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FORADIL

Active substance(s): EFORMOTEROL FUMARATE / FORMOTEROL FUMARATE

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12 mcg
1898

formoterol fumarate

1127708-A15-GB

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Comp. Description:

BRO_FORADIL_HGCI_12MCG_GB

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1127708-A15-GB
1127708-ST 13 A/B-GB
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Date: 26 May 2015

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Barbera
Gonzalez Conde, Rebeca
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PANTONE 314 C
PANTONE 179 C
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Patient Information Leaflet

FORADIL®
(formoterol fumarate)

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What you need to know about Foradil
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It
contains important information. Keep the leaflet in a safe place because you may
want to read it again.
If you have any other questions, or if there is something you don’t understand, please
ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be
the right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

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In this leaflet:
1. What Foradil is, and what it’s used for
2. Things to consider before you start to take Foradil
3. How to take Foradil
4. Possible side effects
5. How to store Foradil
6. Further information

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1. What Foradil is and what it’s used for
The Foradil pack includes a blister pack of capsules containing the medicine and an
inhaler device for taking the medicine. Instructions for using the inhaler are given later
on in the leaflet.
The active ingredient in this medicine is formoterol. Formoterol is one of a group of
medicines called long-acting bronchodilators. It makes breathing easier by relaxing
muscle spasms in the air passages of the lungs.
• Foradil is used to treat asthma in people who are already taking inhaled steroids but
still have symptoms such as wheezing and breathlessness. Taking Foradil regularly
together with inhaled steroids will help to prevent breathing problems
• Foradil is also used to treat breathing problems in patients with chronic obstructive
pulmonary disease (COPD)
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2. Things to consider before you start to take Foradil
Some people MUST NOT take Foradil. Talk to your doctor if:
• you know you’re allergic to Foradil, or if you have ever had an unusual or allergic
reaction to formoterol or inhaled lactose
• you are breastfeeding
Foradil is not suitable for children under six years of age.
The very small amount of lactose in Foradil is unlikely to cause problems in lactose-­
intolerant patients.

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You should also ask yourself these questions before taking Foradil. If the answer
to any of these questions is YES, tell your doctor or pharmacist because Foradil
might not be the right medicine for you.
• Is this the only asthma medicine you have?
• Do you suffer from any heart problems?
• Do you have high blood pressure?
• Do you have an overactive thyroid gland?
• Do you have an aneurysm (area where an artery is swollen because the wall of the
artery is weak)?
• Do you have a heart disorder such as abnormal electrical signal called “prolongation
of QT interval”?

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• Are you diabetic?
• Do you have pheochromocytoma (a tumor of the adrenal gland that can affect blood
pressure)?
• Are you pregnant?
Are you taking other medicines?
Some medicines can interfere with your treatment. Make sure your doctor knows if you
are taking any of the following:
• Medicines for heart conditions including irregular heart beats, angina and heart
failure
• Medicines for high blood pressure
• Beta blockers (either as tablets or eye drops)
• Water tablets (diuretics)
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• Medicines for depression, for example, monoamine oxidase inhibitors (MAOIs) or
tricyclics
• Anti-histamines or cold remedies (including any bought from the chemist)
• Medicines called ‘steroids’. Your doctor will know which these are
• Sympathomimetic agents, which are adrenaline-like medicines used to treat asthma
and nasal congestion
• Phenothiazines, which are a group of medicines which control mental disorders such
as schizophrenia, mania, psychotic conditions and anxiety
• Xanthines, for example theophylline or aminophylline, which are a class of medicines
used to treat asthma and chronic obstructive airways diseases
• Macrolides (for example Erythromycin) used to treat bacterial infections.

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• Anaesthetics like Halogenated hydrocarbons (for example Halothane). These drugs
are used to produce anaesthesia during surgery
• Anticholinergic drugs (for example Ipratropium bromide) used to treat gastrointestinal
disorders and genitourinary disorders
Always tell your doctor about all the medicines you are taking. This means medicines you
have bought yourself as well as medicines on prescription from your doctor.

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Other special warnings
• You must not use Foradil to treat a sudden asthma attack. Your doctor will have given
you another inhaler (a ‘reliever’) for this
• It is very important to keep using your other asthma medicines, (inhaled steroids
known as a ‘preventer’), regularly. DO NOT stop using them or change the dose when
you start using Foradil
• If you feel that you are getting breathless or wheezy while you are using Foradil, you
should continue to use it, but go to see your doctor as soon as possible in case you
need another medicine
• Treatment with Foradil may lead to your blood level of potassium becoming too low.
This may make you more susceptible to abnormal heart rhythm. Therefore, your doctor
may monitor your blood level of potassium, especially if you have severe asthma
• Treatment with Foradil may lead to increased sugar levels in the blood.
Therefore, you might need to monitor your blood sugar levels if you are diabetic
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Will there be any problems with driving or using machinery?
In some patients, Foradil has been reported to cause dizziness. If you feel dizzy, do not
drive or operate machinery.
3. How to take Foradil
The doctor will tell you how much Foradil to take and when to take it. Always follow his/
her instructions carefully. The dose will be on the pharmacist’s label. Check the label
carefully. If you are not sure, ask your doctor or pharmacist. Keep using the inhaler for
as long as you have been told unless you have any problems. In that case, check with
your doctor.

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Foradil capsules must only be used with the inhaler provided. You must not try to inhale
them using another inhaler. Also, do not put other types of capsules into the inhaler
supplied with Foradil.
• Do not swallow the capsules. The contents of the capsule must be inhaled
using the inhaler provided
For the treatment of asthma
Adults and the elderly
• The usual dose is 1 puff (1 capsule=1 puff) morning and evening
• The usual dose for more severe cases is 2 puffs (2 capsules) morning and evening
• You should not take more than 4 capsules in a day

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Children aged 6 and over
• The usual dose is 1 puff (1 capsule=1 puff) morning and evening
• A child should not take more than 2 capsules in a day.
When you have asthma you must also be taking an inhaled steroid at the same
time as Foradil.
For the treatment of COPD (Chronic Obstructive Pulmonary Disease)
Adults and the elderly
• The usual dose is 1 puff in the morning and evening
Children under 18
• Not applicable

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The effects of this medicine will normally last for 12 hours. If you do get attacks of
wheezing between doses, do not take extra doses of Foradil. Your doctor will have
prescribed another medicine for this purpose. If you are not sure about this, check with
your doctor.
• Do not stop or reduce the dose of Foradil or any other medicine for your breathing
just because you feel better, without talking to your doctor first. It is very important to
use these medicines regularly
• Do not increase your dose of Foradil without talking to your doctor first
• If you feel sick or very shaky or if you have an unusually fast heart beat, your Foradil
dose may be too high. Tell your doctor as soon as possible

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How to use the capsules with the inhaler device
A child should be shown how to use the inhaler correctly and should only use it with the
help of an adult.

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1 Pull off the cap.

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2 Hold the base of the inhaler firmly and turn the
mouthpiece in the direction of the arrow on the
bottom of the mouthpiece to open.

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3 Take one of today’s capsules out of the blister
strip. Place it in the capsule-shaped compartment
in the base of the inhaler. It is important that you
remove the capsule from the blister pack only
immediately before you use it.

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4 Twist the mouthpiece to the closed position until it
clicks.

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5 Keeping the inhaler upright, firmly squeeze the
two blue buttons once only. This will pierce the
capsule. Release the buttons. Although the
capsule is now pierced, the powder will not be
released until you inhale it.

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6. Breathe out fully.

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7 Place the mouthpiece in your mouth and tilt your
head slightly backwards. Close your lips around
the mouthpiece and breathe in as quickly and as
deeply as you can. As you breathe in, you will
inhale the medicine into your lungs.
You should hear the capsule spinning in the
inhaler. If you do not hear this whirring noise, the
capsule may be stuck in the compartment. If this
occurs, open the inhaler and loosen the capsule
by prising it out of the compartment. Do not try
to loosen the capsule by repeatedly pressing the
buttons.
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8. If you have heard the whirring noise, hold your breath for as long as you
comfortably can while taking the inhaler out of your mouth. Then breathe normally.
Open the inhaler to see if any powder is still in the capsule. If there is still powder in
the capsule repeat steps 6 to 8.
9. After use, tip out the empty capsule and close the mouthpiece.
10. Replace the cap.
11. If you need to clean the inhaler, wipe the mouthpiece and capsule compartment with
a dry cloth or a clean soft brush.

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Very occasionally, very small pieces of the capsule shell can get in the mouth. If this
happens, you may be able to feel these pieces on your tongue. The capsule shell is
made of gelatin which is harmless to humans, and will soften or dissolve in the mouth
and be swallowed. The chances of this happening will be increased if the capsule is
pierced many times (Step 5); hence it is recommended that you do this only once for
each capsule.
What if you forget to take a dose?
If you miss a dose, take it as soon as you remember. Then go on as before. Do not
double the dose.
What if you take too much?
If you, or anyone else, accidentally takes too much, tell your doctor or your nearest
hospital casualty department immediately. Take your medicine pack with you so that
people can see what you have taken.
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4. Possible side effects
Foradil is suitable for most people, but, like all medicines, it can sometimes cause side
effects.
Some side effects can be serious
Stop using Foradil and tell your doctor straight away if you notice:
• Bronchospasm with wheezing or coughing and difficulty in breathing. This might
affect up to 1 in 100 people
• An allergic reaction such as if you feel faint (you might have low blood pressure),
have a rash, or experience itching or facial swelling. This might affect less than 1 in
10,000 people

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• If you feel you have muscle weakness, muscle spasms or an abnormal heart rhythm
(these could mean you have a low blood potassium level)
• If you feel you have an irregular heart beat or a fast heart beat. This might affect up
to 1 in 10 people
• If you feel a crushing chest pain (symptoms of angina pectoris). This might affect less
than 1 in 1000 people
The side effects listed below have also been reported.
Up to 1 in 10 people have experienced:
Headache, tremor, palpitations.
Up to 1 in 100 people have experienced:
Agitation, anxiety, feeling nervous, difficulties with sleeping, dizziness, fast heart beat,
throat irritation, dry mouth, muscle cramps, muscle pain, worsening of asthma.
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Very rare side effects (likely to affect less than 1 in 10,000 patients):
Nausea, distorted sense of taste, swelling of hands, ankles or feet, variations in blood
pressure.
It is not known how frequently these effects may happen:
Excessive thirst, frequent urination and tiredness over an extended period of time (a
possible indication of high blood sugar). Headache and dizziness (symptoms of high
blood pressure), cough and rash.
Some of these effects may wear off as you get used to the medicine.
If any of the symptoms become troublesome, or if you notice anything else not
mentioned here, please go and see your doctor. He/she may want to give you a
different medicine.
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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 provide more information on the safety of this medicine.

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5. How to store Foradil
Store below 25°C in a dry place. Do not take the capsules out of the blister pack until
you need them.
Keep out of the reach and sight of children.
Do not use Foradil after the expiry date which is printed on the outside of the pack.
If your doctor tells you to stop taking Foradil, please take any unused capsules back to
your pharmacist to be destroyed. Do not throw them away with your normal household
water or waste. This will help to protect the environment.

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6. Further information
Each hard gelatin capsule contains 12 micrograms of the active ingredient formoterol
fumarate dihydrate. It also contains lactose.
The pack contains an inhaler and a blister pack containing 60 capsules.
The Product licence holder is Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR, England.
Foradil is manufactured by Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Camberley, Surrey Gu16 7SR, England and Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West Sussex RH12 5AB, England.

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This leaflet was revised in May 2015.
If you would like any more information, or would like the leaflet in a different format,
please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370.

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Inhaler CE
The device conforms with Directive 93/42/EEC
FORADIL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

1127708-A15-GB

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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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