and Formoterol
fumarate
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, particularly:
 Medicines for heart conditions including
irregular heart beats, angina and heart
failure



Medicines for high blood pressure
Beta blockers (either as tablets or eye
drops)
Water tablets (diuretics)
Medicines for depression, for example,
monoamine oxidase inhibitors (MAOIs)
or tricyclics
Anti-histamines or cold remedies
(including any bought from the chemist)
Medicines called ‘steroids’. Your doctor
will know which these are
Sympathomimetic agents, which are
adrenaline-like medicines used to treat
asthma and nasal congestion
Phenothiazines, which are a group of
medicines which control mental
disorders such as schizophrenia, mania,
psychotic conditions and anxiety
Xanthines, for example theophylline or
aminophylline, which are a class of
medicines used to treat asthma and
chronic obstructive airways diseases
Macrolides (for example Erythromycin)
used to treat bacterial infections
Anaesthetics like Halogenated
hydrocarbons (for example Halothane).
These drugs are used to produce
anaesthesia during surgery
Anticholinergic drugs (for example
Ipratropium bromide) used to treat
gastrointestinal disorders and
genitourinary disorders

Other special warnings








You must not use Formoterol fumarate
to treat a sudden asthma attack. Your
doctor will have given you another
inhaler (a ‘reliever’) for this
It is very important to keep using your
other asthma medicines, (inhaled
steroids known as a ‘preventer’),
regularly. DO NOT stop using them or
change the dose when you start using
Formoterol fumarate
If you feel that you are getting breathless
or wheezy while you are using
Formoterol fumarate, you should
continue to use it, but go to see your
doctor as soon as possible in case you
need another medicine
Treatment with Formoterol fumarate may
lead to your blood level of potassium
becoming too



low. This may make you more
susceptible to abnormal heart rhythm.
Therefore, your doctor may monitor your
blood level of potassium, especially if
you have severe asthma
Treatment with Formoterol fumarate may
lead to increased sugar levels in the
blood.
Therefore, you might need to monitor
your blood sugar levels if you are
diabetic



You should not take more than 4
capsules in a day

Children aged 6 and over
 The usual dose is 1 puff (1 capsule=
1 puff) morning and evening
 A child should not take more than 2
capsules in a day.
When you have asthma you must also be
taking an inhaled steroid at the same
time as Formoterol fumarate .

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.

For the treatment of COPD (Chronic
Obstructive Pulmonary Disease)

Driving and using machines
In some patients, Formoterol fumarate has
been reported to cause dizziness. If you feel
dizzy, do
not drive or operate machinery.

Children under 18
 Not applicable

Formoterol fumarate contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

Adults and the elderly
 The usual dose is 1 puff in the morning
and evening

The effects of this medicine will normally last
for 12 hours. If you do get attacks of
wheezing between doses, do not take extra
doses of Formoterol fumarate . Your doctor
will have prescribed another medicine for
this purpose. If you are not sure about this,
check with your doctor.


3. How to take Formoterol
fumarate
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.



Do not stop or reduce the dose of
Formoterol fumarate or any other
medicine for your breathing just because
you feel better, without talking to your
doctor first. It is very important to use
these medicines regularly
Do not increase your dose of Formoterol
fumarate without talking to your doctor
first
If you feel sick or very shaky or if you
have an unusually fast heart beat, your
Formoterol fumarate dose may be too
high. Tell your doctor as soon as
possible

Formoterol fumarate capsules must only be
used with the inhaler provided. You must not
try to inhale them using another inhaler.
Also, do not put other types of capsules into
the inhaler supplied with Formoterol
fumarate .



Do not swallow the capsules. The
contents of the capsule must be inhaled
using the inhaler provided.

How to use the capsules with the
inhaler device
A child should be shown how to use the
inhaler correctly and should only use it with
the help of an adult.

For the treatment of asthma
Adults and the elderly
 The usual dose is 1 puff (1 capsule=
1 puff) morning and evening
 The usual dose for more severe cases is
2 puffs (2 capsules) morning and
evening

1. Pull off the cap.

Cap

Mouthpiece

Base

Capsule
Compartment

2. Hold the base of
the inhaler firmly
and turn the
mouthpiece in the
direction of the
arrow on the bottom
of the mouthpiece
to open.

3. Take one of today's
capsules out of the
blister strip. Place it
in the capsuleshaped
compartment in the
base of the inhaler.
It is important that
you remove the
capsule from the
blister pack only
immediately
before you use it.
4. Twist the
mouthpiece to the
closed position until
it clicks.

5. Keeping the inhaler
upright, firmly
squeeze the two
blue buttons once
only. This will
pierce the capsule.
Release the
buttons.
Although the
capsule is now
pierced, the powder
will not be released
until you inhale it.
6. Breathe out fully.

7. Place the
mouthpiece in your
mouth and tilt your
head slightly
backwards. Close
your lips around the
mouthpiece and
breathe in as
quickly and as
deeply as you can.
As you breathe in,
you will inhale the
medicine into your
lungs.
You should hear the capsule spinning in the
inhaler. If you do not hear this whirring
noise, the capsule may be stuck in the
compartment. If this occurs, open the inhaler
and loosen the capsule by prising it out of
the compartment. Do not try to loosen the
capsule by repeatedly pressing the buttons.

8. If you have heard the whirring noise,
hold your breath for as long as you
comfortably can while taking the inhaler
out of your mouth. Then breathe
normally. Open the inhaler to see if any
powder is still in the capsule. If there is
still powder in the capsule repeat steps
6 to 8.
9. After use, tip out the empty capsule and
close the mouthpiece.
10. Replace the cap.
11. If you need to clean the inhaler, wipe the
mouthpiece and capsule compartment
with a dry cloth or a clean soft brush.
Very occasionally, very small pieces of the
capsule shell can get in the mouth. If
this happens, you may be able to feel these
pieces on your tongue. The capsule
shell is made of gelatin which is harmless to
humans, and will soften or dissolve
in the mouth and be swallowed. The
chances of this happening will be increased
if the capsule is pierced many times
(Step 5); hence it is recommended that you
do this only once for each capsule.
If you forget to take Formoterol fumarate
If you miss a dose, take it as soon as you
remember. Then go on as before. Do not
double the dose to make up for the forgotten
dose.
What if you take too much?
If you, or anyone else, accidentally takes too
much, tell your doctor or your nearest
hospital casualty department immediately.
Take your medicine pack with you so
that people can see what you have taken.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Some side effects can be serious
Stop using Formoterol fumarate and tell
your doctor straight away if you notice:
 Bronchospasm with wheezing or
coughing and difficulty in breathing. This
may affect up to 1 in 100 people








An allergic reaction such as if you feel
faint (you might have low blood
pressure), have a rash, or experience
itching or facial swelling. This may affect
up to 1 in 1,000 people
If you feel you have muscle weakness,
muscle spasms or an abnormal heart
rhythm (these could mean you have a
low blood potassium level). This may
affect up to 1 in 1,000 people
If you feel you have an irregular heart
beat or a fast heart beat. This may affect
up to 1 in 1,000 people
If you feel a crushing chest pain
(symptoms of angina pectoris). This may
affect up to 1 in 10,000 people.

The side effects listed below have also
been reported.
Common (may affect up to 1 in 10
people)
Headache, tremor, palpitations.
Uncommon (may affect up to 1 in 100
people)
Agitation, anxiety, feeling nervous,
difficulties with sleeping, dizziness, fast
heart beat, throat irritation, dry mouth,
muscle cramps, muscle pain, worsening of
asthma.
Rare (may affect up to 1 in 1,000 people)
Nausea
Very rare side effects (may affect up to
1 in 10,000 people)
Distorted sense of taste, swelling of hands,
ankles or feet, variations in blood pressure.
Excessive thirst, frequent urination and
tiredness over an extended period of time (a
possible indication of high blood sugar).
Not known (frequency cannot be
estimated from the available data)
Headache and dizziness (symptoms of high
blood pressure), cough and rash.
Some of these effects may wear off as you
get used to the medicine.
If any of the symptoms become
troublesome, or if you notice anything
else not mentioned here, please go and
see your doctor. He/she may want to give
you a different medicine.

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 any side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting any side effects, you can help
provide more information on the safety of
this medicine.

5. How to store Formoterol
fumarate
KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN.
Do not take the capsules after the expiry
date which is stated on the carton and
blister label after 'Exp'. The expiry date
refers to the last day of that month.
Do not store above 25°C. Protect from
moisture and heat.
Do not take the capsules out of the blister
pack until you need them. Return any
unused medicine to your pharmacist.
If the capsules becomes discoloured or
show any signs of deterioration, seek the
advice of your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine to your pharmacist for safe
disposal. Only keep this medicine if your
doctor tells you to.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
The active ingredient in this medicine is
formoterol. (as formoterol fumarate
dihydrate) This is the new name for
eformoterol. The ingredient itself has not
changed. Formoterol fumarate comes as
capsules containing a dry powder for
inhalation.
Each capsule contains 12 micrograms of
formoterol fumarate dihydrate. This is one of
a group of medicines called bronchodilators.
The gelatin capsules also contain lactose.

Formoterol fumarate comes as a clear
capsules marked with ‘CG’ and ‘FXF’ in
black ink containing white dry powder for
inhalation. They come with a light blue and
white inhaler device. The dry powder is
inhaled into the lungs using the inhaler
provided in the pack.
Formoterol fumarate comes in blister packs
of 60 inhalation capsules with inhaler.
Manufactured by: Novartis Farma S.p.A,
Via Provinciale Schito 131,
Torre Annunziata NA, Italy.
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
12microgram Dry Powder Capsules for
Inhalation; PL 18799/1227
Leaflet date: 09.01.2017

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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