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FORADIL 12MCG CAPSULES

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

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12 micrograms inhalation
powder, hard capsules
formoterol fumarate dihydrate

1523070_GB

Package leaflet:
Information for the user and instructions for use

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Telephone +353 (0)1 440 3222
novartis@perigordgroup.com
www.perigordpremedia.com

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1523070

Comp. Description:

BKLT_FORADIL_HGCI_12MCG_GB

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110 x 62 mm
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Date: 03 Oct 2016

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Perigord House
Damastown Industrial Park
Dublin 15
Ireland

Barbera
Gonzalez Conde, Rebeca
Black
PANTONE 314 C
PANTONE 179 C
PANTONE 138 C
PANTONE 124 C
Cutting
Guides

J.N.: 286177

N/A

! PLEASE TURN OVERPRINTING ON !

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).

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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

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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)
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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)
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• h ave 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
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• A nti-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
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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
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• T reatment 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.

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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
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• T he 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
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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

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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.

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1. Pull off the cap.

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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.

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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.

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

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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.

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6. Breathe out fully.

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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.
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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.

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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.
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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
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• 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.

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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.
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.
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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.

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5. How to store Foradil
Keep out of the sight and reach of children.
Do not store above 25°C. Store the capsules in the original blister in order to
protect from moisture and do not remove until immediately before use.
Do not use this medicine after the expiry date which is stated on the label. The
expiry date refers to the last day of that month. Do not throw away any medicine
via wasterwater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information
What Foradil contains
Each hard gelatin capsule contains 12 micrograms of the active ingredient
formoterol fumarate dihydrate. Each capsule also contains lactose.
The pack contains an inhaler and a blister pack containing 60 capsules.
The Product licence holder is Novartis Pharmaceuticals UK Ltd, Frimley Business
Park, Frimley, Camberley, Surrey GU16 7SR, England.
Foradil is manufactured by Novartis Pharmaceuticals UK Ltd, Frimley Business
Park, Frimley, Camberley, Surrey Gu16 7SR, England and Novartis Pharmaceuticals
UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, England.

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This leaflet was revised in [to be updated on approval].
If you would like any more information, or would like the leaflet in a different
format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
Inhaler CE
The device conforms with Directive 93/42/EEC
FORADIL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

1523070_GB

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Expand Transcript

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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