ATIMOS MODULITE 12 MICROGRAMS PRESSURISED INHALATION SOLUTION

Active substance: FORMOTEROL FUMARATE DIHYDRATE

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Atimos Modulite PIL CP0015-5 update after PSUR worksharing pending May 12:Layout 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atimos® Modulite® 12 micrograms/actuation pressurised inhalation solution
Formoterol fumarate dihydrate
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.

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

Please read back of this leaflet

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Atimos Modulite PIL CP0015-5 update after PSUR worksharing pending May 12:Layout 1

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.

1

2

3
7

5-6

4

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 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.
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.
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


Keep out of the reach and sight 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.

6. Further information
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).
What Atimos Modulite looks like and contents of the pack:
Atimos Modulite is a pressurised inhalation solution contained in an aluminium canister with plastic actuator and
protective cap.
Each pack contains 1 inhaler which provides 50, 100 or 120 puffs.
Marketing Authorisation Holder:
Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK.
Manufacturer:
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43100 Parma, Italy
This medicinal product has been authorised in the member states of the EEA under the following
Austria

FORADIL

Belgium

ATIMOS

Portugal

ATIMOS

France

ATIMOS

Holland

ATIMOS

Slovenia

ATIMOS

Germany

ATIFOR CHIESI

UK

ATIMOS MODULITE Poland

Greece

FORADIL

Czech Republic ATIMOS

Spain

BRONCORAL NEO Slovak Republic ATIMOS
Hungary

ATIMOS

ATIMOS

Estonia

ATIMOS

Latvia

ATIMOS

Lithuania

ATIMOS

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in 05/2012
CP0015/5

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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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