Leaflet: information for the user

Ventoaldo 100 micrograms/dose suspension for inhalation in a pressurized container

salbutamol

Read this leaflet carefully before you start using this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What it isVentoaldo 100micrograms/doseand what it is used for

2. What you need to know before you start usingVentoaldo 100micrograms/dose

3. How to useVentoaldo 100micrograms/dose

4. Possible side effects

5. Storage ofVentoaldo 100micrograms/dose

6. Contents of the container and additional information

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

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

No use Ventoaldo 100 micrograms/dose:

• If you are allergic to salbutamol or to 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 hyperthyroidism, diabetes mellitus, severe cardiovascular disorders, or hypertension (elevated blood pressure).
• If during treatment your condition worsens, you should consult your doctor, as you may need another treatment.

Other medications and Ventoaldo 100 micrograms/dose

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

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

• Beta-blockers that are not cardioselective, as they are contraindicated in asthmatic patients. Propranolol and similar medications antagonize the effects of salbutamol.
• During treatment with salbutamol, it is preferable not to administer imipramine, chlorpromazine, or chlorpropamide.
• Medications that decrease serum potassium levels, as their effects may be additive when administered together.

Pregnancy, breastfeeding, and fertility

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

Salbutamol is not recommended during pregnancy, and it should only be administered when, in the doctor's opinion, the expected benefit to the mother outweighs any possible risk to the fetus.

If you need to administer this medication to a breastfeeding mother, it is recommended to substitute breastfeeding.

Driving and operating machinery:

Although it is not expected to have an effect on your ability to drive and operate machinery, 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 control tests.

Ventoaldo 100 micrograms/dose contains ethanol

This medication contains 3 mg of alcohol (ethanol) in each dose. The amount of alcohol in each dose 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.

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

Remember to take your medication.

This medication is administered via inhalation.

Ventoaldo 100 micrograms/dose should be used on demand and not in a regular manner.

If your asthma is active (for example, you have symptoms or frequent crises, such as difficulty breathing that makes it hard to speak, eat or sleep, cough, wheezing, chest tightness or limited physical capacity), you must inform your doctor immediately, who may start administering a medication or increasing the treatment dose, 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 (for example, 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 Ventoaldo 100 micrograms/dose more than two times 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 (worsening of asthma) that may have serious complications and may put your life at risk or even be fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a daily anti-inflammatory medication for your lungs, 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 inhalation as a single dose may be administered, increasing to two inhalations if necessary. If the response is inadequate, higher doses above two inhalations may be used. The maximum recommended dose is two inhalations, three or four times a day.

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

One or two inhalations may be administered before a planned encounter with allergens.

Use in advanced age:

The same recommendations as for adults.

Use in children and adolescents

The recommended dose for relieving acute bronchospasm in episodic asthma treatment or to prevent exercise-induced asthma is one inhalation. If the response is inadequate, higher doses greater than one inhalation may be administered.

It is very important to follow the instructions indicated by the doctor.

Instructions for correct administration of the preparation:

A.Remove the cap (fig. 1). In the case of a new inhaler or one that has not been used for several days, shake the aerosol (fig. 2) and perform a pulse to ensure the good functioning of the inhaler. In the case of regular use, proceed to the following instructions:

1. Shake the inhaler (fig. 2).
2. Remove as much air as possible from your lungs.

D.Adapt the aerosol to your mouth as indicated in the drawing (fig. 3).

E.Breathe in as deeply as possible.

You should press, as indicated by the arrows in the drawing (fig. 4), the device while making this inspiration.

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

G.It is recommended to clean the mouthpiece and adapter periodically. To do this, remove the mouthpiece from the aerosol and clean it with a cloth or a paper towel. H.Put the cap back on and protect it from dust and dirt.

The inhaler has a dose indicator that can be seen through a small hole or window of the mouthpiece and indicates how many applications are left. In a new inhaler, you can read through the window of the mouthpiece a "200". This number corresponds to the dose left in the inhaler. As the inhaler is used, the dose indicator decreases by 5-7 pulses until it reaches 0.

When there are approximately 40 doses left, the indicator changes from green to red (see figure 5) to remind the patient to consult their doctor if they need to continue treatment or need a new prescription. Dispose of the inhaler once the indicator reaches "0".

(figure 5)

If you use more Ventoaldo 100 micrograms/dose than you should

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.

In case of taking a higher dose than recommended, peripheral vasodilation, increased heart rate, and skeletal muscle tremor may appear. This symptomatology disappears rapidly spontaneously. To cancel the effects of adrenergic beta-stimulation, cardioselective beta-blockers (practolol) may be used. Other beta-blockers are not recommended, as they may cause bronchoconstriction in asthmatics. In the case of acute intoxication, ventricular arrhythmia, the slow intravenous infusion of potassium chloride, 40 mEq in 500 ml of 5% dextrose solution, is recommended.

If you forgot to use Ventoaldo 100 micrograms/dose

Do not take a double dose to compensate for the missed doses. Inhale the next dose when it is due or before if you experience shortness of breath or "whistling".

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

Like all medicines, this medicine 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 it is not known exactly how often it occurs, 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 medicine unless your doctor tells you to.

In very rare cases, allergic reactions have been reported, which include 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 (a drop in blood pressure) and fainting.

Vascular and lymphatic system disorders: potentially severe hypokalemia may occur as a result of systemic treatment with beta-2 agonists.

Psychiatric disorders: nervousness, feeling of tension. Like other beta-2 agonists, rare cases of hyperactivity have been reported in children.

Nervous system disorders: 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 taken into account.

Gastrointestinal disorders: nausea.

Skin and subcutaneous tissue disorders: urticaria.

Musculoskeletal, connective tissue, and bone 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 any other adverse reaction not previously described is observed, consult your doctor or pharmacist.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https//www.notificaram.es By reporting adverse reactions, 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 store at a temperature above30°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 empty.

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

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Ventoaldo 100 micrograms/dose

-The active ingredient is salbutamol base (equivalent to 120 micrograms of salbutamol sulfate)

-The other components (excipients) are oleic acid, ethanol and Norflurano.

Appearance of the product and contents of the packaging

Ventoaldo 100 micrograms/dose is presented in the form of a pressure-packed suspension with a dose indicator; each box contains a 10 ml container that allows for 200 applications.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Date of the last review of this leaflet:

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