Foradil

Patient Information Leaflet

Foradil, 12 micrograms, powder for inhalation in hard capsules
Formoterol fumarate dihydrate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Foradil is and what it is used for
2. Important information 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

1. What Foradil is and what it is used for

The active substance in Foradil is formoterol fumarate dihydrate. It is a bronchodilator medicine. Its action consists of relaxing the smooth muscles of the bronchi, thereby facilitating breathing. This effect occurs rapidly (within 1–3 minutes) and lasts for 12 hours after inhalation. Each hard capsule contains 12 micrograms of formoterol fumarate dihydrate and is intended for use with the Aerolizer inhaler device.

Foradil is indicated for:

• Prevention and treatment of bronchial constriction in patients with bronchial asthma, as an add-on to inhaled glucocorticosteroid therapy;
• Prevention of bronchospasm induced by inhaled allergens, cold air, or physical exertion;
• Prevention and treatment of bronchial constriction in patients with reversible or irreversible chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Foradil improves quality of life in patients with COPD.

The bronchodilating effect lasts for 12 hours after inhalation of Foradil. Therefore, maintenance treatment consisting of twice-daily administration of the medicine contributes, in most cases, to relief from bronchoconstriction associated with chronic conditions, both during the day and at night.

2. Important information before using Foradil

When not to use Foradil

• if the patient is allergic to formoterol fumarate dihydrate, lactose (which contains a small amount of milk protein), or any of the other ingredients of Foradil (the excipients are listed in section 6 at the end of the leaflet).

If this applies to the patient, Foradil must not be used and the patient should consult their doctor.
If the patient thinks they may be allergic, they should discuss this with their doctor.
Warnings and precautions
Before starting treatment with Foradil, discuss the following with your doctor:

• if the patient has a heart condition, including heart rhythm disorders;
• if the patient has high blood pressure;
• if the patient has diabetes;
• if the patient has hyperthyroidism;
• if the patient has an aneurysm (a bulge in an artery wall caused by weakening);
• if the patient has a heart condition related to abnormal electrical impulses, known as "prolonged QT interval";
• if the patient has a phaeochromocytoma (a tumour of the adrenal gland that may affect blood pressure);
• if the patient has a rapid heartbeat;
• if the patient has severe heart failure.
  Immediately inform your doctor or pharmacist if any of these symptoms occur during treatment with Foradil.

Important information
Do not swallow the capsules – the capsules must be inhaled using the Aerolizer inhaler.
If the patient's doctor has prescribed other regular medications for respiratory disease, it is important to continue taking them regularly.
DO NOT STOP using Foradil or reduce the dose without consulting your doctor, even if there is a significant improvement in health.
If the patient experiences breathlessness or wheezing while using Foradil, treatment should be continued and the patient should contact their doctor as soon as possible, as a change in therapy may be necessary.
For patients with diabetes, the doctor may recommend monitoring blood glucose levels.
For patients with asthma, Foradil must not be used as the only asthma-control medication. Foradil should always be used in combination with an inhaled corticosteroid.
During treatment with Foradil, do not use other products containing long-acting beta-adrenergic agonists, such as salmeterol.
Do not use Foradil if:

• the patient's condition is well controlled with an inhaled corticosteroid alone.
• the patient only needs a short-acting beta-adrenergic agonist occasionally.

Severe asthma attacks have been observed in clinical trials with Foradil (see section 4, "Possible side effects").
Do not start using Foradil or increase the dose prescribed by the doctor during an asthma attack.
Do not change or stop using any medications used to control or treat breathing problems, including inhaled corticosteroids.
In asthma, Foradil must not be used to relieve sudden-onset wheezing. For sudden asthma symptoms, always use a short-acting beta-adrenergic agonist (a rescue inhaler prescribed by the doctor).
Important information about a similar medicine
Foradil belongs to a group of medicines called long-acting beta-adrenergic agonists. A large clinical trial with another long-acting beta-adrenergic agonist showed an increased risk of asthma-related death. It has not been established whether Foradil has a similar effect. Discuss with your doctor the benefits and risks of treating asthma with Foradil.
Monitoring during treatment with Foradil
Treatment with Foradil may increase blood sugar levels. Therefore, patients with diabetes may require regular monitoring of blood glucose.
Treatment with Foradil may cause a significant decrease in blood potassium levels, increasing the patient's susceptibility to heart rhythm disturbances. Therefore, especially in cases of severe asthma, the doctor may recommend monitoring blood potassium levels.
If you have any questions about how Foradil works or why it has been prescribed, consult your doctor.
Paradoxical bronchospasm
As with other inhaled medicines, paradoxical bronchospasm may occur after using Foradil. In such cases, stop using the medicine immediately and contact your doctor, who may recommend alternative treatment.
Children and adolescents
Foradil is not recommended for children under 6 years of age.
Use in elderly patients (over 65 years)
The same dose of Foradil as in adult patients may be used in elderly patients.
Foradil and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Dosage adjustment or, in some cases, discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, especially:

• monoamine oxidase inhibitors (MAO inhibitors) or tricyclic antidepressants (medicines used to treat depression and mood disorders);
• sympathomimetic medicines (medicines similar to adrenaline used to treat asthma or to reduce nasal mucosal swelling);
• antihistamines (antiallergic medicines used to prevent and treat allergic symptoms);
• corticosteroids (medicines often used to treat asthma and other inflammatory conditions);
• diuretics (medicines used to treat oedema caused by fluid retention, heart failure, and high blood pressure);
• beta-blockers (medicines used to treat high blood pressure, heart failure, angina, anxiety, and heart rhythm disorders. Some eye drops used to treat glaucoma may contain beta-blockers);
• quinidine, disopyramide, procainamide (medicines used to treat heart rhythm disorders);
• phenothiazine derivatives (medicines used to treat psychiatric disorders such as schizophrenia, manic excitement, psychotic reactions, anxiety);
• cardiac glycosides (medicines used to treat heart failure and heart rhythm disorders);
• xanthine derivatives (medicines used to treat asthma or other chronic obstructive pulmonary diseases);
• macrolides (e.g. erythromycin, azithromycin) used to treat bacterial infections;
• general anaesthetics used during surgery, such as halogenated hydrocarbons (e.g. halothane). Inform your doctor that you are using Foradil if you are scheduled for surgery under general anaesthesia;
• anticholinergic medicines (e.g. ipratropium bromide) used to treat gastrointestinal disorders, urinary and genital tract disorders, etc.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Foradil should not be used during pregnancy unless clearly prescribed by a doctor.
The doctor will inform the patient about potential risks associated with using Foradil during pregnancy.
Breastfeeding
If the patient is breastfeeding, she should consult her doctor before using Foradil.
Driving and operating machinery
If dizziness or other similar side effects occur, do not drive or operate machinery.
Foradil contains lactose (milk sugar)
If the patient has severe lactose intolerance, they should inform their doctor before using Foradil.
The excipient lactose contains a small amount of milk protein, which may cause allergic reactions.

3. How to use Foradil

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Do not exceed the recommended dose.
Do not swallow the capsules – the contents of the capsules must be inhaled through the
Aerolizer inhaler.
Dosage
Adults
Asthma
In the treatment of asthma, Foradil should always be prescribed as an add-on therapy used in
combination with an inhaled corticosteroid.
Maintenance treatment: inhale the contents of 1 to 2 capsules (12 to 24 micrograms) twice daily.
The maximum recommended maintenance dose is 4 capsules (48 micrograms) per day.
If necessary, your doctor may prescribe an additional 1 to 2 capsules per day to relieve worsening
symptoms, provided that the maximum recommended daily dose of 48 micrograms is not exceeded.
If additional doses are needed frequently (e.g. more than two days per week), you should inform your
doctor as soon as possible, as this may indicate worsening asthma. In the case of an acute asthma
attack, use a short-acting bronchodilator (rescue inhaler prescribed by your doctor).
Prevention of bronchospasm induced by physical exertion or allergens
Inhale the contents of one capsule (12 micrograms) at least 15 minutes before physical exertion or
exposure to an allergen. In patients with severe bronchoconstriction, two capsules (24 micrograms)
may be required.
Inhaled corticosteroids are always used in asthma treatment.
Chronic obstructive pulmonary disease (COPD)
Maintenance treatment: inhale the contents of 1 to 2 capsules (12 to 24 micrograms) twice daily.
Use in children over 6 years of age and adolescents
Asthma:
Maintenance treatment: inhale the contents of one capsule (12 micrograms) twice daily. The maximum
recommended daily dose is 2 capsules.
In the case of an acute asthma attack, use a short-acting bronchodilator (e.g. salbutamol).
Prevention of bronchospasm induced by physical exertion or allergens
Inhale the contents of one capsule (12 micrograms) at least 15 minutes before physical exertion or
exposure to an allergen.
Children over 6 years of age may use Foradil only when they are able to use the inhaler correctly
(see: "Inhaler instructions for use") and only under adult supervision.
Foradil is not recommended for use in children under 6 years of age.
Inhaler instructions for use
Immediately before use, remove the capsule from the foil blister. Ensure that your hands are
completely dry to avoid wetting the capsule.
Do not swallow the capsule. The powder in the capsule is intended for inhalation only.

1. Remove the cap.

2. Firmly hold the base of the inhaler and open it by twisting the mouthpiece in the direction of the arrow.

3. Place the capsule into the capsule-shaped compartment in the base of the inhaler. Remove the capsule from the foil blister immediately before use.

4. Twist the mouthpiece back to the closed position.

5. Press the blue buttons fully down ONCE ONLY, holding the inhaler in an upright position. Release the buttons.

Note: At this point, the capsule may break, and small pieces of gelatin may enter the mouth or throat. Since gelatin is edible, ingestion is not harmful. The likelihood of this occurring is minimal if the capsule is punctured only once, storage conditions are maintained, and the capsule is removed from the foil blister immediately before use (see step 3).

6. Breathe out deeply.

7. Place the mouthpiece in your mouth and tilt your head slightly backward. Close your lips around the mouthpiece and inhale quickly but steadily and deeply. While the capsule spins in the inhaler chamber and the powder disperses, a characteristic sound should be heard. If no sound is heard, this may indicate that the capsule is stuck in the compartment. In this case, open the inhaler and remove the capsule by gently dislodging it. DO NOT attempt to dislodge the capsule by repeatedly pressing the buttons. Then repeat the steps described in step 7.

8. After hearing the characteristic sound, hold your breath as long as possible without discomfort, then remove the inhaler from your mouth. Breathe out through your nose. Open the inhaler and check whether any powder remains in the capsule. If powder remains, repeat the steps described in points 6 to 8.
9. After use, open the inhaler, remove the empty capsule, close the mouthpiece, and replace the cap.

Cleaning the inhaler:
To remove residual powder, wipe the mouthpiece and capsule compartment with a DRY cloth.
A clean, soft brush may also be used for this purpose. DO NOT USE WATER TO CLEAN THE INHALER.
Use of a higher than recommended dose of Foradil
If a higher than recommended dose of Foradil has been accidentally taken, consult your doctor or
pharmacist immediately.
Symptoms such as nausea and/or vomiting, muscle tremors, headache, dizziness (possible signs of
high blood pressure), rapid or irregular heartbeat, drowsiness, increased blood glucose levels, or
decreased blood potassium levels may indicate that the dose of Foradil taken was too high. You should
contact your doctor immediately or go to the nearest hospital emergency department. The patient may
require appropriate treatment.
Missed dose of Foradil
If a dose is missed, take the medicine as soon as possible. If it is almost time for the next scheduled
dose, do not take a double dose to make up for the missed dose; instead, return to your regular
dosing schedule.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
In clinical trials with Foradil, severe asthma attacks (shortness of breath, cough, wheezing and chest tightness) have been observed, which may require hospital treatment.

Serious adverse reactions
Stop using the medicine immediately and inform your doctor if any of the following adverse reactions occur:
Uncommon (may occur in fewer than 1 in 100 patients):

• Bronchospasm with cough, wheezing and breathing difficulties.

Rare (may occur in fewer than 1 in 1000 patients):

• Allergic reactions, e.g. rash, urticaria, itching, facial swelling, throat swelling, low blood pressure and bronchospasm.

Very rare (may occur in fewer than 1 in 10,000 patients):

• Severe, described as tearing, chest pain (symptoms of angina), changes in ECG.

Frequency not known (frequency cannot be estimated from the available data):

• Muscle weakness, muscle cramps and cardiac arrhythmias (these symptoms may be caused by decreased potassium levels in the blood),
• Irregular heartbeat (including rapid heartbeat).

Other adverse reactions
If any of the following adverse effects worsen, inform your doctor, pharmacist or healthcare provider.
Common adverse reactions (may occur in fewer than 1 in 10 patients):
Headache, muscle tremor, palpitations.

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):
Nervousness, anxiety, restlessness, insomnia, dizziness, increased heart rate, throat mucosa irritation, dryness of the oral mucosa, muscle cramps, muscle pain.

Rare adverse reactions (may occur in fewer than 1 in 1000 patients):
Decreased potassium levels in the blood, cardiac arrhythmias, extrasystoles, nausea.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
Increased blood glucose levels, taste disturbances, swelling of hands, ankles and feet, excessive thirst, frequent urination, fatigue (these symptoms may indicate increased blood sugar levels).

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Cough, rash, headache and dizziness (possible symptoms of high blood pressure).

Use of the medicine may lead to increased levels of insulin, free fatty acids, glycerol and ketone bodies in the blood.

Some people may experience other adverse reactions during treatment with Foradil. If any adverse reactions occur that are not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel. +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store the medicine Foradil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Foradil contains

• The active substance is formoterol fumarate dihydrate. Each hard capsule contains 12 micrograms of formoterol fumarate dihydrate.
• The other ingredients are: monohydrate lactose (25 mg per capsule, contains milk proteins), gelatin, and ink composed of: shellac, iron oxide black (E 172), propylene glycol, and ammonium hydroxide 28%.

What Foradil looks like and contents of the pack
Foradil is a powder for inhalation in hard capsules. The powder contained in the capsule is intended for inhalation into the lungs using an inhaler called the Aerolizer.
Foradil is available in packs containing 30 or 60 capsules in blisters and one inhaler, or 180 capsules and 3 inhalers (3 packs, each containing 60 capsules in blisters and one inhaler).

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer/Importer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Poland
Salutas Pharma GmbH
Otto-von-Guericke Allee 1,
39179 Barleben,
Germany