FOSTAIR 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance: FORMOTEROL FUMARATE DIHYDRATE

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PATIENT INFORMATION LEAFLET

Fostair® 100/6 micrograms per actuation pressurised inhalation
solution
(beclometasone dipropionate / formoterol fumarate dihydrate)
For use in adults
This product is available as the above name but will be referred to as Fostair throughout
remainder of this leaflet:
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 Fostair is and what it is used for
2. Before you use Fostair
3. How to use Fostair
4. Possible side effects
5. How to store Fostair
6. Further information
1. What Fostair is and what it is used for
Fostair 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 are often referred to simply as steroids and have an anti-inflammatory
action reducing the swelling and irritation in the walls of the small air passages in the lungs.
Steroids are used in asthma to help treat symptoms and prevent symptoms.

Using Fostair with other medicines:
Before starting treatment, please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including any other inhalers and including
medicines obtained without a prescription.
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 Fostair 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 and breast-feeding:
There are no clinical data on the use of Fostair during pregnancy.
Fostair 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.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting
bronchodilators which relax the muscles in your airways and by doing this widen the
airways which makes it easier for you to breathe air in and out of your lungs.

Driving and using machines:
Fostair 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.

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 and
also help to prevent the symptoms of asthma.

Important information about some of the ingredients of Fostair:
Fostair contains a small amount of alcohol. Each actuation (puff) from your inhaler contains
7mg of ethanol.

Fostair is indicated in the regular treatment of people with asthma 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.

3. How to use Fostair

2. Before you use Fostair

Your doctor will give you a regular check-up to make sure you are taking the optimal dose of
Fostair. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Under no circumstances must you change the dose without first speaking to your doctor.

Do not use Fostair:
■ if you are allergic or think you are allergic to one or other of the active ingredients of
Fostair or if you are allergic to other medicines or inhalers used to treat asthma or to any
of the other ingredients of Fostair (see section 6: Further Information), contact your
doctor for advice.

Fostair is for inhalation use. Fostair should be inhaled via your mouth into your lungs.
Always use Fostair exactly as your doctor has told you to. You must 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.

Fostair can be prescribed by your doctor in two different ways:
a)

Use Fostair 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 Fostair every day to treat your asthma and also use Fostair to treat sudden
worsening of your asthma symptoms, such as shortness of breath, wheezing and
cough

Take special care with Fostair
Always tell your doctor before using Fostair:
■ 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 Fostair 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 apply to you, always inform your doctor before you use Fostair.
If you have or have had any medical problems or any allergies or if you are not sure as to
whether you can use Fostair talk to your doctor, asthma nurse or pharmacist before using
the inhaler.
Treatment with a beta-2-agonist like the formoterol contained in Fostair 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 Fostair,
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 Fostair and any medicines or tablets bought without a prescription, in
their original package, if possible.

a) Using Fostair together with a separate “reliever”:
Adults and the elderly:
The usual 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 Fostair as your only asthma inhaler:
Adults and the elderly:
The usual dose is one puff in the morning and one puff in the evening.
You should also use Fostair 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 Fostair “reliever” puffs per day.
The maximum daily dose using Fostair 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.
Children and adolescents less than 18 years of age:
Children and adolescents aged less than 18 years must NOT take this medicine.
At-risk patients:
Older people do not need to have their dose adjusted. No information is available regarding
the use of Fostair in people with liver or kidney problems.
Fostair 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 Fostair 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 Fostair 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 Fostair:
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 Fostair:
Do not lower the dose or stop using your medication.
Even if you are feeling better, do not stop using Fostair or lower the dose. If you want to do
this, talk to your doctor. It is very important for you to use Fostair 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 Fostair 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 Fostair as a reliever inhaler more frequently) or if your ‘reliever’ inhaler
or Fostair 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 Fostair or
prescribe alternative treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Instructions for use:
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.
2.
3.
4.

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.
Breathe out as slowly and deeply as possible.
Hold the canister vertically with its body upwards and put your lips around the
mouthpiece. Do not bite the mouthpiece.
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.

1
5.

2

3

4

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 Fostair 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 Fostair 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 PlusTM 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
PlusTM spacer device and that you follow the instructions on how to use the AeroChamber
TM
Plus spacer device and how to clean it carefully.
4. Possible side effects
Like all medicines Fostair can cause side effects although not everybody gets them.
Possible side effects are listed below according to their frequency.
As with other inhaler treatments there is a risk of worsening shortness of breath and
wheezing immediately after using Fostair and this is known as paradoxical bronchospasm.
If this occurs you must STOP using Fostair immediately and use your quick acting
‘reliever’ inhaler straightaway to treat the symptoms of shortness of breath and wheezing.
You must contact your doctor straightaway.
Also tell your doctor immediately if you experience any of the following:
■ unusual fast heartbeat
■ tightness in the chest
■ hallucinations
■ problems with how your adrenal glands work
■ allergic reactions which include 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.
Your doctor is likely to assess your asthma and if necessary may start you on another
course of treatment. You may be told that you must not use Fostair again.
Other side effects of Fostair are:
Common (affecting less than 1 in 10 people):
■ 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 mouth and throat
■ 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

















Rare (affecting less than 1 in 1,000 people):
■ tightness in the chest
■ sensation of a missed heartbeat
■ increase or decrease in blood pressure
■ inflammation of the kidney
■ nettle rash or hives
■ swelling of the skin and mucous membrane persisting for several days
Very rare (affecting less than 1 in 10,000 people):
■ worsening of asthma
■ irregular heartbeat
■ shortness of breath
■ a fall in the number of blood platelets
■ hallucinations
■ 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 adrenal glands work (adrenosuppression)
■ increased pressure in your eyes (glaucoma)
■ cataracts
■ growth retardation (slowing of growth) in children and adolescents
■ decrease in bone mineral density (thinning of the bones)
Unknown:
■ Sleeping problems, depression or feeling worried, restless, nervous, over-excited or
irritable. These effects are more likely to occur in children.
If you experience any of the above side effects and they cause you distress, are severe or
last for several days, or if you feel unwell or notice anything unusual or a side effect which
is not mentioned in this leaflet, or if you are worried in any way or if there is anything you do
not understand, you should contact your doctor or pharmacist immediately.
5. How to store Fostair









Keep out of the sight and reach of children.
Do not use Fostair 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.
If your inhaler does not work properly or if your medicine shows visible signs of
deterioration, show it to a pharmacist who will advise you what to do.

6. Further information
What Fostair 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 134-a). 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. Fostair does not contain CFCs.
What Fostair looks like and contents of the pack:
Fostair is a pressurised solution contained in an aluminium canister with a metering valve,
fitted in a pink plastic actuator with a purple plastic protective cap.
Each pack contains one canister which provides 120 actuations (puffs).
POM

PL No: 15814/1000, 15814/1001

This product is manufactured by Chiesi Farmaceutici Spa, via Palermo 26/A, Parma I43100, Italy and is procured from within the EU by the Product Licence holder: OPD
Laboratories Ltd., 6, Colonial Way, North Watford, WD24 4PR.
Leaflet revision and issue date (Ref.) 11.11.2013.
Fostair is a registered trademark of Chiesi Limited, U.K.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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