ATIMOS MODULITE 12 MICROGRAMS/ACTUATION PRESSURISED INHALATION SOLUTION

Active substance: FORMOTEROL FUMARATE DIHYDRATE

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Atimos® Modulite® 12 micrograms/actuation Pressurised Inhalation Solution
(Formoterol fumarate dihydrate)

Your medicine is known by the above name but will be referred to as
Atimos Modulite throughout this
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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.
In this leaflet:
1) What Atimos Modulite is and what it is used for
2) Before you use Atimos Modulite
3) How to use Atimos Modulite
4) Possible side effects
5) How to store Atimos Modulite
6) 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.

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 9 mg of ethanol.

3) How to use Atimos Modulite
Dosage:
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.

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

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.

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

Do not take more than 2 puffs at any one time.

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)

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.

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.

This product is not suitable for COPD patients under 18 years old.

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 conside it appropriate to
gradually reduce the dose of Atimos Modulite.

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.

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.

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.

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.

1

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.
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.

5) How to store Atimos Modulite






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3




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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. Protect from frost and direct
sunlight.
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.
If your Atimos Modulite inhaler fails to work properly or you notice any
other signs of deterioration in the inhaler, you should seek the advice
of your pharmacist.
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.

6) Further Information

4

5-6

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

What Atimos Modulite contains:
The active substance of Atimos Modulite is formoterol fumarate dihydrate.
Each metered actuation 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).

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.

What Atimos Modulite looks like and contents of the pack:
Atimos Modulite is a pressurised inhalation solution contained in an
aluminium canister with a white plastic actuator and a green protective
cap.

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.

Each pack contains 1 inhaler which provides 100 puffs (actuations).

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

PL 10383/1729

Atimos® Modulite® 12 micrograms/actuation
Pressurised Inhalation Solution
POM

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 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.

Who makes and repackages your medicine?
Your medicine is manufactured by Chiesi Farmaceutici S.p.A., Officina di
Parma, Via S. Leonardo 96 Italy and is procured from within the EU and
repackaged by the Product Licence Holder: Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 29.05.2013

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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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