Prospect: information for the user

Foradil Aerolizer 12 micrograms powder for inhalation (hard capsule)

Formoterol fumarate dihydrate

Foradil Aerolizer contains a substance called formoterol fumarate dihydrate. It belongs to a group of medications called “bronchodilators” or “long-acting beta agonists”.

This medication is used:

• Along with inhaled corticosteroids as maintenance treatment for moderate to severe asthma.
• To prevent breathing difficulty caused by inhaling allergens (substances that cause allergy), cold air, or exercise.
• As maintenance treatment for symptom relief in patients with chronic obstructive pulmonary disease (COPD).

Follow all instructions from your doctor or pharmacist carefully, even if they differ from those contained in this leaflet.

Do not use Foradil Aerolizer:

• If you are allergic to formoterol, or to any of the other components of this medication (including those listed in section 6).

Discuss with your doctorabout the risks and benefits of treating your asthma with this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Foradil Aerolizer.

Be especially careful with this medication:

• If you have any heart disease or any "prolongation of the QT interval" (an abnormal electrical signal detected in your electrocardiogram).

• If you have high blood pressure.

• If you have hyperthyroidism (thyroid gland disease).

• If you have an aneurysm (localized dilation of an artery caused by degeneration or weakening of the vascular wall).

• If you are diabetic or if your doctor has warned you that you have intolerance to some sugars, consult your doctor before taking this medication.

The treatment with Foradil Aerolizer may lead to an increase in blood sugar levels. Therefore, if you are diabetic, you will need to control your blood sugar levels.

• If you have pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure).

• Do not use Foradil Aerolizer as your only asthma medication. Use this medication only with an inhaled corticosteroid (ICS).

• If you feel that you have difficulty breathing or wheezing (whistling) during the use of this medication, you should continue using Foradil Aerolizer, but you should see your doctor as soon as possible, as you may need additional treatment.

Do not use this medication to relieve sudden wheezing. Always carry a short-acting beta2 agonist (rescue inhaler prescribed by your doctor) to treat sudden asthma symptoms.

Important information about this medication

• Do not change or interrupt any of the treatments for controlling or treating your respiratory problems, including inhaled corticosteroids. Your doctor will adjust your treatment according to your needs.
• Once your asthma is well-controlled, your doctor may consider reducing the dose of this medication gradually.
• If you are well-controlled with an inhaled corticosteroid, do not use this medication.
• Do not use this medication if you only need, from time to time, a short-acting beta2 agonist (rescue inhaler).
• While using Foradil Aerolizer, do not use other medications with similar effects, such as salmeterol (long-acting beta2 agonists).
• Do not start treatment with this medication or increase the recommended dose by your doctor while experiencing an asthma attack.

The treatment with Foradil Aerolizer may lead to low potassium levels in the blood. This may make you more susceptible to an abnormal heart rhythm. Therefore, your doctor may need to control your potassium levels in the blood, especially if you have severe asthma.

Consult your doctor if you have any doubts about how Foradil Aerolizer works or why you have been prescribed this medication.

Patients aged 65 years and over

If you are 65 years or older, you can use this medication at the same dose as adults.

Children and adolescents

Foradil Aerolizeris not suitable for children under 6 years.

Children aged 6 years and over should only use this medication if they are able to use it correctly (see "How to use the capsules of this medication with your inhaler"). They should only use the inhaler with adult supervision.

Use of Foradil Aerolizer with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is especially important if you are taking any of the following medications:

• Monamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (TCAs), used to treat depression and mood disorders.
• Sympathomimetics, which are medications similar to adrenaline and are used to treat asthma and nasal congestion.
• Antihistamines, which are usually used to prevent or treat the main symptoms of an allergic reaction.
• Glucocorticoids, which are often used to treat asthma and other inflammatory diseases.
• Diuretics, which are used to treat edema (water retention), heart failure, and high blood pressure.
• Beta-blockers, used to treat high blood pressure, heart failure, angina, anxiety, abnormal heart rhythm. Certain eye drops used to treat glaucoma may contain beta-blockers.
• Quinidine, disopyramide, and procainamide, used to treat abnormal heart rhythm.
• Phenothiazine derivatives, used to control mental disorders such as schizophrenia, mania, psychotic states, and anxiety.
• Digitals, used to treat heart failure and abnormal heart rhythm.
• Xanthine derivatives, which are used to treat asthma and chronic obstructive pulmonary disease.
• Macrolides (e.g. erythromycin), used to treat bacterial infections.
• Anesthetics such as halothane, which are used to produce anesthesia during surgery.
• Anticholinergics (e.g. ipratropium bromide), used to treat gastrointestinal and genitourinary disorders.

Your doctor may need to change or even stop one of the medications.

If your doctor has prescribed you other medications that you need to take regularly to treat your respiratory disease, it is essential that you continue taking them as usual and DO NOT INTERRUPT or reduce the dose, even if you start feeling much better.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use this medication during pregnancy unless your doctor tells you to. They will inform you of the potential risk of taking Foradil Aerolizer during pregnancy.

Breastfeeding

You should consult your doctor before taking Foradil if you are breastfeeding.

Driving and operating machinery

In some patients, this medication may cause dizziness. If you feel dizzy, do not drive, operate machinery, or perform any other activity that requires your attention.

Foradil Aerolizer contains lactose

This medicationcontains lactose. It may cause allergic reactions in patients with milk protein allergy. If your doctor has told you that you have intolerance to certain sugars, consult with them before taking this medication.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result in doping control.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will tell you the amount and frequency of use of Foradil Aerolizer according to your needs. Do not exceed the recommended dose. Remember to use your medication.

The effect of the dose lasts up to 12 hours.

Do not swallow the capsules. They must be used by inhaling the contents of them with the Aerolizer inhaler.

Use in adults (including the elderly)

Maintenance treatment of asthma

For the treatment of asthma, Foradil Aerolizer will always be prescribed along with an inhaled corticosteroid.

• The recommended normal dose is 1 capsule inhaled twice a day. In more severe cases, 2 capsules may be administered twice a day.
• In addition to the normal dose, you may occasionally need 1 or 2 additional capsules per day to alleviate common symptoms. If you need to receive these additional doses more than twice a week, consult your doctor as it may indicate a worsening of the disease.
• The maximum recommended daily dose for adults is 4 capsules.

Prevention of breathing difficultycausedby inhaling allergens, bycold air orby exercise

• The recommended dose is 1 capsule inhaled at least 15 minutes before exercise or exposure to the allergen or cold air.
• In some cases, your doctor may advise you to use 2 capsules to prevent wheezing (whistling) and bronchospasm.

Maintenance treatment of COPD (chronic obstructive pulmonary disease)

• The recommended dose is 1 capsule inhaled twice a day, which should be administered with the inhaler as described in the "How to use the capsules of this medication with your inhaler" section. In more severe cases, 2 capsules may be administered twice a day.

Use in childrenand adolescents (from 6 years of age)

This medication is not recommended for children under 6 years of age. See the "Children and adolescents" section of section 2. What you need to know before starting to use Foradil Aerolizer.

Maintenance treatment of asthma

• The recommended dose is 1 capsule inhaled twice a day.
• The maximum recommended daily dose is 2 capsules per day.

Prevention of breathing difficultycausedby inhaling allergens, bycold air orby exercise

• The recommended dose is 1 capsule inhaled at least 15 minutes before exercise or exposure to the allergen or cold air.

How to use the capsules of this medication with your inhaler

Follow the instructions below to learn how to use this medication.

Use the capsules of this medicationonly with the inhalerprovided in the package. The Aerolizer inhaler included in the package has been developed specifically for use with this medication.

Remove the capsule from the blister just before use. Make sure your fingers are completely dry so that the capsule does not become moist.

Do not swallow the capsule. The powder in the capsule is only for inhalation.

Instructions for correct use

Questions / How to avoid problems

1. How can I avoid breaking the capsule into small fragments?

The capsules can break when you press the blue buttons (step 5) and small fragments can be introduced into your mouth or throat when you inhale. You can avoid it:

• By pressing the blue buttons only once.
• By keeping the capsules in their original packaging (blister) before use.
• By storing the capsules at a temperature not exceeding 25°C.
• By protecting the capsules from moisture.

2. Are the fragments of the capsules harmful to health?

No. The capsule is made of edible gelatin that is not harmful to health.

Any gelatin fragment that is introduced into your mouth or throat can be swallowed.

3. How can I release the capsule if it is stuck in the compartment?

Open the Aerolizer, turn it downwards and gently tap on the bottom.

4. What can I do if the blue buttons get stuck?

Try to pull the blue buttons gently towards their initial position with the help of the lateral protrusions.

5. How can I know if I have taken the correct dose?

• You will hear a sound when you inhale through the Aerolizer.
• You will have a sweet taste in your mouth due to lactose. You may notice powder in the back of your throat, which is normal.
• The capsule will be empty.

6. How can I remove the powder from the inside of the Aerolizer?

• Use a dry cloth or a soft brush.
• Remember that you should never wash the Aerolizer.

If you use more Foradil Aerolizer than you should

If you accidentally use more Foradil Aerolizer than your doctor prescribed, you may feel nausea or vomiting, or you may experience rapid heartbeat, headache, dizziness (possible symptoms of high blood pressure), rapid heartbeat or drowsiness. Inform your doctor immediately or go to the nearest emergency service. You may need medical attention. Bring the package of your medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to use Foradil Aerolizer

Do not take a double dose to compensate for the missed doses.If you forgot a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In some cases, severe asthma attacks (severe shortness of breath, cough, wheezing (whistling), or chest tightness, which may lead to hospitalization) have been observed.

Some side effects can be serious:if you experience any of these side effects,stop taking this medicine and inform your doctor immediately:

Rare:may affect up to 1 in 100 people

• Bronchospasm (bronchial constriction causing difficulty breathing) with rapid breathing or cough and difficulty breathing.

Very rare:may affect up to 1 in 10,000 people

• Allergic reactions, for example if you feel weak (have low blood pressure), if a skin rash appears, or if you experience itching or swelling of the face.

Frequency not known:cannot be estimated from available data

• Muscle weakness, muscle spasms, and/or abnormal heart rhythm (these symptoms may indicate low potassium levels in the blood).
• Irregular heartbeat (including rapid heartbeat).

Chest pain of oppressive character (symptom of angina pectoris).

Other side effects:

Common:may affect up to 1 in 10 people.

• Headache
• Tremor
• Palpitations

Rare:may affect up to 1 in 100 people.

• Agitation
• Anxiety
• Nervousness
• Sleep disturbances
• Fast heart rate
• Irritation of the throat
• Dry mouth
• Muscle cramps
• Muscle pain
• Dizziness

Very rare:may affect up to 1 in 10,000 people.

• Nausea
• Alteration of taste
• Swelling of the hands, ankles, or feet

• Prolongation of the QT interval

Frequency not known:cannot be estimated from available data.

• Excessive thirst, frequent urination, and fatigue over a long period of time (a possible indication of high blood sugar levels).
• Cough
• Skin rash
• Headache and dizziness (symptoms of high blood pressure).

Some of these side effects may disappear spontaneously.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging (blister pack) along with the inhaler to protect it from moisture.

Always dispose of the old inhaler and use the new one provided in the packaging.

Medications should not be thrown away through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy (or any other medication waste collection system). Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

To request more information about this medication, contact your doctor or pharmacist.

Composition of Foradil Aerolizer:

• The active ingredient is formoterol fumarate dihydrate.

• The other components are lactose monohydrate (which contains milk proteins) and gelatin.

Appearance of the product and contents of the packaging

The Foradil Aerolizer capsules are packaged in blister packs.

Each package contains 60 hard capsules and an inhaler.

Each hard capsule of Foradil Aerolizer contains 12 micrograms of formoterol fumarate dihydrate and must be used with the Aerolizer inhaler provided in the package.

Holder of the marketing authorization and responsible manufacturer

Holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Responsible manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Last review date of this leaflet:October 2022

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/