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FOSTAIR 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance: FORMOTEROL FUMARATE DIHYDRATE

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PATIENT INFORMATION LEAFLET

2713
30.07.15[3]

Fostair® 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.
To correct Section 4  This medicine has been prescribed for you only. Do not pass it on to
Using high-dose
others. It may harm them, even if their signs of illness are the same as
inhaled
yours.
corticosteroids over
 If you get any side effects talk with your doctor, or pharmacist or
a long time can
nurse. This includes any possible side effects not listed in this leaflet.

cause, in very rare
Your medicine is available using the above name, but will be referred to
cases,
as Fostair throughout this leaflet.
systemic effects.
What is in this leaflet:
1. What Fostair is and what it is used for
2. What you need to know before you use Fostair
3. How to use Fostair
4. Possible side effects
5. How to store Fostair
6. Content of the pack and other 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 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
Fostair 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
Fostair 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 Fostair
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 (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 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 applies 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.
Children and adolescents
Fostair should not be used in children and adolescents less then 18
years old, until further data become available.
Other medicines and Fostair:
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 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, breast-feeding and fertility
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.
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.
Fostair contains alcohol
Fostair contains a small amount of alcohol. Each actuation (puff) from
your inhaler contains 7mg of ethanol.
3. How to use Fostair
Fostair is for inhalation use.
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.

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.
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.

Asthma
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.
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
a) Using Fostair 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 Fostair 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 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.

1

2

3
4
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 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.

Use in children and adolescents less than 18 years of age:
Children and adolescents aged less than 18 years must NOT take this
medicine.

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.

Chronic obstructive pulmonary disease (COPD)
Adults and the elderly:
The recommended dose is two puffs in the morning and two puffs in the
evening.

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 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, Fostair 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 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 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
 diarrhoea
disorders of heart rhythm
 pain in the muscles and
 some changes in the
muscle cramp
electrocardiogram (ECG)
 reddening of the face
 asthma attack
 excessive sweating
 trembling
 increased blood flow to
 restlessness
some tissue in the body
 dizziness
 rhinitis
 palpitations
Alterations of some
 flu symptoms
constituents of the blood:
 fungal infections of the vagina
 fall in the number of white
 inflammation of the sinuses
blood cells
 inflammation of the ear
 increases in the number
of blood platelets
 throat irritation
 a fall in the level of
 cough and productive cough
potassium in the blood
 nausea
 increase in blood sugar
 abnormal or impaired sense of
level
taste
 increase in the blood
 burning of the lips
level of insulin, free fatty
 dry mouth
acid and ketones
 swallowing difficulties
 nettle rash or hives
 indigestion
 upset stomach
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
sensation of a missed heartbeat
increase or decrease in blood pressure
inflammation of the kidney
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 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.



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 Fostair
Keep this medicine 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 fails to work properly or shows any signs of
deterioration, you should seek the advice of your pharmacist.

6. Content of the pack and other information
What Fostair contains:
The active substances are: beclometasone dipropionate, formoterol
fumarate dihydrate.
Each actuation/metered dose (ex-valve) contains of beclometasone
dipropionate 100 micrograms and formoterol fumarate dihydrate 6
micrograms. This is equivalent to a delivered dose (ex-actuator)
containing beclometasone dipropionate of 84.6 micrograms and
formoterol fumarate dihydrate 5 micrograms.
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.
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 polypropylene pink plastic actuator with a
dark pink plastic protective cap.
Each pack contains one canister which provides 120 actuations (puffs).
Manufacturer and Product Licence holder:
Manufactured by Chiesi Farmaceutici S.p.A., Via Palermo 26/A, I-43100
Parma, Italy and is procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd
POM

PL 20636/2713

Leaflet revision and issue date (Ref.) 30.07.15[3]
Fostair is a trademark of Chiesi Farmaceutici S.p.A.
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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