SALBUTAMOL ALDO-UNION 100 micrograms/dose PRESSURIZED INHALER SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Salbutamol Aldo-Unión 100 micrograms/doseinhalation suspension in pressurized container

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Salbutamol Aldo-Unión 100 micrograms/dose is and what it is used for
2. What you need to know before starting to use Salbutamol Aldo-Unión 100 micrograms/dose
3. How to use Salbutamol Aldo-Unión 100 micrograms/dose
4. Possible side effects
5. Storage of Salbutamol Aldo-Unión 100 micrograms/dose
6. Contents of the container and additional information

1. What Salbutamol Aldo-Unión 100 micrograms/dose is and what it is used for

Salbutamol belongs to the group of medications called bronchodilators that act by relaxing the muscles of the walls of the small airways in the lungs. It facilitates breathing and relieves coughing.

It is indicated in:

• Symptomatic treatment of bronchospasm (closure of airways in the lungs) in bronchial asthma and in other processes associated with reversible obstruction of the airways. These are a group of lung diseases that cause inflammation of the airways, resulting in a blockage of airflow in the lungs.
• Prevention of bronchospasm (closure of airways in the lungs) induced by physical exercise or before exposure to a known and unavoidable allergenic stimulus (substance capable of producing an allergic reaction).

2. What you need to know before starting to use Salbutamol Aldo-Unión 100 micrograms/dose

Do not useSalbutamol Aldo-Unión100 micrograms/dose:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication:

• If you have a history of heart disease, irregular heartbeat, or angina pectoris.
• If you suffer from thyrotoxicosis, diabetes mellitus, severe cardiovascular disorders, or hypertension (high blood pressure).
• If your condition worsens during treatment, you should consult your doctor, as you may need another treatment.

Other medications and Salbutamol Aldo-Unión 100 micrograms/dose

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

It is essential to inform your doctor if you are taking any of the following medications:

• Non-cardioselective beta-blockers, as they are contraindicated in asthmatic patients. Propranolol and similar medications counteract the effects of salbutamol.
• During treatment with salbutamol, it is preferable not to administer imipramine, chlorpromazine, or chlordiazepoxide.
• Medications that decrease serum potassium, as the effects may be additive if administered together.

Pregnancy, breastfeeding, and fertility

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

Salbutamol is not recommended during pregnancy, and it should only be administered when the expected benefit to the mother is greater than any possible risk to the fetus.

In the case of administration to a breastfeeding mother, it is recommended to substitute breastfeeding.

Driving and using machines:

Although no effects on the ability to drive and use machines are expected, you should be aware of the possibility of muscle cramps and tremors.

Use in athletes

This medication contains salbutamol, which may produce a positive result in doping tests.

Salbutamol Aldo-Unión 100 micrograms/dose contains ethanol

This medication contains 3 mg of alcohol (ethanol) per puff. The amount per puff of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to use Salbutamol Aldo-Unión 100 micrograms/dose

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

This medication is administered by inhalation.

Salbutamol Aldo-Unión 100 micrograms/dose should be used as needed and not on a regular basis.

If your asthma is active (e.g., you have symptoms or frequent episodes, such as difficulty breathing that makes it hard to speak, eat, or sleep, coughing, wheezing, chest tightness, or limited physical ability), you should inform your doctor immediately, as they may start you on another medication or increase the dose of treatment, such as an inhaled corticosteroid, to control your asthma.

Inform your doctor as soon as possible if your medication seems not to be working as well as usual (e.g., if you need higher doses to relieve your respiratory problems or if your inhaler does not provide relief for at least 3 hours), as your asthma may be worsening, and you may need a different medication.

If you use Salbutamol Aldo-Unión 100 micrograms/dose more than twice a week to treat your asthma symptoms, excluding preventive use before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (asthma worsening) that can have serious complications and can be life-threatening. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a medication to control inflammation in your lungs daily, e.g., an "inhaled corticosteroid," it is essential to continue using it regularly, even if you feel better.

The recommended dose is:

Adults

To relieve acute bronchospasm and treat intermittent asthma episodes, one puff can be administered as a single dose, which can be increased to two puffs if necessary. If the response is inadequate, higher doses than two puffs can be used. The maximum recommended dose is two puffs, three or four times a day.

To prevent exercise-induced bronchospasm, one or two puffs should be administered 15 minutes before exercise.

One or two puffs can be administered before a planned contact with allergens.

Use in the elderly

The same recommendations as for adults.

Use in children and adolescents

The recommended dose for relieving acute bronchospasm in the treatment of episodic asthma or for preventing exercise-induced asthma is one puff. If the response is inadequate, higher doses than one puff can be administered.

It is crucial to follow the instructions indicated by the doctor.

Instructions for the correct administration of the preparation:

• Remove the cap (fig. 1). If it is a new inhaler or has not been used for several days, shake the aerosol (fig. 2) and perform a puff to ensure the inhaler is working properly. If the inhaler is used regularly, proceed to the next instructions:
1. Shake the inhaler (fig. 2).
2. Expel as much air as possible from your lungs.

• Place the aerosol in your mouth according to the position indicated in the drawing (fig. 3).

• Take a deep breath.

You should press the device, following the arrows in the drawing (fig. 4), while taking this breath.

• Remove the aerosol from your mouth and try to hold your breath for a few seconds.

• You should periodically wash the oral adapter of the aerosol. To do this, remove the adapter from the aerosol and rinse it with plenty of water.

• Store it with the cap on and protect it from dust and dirt.

If you use more Salbutamol Aldo-Unión 100 micrograms/dose than you should

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 medication and the amount ingested.

In case of taking a higher dose than recommended, peripheral vasodilation, increased heart rate, and muscle tremors may occur. This symptomatology disappears quickly on its own. To counteract the effects of beta-adrenergic stimulation, cardioselective beta-blockers (practolol) can be used. Other adrenergic beta-blockers are not recommended, as they may cause bronchoconstriction in asthmatics. In case of acute intoxication, if ventricular arrhythmia occurs, it is recommended to administer a slow intravenous infusion of potassium chloride, 40 mEq in 500 ml of 5% dextrose solution.

If you forget to use Salbutamol Aldo-Unión 100 micrograms/dose

Do not take a double dose to make up for forgotten doses. Inhale the next dose when it is due or sooner if you notice shortness of breath or "wheezing."

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are dose-dependent and are due to the mechanism of action of beta-2 agonists.

Although the exact frequency is not known, some people may occasionally experience chest pain (due to heart problems such as angina pectoris). Inform your doctor if you develop these symptoms while being treated with salbutamol, but do not stop taking this medication unless your doctor indicates so.

In very rare cases, allergic reactions have been reported, including angioedema (inflammation of the deep layers of the skin that manifests as large hives around the eyes and lips, which can also affect the hands, feet, and throat) and urticaria, bronchospasm, hypotension (low blood pressure), and fainting.

Disorders of the circulatory and lymphatic systems: potentially severe hypokalemia may occur as a consequence of systemic treatment with beta-2 agonists.

Psychiatric disorders: nervousness, feeling of tension. As with other beta-2 agonists, hyperactivity has been rarely reported in children.

Disorders of the nervous system: mild tremor, headache, dizziness.

Cardiovascular disorders: tachycardia, angioedema, hypotension. Cases of cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystole) have been reported in association with beta-2 agonists, usually in susceptible patients.

Respiratory, thoracic, and mediastinal disorders: as with other inhalation therapies, the possibility of paradoxical bronchospasm with an immediate increase in wheezing after administration should be considered.

Gastrointestinal disorders: nausea.

Skin and subcutaneous tissue disorders: urticaria.

Musculoskeletal and connective tissue disorders: rare cases of transient muscle cramps have been reported.

General disorders and administration site conditions: cases of oral and pharyngeal irritation may occur.

If you observe any other adverse reaction not described above, consult your doctor or pharmacist.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Salbutamol Aldo-Unión 100 micrograms/dose

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

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light. Do not freeze.

The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not puncture the container, even if it appears to be empty.

Do not use this medication after the expiration date shown on the label and carton after "EXP." The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Salbutamol Aldo-Unión 100 micrograms/dose

• The active ingredient is Salbutamol base (equivalent to 120 micrograms of Salbutamol sulfate)
• The other components are oleic acid, ethanol, and Norflurane.

Appearance of the product and contents of the container

Salbutamol Aldo-Unión 100 micrograms/dose is presented as an inhalation suspension in a pressurized container; each box contains a 10 ml container that allows for 200 applications.

Marketing authorization holder and manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Date of the last revision of this package leaflet:

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