FORADIL 12 MCG Proszek do inhalacji, twarda kapsułka

Treść ulotki

1. Foradil 12 mcg powder for inhalation, hard capsules
   1. What is Foradil and what it is used for
   2. What you need to know before using Foradil
   3. How to use Foradil
   4. Possible side effects
   5. How to store Foradil
   6. Contents of the pack and other information

Foradil 12 mcg powder for inhalation, hard capsules

formoterol
(formoterol fumarate)

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Foradil is and what it is used for
• 2. What you need to know before you use Foradil
• 3. How to use Foradil
• 4. Possible side effects
• 5. How to store Foradil
• 6. Contents of the pack and other information

1. What is Foradil and what it is used for

Foradil contains the active substance formoterol. Formoterol belongs to a class of substances called
bronchodilators, which make breathing easier by relaxing the muscles of the airways. This makes it
easier for air to enter and leave the lungs.
Foradil is used to prevent and treat breathing difficulties (bronchospasms):

• in patients with bronchial asthma with or without emphysema (a disease that affects the alveoli of the lung with a gradual worsening of breathing and oxygen supply)
• in patients with chronic bronchitis, with or without emphysema
• caused by substances that cause allergies or by exertion or cold.

2. What you need to know before using Foradil

DO NOT use Foradil

• if you are allergic to formoterol fumarate, or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is a child under 6 years of age, as there is no adequate experience in this age group
• if you are pregnant or breastfeeding.

Warnings and precautions
In the treatment of asthma, Foradil must be used in association with other medicines (corticosteroids) via inhalation.

• Your doctor will prescribe you to start treatment with Foradil together with inhaled corticosteroids only if your condition is not adequately controlled by these medicines or if your condition is very severe.
• Continue corticosteroid therapy after starting therapy with Foradil, even if you notice an improvement in symptoms.

Do not use Foradil:

• as initial treatment for asthma.
• if you are having an acute asthma attack. In this case, you should use the emergency medicines prescribed by your doctor (short-acting bronchodilators)

Consult your doctor before using Foradil:

• if you have a disease due to excessive functioning of the thyroid gland (thyrotoxicosis)
• if you have a tumor of the adrenal glands (pheochromocytoma)
• if you suffer from high blood pressure
• if you have heart problems
• if you have a dilation of an artery, known as an aneurysm
• if you have diabetes
• if your electrocardiogram is altered (e.g. prolongation of the QT interval)
• if you have prostate problems (prostatic hypertrophy)
• if you have increased pressure in the eye (glaucoma).

During treatment with Foradil,

• strictly adhere to the dosage recommended by your doctor and do not exceed the maximum recommended daily dose (see section 3 “How to use Foradil”)
• do not start treatment with Foradil or increase the dose during an asthma exacerbation (acute and significant worsening of asthma)
• the use of Foradil may cause a decrease in blood potassium levels, which may be severe. A decrease in blood potassium levels can lead to an alteration of the heart rhythm. Your doctor will advise you, based on your situation, to monitor potassium levels.
• if symptoms do not improve or worsen, or if the number of doses needed to control symptoms increases, consult your doctor to re-evaluate your therapy. Stop treatment with Foradil and inform your doctor immediatelyif, shortly after taking the medicine, you feel:
• chest tightness
• cough
• wheezing or shortness of breath, as this may be a sign of a condition called bronchospasm.

Children and adolescents
Children aged between 0 and 6 years should not use Foradil.
Children aged between 6 and 12 years should use the fixed combination of an inhaled corticosteroid and a long-acting bronchodilator, except in cases where their separate administration is required.
Children aged between 6 and 12 years may experience an increase in asthma attacks during treatment with Foradil.

Other medicines and Foradil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:

• medicines for breathing problems that are similar to Foradil (long-acting bronchodilators);
• medicines called beta-blockers, used for high blood pressure, heart problems or an eye disease called glaucoma, including eye drops;
• medicines against heart rhythm disorders (antiarrhythmics) e.g. quinidine, disopyramide and procainamide;
• psychotropic drugs (phenothiazines);
• medicines against allergies (antihistamines) e.g. terfenadine, astemizole and mizolastine;
• medicines against depression (monoamine oxidase inhibitors, tricyclic antidepressants);
• antibiotics (macrolides);
• medicines that can cause changes in the electrocardiogram (QT prolongation);
• medicines used for the treatment of asthma (ephedrine, xanthine medications);
• steroids (hormone-like medicines);
• medicines that increase urine production and reduce pressure (diuretics);
• if you are to undergo anesthesia with halogenated hydrocarbons;
• medicines that act on the central and peripheral nervous system (anticholinergics).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Foradil during pregnancy.
The medicine may block labor due to the relaxing effect on the muscles of the uterus.
Breastfeeding
Do not use Foradil during breastfeeding.
Fertility
There is no information available on the use of Foradil and its effects on fertility.

Driving and using machines
Foradil does not impair the ability to drive vehicles or operate machinery.

Foradil contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

For athletes
The use of the drug without therapeutic need constitutes doping and may still result in positive anti-doping tests.

3. How to use Foradil

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

Maintenance and prevention therapy
Use in adults
Your doctor will prescribe Foradil only as an add-on therapy to inhaled corticosteroids.

• The recommended doseis 1 capsule (12 micrograms) by inhalation twice a day (morning and evening).
• The recommended maximum daily dosefor maintenance is 4 capsules (48 micrograms) per day.
• If necessary to obtain relief from symptoms, your doctor may increase the dose, in addition to the one prescribed for normal maintenance therapy, up to two additional capsules per day, considering that the recommended maximum dose of 4 capsules per day must not be exceeded. In any case, if the need for additional doses is more than occasional (e.g. more than two days a week),

further medical advice should be sought to review the therapy, as this may mean that your underlying condition is
worsening.

• Do not use Foradil to relieve the symptoms of an acute asthma attack. In this case, use the emergency medicines prescribed by your doctor (short-acting β2-agonists).

Use in children over 6 years of age
Your doctor will prescribe Foradil only as an add-on therapy to inhaled corticosteroids.

• The recommended doseis 1 capsule (12 micrograms) by inhalation twice a day (morning and evening).
• For children between 6 and 12 years of age, treatment with a fixed combination of an inhaled corticosteroid and a long-acting bronchodilator is recommended, except in cases where separate administration of an inhaled corticosteroid and a long-acting bronchodilator is required.
• The maximum daily doseshould not exceed 2 capsules (24 micrograms).
• Do not use Foradil if the child has an acute asthma attack. In this case, use the emergency medicines prescribed by your doctor (short-acting β2-agonists).

Prevention of exercise-induced bronchospasm or before exposure to known substances that may
cause allergy
In patients with persistent asthma, the use of Foradil may be indicated for the prevention of exercise-induced
bronchospasm or before unavoidable exposure to known substances that may cause allergy, but
asthma treatment should also include an inhaled corticosteroid.

Use in adults

• The recommended doseis 1 capsule for inhalation (12 micrograms) at least 15 minutes in advance.
• You may use a dose of 2 capsules (24 micrograms) as a preventative measure if you suffer from severe bronchospasm.

Use in children over 6 years of age

• The recommended doseis 1 capsule for inhalation (12 micrograms) at least 15 minutes in advance.

HOW TO USE FORADIL:

• Do not swallow the capsules. The powder contained in the capsules must be inhaled.
• Remove the capsules from the blister only immediatelybefore use.
• Use Foradil powder for inhalation hard capsules only with the Aerolizer inhaler present inside the box containing Foradil.

Instructions for use of the inhaler
The Aerolizer inhaler consists of the following
parts:

• 1. A blue cap to protect the mouthpiece of the base
• 2. A base that allows for the proper release of the drug. The base consists of:
• 3. A mouthpiece
• 4. A capsule housing
• 5. A blue button and pins on each side
• 6. An air inlet channel

• 1. Remove the cap.

• 2. Hold the base firmly and rotate the mouthpiece in the

direction of the arrow.

• 3. With completely dry fingers, remove the

capsule from the blister only immediately before
administration and place it in the appropriate
housing.

IMPORTANT: do not put the capsule in the
mouthpiece

• 4. Close the housing by rotating the mouthpiece

into the closing position. You will feel a “click”

• 5. Press both blue buttons firmly at the same time, holding the inhaler in
  an upright position with the mouthpiece facing
  upwards. Then release the buttons. Perform this
  operation only once.

Note
When the capsule breaks, small fragments
of gelatin may go into your mouth or throat.
Since this is gelatin for food use,
it is not dangerous.

• 6. Exhale completely.

• 7. Put the mouthpiece in your mouth and tilt

your head slightly backwards.
Close your lips tightly around the mouthpiece and
inhale rapidly, but steadily, as deeply as
possible. You should feel a
buzzing in the chamber due to the rotation of the
capsule in the housing; if you did not feel
this buzzing, open the capsule housing and check that the capsule is not
blocked. Then repeat the operations indicated in
point 7. Do not try to unblock the capsule
by repeatedly pressing the buttons.

• 8. After inhaling with the Aerolizer, hold your breath for as long as possible while removing the inhaler then exhale through your nose. Open the housing to see if there is any powder left in the capsule. If so, repeat the operations indicated in points 6-8.
• 9. After inhaling all the powder, open

the capsule housing (see point 2),
remove the empty capsule, and clean the capsule
housing with a dry cloth. Alternatively, you can use a
soft brush. DO NOT USE WATER TO
CLEAN THE AEROLIZER.

• 10.Close the mouthpiece and replace the cap.

If you use more Foradil than you should
In case of accidental ingestion of an excessive dose of Foradil, immediately inform your doctor or
go to the nearest hospital.
After ingestion or use of an excessive dose of Foradil, you may experience:

• tremors
• headache
• palpitations
• fast heartbeat
• high blood sugar
• low potassium levels in the blood
• alteration of the electrical conduction of the heart detected by electrocardiogram (prolongation of the QTc interval)
• heart rhythm disturbance
• high blood pressure
• nausea
• vomiting

If you forget to use Foradil
Do not use a double dose to make up for a missed dose.
Take the medicine as soon as possible unless it is already time to take the next dose. Then return to
the normal dosing schedule.

If you stop taking Foradil
Take the medicine as prescribed by your doctor and continue until your doctor tells you to
stop.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people)

• irregular heartbeat (palpitations)
• headache
• tremors
• cough
• worsening of severe asthma in children aged 6-12 years

Uncommon side effects (may affect up to 1 in 100 people)

• muscle cramps
• muscle pain
• fast heartbeat
• dizziness
• agitation
• anxiety
• restlessness
• sleep disturbances
• asthmatic reaction (bronchospasm), including paradoxical bronchospasm (severe and exaggerated narrowing of the airways following inhalation of a substance that normally dilates them)
• throat irritation
• dry mouth

Rare side effects (may affect up to 1 in 1,000 people)

• heart rhythm disorders: such as atrial fibrillation or supraventricular tachycardia or extrasystoles
• allergic reactions with: o decreased blood pressure o swelling of the face, eyelids, lips o bronchospasm o hives o itching o skin rash with pustules, blisters and bubbles (exanthem)
• nausea
• low levels of potassium in the blood

Very rare side effects (may affect up to 1 in 10,000 people)

• fluid retention in the limbs
• chest pain (angina pectoris)
• alteration of the electrical conduction of the heart detected by electrocardiogram (prolongation of the QTc interval)
• altered taste
• elevated blood sugar (glucose) levels
• changes in blood pressure

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• increased blood pressure
• skin rash

In addition, the following have been reported:

• worsening of asthma
• difficulty breathing (dyspnea)
• cough
• fatigue
• conjunctivitis (irritation of the conjunctiva)
• swelling of the eyelids Treatments with medicines similar to Foradil (ß2 agonists) may cause:
• increased levels of insulin in the blood (hormone that regulates blood sugar)
• increased free fatty acids
• increased glycerol
• increased ketone bodies.

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 through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Foradil

Do not store at a temperature above 25°C.
Store in the original packaging to protect it from moisture.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after Expires. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Foradil contains

• The active ingredient is formoterol fumarate. Each Foradil capsule contains 12 micrograms of formoterol fumarate.
• The other component is lactose monohydrate.

Description of the appearance of Foradil and contents of the pack
Each pack of Foradil contains 3 or 6 blisters of 10 capsules and an inhaler.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA )
Italy

Manufacturer
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy