FORMOTEROL ALDO-UNION 12 micrograms powder for inhalation (hard capsules)

2. What you need to know before you use Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules)

Do not use Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules):

• If you are allergic to formoterol or any of the other ingredients of this medicine (listed in section 6).
• If you have any cardiac disorder (cardiac rhythm disturbances, subvalvular aortic stenosis, third-degree atrioventricular block, hypertrophic obstructive cardiomyopathy) or thyroid disorder (thyrotoxicosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules):

• If you have any heart disease, such as ischemic heart disease, myocardial infarction, cardiac arrhythmias, severe cardiac failure, or if you have any abnormality of the heart rhythm (prolonged QT interval), high blood pressure, or diabetes.
• If after inhalation, there is an increase in bronchospasm, stop using the medicine and inform your doctor immediately.
• If you have high blood pressure.
• If you have hyperthyroidism.
• If you have an aneurysm (a localized dilation of an artery caused by degeneration or weakening of the vascular wall).
• If you have a pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure).

If you feel that you have difficulty breathing or wheezing during the use of formoterol, you should continue using Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules), but you should see your doctor as soon as possible, as you may need additional treatment.

Once asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules).

Treatment with an inhaled corticosteroid should not be stopped when starting treatment with Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules).

Important information about a similar medicine

Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) belongs to a class of medicines called long-acting beta2 agonists. A very large study with a different long-acting beta2 agonist (salmeterol) showed an increased risk of death due to asthma.

No studies have been conducted to determine if this is also an effect of Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules). Consult your doctor about the risks and benefits of treating your asthma with Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules).

If you have asthma, you should always take Formoterol Aldo-Union along with a medicine for asthma that acts against inflammation (such as inhaled corticosteroids).

While taking Formoterol Aldo-Union, do not use other medicines that contain similar active substances (long-acting beta2 agonists), such as salmeterol.

Do not use Formoterol Aldo-Union:

• If you are well-controlled with another asthma medicine, such as a low or medium dose of an inhaled corticosteroid,
• If you only need to use a short-acting beta2 agonist occasionally.

Do not start treatment with Formoterol Aldo-Union or increase the recommended dose by your doctor while you are having an asthma attack.

If you have asthma, do not use Formoterol Aldo-Union to relieve sudden wheezing. Always carry a short-acting beta2 agonist (a rescue inhaler like salbutamol) with you to treat sudden asthma symptoms.

Treatment with Formoterol Aldo-Union may lead to a low level of potassium in the blood. This can make you more susceptible to an abnormal heart rhythm. Therefore, your doctor may monitor your potassium level in the blood, especially if you have severe asthma.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Children

Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) is not indicated in children under 6 years of age. Children should only use Formoterol Aldo-Union if they are able to use it correctly (see section 3).

They should only use the inhaler with the help of an adult.

Using Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is especially important if you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, which are medicines used to treat depression and mood disorders.
• Sympathomimetic agents, which are medicines similar to adrenaline and are used to treat asthma and nasal congestion.
• Antihistamines, which are common anti-allergic medicines used to prevent or treat the main symptoms of an allergic reaction.
• Steroids, 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, which are a type of medicine used to treat high blood pressure, heart failure, angina, anxiety, and abnormal heart rhythm. Certain eye drops used to treat glaucoma may contain beta-blockers.
• Quinidine, disopyramide, and procainamide, which are medicines used to treat abnormal heart rhythm.
• Phenothiazine derivatives, which are a group of medicines used to control mental disorders such as schizophrenia, mania, psychotic states, and anxiety.
• Digitalis, a medicine used to treat heart failure and abnormal heart rhythm.
• Xanthine derivatives, which are a class of drugs used to treat asthma and chronic obstructive pulmonary diseases.
• Macrolides (e.g., erythromycin) used to treat bacterial infections.
• Anesthetics such as halogenated hydrocarbons (e.g., halothane). These drugs are used to produce anesthesia during surgery.
• Anticholinergic drugs (e.g., ipratropium bromide) used to treat gastrointestinal, genitourinary, and other disorders.

It may be necessary for your doctor to change or even stop the dose of one of the medicines.

Your doctor may have prescribed you other medicines that you should take regularly to treat your respiratory disease. It is important that you continue to take them as usual and do not stop or reduce the dose, even if you start to feel much better.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In women who may be or become pregnant, or in breastfeeding mothers, Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) should not be used.

Driving and using machines

If side effects such as tremors or nervousness occur, your ability to drive or use machines may be limited.

Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) contains lactose monohydrate and micronized lactose monohydrate.It may cause allergic reactions in patients with cow's milk protein allergy. If your doctor has told you that you have an intolerance to certain sugars, consult with him before using this medicine.

3. How to use Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules):

Instructions for proper use

Remember to take your medicine.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Dosage

Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) is administered by inhalation.

The dosage in adults, including elderly patients and children over 6 years of age, is generally as follows: 1 capsule (12 micrograms of formoterol fumarate) twice a day, which means a maximum daily dose of 24 micrograms of formoterol fumarate. In more severe cases and on medical indication, 2 capsules (24 micrograms of formoterol fumarate) may be administered twice a day, which means a maximum daily dose of 4 capsules (48 micrograms of formoterol fumarate).

In addition to this maintenance dose, 1 or 2 additional capsules may be taken occasionally to relieve usual symptoms. If you need to take these additional doses more than twice a week, consult your doctor, as it may indicate a worsening of the disease. Always carry a short-acting beta2 agonist (a rescue inhaler like salbutamol) with you to treat sudden asthma symptoms.

Formoterol acts quickly (1-3 minutes) and its bronchodilator effect lasts for about 12 hours.

To prevent asthma attacks (provoked by exercise, exposure to cold air, or other agents), use 1 capsule (12 micrograms of formoterol fumarate) 15 minutes before exercise or exposure, if your doctor recommends it. This is the recommended dose for adults and children over 6 years of age. In some cases, if you are an adult, your doctor may advise you to take 2 capsules to prevent wheezing and bronchospasm.

Use in children and adolescents

Children over 6 years of age should only use Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) if they are able to use the inhaler correctly and under adult supervision.

The recommended dosage in children over 6 years of age is 1 capsule twice a day. The maximum recommended daily dose for children is 2 capsules.

Method of use and/or route(s) of administration

Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) is administered by inhalation. Follow the instructions below to learn how to use the capsules of Formoterol Aldo-Union with the inhaler.

Use Formoterol Aldo-Union only with the inhaler provided in the package.

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

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

1. Remove the protective cap.

2. Hold the base of the inhaler firmly and turn the mouthpiece in the direction of the arrow to open the device.

3. Make sure your fingers are completely dry. Remove a capsule from the blister pack just before use and place it flat in the compartment located at the base of the inhaler. It is important not to remove the capsule from the packaging until the moment of use. It is also important not to place the capsule in the mouthpiece.

4. Turn the mouthpiece to the closed position until you hear a "click".

5. To release the powder from the capsule:

- Hold the inhalation device in a vertical position with the mouthpiece upwards.

- Pierce the capsule by pressing the two red buttons together at the same time and maintaining the vertical position. Release the buttons. Perform this operation only once.

6. Exhale completely.

7. Insert the mouthpiece into your mouth and tilt your head back slightly. Hold the mouthpiece firmly with your lips and breathe in quickly and steadily with the greatest depth possible.

8. Hold your breath for as long as possible without feeling uncomfortable while removing the inhaler from your mouth. Then exhale. Open the inhaler to see if there is any powder left in the capsule. If there is, repeat steps 6 to 8.

9. After you have inhaled all the powder, open the capsule compartment. Remove the empty capsule and use a dry cloth or a soft brush to remove any residual powder. Do not use water to clean the inhalation device.

10. Close the mouthpiece and replace the cap.

If you use more Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules) than you should

Inform your doctor immediately or go to the nearest hospital if you notice nausea, vomiting, headaches, tremors, drowsiness, changes in heart rhythm, decrease in blood pressure, increase in blood sugar, it may be that the dose is too high.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Formoterol Aldo-Union 12 micrograms inhalation powder (hard capsules):

If you forget to take a dose, take it as soon as you can, except if it is almost time for the next dose.

Do not take a double dose to make up for forgotten doses, simply wait for the next dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects have been reported:

• Frequent (may affect up to 1 in 10 people): hoarseness, headache, tremor, palpitations.
• Infrequent (may affect up to 1 in 100 people): agitation, anxiety, nervousness, sleep disorders, dizziness, rapid heartbeats, throat irritation, muscle cramps, and muscle pain. Some adverse effects can be particularly serious, such as bronchospasm (contraction of the bronchi causing difficulty breathing) with wheezing or coughing and difficulty breathing. If you experience this adverse effect, inform your doctor immediately.
• Rare (may affect up to 1 in 1,000 people): dry mouth, fever, and sinusitis. Some adverse effects can be particularly serious, such as oppressive chest pain (symptom of angina pectoris). If you experience this adverse effect, inform your doctor immediately.
• Very rare (may affect up to 1 in 10,000 people): nausea, altered taste, swelling of the hands, ankles, or feet, excessive thirst, frequent urination, and fatigue over a long period (a possible indication of high blood sugar levels). Some adverse effects can be particularly serious, such as allergic reactions, for example, if you feel weak (have low blood pressure), if you experience a skin rash or itching or swelling of the face. If you experience symptoms that include muscle weakness, muscle spasms, and/or abnormal heart rhythm (this could mean you have low potassium levels in your blood). If you experience an irregular heartbeat (including rapid heartbeat). If you experience these adverse effects, inform your doctor immediately.
• Frequency not known (cannot be estimated from the available data): cough, skin rash, headache, and dizziness (symptoms of high blood pressure).

Some of these effects may disappear spontaneously; inform your doctor if they persist or are very bothersome.

If you are taking Formoterol Aldo-Unión for the treatment of asthma, your doctor should regularly review your symptoms, especially the first time you use Formoterol Aldo-Unión.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules)

Do not store above 25°C.

Keep in the original packaging to protect from heat and moisture. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules)

• The active ingredient is formoterol fumarate dihydrate.
• The other components are micronized lactose monohydrate, semi-micronized lactose monohydrate, and gelatin.

Appearance of the Product and Package Contents

Each hard capsule of Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules) contains 12 micrograms of formoterol fumarate and should be used with the inhalation device provided in the packaging. Each package contains 60 hard capsules.

Marketing Authorization Holder:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, 7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

Date of the Last Revision of this Prospectus:January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/