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FORMODUAL 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

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

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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 using 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 includes 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 a 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 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 have 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 must 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 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.

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

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

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.

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 monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic
antidepressants (for example amitriptyline 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 contractions) and alcohol can lower your heart’s
tolerance to beta-2-agonists, such as formoterol.
• monoamine oxidase 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 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. Each actuation (puff) from your inhaler contains 7mg 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 using 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
their advice. They 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.
Please read the back of this leaflet →

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.
Tell your doctor if you have any of the above symptoms.

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 stop using Formodual:
Do not lower the dose or stop using your medication.
Even if you are feeling better, do not stop using 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 your 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 a 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:
Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, release
one puff into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an
upright position when inhaling.
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 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. After use, close with the protective cap.

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.

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, carefully following the
instructions from Step 2 onwards.
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.

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 the 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.

Cleaning:
Remove the cap from the mouthpiece and regularly (once a week) wipe the outside and inside of the
mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.
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.
4. Possible side effects

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

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 must
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.
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
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
• increases 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):
• inflammation of the
• tightness in the chest
kidney
• sensation of a missed
heartbeat
• increase or decrease in
blood pressure

• swelling of the skin and
mucous membrane
persisting for several
days

Very rare (affecting less than 1 in 10,000 people):
• worsening of asthma
• shortness of breath

• a fall in the number of blood platelets
• 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)
Unkown:

• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable.
These effects 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 medicine.
5. How to store Formodual
• Keep this medicine out of the sight and reach of children.
• Do not use Formodual beyond five 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.
• Do not store the inhaler above 25°C.
• If the inhaler has been exposed to severe cold, take the canister out of the mouthpiece and 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). Not all pack sizes may be marketed.
Marketing Authorisation Holder: Chiesi Limited, Cheadle Royal Business Park, Highfield,
Cheadle, SK8 3GY
Manufacturer: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, I-43122 Parma, Italy.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in: 03/2014
AeroChamber Plus™ is a Trademark of Trudell Medical International

CP0026/6

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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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