Skip to Content

FORMOTEROL FUMARATE DIHYDRATE 12 MICROGRAM CAPSULES

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.

 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.

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.

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

 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.

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.

PATIENT INFORMATION LEAFLET

2347
08.03.13[7]

Foradil® 12 microgram Capsules
(formoterol fumarate)
This medicine 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.

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 breastfeeding
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 lactose-intolerant 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?
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)

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.
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.

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.

Pull off the cap.

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.

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

Take one of today's capsules out of the blister
strip. Place it in the capsule-shaped
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.

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.
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 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.

Twist the mouthpiece to the closed position
until it clicks.

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.

Breathe out fully.

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.
 If you feel a crushing chest pain (symptoms of angina pectoris). This
might affect less than 1 in 1000 people.
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, muscle cramps, muscle pain, worsening
of your asthma.

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.

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 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.

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.
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.

5. How to store Foradil
o
 Do not store your medicine above 25 C. Store in the original package.
 Protect from moisture.
 Do not remove the capsule from the blister until you are ready to use it.
 Keep out of the sight and reach of children.
 Do not use Foradil after the expiry date which is printed on the
outside of the pack.
 If your doctor tells you to stop taking Foradil, please take any unused
capsules back to your pharmacist to be destroyed.
 Do not throw them away with your normal household water or waste.
This will help to protect the environment.
6. Further information
Each capsule contains 12 micrograms formoterol fumarate dihydrate.
The capsules also contain lactose monohydrate, gelatin and titanium
dioxide.
Foradil are clear hard capsules marked 'CG FXF' in black ink containing a
white powder for inhalation using the pale blue inhaler.
Foradil is available in packs containing 60 capsules and 1 inhaler device.
Manufacturer and Product Licence Holder
Manufactured by Polpharma SA, ul. Pelplinksa-19, Poland.
Procured from the EU by Product Licence holder Tenolol Ltd.,
Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 30900/2347

Leaflet revision and issue date (Ref) 08.03.13[7]
Foradil is a trademark of Astellas Pharma Inc.

PATIENT INFORMATION LEAFLET

2347
08.03.13[7]

Formoterol Fumarate Dihydrate 12 microgram
Capsules
(formoterol fumarate)
This medicine 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.
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 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
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. 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.
 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. Things to consider before you start to take Formoterol Fumarate
Some people MUST NOT take Formoterol Fumarate.
Talk to your doctor if:
 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 breastfeeding
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?
 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?
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.
 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
 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

 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.

Pull off the cap.

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.

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

Take one of today's capsules out of the blister
strip. Place it in the capsule-shaped
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.

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.
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.

Twist the mouthpiece to the closed position
until it clicks.

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.

Breathe out fully.

4. Possible side effects
Formoterol Fumarate is suitable for most people, but like all medicines, it
can sometimes cause side effects.
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 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.
 If you feel a crushing chest pain (symptoms of angina pectoris). This
might affect less than 1 in 1000 people.
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, muscle cramps, muscle pain, worsening
of your 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.

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.

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.
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.

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.
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.

5. How to store Formoterol Fumarate
o
 Do not store your medicine above 25 C. Store in the original package.
 Protect from moisture.
 Do not remove the capsule from the blister until you are ready to use it.
 Keep out of the sight and reach of children.
 Do not use Formoterol Fumarate after the expiry date which is printed
on the outside of the pack.
 If your doctor tells you to stop taking Formoterol Fumarate, please
take any unused capsules back to your pharmacist to be destroyed.
 Do not throw them away with your normal household water or waste.
This will help to protect the environment.
6. Further information
Each capsule contains 12 micrograms formoterol fumarate dihydrate.
The capsules also contain lactose monohydrate, gelatin and titanium
dioxide.
Formoterol Fumarate are clear hard capsules marked 'CG FXF' in black
ink containing a white powder for inhalation using the pale blue inhaler.
Formoterol Fumarate is available in packs containing 60 capsules and 1
inhaler device.
Manufacturer and Product Licence Holder
Manufactured by Polpharma SA, ul. Pelplinksa-19, Poland. Procured from
the EU by Product Licence holder Tenolol Ltd., Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL No: 30900/2347

Leaflet revision and issue date (Ref) 08.03.13[7]

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

Hide