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Foradil® 12 microgram Capsules for Inhalation
(formoterol fumarate)
This product is available using above name but will be referred to as Foradil
throughout the following 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

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
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 monohydrate
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
■ 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.

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
■ 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

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.

Pull off the cap.

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.

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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

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.

Twist the mouthpiece to the closed position until it clicks.

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

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)
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.

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, 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:
By reporting side effects, you can help provide more information on the safety of
this medicine.
5. How to store Foradil

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
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.


Do not store above 25°C. Store in original packaging. Protect from moisture
and heat.
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. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking Foradil, please take any unused capsules
back to your pharmacist to be destroyed.
If the medicine become discoloured or show signs of any deterioration, consult
your doctor or pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

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.

6. Contents of the pack and other information

After use, tip out the empty capsule and close the mouthpiece.

The capsules also contain lactose monohydrate, gelatin and ink containing:
shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide 28%.

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.

Each hard gelatin capsule contains 12 micrograms of the active ingredient
formoterol fumarate dihydrate.

Foradil is available as clear capsules which has a white powder, marked ‘CG’ and
‘FXF’ on the capsule in black ink, and a blue plastic inhaler device.
The pack contains an inhaler and a blister pack containing 60 capsules.
PL No: 29510/0055

Foradil® 12 microgram Capsules for inhalation POM

Manufactured by Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw,
Poland. Procured from within the EU by the Product Licence holder: Pharma-XL
Ltd., Unit 5-7 Colonial Way, Watford, Herts WD24 4PR and repackaged by OPD
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.11.2016.
To request a copy of this in Braille, large print or audio please call 01923 332 796.
Foradil is a registered Trademark of Novartis Pharmaceuticals UK Ltd.

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