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FORADIL 12 MICROGRAMS INHALATION POWDER HARD CAPSULES

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

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Patient information leaflet

Foradil® 12 micrograms inhalation powder, hard capsules
(formoterol fumarate)
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.
 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 to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet
(see section 4).
 The name of this medicine is Foradil® 12 micrograms inhalation
powder, hard capsules but will be referred to as Foradil throughout the
remainder of this leaflet.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
In some patients, Foradil has been reported to cause dizziness. If you
feel dizzy, do not drive or operate machinery.
Foradil contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
3. How to take Foradil

What is in this leaflet:
1. What Foradil is and what it is used for
2. Before you take Foradil
3. How to take Foradil
4. Possible side effects
5. How to store Foradil
6. Contents of the pack and other information
1. What Foradil is and what it is used for
The Foradil pack includes a blister pack of capsules containing the
medicine and an inhaler device for taking the medicine. The capsules are
for inhalation use only. Instructions for using the inhaler are given later on
in the leaflet.
The active ingredient in this medicine is formoterol fumarate dihydrate.
Formoterol fumarate dihydrate 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)
2. Before you take Foradil
Do not take Foradil if:
 you are allergic to formoterol fumarate dihydrate or any of the other
ingredients of this medicine (listed in section 6).
Foradil is not suitable for children under six years of age.
Talk to your doctor or pharmacist before taking Foradil if you:
 are taking any other asthma medicine
 suffer from any heart problems
 have high blood pressure
 have an overactive thyroid gland
 have an aneurysm (area where an artery is swollen because the wall
of the artery is weak)
 have a heart disorder such as abnormal electrical signal called
“prolongation of QT interval”
 are diabetic
 have pheochromocytoma (a tumor of the adrenal gland that can affect
blood pressure)
Other medicines and Foradil
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, particularly:
 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)
 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
 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
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

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
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
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
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
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.

1. Pull off the cap.

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.

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.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
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 may 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
may affect up to 1 in 1,000 people
 If you feel you have muscle weakness, muscle spasms or an abnormal
heart rhythm (these could mean you have a low blood potassium
level). This may affect up to 1 in 1,000 people
 If you feel you have an irregular heart beat or a fast heart beat. This
may affect up to 1 in 1,000 people
 If you feel a crushing chest pain (symptoms of angina pectoris). This
may affect up to 1 in 10,000 people
The side effects listed below have also been reported.
Common (may affect up to 1 in 10 people)
Headache, tremor, palpitations.
Uncommon (may affect up to 1 in 100 people)
Agitation, anxiety, feeling nervous, difficulties with sleeping, dizziness,
fast heart beat, throat irritation, dry mouth, muscle cramps, muscle pain,
worsening of asthma.

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.

Rare (may affect up to 1 in 1,000 people)
Nausea.
Very rare side effects (may affect up to 1 in 10,000 people)
Distorted sense of taste, swelling of hands, ankles or feet, variations in
blood pressure. Excessive thirst, frequent urination and tiredness over an
extended period of time (a possible indication of high blood sugar).
Not known (frequency cannot be estimated from the available data)
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.

6. Breathe out fully.

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.
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.
5. How to store Foradil
Do not store above 25oC. Protect from heat. Protect from moisture.
Do not take the capsules out of the blister pack until you need them.

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.
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.
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.
If you forget to take Foradil
If you miss a dose, take it as soon as you remember. Then go on as
before. Do not double the dose to make up for the forgotten 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.

Keep out of the sight and reach 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.
If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
Do not throw them away with your normal household water or waste.
This will help to protect the environment.
6. Contents of the pack and other information
Each hard gelatin capsule contains 12 micrograms of the active
ingredient formoterol fumarate dihydrate. It also contains lactose
monohydrate (25mg per capsule contains milk proteins), gelatin and ink
containing shellac, black iron oxide (E 172), propylene glycol and
ammonium hydroxide 28%.
The pack contains 1 inhaler device and a blister pack containing 60
capsules for inhalation.
The clear gelatin capsules are marked “CG” “FXF” and contain a white
powder for inhalation. The blue and white plastic breath actuated inhaler
device is marked “Foradil” on the front and “CE” on the base.
Manufactured by
Novartis Poland Sp. Z o.o., ul. Marynarska 15, 02-674 Warszawa,
Poland.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK.
Repackaged by XXXXX
Leaflet dated 25th November 2016
Leaflet coded XXXXXXXXXX
PL: 33532/0007

POM

Inhaler CE. The device conforms with Directive 93/42/EEC.
Foradil® is a registered trademark of Novartis Pharmaceuticals UK
Limited.

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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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