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FORADIL 12 MICROGRAMS INHALATION POWDER HARD CAPSULES

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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Patient information leaflet

Foradil® 12 micrograms inhalation powder, hard capsules
(formoterol fumarate)
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.
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

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

Foradil is not suitable for children under six years of age.

When you have asthma you must also be taking an inhaled steroid
at the same time as Foradil.

The very small amount of lactose in Foradil is unlikely to cause problems
in lactose-intolerant patients.

For the treatment of COPD (Chronic Obstructive Pulmonary
Disease)

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?

Adults and the elderly
• The usual dose is 1 puff in the morning and evening

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
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.

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.

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.

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

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.

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
• 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.

Twist the mouthpiece to the closed position
until it clicks.

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.
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.

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.

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

Breathe out fully.

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.
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.

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.

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. 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.

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.

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.

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

Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER

10. Replace the cap.

Repackaged by XXXXX

11. If you need to clean the inhaler, wipe the mouthpiece and capsule
compartment with a dry cloth or a clean soft brush.

PL: 33532/0007

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.

POM

Inhaler CE. The device conforms with Directive 93/42/EEC.
Foradil® is a registered trademark of Astellas Pharma Inc.
Leaflet dated 21st April 2016
Leaflet coded XXXXXXXXXX

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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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