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FORMODUAL 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): BECLOMETASONE DIPROPIONATE / FORMOTEROL FUMARATE DIHYDRATE / BECLOMETASONE DIPROPIONATE / FORMOTEROL FUMARATE DIHYDRATE / BECLOMETASONE DIPROPIONATE / FORMOTEROL FUMARATE DIHYDRATE

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LEAFLET Formodual 100/6 mcg MDI 120D DC Ch. Ltd
DIMENSIONS

SIZE

F065

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Package Leaflet
Information for the user

Formodual 100/6 micrograms per actuation
pressurised inhalation solution
beclometasone dipropionate/ formoterol fumarate dihydrate.
For use in adults.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects talk with your doctor, or pharmacist or nurse. This include any
possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Formodual is and what it is used for.
2. What you need to know before you use Formodual
3. How to use Formodual
4. Possible side effects
5. How to store Formodual
6. Content of the pack and other information
1. What Formodual is and what it is used for
Formodual is a pressurised inhalation solution containing two active substances which are inhaled
through your mouth and delivered directly into your lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an
anti-inflammatory action reducing the swelling and irritation in your lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators
which relax the muscles in your airways and helps you to breathe more easily.
Together these two active substances make breathing easier, by providing relief from symptoms
such as shortness of breath, wheezing and cough in patients with asthma or COPD and also help
to prevent the symptoms of asthma.
Asthma
Formodual is indicated in the regular treatment of asthma in adult patients in whom:
• asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting
bronchodilators
or
• asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.
COPD
Formodual can also be used to treat the symptoms of severe chronic obstructive pulmonary
disease (COPD) in adult patients. COPD is a long term disease of the airways in the lungs which
is primarily caused by cigarette smoking.
2. What you need to know before you use Formodual
Do not use Formodual:
• if you are allergic or think you are allergic to one or other of the active ingredients of Formodual
or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other
ingredients of Formodual (listed in section 6: Content of the pack and other Information), contact
your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Formodual:
• If you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart
attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary
heart disease), valvular heart disease or any other known abnormalities of your heart or if you have
a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition
where the heart muscle is abnormal).
• If you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood

pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall).
• If you have disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or
palpitations or if you have been told that your heart trace is abnormal.
• If you have an overactive thyroid gland.
• If you have low blood levels of potassium.
• If you have any disease of your liver or kidneys.
• If you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore
you may need to have some additional blood tests to check your blood sugar when you start using this
inhaler and from time to time during treatment).
• If you have a tumour of the adrenal gland (known as a phaeochromocytoma).
• If you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop
taking Formodual at least 12 hours before the anaesthesia.
• If you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal
infection of your chest.
• If you must avoid alcohol for any reason
If any of the above applies to you, always inform your doctor before you use Formodual.
If you have or had any medical problems or any allergies or if you are not sure as to whether you can use
Formodual talk to your doctor, asthma nurse or pharmacist before using the inhaler.
Treatment with a beta-2-agonist like the formoterol contained in Formodual can cause a sharp fall in your
serum potassium level (hypokalaemia).
If you have severe asthma, you should take special care. This is because a lack of oxygen in the blood
and some other treatments you may be taking together with Formodual, such as medicines for treating heart
disease or high blood pressure, known as diuretics or “water tablets” or other medicines used to treat asthma
can make the fall in potassium level worse. For this reason your doctor may wish to measure the potassium
levels in your blood from time to time.
If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need
for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an
accident, having a serious injury or before an operation. In this case, the doctor treating you will decide
whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a
steroid injection.
Should you need to go to the hospital, remember to take all of your medicines and inhalers with you,
including Formodual and any medicines or tablets bought without a prescription, in their original package, if
possible.

DATE

00218/RE

180 x 38 mm

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Regulatory modify: new registration product

NAME (IN CAPITAL LETTERS):

5) ARTWORK LAB

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21/07/2016

CHIESI Ltd ITEM

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Formodual must not be used if you are pregnant, think that you might be pregnant or are planning to become
pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor
Driving and using machines
Formodual is unlikely to affect your ability to drive and use machines. However if you experience side effects
such as dizziness and/or trembling, your ability to drive or operate machinery may be affected.
Formodual contains alcohol
Formodual contains a small amount of alcohol. Every actuation (puff) from your inhaler contains 7 mg of ethanol.
3. How to use Formodual
Formodual is for inhalation use. Formodual should be inhaled via your mouth into your lungs.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The pharmacist’s label will tell you how many puffs to take and how often they
must be taken.
Asthma
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Formodual.
Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Formodual can be prescribed by your doctor in two different ways:
a) Use Formodual every day to treat your asthma together with a separate “reliever “ inhaler to treat
sudden worsening of asthma symptoms, such as shortness of breath, wheezing and cough
b) Use Formodual every day to treat your asthma and also use Formodual to treat sudden
worsening of your asthma symptoms, such as shortness of breath, wheezing and cough
a) Using Formodual together with a separate “reliever”:
Adults and the elderly:
The recommended dose of this medicine is one or two puffs twice daily. The maximum daily dose is 4 puffs.
Remember: You should always have your quick-acting “reliever” inhaler with you at all times to treat
worsening symptoms of asthma or a sudden asthma attack.
b) Using Formodual as your only asthma inhaler:
Adults and the elderly:
The recommended dose is one puff in the morning and one puff in the evening.
You should also use Formodual as a “reliever” inhaler to treat sudden asthma symptoms.

Children and adolescents
Formodual should not be used in children and adolescent less then 18 years old, until further data become
available.

If you get asthma symptoms, take one puff and wait a few minutes.
If you do not feel better, take another puff.
Do not take more than 6 Formodual “reliever” puffs per day.

Other medicines and Formodual:
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other
medicines.

The maximum daily dose of Formodual as your only asthma inhaler is 8 puffs.
If you feel you need more puffs each day to control your asthma symptoms, contact your doctor to seek his
advice. He may need to change your treatment.

Do not use beta blockers with this medicine. Beta blockers such as atenolol, propranolol and sotalol are
used to treat a number of conditions including high blood pressure and heart conditions such as abnormal
heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta blockers, and
including beta blockers in eye-drops, the effect of formoterol may be reduced or formoterol may not work at
all. On the other hand, using other beta adrenergic drugs (drugs which work in the same way as formoterol)
may increase the effects of formoterol.

Use in children and adolescents less than 18 years of age:

Using Formodual together with:
• medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used
to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental
disorders such as monoaminoxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic
antidepressants (for example amitryptiline and imipramine), phenothiazines can cause some changes in
the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm
(ventricular arrhythmias).
• medicines for treating Parkinson’s Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine),
medicines containing oxytocin (which causes uterine contraction) and alcohol can lower your heart’s
tolerance to beta-2 agonists, such as formoterol.
• monoaminoxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and
procarbazine, used to treat mental disorders, can cause a rise in blood pressure.
• medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may
increase the likelihood of abnormal heart rhythms.
• other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets)
may cause a fall in your potassium level.
• Some anaesthetics can increase the risk of abnormal heart rhythms.

At-risk patients:
Older people do not need to have their dose adjusted. No information is available regarding the use of
Formodual in people with liver or kidney problems.

Pregnancy, breast- feeding and fertility
There are no clinical data on the use of Formodual during pregnancy.

Children and adolescents aged less than 18 years must NOT take this medicine.
Chronic obstructive pulmonary disease (COPD)
Adults and the elderly:
The recommended dose is two puffs in the morning and two puffs in the evening.

Formodual is effective for the treatment of asthma in a dose of beclometasone dipropionate which
may be lower than that of some other inhalers containing beclometasone dipropionate. If you have
been using a different inhaler containing beclometasone dipropionate previously, your doctor will
advise you on the exact dose of Formodual you should take for your asthma.
Do not increase the dose
If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.
If you use more Formodual than you should:
• Taking more formoterol than you should can have the following effects: feeling sick, being sick, heart
racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace),
headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of
glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and
blood glucose levels.
• Taking too much beclometasone dipropionate can lead to short-term problems with your adrenal glands.
This will get better within a few days however your doctor may need to carry out some blood tests to check
your serum cortisol levels.
Please read the back of this leaflet

00218/RE

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BOZZA (MAC-ID CC ) BOZZA (MAC-ID CC )
Creating artworks on UG: Informative Panel
indication of Vamish
correction
21/07/2016

CHIESI FARMACEUTICI S.p.A. - Parma
NOT TO TAMPER THIS DOCUMENT

21/07/2016

APPROVAL ARTWORK

PRODUCT

1) ARTWORK LAB : (tecnichal part)

(signature)

Date:

2) ARTWORK LAB. HEAD

(signature)

Date:

3) MANUFACTURING DEPT. :

(signature)

Date:

LEAFLET Formodual 100/6 mcg MDI 120D DC Ch. Ltd
DIMENSIONS

SIZE

F065

4) I certify here by under my personal responsibility that the signed text is in full compliance with the official version approved
by the relevant regulatory Authority and in agreement with all regulations in force in the country, where the product will be
distributed.

Request for new draft
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Tell your doctor if you have any of these symptoms.

instruction starting again from step 2.

If you forget to use Formodual:
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 correct time. Do not double the dose.

If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the
inhaler with both index fingers and its lower part with both thumbs.

If you stop using Formodual:
Do not lower the dose or stop using the medication.
Even if you are feeling better, do not stop taking Formodual or lower the dose. If you want to do this, talk to
your doctor. It is very important for you to use Formodual regularly even though you may have no symptoms.
If your breathing gets worse:
If you develop worsening shortness of breath or wheezing (breathing with an audible whistling sound),
straight after inhaling your medicine, stop using Formodual inhaler immediately and use your quick-acting
“reliever” inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your
symptoms and if necessary may start you on a different course of treatment.
See also section 4.Possible side effects
If your asthma gets worse:
If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler or
Formodual as reliever inhaler more frequently) or if your “reliever” inhaler or Formodual does not improve
your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need
to increase your dose of Formodual or prescribe alternative treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Method of administration:
This medicine is contained in a pressurised canister in a plastic casing with a mouthpiece. There is a counter
on the back of the inhaler, which tells you how many doses are left. Each time you press the canister, a puff
of medicine is released and the counter will count down by one. Take care not to drop the inhaler as this may
cause the counter to count down.
Testing your inhaler
Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, you should
test your inhaler to make sure that it is working properly.
1. Remove the protective cap from the mouthpiece
2. Hold your inhaler upright with the mouthpiece at the bottom
3. Direct the mouthpiece away from yourself and firmly depress the canister to release one puff
4. Check the dose counter. If you are testing your inhaler for the first time, the counter should read 120.

120

120

DOSE
COUNTER

How to use your inhaler
Whenever possible, stand or sit in an upright position when inhaling.

1 2 3 4 5
1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from
dust and dirt or any other foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the
mouthpiece.
4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down firmly on
the top of the inhaler to release one puff.
5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out
slowly. Do not Breathe into the inhaler.
If you need to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat
steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose counter.
You should get a replacement when the counter shows the number 20. Stop using the inhaler when the
counter shows 0 as any puffs left in the device may not be enough to give you a full dose.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, this means that
Formodual will not be getting into your lungs as it should. Take another puff, following the

To lower the risk of a fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush
your teeth each time you use your inhaler.
If you think the effect of Formodual is too much or not enough, tell your doctor or pharmacist.
If you find it difficult to operate the inhaler while starting to breathe in you may use the AeroChamber Plus™
spacer device. Ask your doctor, pharmacist or a nurse about this device.
It is important that you read the package leaflet which is supplied with your AeroChamber Plus™ spacer
device and that you follow the instructions on how to use the AeroChamber Plus™ spacer device and how to
clean it, carefully.
Cleaning
You should clean your inhaler once a week. When cleaning, do not remove the canister from the actuator
and do not use water or other liquids to clean your inhaler.
To clean your inhaler:
1. Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
2. Wipe inside and outside of the mouthpiece and the actuator with a clean, dry cloth or tissue.
3. Replace the mouthpiece cover

21/07/2016

CHIESI Ltd ITEM

Date:

(Final check)

DATE

00218/RE

180 x 38 mm

Item request by GOURISHETTI Vamshi on 20/07/2016
Regulatory modify: new registration product

NAME (IN CAPITAL LETTERS):

5) ARTWORK LAB

D.Q.O.C.
Artworks Lab.
by: MS
m.sigurani@chiesigroup.com

CP0026/8
FONT Arial
SIZE 10 pt

Language:
English

BACK

Very rare (affecting less than 1 in 10,000 people)
• worsening of asthma
• a fall in the number of blood platelets
• shortness of breath
• swelling of the hands and feet
Using high dose inhaled corticosteroids over a long time can cause, in very rare cases,
systemic effects. These include:
• problems with how your
• cataracts
• decrease in bone mineral
adrenal glands work
• growth retardation
density (thinning of the
(adrenosuppression)
(slowing of growth in
bones)
• increased pressure in
children and adolescents
your eyes (glaucoma)
Unknown:
• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable.
These events are more likely to occur in children.
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 product.
5. How to store Formodual

4. Possible side effects
Like all medicines, Formodual can cause side effects, although not everybody gets them.

• Keep this medicine out of the sight and reach of children.

As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately
after using Formodual and this is known as paradoxical bronchospasm. If this occurs you should STOP
using Formodual immediately and use your quick-acting “reliever” inhaler straightaway to treat the
symptoms of shortness of breath and wheezing. You should contact your doctor straightaway.

• Do not use Formodual beyond 5 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.

Tell your doctor immediately if you experience any hypersensitivity reactions like skin allergies, skin itching,
skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips
and throat.
Other possible side effects are listed below according to their frequency.
Common (affecting less than 1 in 10 people):
• Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.
Uncommon (affecting less than 1 in 100 people);
• unusual fast heartbeat
• throat irritation
and disorders of heart
• cough and productive
rhythm
cough
• some changes in the
• nausea
electrocardiogram
• abnormal or impaired
(ECG)
sense of taste
• asthma attack
• burning of the lips
• trembling
• dry mouth
• restlessness
• swallowing difficulties
• dizziness
• indigestion
• palpitations
• upset stomach
• flu symptoms
• diarrhoea
• fungal infections of the
• pain in the muscles and
vagina
muscle cramp
• inflammation of the
• reddening of the face
sinuses
• excessive sweating
• inflammation of the ear

• increased blood flow to
some tissue in the body
• rhinitis
Alterations of some
constituents of the blood:
• fall in the number of
white blood cells
• increase in the number
of blood platelets
• a fall in the level of
potassium in the blood
• increase in blood sugar
level
• increase in the blood
level of insulin, free fatty
acid and ketones
• nettle rash or hives

• Do not store the inhaler above 25 °C.
• If the inhaler has been exposed to severe cold, warm it with your hands for a few minutes before
using. Never warm it by artificial means.
• Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures
higher than 50 °C. Do not pierce the canister.
• Medicines should not be disposed of via waste water or household waste. Return all used,
partially used and unused inhalers to your pharmacist to be disposed of. These measures
will help to protect the environment.
6. Content of the pack and other information
What Formodual contains:
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation/metered dose from the inhaler contains 100 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered
dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms
of formoterol fumarate dihydrate.
The other ingredients are: ethanol anhydrous, hydrochloric acid and the CFC-free propellant norflurane (HFA -134a). To help protect the environment, the inhaler contains the CFC-free
propellant, HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants
present in some other inhalers and appears to have a less damaging effect on the ozone layer.
Formodual does not contain CFCs.
What Formodual looks like and contents of the pack:
Formodual is a pressurised solution contained in an aluminium canister with a metering valve,
fitted in a polypropylene plastic actuator with a plastic protective cap.
Each pack contains one canister which provides 120 or 180 actuations (puffs).

The following side effects have also been reported as “uncommon” in patients with Chronic Obstructive
pulmonary disease:
• Pneumonia; tell your doctor if you notice any of the following symptoms: increase in sputum production,
increase in sputum colour, fever, increasing cough, increased breathing problems.
• Reduction of the amount of cortisol in the blood; this is caused by the effect of corticosteroids on your
adrenal gland.
• Irregular heart beat.

Not all pack sizes may be marketed.

Rare (affecting less than 1 in 1,000 people)

This leaflet was last revised in July 2016

• tightness in the chest
• sensation of a missed
heartbeat
• increase or decrease in
blood pressure

• inflammation of the
kidney

• swelling of skin and
mucous membrane
persisting for several
days

Marketing Authorisation Holder: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.
Manufacturer responsible for batch release:
Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma - Italy
Chiesi S.A.S, Rue Faraday Z.A. des Gaillestrous, 41260 La Chaussee Saint-Victor, France

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
AeroChamber Plus™ is a Trademark of Trudell Medical International

CP0026/8

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UG: Informative Panel
correction

CHIESI FARMACEUTICI S.p.A. - Parma

21/07/2016

NOT TO TAMPER THIS DOCUMENT

APPROVAL ARTWORK
1) ARTWORK LAB : (tecnichal part)

(signature)

Date:

2) ARTWORK LAB. HEAD

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3) MANUFACTURING DEPT. :

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Date:

PRODUCT

F065

NAME (IN CAPITAL LETTERS):
Signature

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Item request by GOURISHETTI Vamshi on 20/07/2016
Regulatory modify: new registration product

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540 x 300 mm

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LEAFLET Formodual 100/6 mcg 180D MDI DI Ch. Ltd
DIMENSIONS

SIZE
4) I certify here by under my personal responsibility that the signed text is in full compliance with the official version approved
by the relevant regulatory Authority and in agreement with all regulations in force in the country, where the product will be
distributed.

5) ARTWORK LAB

D.Q.O.C.
Artworks Lab.
by: MS
m.sigurani@chiesi.com

(signature)

Date:

(signature)

Date:

(signature)

Date:

Package Leaflet
Information for the user

Formodual 100/6 micrograms per actuation
pressurised inhalation solution
beclometasone dipropionate/ formoterol fumarate dihydrate.
For use in adults.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects talk with your doctor, or pharmacist or nurse. This include any
possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Formodual is and what it is used for.
2. What you need to know before you use Formodual
3. How to use Formodual
4. Possible side effects
5. How to store Formodual
6. Content of the pack and other information
1. What Formodual is and what it is used for
Formodual is a pressurised inhalation solution containing two active substances which are inhaled
through your mouth and delivered directly into your lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an
anti-inflammatory action reducing the swelling and irritation in your lungs.

pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall).
• If you have disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or
palpitations or if you have been told that your heart trace is abnormal.
• If you have an overactive thyroid gland.
• If you have low blood levels of potassium.
• If you have any disease of your liver or kidneys.
• If you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore
you may need to have some additional blood tests to check your blood sugar when you start using this
inhaler and from time to time during treatment).
• If you have a tumour of the adrenal gland (known as a phaeochromocytoma).
• If you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop
taking Formodual at least 12 hours before the anaesthesia.
• If you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal
infection of your chest.
• If you must avoid alcohol for any reason
If any of the above applies to you, always inform your doctor before you use Formodual.
If you have or had any medical problems or any allergies or if you are not sure as to whether you can use
Formodual talk to your doctor, asthma nurse or pharmacist before using the inhaler.
Treatment with a beta-2-agonist like the formoterol contained in Formodual can cause a sharp fall in your
serum potassium level (hypokalaemia).
If you have severe asthma, you should take special care. This is because a lack of oxygen in the blood
and some other treatments you may be taking together with Formodual, such as medicines for treating heart
disease or high blood pressure, known as diuretics or “water tablets” or other medicines used to treat asthma
can make the fall in potassium level worse. For this reason your doctor may wish to measure the potassium
levels in your blood from time to time.
If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need
for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an
accident, having a serious injury or before an operation. In this case, the doctor treating you will decide
whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a
steroid injection.
Should you need to go to the hospital, remember to take all of your medicines and inhalers with you,
including Formodual and any medicines or tablets bought without a prescription, in their original package, if
possible.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators
which relax the muscles in your airways and helps you to breathe more easily.

Children and adolescents
Formodual should not be used in children and adolescent less then 18 years old, until further data become
available.

Together these two active substances make breathing easier, by providing relief from symptoms
such as shortness of breath, wheezing and cough in patients with asthma or COPD and also help
to prevent the symptoms of asthma.

Other medicines and Formodual:
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other
medicines.

Asthma
Formodual is indicated in the regular treatment of asthma in adult patients in whom:

Do not use beta blockers with this medicine. Beta blockers such as atenolol, propranolol and sotalol are
used to treat a number of conditions including high blood pressure and heart conditions such as abnormal
heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta blockers, and
including beta blockers in eye-drops, the effect of formoterol may be reduced or formoterol may not work at
all. On the other hand, using other beta adrenergic drugs (drugs which work in the same way as formoterol)
may increase the effects of formoterol.

• asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting
bronchodilators
or
• asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.
COPD
Formodual can also be used to treat the symptoms of severe chronic obstructive pulmonary
disease (COPD) in adult patients. COPD is a long term disease of the airways in the lungs which
is primarily caused by cigarette smoking.
2. What you need to know before you use Formodual
Do not use Formodual:
• if you are allergic or think you are allergic to one or other of the active ingredients of Formodual
or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other
ingredients of Formodual (listed in section 6: Content of the pack and other Information), contact
your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Formodual:
• If you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart
attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary
heart disease), valvular heart disease or any other known abnormalities of your heart or if you
have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a
condition where the heart muscle is abnormal).
• If you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood

Using Formodual together with:
• medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used
to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental
disorders such as monoaminoxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic
antidepressants (for example amitryptiline and imipramine), phenothiazines can cause some changes in
the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm
(ventricular arrhythmias).
• medicines for treating Parkinson’s Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine),
medicines containing oxytocin (which causes uterine contraction) and alcohol can lower your heart’s
tolerance to beta-2 agonists, such as formoterol.
• monoaminoxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and
procarbazine, used to treat mental disorders, can cause a rise in blood pressure.
• medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may
increase the likelihood of abnormal heart rhythms.
• other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets)
may cause a fall in your potassium level.
• Some anaesthetics can increase the risk of abnormal heart rhythms.
Pregnancy, breast- feeding and fertility
There are no clinical data on the use of Formodual during pregnancy.
Formodual must not be used if you are pregnant, think that you might be pregnant or are planning to become

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pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor
Driving and using machines
Formodual is unlikely to affect your ability to drive and use machines. However if you experience side effects
such as dizziness and/or trembling, your ability to drive or operate machinery may be affected.
Formodual contains alcohol
Formodual contains a small amount of alcohol. Every actuation (puff) from your inhaler contains 7 mg of ethanol.
3. How to use Formodual
Formodual is for inhalation use. Formodual should be inhaled via your mouth into your lungs.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The pharmacist’s label will tell you how many puffs to take and how often they
must be taken.
Asthma
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Formodual.
Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Formodual can be prescribed by your doctor in two different ways:
a) Use Formodual every day to treat your asthma together with a separate “reliever “ inhaler to treat
sudden worsening of asthma symptoms, such as shortness of breath, wheezing and cough
b) Use Formodual every day to treat your asthma and also use Formodual to treat sudden
worsening of your asthma symptoms, such as shortness of breath, wheezing and cough
a) Using Formodual together with a separate “reliever”:
Adults and the elderly:
The recommended dose of this medicine is one or two puffs twice daily. The maximum daily dose is 4 puffs.
Remember: You should always have your quick-acting “reliever” inhaler with you at all times to treat
worsening symptoms of asthma or a sudden asthma attack.
b) Using Formodual as your only asthma inhaler:
Adults and the elderly:
The recommended dose is one puff in the morning and one puff in the evening.
You should also use Formodual as a “reliever” inhaler to treat sudden asthma symptoms.
If you get asthma symptoms, take one puff and wait a few minutes.
If you do not feel better, take another puff.
Do not take more than 6 Formodual “reliever” puffs per day.
The maximum daily dose of Formodual as your only asthma inhaler is 8 puffs.
If you feel you need more puffs each day to control your asthma symptoms, contact your doctor to seek his
advice. He may need to change your treatment.
Use in children and adolescents less than 18 years of age:
Children and adolescents aged less than 18 years must NOT take this medicine.
Chronic obstructive pulmonary disease (COPD)
Adults and the elderly:
The recommended dose is two puffs in the morning and two puffs in the evening.
At-risk patients:
Older people do not need to have their dose adjusted. No information is available regarding the use of
Formodual in people with liver or kidney problems.
Formodual is effective for the treatment of asthma in a dose of beclometasone dipropionate which
may be lower than that of some other inhalers containing beclometasone dipropionate. If you have
been using a different inhaler containing beclometasone dipropionate previously, your doctor will
advise you on the exact dose of Formodual you should take for your asthma.
Do not increase the dose
If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.
If you use more Formodual than you should:
• Taking more formoterol than you should can have the following effects: feeling sick, being sick, heart
racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace),
headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of
glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and
blood glucose levels.
• Taking too much beclometasone dipropionate can lead to short-term problems with your adrenal glands.
This will get better within a few days however your doctor may need to carry out some blood tests to check
your serum cortisol levels.
Please read the back of this leaflet

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Tell your doctor if you have any of these symptoms.

instruction starting again from step 2.

If you forget to use Formodual:
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 correct time. Do not double the dose.

If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the
inhaler with both index fingers and its lower part with both thumbs.

If you stop using Formodual:
Do not lower the dose or stop using the medication.
Even if you are feeling better, do not stop taking Formodual or lower the dose. If you want to do this, talk to
your doctor. It is very important for you to use Formodual regularly even though you may have no symptoms.
If your breathing gets worse:
If you develop worsening shortness of breath or wheezing (breathing with an audible whistling sound),
straight after inhaling your medicine, stop using Formodual inhaler immediately and use your quick-acting
“reliever” inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your
symptoms and if necessary may start you on a different course of treatment.
See also section 4.Possible side effects
If your asthma gets worse:
If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler or
Formodual as reliever inhaler more frequently) or if your “reliever” inhaler or Formodual does not improve
your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need
to increase your dose of Formodual or prescribe alternative treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

To lower the risk of a fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush
your teeth each time you use your inhaler.
If you think the effect of Formodual is too much or not enough, tell your doctor or pharmacist.
If you find it difficult to operate the inhaler while starting to breathe in you may use the AeroChamber Plus™
spacer device. Ask your doctor, pharmacist or a nurse about this device.
It is important that you read the package leaflet which is supplied with your AeroChamber Plus™ spacer
device and that you follow the instructions on how to use the AeroChamber Plus™ spacer device and how to
clean it, carefully.
Cleaning
You should clean your inhaler once a week. When cleaning, do not remove the canister from the actuator
and do not use water or other liquids to clean your inhaler.
To clean your inhaler:
1. Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
2. Wipe inside and outside of the mouthpiece and the actuator with a clean, dry cloth or tissue.
3. Replace the mouthpiece cover
4. Possible side effects

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Very rare (affecting less than 1 in 10,000 people)
• worsening of asthma
• a fall in the number of blood platelets
• shortness of breath
• swelling of the hands and feet
Using high dose inhaled corticosteroids over a long time can cause, in very rare cases,
systemic effects. These include:
• problems with how your
• cataracts
• decrease in bone mineral
adrenal glands work
• growth retardation
density (thinning of the
(adrenosuppression)
(slowing of growth in
bones)
• increased pressure in
children and adolescents
your eyes (glaucoma)
Unknown:
• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable.
These events are more likely to occur in children.
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 product.
5. How to store Formodual

Method of administration:
This medicine is contained in a pressurised canister in a plastic casing with a mouthpiece. There is a dose
indicator on the back of the inhaler, which tells you how many puffs are left. Each time you press the canister,
the dose indicator rotates by a small amount. The number of puffs remaining is displayed in intervals of 20.
Take care not to drop the inhaler as this may cause the dose indicator to count down.

Like all medicines, Formodual can cause side effects, although not everybody gets them.

• Keep this medicine out of the sight and reach of children.
• Do not use Formodual beyond 5 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.

Testing your inhaler
Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, you should
test your inhaler to make sure that it is working properly.
• Remove the protective cap from the mouthpiece
• Hold your inhaler upright with the mouthpiece at the bottom
• Direct the mouthpiece away from yourself and firmly depress the canister to release one puff
• Check the dose indicator. If you are testing your inhaler for the first time, the dose indicator should read 180.

As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately
after using Formodual and this is known as paradoxical bronchospasm. If this occurs you should STOP
using Formodual immediately and use your quick-acting “reliever” inhaler straightaway to treat the
symptoms of shortness of breath and wheezing. You should contact your doctor straightaway.
Tell your doctor immediately if you experience any hypersensitivity reactions like skin allergies, skin itching,
skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips
and throat.

• If the inhaler has been exposed to severe cold, warm it with your hands for a few minutes before
using. Never warm it by artificial means.

Common (affecting less than 1 in 10 people):
• Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.
Uncommon (affecting less than 1 in 100 people);

180

DOSE
INDICATOR

180

Other possible side effects are listed below according to their frequency.

How to use your inhaler
Whenever possible, stand or sit in an upright position when inhaling.

1 2 3 4 5
1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from
dust and dirt or any other foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the
mouthpiece.
4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down firmly on
the top of the inhaler to release one puff.
5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out
slowly. Do not Breathe into the inhaler.
If you need to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat
steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose indicator.
You should get a replacement when the indicator shows the number 20. Stop using the inhaler when the
counter shows 0 as any puffs left in the device may not be enough to give you a full dose.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, this means that
Formodual will not be getting into your lungs as it should. Take another puff, following the

• unusual fast heartbeat
and disorders of heart
rhythm
• some changes in the
electrocardiogram
(ECG)
• asthma attack
• trembling
• restlessness
• dizziness
• palpitations
• flu symptoms
• fungal infections of the
vagina
• inflammation of the
sinuses
• inflammation of the ear

• throat irritation
• cough and productive
cough
• nausea
• abnormal or impaired
sense of taste
• burning of the lips
• dry mouth
• swallowing difficulties
• indigestion
• upset stomach
• diarrhoea
• pain in the muscles and
muscle cramp
• reddening of the face
• excessive sweating

• increased blood flow to
some tissue in the body
• rhinitis
Alterations of some
constituents of the blood:
• fall in the number of
white blood cells
• increase in the number
of blood platelets
• a fall in the level of
potassium in the blood
• increase in blood sugar
level
• increase in the blood
level of insulin, free fatty
acid and ketones
• nettle rash or hives

The following side effects have also been reported as “uncommon” in patients with Chronic Obstructive
pulmonary disease:
• Pneumonia; tell your doctor if you notice any of the following symptoms: increase in sputum production,
increase in sputum colour, fever, increasing cough, increased breathing problems.
• Reduction of the amount of cortisol in the blood; this is caused by the effect of corticosteroids on your
adrenal gland.
• Irregular heart beat.
Rare (affecting less than 1 in 1,000 people)
• tightness in the chest
• inflammation of the
• sensation of a missed
kidney
heartbeat
• increase or decrease in
blood pressure

• swelling of skin and
mucous membrane
persisting for several
days

• Do not store the inhaler above 25 °C.

• Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures
higher than 50 °C. Do not pierce the canister.
• Medicines should not be disposed of via waste water or household waste. Return all used,
partially used and unused inhalers to your pharmacist to be disposed of. These measures
will help to protect the environment.
6. Content of the pack and other information
What Formodual contains:
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation/metered dose from the inhaler contains 100 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered
dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms
of formoterol fumarate dihydrate.
The other ingredients are: ethanol anhydrous, hydrochloric acid and the CFC-free propellant norflurane (HFA -134a). To help protect the environment, the inhaler contains the CFC-free
propellant, HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants
present in some other inhalers and appears to have a less damaging effect on the ozone layer.
Formodual does not contain CFCs.
What Formodual looks like and contents of the pack:
Formodual is a pressurised solution contained in an aluminium canister with a metering valve,
fitted in a polypropylene plastic actuator with a plastic protective cap.
Each pack contains one canister which provides 120 or 180 actuations (puffs).
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.
Manufacturer responsible for batch release:
Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma - Italy
Chiesi S.A.S, Rue Faraday Z.A. des Gaillestrous, 41260 La Chaussee Saint-Victor, France

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in July 2016
AeroChamber Plus™ is a Trademark of Trudell Medical International

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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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