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FORADIL 12 MICROGRAM CAPSULES

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

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Package Leaflet: Information for the User

Foradil® 12 microgram
capsules
(formoterol fumarate)
The medicine is called Foradil 12 microgram capsules but it will be referred to
as Foradil through the remainder of this leaflet.

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.
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

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)

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.
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”?
 Are you diabetic?
 Do you have pheochromocytoma (a tumor of the adrenal gland that can affect
blood pressure)?
 Are you pregnant?

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.

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

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.
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.

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)
 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

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.

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
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:
3.

Take one of today’s capsules out of the
blister strip. Place it in the capsuleshaped 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.

 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
 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

4.

Twist the mouthpiece to the closed
position until it clicks.

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.
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.

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.

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.
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.

6.

Breathe out fully.

By reporting side effects you can provide more information on the safety of this
medicine.

5. How to store Foradil
 Protect from moisture and heat. Do not store above 25ºC.
 Do not remove the capsules from the blister until you are ready to use them.
 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.

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.

9.

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.
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.

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.

 If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will advice
you what to do.
 Do not throw them away with your normal household water or waste. This will
help to protect the environment.

6. Further information
Each hard gelatin capsule contains 12 micrograms of the active ingredient
formoterol fumarate dihydrate. The capsules also contain: lactose
monohydrate, gelatine, shellac, black iron oxide (E172), propylene glycol and
ammonium hydroxide 28%.
The pack contains an inhaler and a blister pack containing 60 capsules.
The hard gelatin capsules are clear, printed with “CG” on one cap and “FXF”
on the other cap and contain a white powder for inhalation. The blue and white
plastic breath actuated inhaler device has “Foradil” printed on the front and
marked “CE” on the base.

Manufacturer
This product is manufactured by Novartis Poland Sp. z.o.o., ul. Marynarska 15,
02-674 Warsaw, Poland. It is procured from within the EU and repackaged by
Mediwin Limited, Product Licence Holder: Mediport Limited,
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex,
BN17 7PA, United Kingdom.

POM

PL No: 18980/0831

Inhaler
The device conforms with Directive 93/42/EEC
FORADIL® is a registered trade mark of Astellas Pharma Inc.
Date of leaflet preparation: 18/01/2016
PIL-0831-S0008

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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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