Prospect: information for the patient

Formoterol Aldo-Union 12 micrograms powder for inhalation (hard capsules)

Formoterol fumarate dihydrate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Formoterol Aldo-Union 12 micrograms powder for inhalation (hard capsules) and for what it is used

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

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

4. Possible adverse effects

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

6. Contents of the package and additional information

Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules) belongs to a group of medicines called bronchodilators.

Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules) is indicated for the treatment and prevention of chronic obstructive pulmonary disease such as asthma and chronic bronchitis. It is also used for the prevention of bronchospasm induced by inhaled allergens, cold air or exercise. It works by relieving the spasm or narrowing of the small air passages in the lungs and reducing some of the other factors involved in the production of symptoms of choking and wheezing.

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

No use Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras):

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

- If you have any heart condition (arrhythmia, idiopathic subvalvular aortic stenosis, third-degree atrioventricular block, obstructive hypertrophic cardiomyopathy) or thyroid condition (hyperthyroidism).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras):

- If you have any heart disease such as ischemic cardiopathy, myocardial infarction, cardiac arrhythmias, severe heart failure, or if you have any alteration of the type "prolongation of the QT interval" (abnormal electrical signal detected in your electrocardiogram), severe hypertension, or diabetes.

- If after inhalation, there is an increase in bronchospasm, stop using the medication and immediately inform your doctor.

- If you have high blood pressure.

- If you suffer from hyperthyroidism.

- If you suffer from aneurysm (localized dilation of an artery caused by degeneration or weakening of the vascular wall).

- If you suffer from pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure).

If you feel you have difficulty breathing or wheezing during the use of formoterol, you should continue using Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras), but you should see your doctor as soon as possible, as you may need additional treatment.

Once your asthma is well controlled, your doctor may consider it advisable to gradually reduce the dose of Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras).

The treatment with an inhaled corticosteroid should not be interrupted when starting treatment with Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras).

Important information about a similar medication

Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras) belongs to a class of medications called long-acting beta2 agonists. A very large study with a different long-acting beta2 agonist (salmeterol) showed an increase in the risk of death due to asthma.

No studies have been conducted to determine if this is also an effect of Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras). Consult with your doctor about the risks and benefits of treating your asthma with Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras).

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

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

Do not use Formoterol Aldo-Unión:

- If you are well controlled with another medication for treating asthma, such as a low or medium dose of an inhaled corticosteroid,

- If you only need, from time to time, a short-acting beta2 agonist.

Do not start treatment with Formoterol Aldo-Unión or increase the recommended dose by your doctor while suffering from an asthma attack.

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

The treatment with Formoterol Aldo-Unión 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.

It is reported to athletes that this medication contains a component that can establish a positive analytical result for doping control.

Children

Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras) is not indicated in children under 6 years old. Children should only use Formoterol Aldo-Unión if they are able to handle it correctly (see section 3).

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

Use of Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras) with other medications

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

- Monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, which are medications used to treat depression and mood disorders.

- Sympathomimetics, which are medications similar to adrenaline and used to treat asthma and nasal congestion.

- Antihistamines, which are common antiallergic medications used to prevent or treat the main symptoms of an allergic response.

- 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 the type of medications 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 medications used to treat abnormal heart rhythm.

- Phenothiazine derivatives, which are a group of medications used to control mental disorders such as schizophrenia, mania, psychotic states, and anxiety.

- Digitalis, a medication used to treat heart failure and abnormal heart rhythm.

- Xanthine derivatives, which are a class of medications used to treat asthma and chronic obstructive pulmonary disease.

- Macrolides (e.g. erythromycin), which are used to treat bacterial infections.

- Anesthetics such as halogenated hydrocarbons (e.g. halothane), which are used to produce anesthesia during surgery.

- Anticholinergic medications (e.g. ipratropium bromide), which are used to treat gastrointestinal and genitourinary disorders.

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

You may have been prescribed other medications by your doctor that you should take regularly to treat your respiratory disease. It is essential that you continue taking them as directed and do not interrupt or reduce the dose, even if you start feeling much better.

Pregnancy and lactation

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

In women who may be or become pregnant, or in breastfeeding mothers, Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras) should not be used.

Driving and operating machinery

If you experience side effects such as tremor or nervousness, you may be limited in your ability to drive or operate machinery.

Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras) contains lactose monohydrate micronized and lactose monohydrate semimicronized.This may cause allergic reactions in patients with lactose intolerance. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication.

Instructions for Proper Use

Remember to take your medication.

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

Dosage

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

The dosage in adults, including elderly patients and children over 6 years old is, in general, 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 at the doctor's 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, occasional additional doses may be taken to relieve habitual symptoms, 1 or 2 capsules per day. If you need to take these additional doses more than twice a week, consult your doctor, as it may be indicative of a worsening of the disease. Always carry a short-acting beta2 agonist (a rescue inhaler such as 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 (caused by exercise, cold air exposure, or other agents), use 1 capsule (12 micrograms of formoterol fumarate), if your doctor recommends it, 15 minutes before exercise or exposure. This is the recommended dose for adults and children over 6 years old. 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 old can only use Formoterol Aldo-Union 12 micrograms powder for inhalation (hard capsules) if they are able to use the inhaler correctly and under adult supervision.

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

Administration and/or Form of Use

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

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

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

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

1st Remove the protective cap.

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

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

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

5th To release the powder from the capsule:

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

-Pierce the capsule by pressing both red buttons simultaneously and maintaining the vertical position. Release the buttons. Perform this operation only once.

6th Breathe out completely.

7th Insert the mouthpiece into your mouth and tilt your head slightly back. Press the mouthpiece firmly with your lips and breathe in rapidly and constantly to the greatest depth possible.

8th Retain the breath as long as possible without feeling discomfort while removing the inhaler from your mouth. Then breathe out. Open the inhaler to see if there is powder left in the capsule. If so, repeat steps 6-8.

9th 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.

10th Close the mouthpiece and replace the protective cap.

If you use more Formoterol Aldo-Union 12 micrograms powder for inhalation (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, low blood pressure, increased blood sugar, or if you suspect the dose is too high.

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

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

If you forgot to take a dose, take it as soon as you remember, except if it is almost time for the next one.

Do not take a double dose to compensate for the missed doses, simply wait for the next dose.

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

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

The following side effects have been reported:

- Frequent (may affect up to 1 in 10 people): snoring, headache, tremor, palpitations.

- Infrequent (may affect up to 1 in 100 people): agitation, anxiety, nervousness, sleep disturbances, dizziness, rapid heartbeat, throat irritation, muscle cramps, and muscle pain.Some side effects may be especially serious, such as bronchospasm(bronchial constriction causing difficulty breathing) with labored breathing or coughing and difficulty breathing. If you experience this side effect, inform your doctor immediately.

- Rare (may affect up to 1 in 1,000 people): dry mouth, fever, and sinusitis.Some side effects may be especially serious, such as oppressive chest pain(angina pectoris symptom). If you experience this side effect, inform your doctor immediately.

- Very rare (may affect up to 1 in 10,000 people): nausea, altered taste, swelling of hands, ankles, or feet, excessive thirst, frequent urination, and prolonged fatigue (a possible indication of elevated blood sugar levels).Some side effects may be especially serious, such as allergic reactions, for example, if you feel weak (low blood pressure), if a skin rash appears, or if you experience 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 side effects, inform your doctor immediately.

- Unknown frequency (cannot be estimated from available data): cough, skin rash, headache, and dizziness (symptoms of high blood pressure).

Some of these side 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 will regularly review your symptoms, especially the first time you use Formoterol Aldo-Unión.

Reporting 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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 25°C.

Store in the original packaging to protect it from heat and humidity. Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated. Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Formoterol Aldo-Union 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 contents of the packaging

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

Marketing Authorization Holder:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, 7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

Last review date of this leaflet:January 2021

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