Leaflet: information for the user

Ventoduo 100 micrograms/50 micrograms / pulsation suspension for inhalation in a pressure container

Salbutamol / Dipropionate of beclometasone

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

• Keep this leaflet, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they 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 leaflet. See section 4.

1. What isVentoduoand for what it is used

2. What you need to know before starting to useVentoduo

3. How to useVentoduo

4. Possible adverse effects

5. Storage ofVentoduo

6. Contents of the container and additional information

Ventoduo contains two active ingredients, salbutamol and beclometasona dipropionate.

Salbutamol is a short-acting bronchodilator. Bronchodilators relax the muscles of the airway walls in the lungs, making it easier to open the airways to breathe more easily.

Beclometasona dipropionate is a corticosteroid that acts by reducing inflammation and irritation in the lungs.

Ventoduo is indicated for the treatment of asthma in patients who require a corticosteroid and a short-acting bronchodilator..

No use Ventoduo:

- If you are allergic to salbutamol, beclometasone dipropionate, 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 Ventoduo:

- If you have had mouth ulcers

- If your asthma worsens or you have greater difficulty breathing. You may notice more "puffs" or a sensation of choking or have to use your medication much more frequently than usual. If any of these things happen, you should see your doctor as soon as possible.

- If you have active or latent tuberculosis.

- If you have severe heart and blood vessel disorders (severe cardiopathy, history of heart disease, irregular heartbeat, angina, or severe and untreated hypertension). If you experience chest pain or worsening symptoms of your heart disease, consult your doctor immediately.

- If you have hyperthyroidism (overactive thyroid gland), hypokalemia (low potassium levels in the blood), known aneurysm (arterial dilation), or diabetes mellitus (your doctor may perform additional glucose controls before starting treatment).

- If you have pheochromocytoma (a tumor of the adrenal gland).

- If you have acute asthma. This medication may cause a decrease in potassium levels, which could be increased by hypoxia (low oxygen levels).

- The decrease in potassium levels that this medication may cause could also be increased by medications used to treat asthma.

- If you have previously been treated with oral corticosteroids. Your doctor may recommend regular adrenal gland function checks and will indicate how to gradually reduce the dose of the previous treatment. You may need additional symptomatic treatment.

- Your doctor will instruct you on how to use the inhaler. You must use this medication even if you do not have symptoms.

- Always use the dose indicated by your doctor. Do not increase it, as it could cause adverse effects.

- Ventoduo treatment should not be stopped abruptly, but rather gradually. Your doctor will instruct you on how to do it.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Regularly monitor the height of children receiving prolonged treatment with inhaled corticosteroids.

Use in athletes

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

Use of Ventoduo with other medications

Inform your doctor if you are taking or have recently taken other medications, including those purchased without a prescription.

Some medications may increase the effects of Ventoduo, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Inform your doctor if you are taking the following medications:

- Cardiac and vascular medications that may narrow the airways (non-selective β-blockers such as atenolol, propranolol).

- Other bronchodilator medications.

- Certain medications for depression, known as monoamine oxidase inhibitors (e.g., moclobemide) and tricyclic antidepressants (e.g., amitriptyline).

- Anesthetics (inducers of partial or total loss of sensitivity) such as halothane.

- Medications for irregular heartbeat, such as digoxin.

- Xanthine derivatives (used to help with breathing), such as theophylline.

- Diuretics (medications for urination), such as furosemide.

- Disulfiram or metronidazole.

- Other corticosteroids.

- HIV medications (e.g., ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Ventoduo will only be administered during pregnancy or breastfeeding when, in the doctor's opinion, the expected benefit for the mother outweighs any possible risk to the fetus.

Driving and operating machinery

Although no effects on the ability to drive and operate machinery are expected, you should be aware of the possibility of dizziness and tremors.

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

Ventoduo is administered by inhalation and should be used on demand and not regularly.

If your asthma is active (for example, you have symptoms or frequent attacks, such as difficulty breathing that makes it hard to speak, eat, or sleep, cough, wheezing, chest tightness, or limited physical ability), 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 Ventoduo 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 can 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, for example, an "inhaled corticosteroid," it is essential to continue using it regularly, even if you feel better.

The recommended and maximum doses are:

Use in adults and adolescents (12 years and older):

Recommended dose:2 inhalations (200 micrograms of salbutamol and 100 micrograms of beclometasona dipropionate), 1 or 2 times a day.

Maximum dose:2 inhalations (200 micrograms of salbutamol and 100 micrograms of beclometasona dipropionate), 3 or 4 times a day.

Use in children 5 to 11 years:

Recommended dose:1 inhalation (100 micrograms of salbutamol and 50 micrograms of beclometasona dipropionate), 1 or 2 times a day.

Maximum dose:2 inhalations (200 micrograms of salbutamol and 100 micrograms of beclometasona dipropionate), 2 times a day.

You should not increase the dose or frequency of administration on your own, as excessive high doses may cause adverse effects.

Usage instructions:

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

B. Shake the inhaler (fig. 2).

C. Remove as much air as possible from your lungs.

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

E. Take a deep breath as possible.

You must press, according to the arrows in the drawing (fig. 4), the device while making this inspiration.

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

G. You should periodically clean the oral adapter-pulsator of the aerosol. To do this, remove the pulsator from the aerosol and wipe it with a cloth or a paper towel.

H. Store with the cap in place and to protect it from dust and dirt.

I. It is recommended to rinse your mouth with water after each application.

The inhaler has a dose indicator that can be seen through a small opening or window of the pulsator and indicates how many applications are left. In this indicator of a new inhaler, you can read through the window of the pulsator a "200". This number corresponds to the dose left in the inhaler. As the inhaler is used, the dose indicator rotates in a decreasing manner every 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 if they need a new prescription. Discard the inhaler once the indicator reaches "0".

(figure 5)

If you use more Ventoduo than you should

It is essential to take your dose as indicated by your doctor. Do not increase or decrease your dose without medical supervision.

If you use more Ventoduo than recommended, neuromuscular alterations may occur, ranging from muscle weakness to paralysis and respiratory insufficiency. Changes in your electrocardiogram (ECG) may also occur, and an increased risk of toxicity from other medications you may be using (digoxin) may occur.

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

If you forgot to take Ventoduo

Do not take a double dose to compensate for the missed doses. Inhale the next dose when due.

Like all medications, Ventoduo may cause side effects, although not everyone will experience them. The following side effects associated with Ventoduo are classified by frequency.

Very frequent (may affect more than 1 in 10 people)

- Oral and/or throat candidiasis (thrush)

Frequent (may affect up to 1 in 10 people)

- General tremor, usually in the hands, related to the dose

- Headache

- Dizziness

-Hoarseness and/or throat irritation.

- Tachycardia (rapid heart rate)

Not very frequent (may affect up to 1 in 100 people)

- Palpitations (rapid or irregular heart rate)

- Transient muscle cramps

-Skin eruptions, urticaria, pruritus, and/or erythema, hypotension.

Rare(may affect up to 1 in 1,000 people)

- Hypokalemia (low potassium levels in the blood)

The therapy with β2 agonists may lead to potentially severe hypokalemia and this effect may be increased by the concomitant administration of salbutamol and a corticosteroid.

- Eosinophilic pneumonia (lung disorder)

Very rare(may affect up to 1 in 10,000 people)

- Allergies, which manifest with swelling of the eyelids, face, lips, and/or throat (angioedema).

- Respiratory alterations such as dyspnea (sensation of lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air entry).

- Anaphylactic or anaphylactoid reactions (severe allergic reactions that may impair breathing or alter consciousness).

- Ventoduo may increase the normal production of steroid hormones, particularly if high doses have been taken for long periods of time. The effects include:

- Delayed growth in children and adolescents

- Decreased bone mineral density (weakening of the bones)

- Cataracts and glaucoma (increased eye pressure)

- Cushing's syndrome (rounded face)

- Anxiety, sleep disorders, and mood changes, including hyperactivity and irritability (mainly in children).

- Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disorders)

Unknown frequency

- Depression or aggression. It is more likely that these effects will appear in children.

- Myocardial ischemia (lack of blood flow to the heart)

- Blurred vision.

In patients where hoarseness or throat irritation occurs, it may be helpful to rinse the mouth with water immediately after inhalation.

As with other inhalation therapies, the possibility of paradoxical bronchospasm should be considered. The treatment with Ventoduo should be suspended immediately, the patient evaluated, and if necessary, an alternative therapy initiated. This should be treated immediately with a rapid-acting bronchodilator administered by inhalation.

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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medications for Human Use Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from light. Do not freeze.

The container is under pressure. Do not pierce, break, or burn it, even if it appears empty.

If the inhaler is cold, remove the cartridge and warm it with your hand for a few minutes before using. Do not use any other method to warm it.

Do not use this medication after the expiration date that appears on the container after "Cad: 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 containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Ventoduo

The active principles are: salbutamol (as sulfate) and beclometasona dipropionate.

The other components are: oleic acid, ethanol and 1,1,1,2-tetrafluoroethane (HFA-134a).

Each puff contains 100 micrograms of salbutamol (as sulfate) and 50 micrograms of beclometasona dipropionate.

Appearance of the product and contents of the packaging

Ventoduo is presented in a 10 ml pressure container (200 puffs) that releases the medication in the form of a suspension for inhalation.

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:August/2019

Other sources of information

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/