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ATIMOS MODULITE12 MICROGRAMS/ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Atimos® Modulite® 12 micrograms/actuation
pressurised inhalation solution
(formoterol fumarate dihydrate)
The product is known by the name above but will be referred to as Atimos
Modulite throughout this leaflet.

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.

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

The use of Atimos Modulite during pregnancy is only indicated if absolutely
necessary.

Keep this leaflet. You may need to read it again.

If you are breast-feeding, talk to your doctor before using Atimos Modulite.

If you have any further questions, ask your doctor, or pharmacist.

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

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.

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 9 mg of ethanol.

In this leaflet:

3. How to use Atimos Modulite

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

Dosage:

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

For Asthma:
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.
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 (24 micrograms) of Atimos Modulite per day.
If you suffer from more severe asthma your doctor may prescribe 4 puffs per day
(48 micrograms), 2 puffs in the morning and 2 puffs in the evening.
4 puffs (48 micrograms) 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.
This product is not suitable for asthmatic children under 12 years old.
For Chronic Obstructive Pulmonary Disease (COPD):
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 (24 micrograms) of Atimos Modulite per day.
If you suffer from more severe COPD your doctor may prescribe 4 puffs per day
(48 micrograms), 2 puffs in the morning and 2 puffs in the evening.
4 puffs (48 micrograms) 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:
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.

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 heartbeat, reduced number of blood platelets, hyperexcitability, abnormal
behaviour, hallucinations.

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.

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 experience any of the side effects and it causes you distress, is severe or
lasts several days, or if you feel unwell or notice anything unusual or a side effect
which is not mentioned in this leaflet, you should contact your doctor or
pharmacist immediately.
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
and label. The expiry date refers to the last day of that month.
 Do not store the inhaler 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 the canister.
 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.
 If your inhaler appears to be discoloured, or show any other signs of
deterioration, take them to your pharmacist who will advise you on what to do.
6. Further information

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.

What Atimos Modulite contains:
The active substance of Atimos Modulite is formoterol fumarate dihydrate.
Each actuation (metered [ex-valve] dose) provides 12 micrograms of formoterol
fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms.
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 clear, colourless pressurised inhalation solution contained in
an aluminium canister with a white/off white plastic actuator and a blue protective
cap.
Each pack contains 1 inhaler which provides 120 actuations.

Tell your doctor, nurse or pharmacist if you have any difficulties.

PL: 15814/1132

Cleaning:
It is important to clean your inhaler regularly, at least once or twice a week to
ensure that it works properly.

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:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

 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
heartbeat, 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
heartbeats 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.

POM

Leaflet revision and issue date (Ref.): 21.10.2015.
Atimos and Modulite are registered trademarks of Chiesi Farmaceutici S.p.A.,
Italy.
To request a copy of this leaflet in Braille, large print or audio please call: 01923
332 796.

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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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