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FORMOTEROL FUMARATE DIHYDRATE 12MICROGRAMS/ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

®

®

3. How to use Atimos Modulite

Atimos Modulite

Dosage:

(formoterol fumarate)

For Asthma:

Read all of this leaflet carefully before you start using this medicine.

The dose of Atimos Modulite you must inhale will depend on the type of asthma you have and how severe it is.
Your dose will be decided by your doctor and it is important that you only take the prescribed dose, regularly.

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. Do not pass it on to others. It may harm them even if their
symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

The usual dose for adults, including the elderly and adolescents 12 years and older is 1 puff in the morning
and 1 puff in the evening. This means you need to take a total of 2 puffs (24micrograms) of Atimos Modulite
per day.
If you suffer from more severe asthma your doctor may prescribe 4 puffs per day (48micrograms), 2 puffs in
the morning and 2 puffs in the evening.

The name of your medicine is Atimos Modulite but will be referred to as Atimos Modulite or Atimos throughout
this leaflet.

4 puffs (48micrograms) of Atimos Modulite is the maximum daily dose and it is important that you do not
take more than the total daily dose that your doctor has told you to take.

In this leaflet:

This product is not suitable for asthmatic children under 12 years old.

1.
2.
3.
4.
5.
6.

For Chronic Obstructive Pulmonary Disease (COPD):

What Atimos Modulite is and what it is used for
Before you use Atimos Modulite
How to use Atimos Modulite
Possible side effects
How to store Atimos Modulite
Further information

1. What Atimos Modulite is and what it is used for
Atimos Modulite is an inhalation medicine delivering its active ingredient directly into your lungs where it is
needed. It is used to treat the symptoms of wheezing and breathlessness in patients with moderate to severe
asthma. Its active ingredient, formoterol fumarate, belongs to a group of medicines called bronchodilators: they
make breathing easier by relaxing muscle spasms in the air passages of the lungs. Regular use of Atimos
Modulite together with steroids (either by inhaler or by mouth), will help to prevent breathing problems over the
long- term.
Atimos Modulite can also be used for the relief of symptoms such as cough, wheezing and shortness of breath
in patients with chronic obstructive pulmonary disease (COPD) who require long-term regular bronchodilator
therapy.

2. Before you use Atimos Modulite
Do not use Atimos Modulite:
if you are allergic to formoterol or to any of the ingredients of Atimos Modulite.
to treat a sudden attack of breathlessness. It will not help. Use a reliever for this purpose and carry it
with you at all times.

Take special care with Atimos Modulite and always tell your doctor if you:
suffer from severe heart disease, especially a recent heart attack, a disease of the coronary vessels of the
heart or severe weakness of the heart muscle (congestive heart failure)
suffer from disorders of heart rhythm such as increased heart rate, heart valve defect or certain
electrocardiogram abnormalities or any other heart disease
have narrowing of the blood vessels, especially the arteries, or abnormal widening of the vessel wall
suffer from high blood pressure
have high sugar levels in the blood (diabetes mellitus)
have low blood potassium levels
have an overactive thyroid gland
are suffering from epinephrine and nor-epinephrine producing tumours of the adrenal medulla
are going to have any surgery or receive halogenated anaesthetics

The usual dose for adults, including the elderly and adolescents 18 years and older is 1 puff in the morning
and 1 puff in the evening. This means you need to take a total of 2 puffs (24micrograms) of Atimos Modulite
per day.
If you suffer from more severe COPD your doctor may prescribe 4 puffs per day (48micrograms), 2 puffs in the
morning and 2 puffs in the evening.
4 puffs (48micrograms) of Atimos is the maximum daily dose and it is important that you do not take more
than the total daily dose that your doctor has told you to take.
Do not take more than 2 puffs at any one time.
This product is not suitable for COPD patients under 18 years old.
Do not use Atimos Modulite to treat a sudden attack of breathlessness. You should use a ‘reliever’ inhaler
prescribed by your doctor for this purpose, carry this medicine with you at all times.

If you use more Atimos Modulite than you should:
You may notice that your heart is beating faster than usual and that you feel shaky. You may also have a
headache, tremor, feeling and being sick (nausea and vomiting) or feel sleepy. Contact your doctor as soon as
possible for advice.

If you forget to use Atimos Modulite:
If you forget to use your Atimos Modulite, take it as soon as you remember. If it is almost time for your next
dose, do not take the dose you have missed, just take the next dose at the usual time. Do not double the
dose.
Do not stop or reduce the dose of Atimos Modulite 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 Atimos Modulite without talking to your doctor first.
If you feel you are getting breathless or wheezy while using Atimos Modulite, you should continue to use
Atimos Modulite but go to see your doctor as soon as possible, you may need additional treatment. Once your
asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of Atimos
Modulite.

Instructions for use:

Taking other medicines:

It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you
how to use your inhaler correctly. You must follow their instructions carefully so that you know how, when and
how many puffs to inhale. The correct instructions are given in this leaflet. If you are not sure what to do or
have problems in inhaling then ask your doctor, nurse or pharmacist for advice.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines
obtained without prescription.

Testing your inhaler. If your inhaler is new or if it has not been used for 3 days or more, one puff should be
released into the air before using it, to make sure that it works.

Some medicines may interfere with the action of Atimos Modulite, these include medicines:

You should stand or sit in the upright position when using your inhaler.

for treating abnormal heart rhythms (for example quinidine, disopyramide, procainamide)
for treating heart disease (for example digitalis)
for treating nasal congestion (for example ephedrine)
called beta adrenergic blockers used to treat heart conditions or glaucoma (an increase of the pressure in
the eye), as tablets or eye drops
containing erythromycin (used to treat infections)
for treating symptoms of depression: monoamine oxidase inhibitors (for example phenelzine and
isocarboxazid) or tricyclic antidepressants (for example amitryptiline and imipramine)
to treat severe mental disorders (for example chlorpromazine and trifluperazine)
used to treat allergic reactions (such as anti-histamines, for example terfenadine, astemizole, mizolastine)
used to treat bronchial asthma (for example theophylline, aminophylline or steroids)
used to increase urine production (such as diuretics)
for treating Parkinsonism (for example levodopa)
containing oxytocin, which causes uterus contraction
to treat an underactive thyroid gland (for example thyroxine)

1. Remove the mouthpiece cover from the inhaler and hold it between the thumb and forefinger as shown.
2. Breathe out as far as is comfortable.
3. Hold the inhaler upright as shown with your thumb on the base below the mouthpiece; place the
mouthpiece in your mouth between your teeth and close your lips tightly around it.
4. Breathe in deeply through your mouth and at the same time press down on the top of the inhaler to release
a puff.
5. Hold your breath as long as is comfortable, then take the inhaler from your mouth.
6. If you are to take another puff, keep the inhaler upright and wait about half a minute before repeating steps
2 to 5.
7. After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly and snap into
position.

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment with Atimos
Modulite can help to open your airways even more.

Other special warnings:
You have also been prescribed corticosteroids for your breathing problems. It is very important to keep
using these regularly. Do not stop using them or change the dose when you start using Atimos Modulite.

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor before using Atimos
Modulite.
The use of Atimos Modulite during pregnancy is only indicated if absolutely necessary.
If you are breast-feeding, talk to your doctor before using Atimos Modulite.

Driving and using machines:
Atimos Modulite is unlikely to have any effect on the ability to drive and operate machinery.

Important information about some of the ingredients of Atimos Modulite:
Atimos Modulite contains a small amount of alcohol: each puff of your inhaler contains about 9mg of ethanol.

Important: Do not rush steps 2, 3, 4 and 5.
It is important that you start to breathe in as slowly as possible just before operating the inhaler.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Atimos Modulite will not
get into your lungs as it should. Take another puff, carefully following the instructions from Step 2
onwards.

If you have weak hands it may be easier to hold the inhaler with both hands. Put the two forefingers on top of
the inhaler and both thumbs on the bottom below the mouthpiece.
Tell your doctor, nurse or pharmacist if you have any difficulties.

Cleaning:
It is important to clean your inhaler regularly, at least once or twice a week to ensure that it works properly.
Pull the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.
Rinse the plastic case and the mouthpiece cover in warm water.
Do not put the metal canister into water.
Leave to dry thoroughly in a warm place. Avoid excessive heat.
Replace the canister and mouthpiece cover.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Atimos Modulite can cause side effects although not everybody gets them. Possible side
effects are listed below according to their frequency. If you are not sure what the side effects below are, ask
your doctor to explain them to you.
If your breathing or wheezing gets worse after using your inhaler stop using Atimos Modulite and tell
your doctor immediately. This is caused by narrowing of the airways in your lungs, but it only occurs rarely.
Common side effects which may affect up to 1 in 10 people are: unusually fast heart beat and palpitations,
cough, trembling (fine tremor), headache.
Uncommon side effects which may affect fewer than 1 in 100 people are: muscle cramps, pain in muscles,
nausea, agitation, restlessness, sleep disorders, dizziness, abnormal or impaired sense of taste, throat
irritation, abnormal rapid heart beat, disorders of heart rhythm with increase heart rate, abnormal low levels of
potassium in the blood, increase in blood sugar levels, increase in the blood level of insulin, free fatty acids,
glycerol and ketones, excessive sweating.
Rare side effects which may affect fewer than 1 in 1,000 people are: missed heart beats caused by too early
contraction of the ventricles of the heart, feeling chest tightness, increase or decrease in blood pressure,
wheezing immediately after using the inhaler, severe fall in blood pressure, inflammation of the kidneys,
allergic reaction such as itching, rash, bronchospasm, urticaria, swelling of skin and mucous membrane
persisting for several days.
Very rare side effects which may affect fewer than 1 in 10,000 people are: worsening of asthma, difficulty
breathing, swelling of the hands and/or feet, irregular heart beat, reduced number of blood platelets,
hyperexcitability, abnormal behaviour, hallucinations.
Some side effects, such as tremor, nausea, abnormal or impaired sense of taste, throat irritation, excessive
sweating, restlessness, headache, dizziness and muscle cramps, may ease during the course of one to two
weeks of continued use of your asthma medication.

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.

5. How to store Atimos Modulite
Keep out of the sight and reach of children.
Do not use beyond three months from the date you get the inhaler from your pharmacist and never use
after the expiry date which is stated on the carton/canister label after ‘Exp’. The expiry date refers to the
last day of that month.
Do not store above 30°C.
If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands for a
few minutes before use. Never use anything else to warm it up.
Warning: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do
not pierce or burn container even when empty.
Medicines should not be disposed of via waste water 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
What Atimos Modulite contains:
The active ingredient is formoterol fumarate dihydrate.
Each metered actuation provides 12micrograms of formoterol fumarate dihydrate. This corresponds to a
delivered dose of 10.1micrograms.
The other ingredients are: hydrochloric acid, ethanol and Norflurane (HFA 134a).

What Atimos Modulite looks like and contents of the pack:
Atimos Modulite is a pressurised inhalation solution, in the form of an aerosol contained in an aluminium
canister with white plastic actuator, metering valve and protective blue cap.
Each pack contains 1 inhaler which provides 120 puffs.

Manufactured by: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, I-43100 Parma, 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.
®

Atimos Modulite

®

PL 18799/2684
Leaflet date: 01.03.2016

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. How to use Formoterol fumarate dihydrate

Formoterol fumarate dihydrate
12micrograms/actuation pressurised inhalation
solution

Dosage:

Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm them even if their
symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Formoterol fumarate dihydrate 12micrograms/actuation pressurised inhalation
solution but will be referred to as Formoterol fumarate dihydrate throughout this leaflet.

For Asthma:
The dose of Formoterol fumarate dihydrate you must inhale will depend on the type of asthma you have and
how severe it is. Your dose will be decided by your doctor and it is important that you only take the prescribed
dose, regularly.
The usual dose for adults, including the elderly and adolescents 12 years and older is 1 puff in the morning
and 1 puff in the evening. This means you need to take a total of 2 puffs (24micrograms) of Formoterol
fumarate dihydrate per day.
If you suffer from more severe asthma your doctor may prescribe 4 puffs per day (48micrograms), 2 puffs in
the morning and 2 puffs in the evening.
4 puffs (48micrograms) of Formoterol fumarate dihydrate is the maximum daily dose and it is important that
you do not take more than the total daily dose that your doctor has told you to take.
This product is not suitable for asthmatic children under 12 years old.

In this leaflet:

For Chronic Obstructive Pulmonary Disease (COPD):

1.
2.
3.
4.
5.
6.

The usual dose for adults, including the elderly and adolescents 18 years and older is 1 puff in the morning
and 1 puff in the evening. This means you need to take a total of 2 puffs (24micrograms) of Formoterol
fumarate dihydrate per day.

What Formoterol fumarate dihydrate is and what it is used for
Before you use Formoterol fumarate dihydrate
How to use Formoterol fumarate dihydrate
Possible side effects
How to store Formoterol fumarate dihydrate
Further information

1. What Formoterol fumarate dihydrate is and what it is used for
Formoterol fumarate dihydrate is an inhalation medicine delivering its active ingredient directly into your lungs
where it is needed. It is used to treat the symptoms of wheezing and breathlessness in patients with moderate
to severe asthma. Its active ingredient, formoterol fumarate, belongs to a group of medicines called
bronchodilators: they make breathing easier by relaxing muscle spasms in the air passages of the lungs.
Regular use of Formoterol fumarate dihydrate together with steroids (either by inhaler or by mouth), will help to
prevent breathing problems over the long-term.
Formoterol fumarate dihydrate can also be used for the relief of symptoms such as cough, wheezing and
shortness of breath in patients with chronic obstructive pulmonary disease (COPD) who require long-term
regular bronchodilator therapy.

If you suffer from more severe COPD your doctor may prescribe 4 puffs per day (48micrograms), 2 puffs in the
morning and 2 puffs in the evening.
4 puffs (48micrograms) of Formoterol fumarate dihydrate is the maximum daily dose and it is important that
you do not take more than the total daily dose that your doctor has told you to take.
Do not take more than 2 puffs at any one time.
This product is not suitable for COPD patients under 18 years old.
Do not use Formoterol fumarate dihydrate to treat a sudden attack of breathlessness. You should use a
‘reliever’ inhaler prescribed by your doctor for this purpose, carry this medicine with you at all times.

If you use more Formoterol fumarate dihydrate than you should:

2. Before you use Formoterol fumarate dihydrate

You may notice that your heart is beating faster than usual and that you feel shaky. You may also have a
headache, tremor, feeling and being sick (nausea and vomiting) or feel sleepy. Contact your doctor as soon as
possible for advice.

Do not use Formoterol fumarate dihydrate:

If you forget to use Formoterol fumarate dihydrate:

if you are allergic to formoterol or to any of the ingredients of Formoterol fumarate dihydrate.
to treat a sudden attack of breathlessness. It will not help. Use a reliever for this purpose and carry it
with you at all times.

Take special care with Formoterol fumarate dihydrate and always tell your doctor if you:
suffer from severe heart disease, especially a recent heart attack, a disease of the coronary vessels of the
heart or severe weakness of the heart muscle (congestive heart failure)
suffer from disorders of heart rhythm such as increased heart rate, heart valve defect or certain
electrocardiogram abnormalities or any other heart disease
have narrowing of the blood vessels, especially the arteries, or abnormal widening of the vessel wall
suffer from high blood pressure
have high sugar levels in the blood (diabetes mellitus)
have low blood potassium levels
have an overactive thyroid gland
are suffering from epinephrine and nor-epinephrine producing tumours of the adrenal medulla
are going to have any surgery or receive halogenated anaesthetics

Taking other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines
obtained without prescription.
Some medicines may interfere with the action of Formoterol fumarate dihydrate, these include medicines:
for treating abnormal heart rhythms (for example quinidine, disopyramide, procainamide)
for treating heart disease (for example digitalis)
for treating nasal congestion (for example ephedrine)
called beta adrenergic blockers used to treat heart conditions or glaucoma (an increase of the pressure in
the eye), as tablets or eye drops
containing erythromycin (used to treat infections)
for treating symptoms of depression: monoamine oxidase inhibitors (for example phenelzine and
isocarboxazid) or tricyclic antidepressants (for example amitryptiline and imipramine)
to treat severe mental disorders (for example chlorpromazine and trifluperazine)
used to treat allergic reactions (such as anti-histamines, for example terfenadine, astemizole, mizolastine)
used to treat bronchial asthma (for example theophylline, aminophylline or steroids)
used to increase urine production (such as diuretics)
for treating Parkinsonism (for example levodopa)
containing oxytocin, which causes uterus contraction
to treat an underactive thyroid gland (for example thyroxine)

If you forget to use your Formoterol fumarate dihydrate, take it as soon as you remember. If it is almost time for
your next dose, do not take the dose you have missed, just take the next dose at the usual time. Do not
double the dose.
Do not stop or reduce the dose of Formoterol fumarate dihydrate 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 dihydrate without talking to your doctor first.
If you feel you are getting breathless or wheezy while using Formoterol fumarate dihydrate, you should
continue to use Formoterol fumarate dihydrate but go to see your doctor as soon as possible, you may need
additional treatment. Once your asthma is well controlled, your doctor may consider it appropriate to gradually
reduce the dose of Formoterol fumarate dihydrate.

Instructions for use:
It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you
how to use your inhaler correctly. You must follow their instructions carefully so that you know how, when and
how many puffs to inhale. The correct instructions are given in this leaflet. If you are not sure what to do or
have problems in inhaling then ask your doctor, nurse or pharmacist for advice.
Testing your inhaler. If your inhaler is new or if it has not been used for 3 days or more, one puff should be
released into the air before using it, to make sure that it works.
You should stand or sit in the upright position when using your inhaler.
1. Remove the mouthpiece cover from the inhaler and hold it between the thumb and forefinger as shown.
2. Breathe out as far as is comfortable.
3. Hold the inhaler upright as shown with your thumb on the base below the mouthpiece; place the
mouthpiece in your mouth between your teeth and close your lips tightly around it.
4. Breathe in deeply through your mouth and at the same time press down on the top of the inhaler to release
a puff.
5. Hold your breath as long as is comfortable, then take the inhaler from your mouth.
6. If you are to take another puff, keep the inhaler upright and wait about half a minute before repeating steps
2 to 5.
7. After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly and snap into
position.

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment with Formoterol
fumarate dihydrate can help to open your airways even more.

Other special warnings:
You have also been prescribed corticosteroids for your breathing problems. It is very important to keep
using these regularly. Do not stop using them or change the dose when you start using Formoterol
fumarate dihydrate.

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor before using Formoterol
fumarate dihydrate.
The use of Formoterol fumarate dihydrate during pregnancy is only indicated if absolutely necessary.
If you are breast-feeding, talk to your doctor before using Formoterol fumarate dihydrate.

Driving and using machines:

Important: Do not rush steps 2, 3, 4 and 5.

Formoterol fumarate dihydrate is unlikely to have any effect on the ability to drive and operate machinery.

It is important that you start to breathe in as slowly as possible just before operating the inhaler.

Important information about some of the ingredients of Formoterol fumarate dihydrate:
Formoterol fumarate dihydrate contains a small amount of alcohol: each puff of your inhaler contains about
9mg of ethanol.

If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Formoterol fumarate
dihydrate will not get into your lungs as it should. Take another puff, carefully following the
instructions from Step 2 onwards.

If you have weak hands it may be easier to hold the inhaler with both hands. Put the two forefingers on top of
the inhaler and both thumbs on the bottom below the mouthpiece.
Tell your doctor, nurse or pharmacist if you have any difficulties.

Cleaning:
It is important to clean your inhaler regularly, at least once or twice a week to ensure that it works properly.
Pull the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.
Rinse the plastic case and the mouthpiece cover in warm water.
Do not put the metal canister into water.
Leave to dry thoroughly in a warm place. Avoid excessive heat.
Replace the canister and mouthpiece cover.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Formoterol fumarate dihydrate can cause side effects although not everybody gets them.
Possible side effects are listed below according to their frequency. If you are not sure what the side effects
below are, ask your doctor to explain them to you.
If your breathing or wheezing gets worse after using your inhaler stop using Formoterol fumarate
dihydrate and tell your doctor immediately. This is caused by narrowing of the airways in your lungs, but it
only occurs rarely.
Common side effects which may affect up to 1 in 10 people are: unusually fast heart beat and palpitations,
cough, trembling (fine tremor), headache.
Uncommon side effects which may affect fewer than 1 in 100 people are: muscle cramps, pain in muscles,
nausea, agitation, restlessness, sleep disorders, dizziness, abnormal or impaired sense of taste, throat
irritation, abnormal rapid heart beat, disorders of heart rhythm with increase heart rate, abnormal low levels of
potassium in the blood, increase in blood sugar levels, increase in the blood level of insulin, free fatty acids,
glycerol and ketones, excessive sweating.
Rare side effects which may affect fewer than 1 in 1,000 people are: missed heart beats caused by too early
contraction of the ventricles of the heart, feeling chest tightness, increase or decrease in blood pressure,
wheezing immediately after using the inhaler, severe fall in blood pressure, inflammation of the kidneys,
allergic reaction such as itching, rash, bronchospasm, urticaria, swelling of skin and mucous membrane
persisting for several days.
Very rare side effects which may affect fewer than 1 in 10,000 people are: worsening of asthma, difficulty
breathing, swelling of the hands and/or feet, irregular heart beat, reduced number of blood platelets,
hyper excitability, abnormal behaviour, hallucinations.
Some side effects, such as tremor, nausea, abnormal or impaired sense of taste, throat irritation, excessive
sweating, restlessness, headache, dizziness and muscle cramps, may ease during the course of one to two
weeks of continued use of your asthma medication.

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.

5. How to store Formoterol fumarate dihydrate
Keep out of the sight and reach of children.
Do not use beyond three months from the date you get the inhaler from your pharmacist and never use
after the expiry date which is stated on the carton/canister label ‘Exp’. The expiry date refers to the last day
of that month.
Do not store above 30°C.
If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands for a
few minutes before use. Never use anything else to warm it up.
Warning: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do
not pierce or burn container even when empty.
Medicines should not be disposed of via waste water 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
What Formoterol fumarate dihydrate contains:
The active ingredient is formoterol fumarate dihydrate.
Each metered actuation provides 12micrograms of formoterol fumarate dihydrate. This corresponds to a
delivered dose of 10.1micrograms.
The other ingredients are: hydrochloric acid, ethanol and Norflurane (HFA 134a).

What Formoterol fumarate dihydrate looks like and contents of the pack:
Formoterol fumarate dihydrate is a pressurised inhalation solution, in the form of an aerosol contained in an
aluminium canister with plastic actuator, metering valve and protective blue cap.
Each pack contains 1 inhaler which provides 120 puffs.

Manufactured by: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, I-43100 Parma, 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 12micrograms/actuation pressurised inhalation solution
PL 18799/2684
Leaflet date: 01.03.2016

POM

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.

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