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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Formoterol fumarate dihydrate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Formoterol Aldo-Unión 12 micrograms inhalation powder (hard capsules) is and what it is used for
2. What you need to know before using Formoterol Aldo-Unión 12 micrograms inhalation powder (hard capsules)
3. How to use Formoterol Aldo-Unión 12 micrograms inhalation powder (hard capsules)
4. Possible side effects
5. How to store Formoterol Aldo-Unión 12 micrograms inhalation powder (hard capsules)
6. Contents of the pack and other information

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

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

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

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

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

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

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

Warnings and precautions

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

• If you have a heart condition such as ischemic heart disease, myocardial infarction, cardiac arrhythmias, severe heart failure, or if you have an abnormality known as “prolongation of the QT interval” (an abnormal electrical signal detected on your electrocardiogram), severe hypertension, or diabetes.
• If after inhalation bronchospasm worsens, stop using the medicine and inform your doctor immediately.
• If you have high blood pressure.
• If you suffer from hyperthyroidism.
• If you have an aneurysm (localized dilation of an artery caused by degeneration or weakening of the blood vessel wall).
• If you have phaeochromocytoma (a tumor of the adrenal gland that can affect blood pressure).

If you experience difficulty breathing or wheezing while using formoterol, you should continue using Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules), but you must see your doctor as soon as possible, as you may need additional treatment.

Once asthma is well controlled, your doctor may consider gradually reducing the dose of Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules).

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

Important information about a similar medicine

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

Studies have not been conducted to determine whether this is also an effect of Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules). Discuss with your doctor the risks and benefits of treating your asthma with Formoterol Aldo-Unión 12 micrograms powder for inhalation (hard capsules).

If you have asthma, you should always take Formoterol Aldo-Unión together with an anti-inflammatory asthma medication (such as inhaled corticosteroids).

While taking Formoterol Aldo-Unión, do not use other medicines containing drugs with a similar effect (long-acting beta2 agonists), such as salmeterol.

Do not use Formoterol Aldo-Unión:

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

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

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

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

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

Children

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

The inhaler should only be used with the help of an adult.

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAO inhibitors) 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 allergy medicines used to prevent or treat the main symptoms of an allergic reaction.
• Steroids, which are often used to treat asthma and other inflammatory conditions.
• Diuretics, which are used to treat edema (fluid retention), heart failure, and high blood pressure.
• Beta-blockers, which are medicines used to treat high blood pressure, heart failure, angina, anxiety, and abnormal heart rhythms. Certain eye drops used to treat glaucoma may contain beta-blockers.
• Quinidine, disopyramide, and procainamide, which are medicines used to treat abnormal heart rhythms.
• 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 rhythms.
• Xanthine derivatives, which are a class of drugs used to treat asthma and chronic obstructive pulmonary disease.
• Macrolides (e.g., erythromycin) used to treat bacterial infections.
• Anesthetics such as halogenated hydrocarbons (e.g., halothane). These drugs are used to induce anesthesia during surgery.
• Anticholinergic drugs (e.g., ipratropium bromide) used to treat gastrointestinal, genitourinary, and other disorders.

Your doctor may need to adjust or even stop the dose of one of these medicines.

Your doctor may have prescribed other medicines that you must take regularly for your respiratory condition. It is important that you continue taking them as usual and that you 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.

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

Driving and using machines

If side effects such as tremor or nervousness occur, your ability to drive or use machinery may be impaired.

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

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

Instructions for proper use

Remember to take your medication.

Always follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Dosage

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

The dosage for adults, including elderly patients and children over 6 years of age, is generally as follows: 1 capsule (12 micrograms of formoterol fumarate) twice daily, meaning a maximum daily dose of 24 micrograms of formoterol fumarate. In more severe cases and as directed by the physician, 2 capsules (24 micrograms of formoterol fumarate) may be administered twice daily, resulting in a maximum daily dose of 4 capsules (48 micrograms of formoterol fumarate).

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

Formoterol acts rapidly (1–3 minutes), and its bronchodilator effect lasts about 12 hours.

To prevent asthma attacks (triggered by exercise, exposure to cold air, or other agents), use 1 capsule (12 micrograms of formoterol fumarate), if recommended by your doctor, 15 minutes before exercise or exposure. 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 taking 2 capsules to prevent wheezing and bronchospasm.

Use in children and adolescents

Children over 6 years of age may only use Formoterol Aldo-Unión 12 micrograms inhalation powder (hard capsules) if they are capable of using the inhaler correctly and under adult supervision.

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

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

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

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

Remove the capsule from the blister immediately before use. Ensure your fingers are completely dry to prevent the capsule from becoming damp.

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

1st Remove the protective cap.

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

3rd Ensure your fingers are completely dry. Remove one capsule from the blister immediately before use and place it flat into the compartment located in the base of the inhaler. It is important not to remove the capsule from its packaging until the moment of use. It is also important not to place the capsule into the mouthpiece.

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

5th To release the powder from the capsule:

• Hold the inhaler device vertically with the mouthpiece pointing upwards.

• Pierce the capsule by pressing both red buttons simultaneously while maintaining the vertical position. Release the buttons. Perform this step only once.

6th Breathe out fully.

7th Place the mouthpiece in your mouth and tilt your head slightly backward. Close your lips firmly around the mouthpiece and inhale quickly and steadily as deeply as possible.

8th Hold your breath as long as possible without discomfort while removing the inhaler from your mouth. Then breathe out slowly. Open the inhaler to check whether any powder remains in the capsule. If so, repeat steps 6th to 8th.

9th After you have inhaled all the powder, open the capsule compartment. Remove the empty capsule and use a dry cloth or 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-Unión 12 micrograms inhalation powder (hard capsules) than you should

Contact your doctor immediately or go to the nearest hospital if you experience nausea, vomiting, headache, tremor, drowsiness, heart rhythm disturbances, low blood pressure, or increased blood sugar levels, as the dose may be too high.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose.

Do not take a double dose to make up for a missed dose. Simply wait for your next scheduled dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

• Common (may affect up to 1 in 10 people): hoarseness, headache, tremor, palpitations.
• Uncommon (may affect up to 1 in 100 people): restlessness, anxiety, nervousness, sleep disorders, dizziness, rapid heartbeat, throat irritation, muscle cramps, and muscle pain. Some adverse effects may be particularly serious, such as bronchospasm (contraction of the bronchi causing difficulty breathing) with wheezing or coughing and breathing difficulties. 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 may be particularly serious, such as oppressive chest pain (a 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, taste disturbances, swelling of the hands, ankles or feet, excessive thirst, frequent urination, and prolonged fatigue (a possible indication of high blood sugar levels). Some adverse effects may be particularly serious, such as allergic reactions—for example, if you feel weak (low blood pressure), develop a skin rash, or experience itching or swelling of the face. If you experience symptoms including muscle weakness, muscle spasms, and/or abnormal heart rhythm (this could mean you have low potassium levels in the 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 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Formoterol Aldo-Unión 12 micrograms inhalation powder (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 expiry date stated on the packaging. The expiry date refers to the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

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

• The active substance 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 pack

Each hard capsule of Formoterol Aldo-Unión 12 micrograms inhalation powder (hard capsules) contains 12 micrograms of formoterol fumarate and must be used with the inhalation device provided in the pack. Each pack 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 most recent revision of this leaflet: January 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/