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FORADIL

Active substance(s): EFORMOTEROL FUMARATE / FORMOTEROL FUMARATE

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T06887

Foradil® 12 microgram inhalation powder, capsules
(formoterol fumarate)

The name of your product is Foradil 12 microgram inhalation powder, capsules but will
be referred as Foradil throughout the patient information leaflet.
Patient Information Leaflet
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).
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
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
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.
Cap

Mouthpiece

Capsule
Compartment

Base

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

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.

• Keep out of the sight and reach of children.
• Capsules along with inhalers should not be store above 25ºC. Keep capsules in the
original package (blister) in order to protect from moisture.
• Do not use Foradil after the expiry date which is printed on the outside of the pack.
The expiry date refers to the last day of that month.
• Always dispose of old inhaler and use a new, built into every product packing.
• If the medicine becomes discoloured or shows any other signs of deterioration, you
should seek the advice of your pharmacist who will tell you what to do.
• 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.

6. Contents of the pack and other information

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.

What Foradil contains
• Each hard gelatin capsule contains 12 micrograms of the active ingredient
formoterol fumarate dihydrate.
• The other ingredients are lactose, which contains milk proteins black ink (shellac,
black iron oxide, propylene glycol, ammonium solution 20%)
• capsules are made of edible gelatin
How Fordil looks like and contents of the pack
Foradil is translucent gelatin capsules labeled 'HCG' at the bottom and 'FXF' on top,
containing white powder.
The pack contains an inhaler and a blister pack containing 60 capsules.
Manufacturer and Product Licence Holder
This product is manufactured by Novartis s.r.o., Na Pankraci 1724/129, 14000 Praha 4,
Czech Republic It is procured from within the EU by the Product Licence Holder:
Swinghope Ltd, Commerce Way, Edenbridge TN8 6ED, UK and repackaged by YMD
Pharma Ltd, Commerce Way, Edenbridge TN8 6ED, UK.
POM
PL No: 10380/1587
Leaflet revision date: 25/04/2017.
Foradil® is registered trademark of Astellas Pharma Inc, Japan.

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Call 02030969700 to obtain the leaflet in a format
suitable for you.
T06887

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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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