Skip to Content

FORMOTEROL FUMARATE 12 MICROGRAM INHALATION CAPSULES

Active substance(s): FORMOTEROL FUMARATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet

Foradil® 12microgram
Inhalation Capsules
(formoterol fumarate)
The name of your medicine is Foradil
12microgram Inhalation Capsules but will be
referred to as Foradil throughout this leaflet

What you need to know about
Foradil
Your doctor has decided that you need this
medicine to help treat your condition.
Please read this leaflet carefully before
you start to take your medicine. It
contains important information. Keep the
leaflet in a safe place because you may
want to read it again.
If you have any other questions, or if there is
something you don‟t understand, please ask
your doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not be
the right medicine for them even if their
symptoms seem to be the same as yours.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Foradil is, and what it‟s used for
2. Things to consider before you start to
take Foradil
3. How to take Foradil
4. Possible side effects
5. How to store Foradil
6. Further information

1. What Foradil is and what it’s
used for
The Foradil pack includes a blister pack of
capsules containing the medicine and an

inhaler device for taking the medicine.
Instructions for using the inhaler are given
later on in the leaflet.
The active ingredient in this medicine is
formoterol. Formoterol 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. Things to consider before you
start to take Foradil
Some people MUST NOT take Foradil.
Talk to your doctor if:
you know you‟re allergic to Foradil, or if
you have ever had an unusual or allergic
reaction to formoterol or inhaled lactose
you are breast-feeding
Foradil is not suitable for children under six
years of age.
The very small amount of lactose in Foradil
is unlikely to cause problems in lactoseintolerant patients.
You should also ask yourself these
questions before taking Foradil. If the
answer to any of these questions is YES,
tell your doctor or pharmacist because
Foradil might not be the right medicine
for you.
Is this the only asthma medicine you
have?
Do you suffer from any heart problems?
Do you have high blood pressure?

Do you have an overactive thyroid
gland?
Do you have an aneurysm (area where
an artery is swollen because the wall of
the artery is weak)?
Do you have a heart disorder, such as
abnormal electrical signal called
“prolongation of the QT interval”?
Are you diabetic?
Do you have pheochromocytoma (a
tumor of the adrenal gland that can
affect blood pressure)?
Are you pregnant?

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.
Always tell your doctor about all the
medicines you are taking. This means
medicines you have bought yourself as well
as medicines on prescription from your
doctor.
Other special warnings

Are you taking other medicines?
Some medicines can interfere with your
treatment. Make sure your doctor knows if
you are taking any of the following:
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.

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

3. How to take Foradil
The doctor will tell you how much Foradil to
take and when to take it. Always follow
his/her instructions carefully. The dose will
be on the pharmacist‟s label. Check the
label carefully. If you are not sure, ask your
doctor or pharmacist. Keep using the inhaler
for as long as you have been told unless
you have any problems. In that case, check
with your doctor.
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

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

Children aged 6 and over

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.

When you have asthma you must also
be taking an inhaled steroid at the
same time as Foradil.

Will there be any problems with driving
or using machinery?
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.
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.
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.
Cap

Mouthpiece

Capsule
Compartment

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.

For the treatment of COPD (Chronic
Obstructive Pulmonary Disease)
Adults and the elderly
The usual dose is 1 puff in the morning
and evening.

Base

1. Pull off the cap.

Although the
capsule is now
pierced, the powder
will not be released
until you inhale it.

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.

6. Breathe out fully.

5. Keeping the inhaler
upright, firmly
squeeze the two
blue buttons once
only.
This will pierce the
capsule. Release
the buttons.

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.
What if you forget to take a dose?

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.

11. If you need to clean the inhaler, wipe the
mouthpiece and capsule compartment
with a dry cloth or a clean soft brush.

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.

If you miss a dose, take it as soon as you
remember. Then go on as before. Do not
double the 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
Foradil is suitable for most people, but,
like all medicines, it can sometimes cause
side effects.
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
might 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 might
affect less than 1 in 10,000 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).

If you feel you have an irregular heart
beat or a fast heart beat. This might
affect up to 1 in 10 people.

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

If you feel a crushing chest pain
(symptoms of angina pectoris). This
might affect less than 1 in 1000 people.

5. How to store Foradil

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
POM

KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN.

Foradil 12microgram Inhalation
Capsules PL 18799/1227

The expiry date for this medicine is given on
the carton. Do not use the medicine after
this date.

Leaflet date:23.06.2016

The side effects listed below have also
been reported.
Up to 1 in 10 people have experienced:
Headache, tremor, palpitations.
Up to 1 in 100 people have experienced:
Agitation, anxiety, feeling nervous,
difficulties with sleeping, dizziness, fast
heart beat, throat irritation, dry mouth,
muscle cramps, muscle pain, worsening of
asthma.

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.

Very rare side effects (likely to affect less
than 1 in 10,000 patients):

Do not throw them away with your normal
household water or waste. This will help to
protect the environment.

Nausea, distorted sense of taste, swelling of
hands, ankles or feet, variations in blood
pressure.

6. Further information

It is not known how frequently these
effects may happen:
Excessive thirst, frequent urination and
tiredness over an extended period of time (a
possible indication of high blood sugar).
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.

The active ingredient in this medicine is
formoterol. (as formeterol fumerate
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.

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.

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.

Reporting of side effects

Foradil comes in blister packs of 60
inhalation capsules with inhaler.

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

Manufactured by: Novartis Farma S.p.A,

Via Provinciale Schito 131,
Torre Annunziata NA, Italy.

Foradil is a registered trademark of Novartis
Pharmaceuticals UK Limited.

Patient Information Leaflet

Formoterol Fumarate Dihydrate
12microgram Dry Powder
Capsules for Inhalation
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 you need to know about
Formoterol fumarate
Your doctor has decided that you need this
medicine to help treat your condition.
Please read this leaflet carefully before
you start to take your medicine. It
contains important information. Keep the
leaflet in a safe place because you may
want to read it again.
If you have any other questions, or if there is
something you don‟t understand, please ask
your doctor or pharmacist.

1. What Formoterol fumarate is
and what it’s used for
The Formoterol fumarate pack includes a
blister pack of capsules containing the
medicine and an inhaler device for taking
the medicine. Instructions for using the
inhaler are given later on in the leaflet.
The active ingredient in this medicine is
formoterol fumerate. Formoterol fumerate is
one of a group of medicines called longacting 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).

This medicine has been prescribed for you.
Never give it to someone else. It may not be
the right medicine for them even if their
symptoms seem to be the same as yours.

2. Things to consider before you
start to take Formoterol
fumarate

If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Some people MUST NOT take Formoterol
fumarate.
Talk to your doctor if:

In this leaflet:
1. What Formoterol fumarate is, and what
it‟s used for
2. Things to consider before you start to
take Formoterol fumarate
3. How to take Formoterol fumarate
4. Possible side effects
5. How to store Formoterol fumarate
6. Further information

you know you‟re allergic to Formoterol
fumarate, or if you have ever had an
unusual or allergic reaction to formoterol
or inhaled lactose
you are breast-feeding
Formoterol fumarate is not suitable for
children under six years of age.
The very small amount of lactose in
Formoterol fumarate is unlikely to cause
problems in lactose-intolerant patients.
You should also ask yourself these
questions before taking Formoterol
fumarate. If the answer to any of these

questions is YES, tell your doctor or
pharmacist because Formoterol fumarate
might not be the right medicine for you.
Is this the only asthma medicine you
have?
Do you suffer from any heart problems?
Do you have high blood pressure?

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

Do you have an overactive thyroid
gland?

Macrolides (for example Erythromycin)
used to treat bacterial infections.

Do you have an aneurysm (area where
an artery is swollen because the wall of
the artery is weak)?

Anaesthetics like Halogenated
hydrocarbons (for example Halothane).
These drugs are used to produce
anaesthesia during surgery.

Do you have a heart disorder, such as
abnormal electrical signal called
“prolongation of the QT interval”?
Are you diabetic?
Do you have pheochromocytoma (a
tumor of the adrenal gland that can
affect blood pressure)?
Are you pregnant?
Are you taking other medicines?
Some medicines can interfere with your
treatment. Make sure your doctor knows if
you are taking any of the following:
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

Anticholinergic drugs (for example
Ipratropium bromide) used to treat
gastrointestinal disorders and
genitourinary disorders.
Always tell your doctor about all the
medicines you are taking. This means
medicines you have bought yourself as well
as medicines on prescription from your
doctor.
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.
Will there be any problems with driving
or using machinery?
In some patients, Formoterol fumarate has
been reported to cause dizziness. If you feel
dizzy, do not drive or operate machinery.

3. How to take Formoterol
fumarate
The doctor will tell you how much
Formoterol fumarate to take and when to
take it. Always follow his/her instructions
carefully. The dose will be on the
pharmacist‟s label. Check the label carefully.
If you are not sure, ask your doctor or
pharmacist. Keep using the inhaler for as
long as you have been told unless you have
any problems. In that case, check with your
doctor.
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
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

(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.
For the treatment of COPD (Chronic
Obstructive Pulmonary Disease)
Adults and the elderly
The usual dose is 1 puff in the morning
and evening.
Children under 18
Not applicable.
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.
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.
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.
Cap

Mouthpiece

Children aged 6 and over
The usual dose is 1 puff

Base

Capsule
Compartment

1. Pull off the cap.

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.

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.

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.

What if you forget to take a dose?
If you miss a dose, take it as soon as you
remember. Then go on as before. Do not
double the 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
Formoterol fumarate is suitable for most
people, but like all medicines, it can
sometimes cause side effects.

Bronchospasm with wheezing or
coughing and difficulty in breathing. This
might 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 might
affect less than 1 in 10,000 people.

If you feel you have an irregular heart
beat or a fast heart beat. This might
affect up to 1 in 10 people.

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

If you feel a crushing chest pain
(symptoms of angina pectoris). This
might affect less than 1 in 1000 people.

5. How to store Formoterol
fumarate

If you feel you have muscle weakness,
muscle spasms or an abnormal heart
rhythm (these could mean you have a
low blood potassium level).

The side effects listed below have also
been reported.

KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN.

Up to 1 in 10 people have experienced:

Do not take your tablets after the expiry date
which is stated on the box/blisters/label after
„Exp‟. The expiry date refers to the last day
of that month.

Headache, tremor, palpitations.
Up to 1 in 100 people have experienced:
Agitation, anxiety, feeling nervous,
difficulties with sleeping, dizziness, fast
heart beat, throat irritation, muscle cramps,
muscle pain, worsening of asthma.
Very rare side effects (likely to affect less
than 1 in 10,000 patients):
Nausea, distorted sense of taste, swelling of
hands, ankles or feet, variations in blood
pressure.
It is not known how frequently these
effects may happen:
Excessive thirst, frequent urination and
tiredness over an extended period of time (a
possible indication of high blood sugar).
Headache and dizziness (symptoms of high
blood pressure), cough and rash.

Some side effects can be serious
Stop using Formoterol fumarate and tell
your doctor straight away if you notice:

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.

Some of these effects may wear off as you
get used to the medicine.

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.
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. Further information
The active ingredient in this medicine is
formoterol (as formeterol fumerate
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.
POM
Formoterol Fumarate Dihydrate
12microgram Dry Powder Capsules for
Inhalation
PL 18799/1227
Leaflet date: 23.06.2016

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