VENTOLIN 5 mg/ml SOLUTION FOR NEBULIZER INHALATION

2. What you need to know before you use Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

Do not use Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

• if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6).
• to stop premature labor or threatened abortion.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ventolin if:

• you have had to stop using this or any other medicine for the treatment of this disease due to allergy or any other problem
• you have high blood pressure
• you have hyperthyroidism (excess thyroid function)
• you have a history of heart problems such as rapid or irregular heartbeat or angina (chest pain)
• you have low potassium levels in the blood
• you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma
• you are taking diuretics, which are sometimes used to treat high blood pressure or heart problems
• you have diabetes
• you use nebulized anticholinergic medications (such as ipratropium bromide) in combination with salbutamol. Make sure that the nebulization does not penetrate the eyes.
• you have taken other medications used to relieve nasal congestion (such as ephedrine or pseudoephedrine) or other medications used to treat asthma.

Your doctor will monitor your potassium levels if you are taking xanthine derivatives, steroids, or diuretics.

Consult your doctorif you think you may have any of these problems.

Symptoms to be aware of

High doses of this medicine may occasionally produce a condition known as lactic acidosis. You should be aware of the appearance of certain symptoms while taking this medicine to reduce the risk of any problems. See “Symptoms to be aware of” in section 4.

Other medicines and Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (e.g., treatments to eliminate fluids, any other type of bronchodilator tablets, steroids...), including those obtained without a prescription.

Some medicines may affect the functioning of Ventolin or make it more likely that you will have side effects. These include:

• Non-selective β-blockers such as propranolol used to treat high blood pressure or heart problems.
• Monoamine oxidase inhibitors (MAOIs) used to treat depression.

Your doctor or pharmacist will decide if you should use Ventolin with these medicines.

Pregnancy and breastfeeding

Ventolin is not normally recommended during pregnancy. 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.

Your doctor will weigh the benefits of treatment with Ventolin for you and the risk to the baby.

It is likely that salbutamol will pass into breast milk, so if you are breastfeeding, you should consult your doctor before using this medicine.

Driving and using machines

No studies have been conducted on the ability to drive and use machines.

Ventolin 5 mg/ml Solution for Inhalation by Nebulizer contains benzalkonium chloride.

This medicine contains 0.1 mg of benzalkonium chloride in each ml of Ventolin 5 mg/ml Solution for Inhalation by Nebulizer.

Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially in patients with asthma.

Use in athletes

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

3. How to use Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

Follow the instructions for administration of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Ventolin. Do not stop treatment before.

Instructions for use:

Important information

Ventolin Solution for Inhalation by Nebulizershould only be used by inhalation using a nebulizer. It should not be injected or swallowed.

1. Prepare the nebulizer for filling.
2. Measure the correct amount of Ventolin and put it in the nebulizer container.
3. Add the correct amount of normal sterile saline solution (make sure your doctor has indicated how much to use). Only use normal sterile saline solution to dilute the solution.
4. Put the cap on the nebulizer container and gently shake to mix the contents.
5. Connect the nebulizer and use as indicated.
6. After use, discard any remaining solution in the nebulizer container. Clean the nebulizer as recommended.

The nebulizer produces a fine mist that is inhaled through a mask or mouthpiece. Make sure you know how to use it correctly. If you have problems, ask your doctor or pharmacist. The instructions for using Ventolin are provided later in this leaflet.

Avoid getting Ventolin or the mist produced by the nebulizer in your eyes.

You should use the nebulizer in a well-ventilated room, as some of the mist may escape and be inhaled by others.

Make sure you know HOW, WHEN, and HOW MUCH solution to use. Your doctor should have indicated this to you, and the instructions should be in writing. If not, or if you are unsure, ask your doctor or pharmacist.

Ventolin 5 mg/ml Solution for Inhalation by Nebulizer should be used as needed and not on a regular basis.

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

Tell your doctor as soon as possible if your medication seems to be not 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 Ventolin 5 mg/ml Solution for Inhalation by Nebulizer 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 exacerbations) 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 daily medication to reduce inflammation in your lungs, e.g., an “inhaled corticosteroid”, it is important that you continue to use it regularly, even if you feel better.

If after administering the medication your breathing or difficulty breathing starts to worsen, stop using it immediately and inform your doctor as soon as possible.

If you use more Ventolin 5 mg/ml Solution for Inhalation by Nebulizer 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 medicine and the amount used.

However, if the amount ingested is significant, go to the doctor immediately or to the emergency department of the nearest hospital. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you accidentally take a higher dose than recommended, you are more likely to experience side effects such as rapid heartbeat, headaches, tremors, or muscle cramps (see Possible side effects). You should inform your doctor as soon as possible if the dose you have taken is higher than recommended.

If you forget to use Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

Do not take a double dose to make up for forgotten doses. Simply inhale the next dose when it is due, or earlier if you start to feel breathing difficulties.

4. Possible side effects

Most people who take this medicine do not have any problems. Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some people may be allergic to medicines. If you experience any of the following symptoms immediately after using Ventolin, stop treatment and inform your doctor as soon as possible.

Symptoms to be aware of

The following adverse reactions are very rare (may affect up to 1 in 10,000 patients) but very serious. Contact your doctor immediatelyif you experience any of these symptoms. Stop using Ventolin.

Allergic reactions:are very rare in patients using Ventolin. They include the following signs:

• sudden onset of “wheezing” or chest tightness
• swelling of eyelids, face, or lips
• skin rash (hives) or urticaria anywhere on the body
• sudden feeling of weakness or dizziness (may lead to collapse or loss of consciousness)

Lactic acidosis: a very rare side effect of Ventolin administered by nebulization is an increase in the amount of lactic acid in the blood (lactic acidosis). This affects patients with severe kidney problems more often. The symptoms of lactic acidosis include:

• rapid breathing, difficulty breathing despite possible improvement in wheezing
• feeling cold
• stomach pain, nausea, and vomiting.

The following side effects are associated with salbutamol, classified by organ system, frequency, and system. The meaning of the terms used to describe the frequency of side effects is as follows:

• very common (may affect more than 1 in 10 patients),
• common (may affect up to 1 in 10 patients),
• uncommon (may affect up to 1 in 100 patients),
• rare (may affect up to 1 in 1,000 patients), and
• very rare (may affect up to 1 in 10,000 patients).

Immune system disorders

Very rare: hypersensitivity reactions (allergic reactions) including angioedema (skin reactions with erythema, edema, and itching), urticaria, bronchospasm (narrowing of the bronchial walls with decreased air intake), hypotension, and collapse.

Metabolic and nutritional disorders

Rare: hypokalemia (low potassium levels in the blood).

Therapy with β2 agonists may lead to potentially serious hypokalemia.

Very rare: lactic acidosis.

Very rare cases of lactic acidosis have been reported in patients receiving salbutamol intravenously or by nebulization for the treatment of acute asthma exacerbations.

Nervous system disorders

Common: tremor, headache.

Very rare: hyperactivity (agitation and excitability).

Cardiac disorders

Common: tachycardia (rapid heartbeat).

Uncommon: palpitations (irregular heartbeat).

Very rare: cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disorders).

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

Vascular disorders

Rare: peripheral vasodilation (dilation of peripheral blood vessels).

Respiratory, thoracic, and mediastinal disorders

Very rare: paradoxical bronchospasm (narrowing of the bronchial walls with decreased air intake).

Gastrointestinal disorders

Uncommon: irritation of the mouth and throat.

Musculoskeletal and connective tissue disorders

Uncommon: muscle cramps.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

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

Do not store above 25°C. Store in the outer packaging to protect from light.

Do not leave remaining solution in the nebulizer after you have finished treatment.

Once the bottle is opened, the product should not be used after one month.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ventolin 5 mg/ml Solution for Inhalation by Nebulizer

• The active ingredient is salbutamol (as salbutamol sulfate). The solution contains 5 mg of salbutamol per ml dissolved in water. Each container contains 10 ml.
• The other components are benzalkonium chloride, diluted sulfuric acid, and purified water.

Appearance of the Product and Container Content

Ventolin solution for inhalation by nebulizer is presented in the form of a clear, colorless to pale yellow solution, in 10 ml amber glass bottles, Type I, with a polypropylene screw cap and a low-density polyethylene insert.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Spain

Tel: +34 900 202 700

[email protected]

Manufacturer:

GLAXO WELLCOME, S.A. Avda. de Extremadura, 3 (Aranda de Duero (Burgos)) - 09400 – Spain

Date of the Last Revision of this Prospectus: April 2024

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/

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This information is intended only for doctors or healthcare professionals

VENTOLIN 5 mg/ml SOLUTION FOR INHALATION BY NEBULIZER MUST NOT BE INJECTED OR SWALLOWED.

MEASURE VENTOLIN 5 mg/ml SOLUTION FOR INHALATION BY NEBULIZER AND SALINE SOLUTION ONLY IN MILLILITERS. For the correct measurement of the amount indicated by the doctor, you can use a syringe or any other alternative system that allows you to measure in milliliters.

The dosage of Ventolin 5 mg/ml solution for inhalation by nebulizer depends on the way it is used:

1. Through intermittent administration:

Intermittent treatment can be repeated up to 4 times a day.

Adults

Dilute 0.5 ml to 1.0 ml of Ventolin 5 mg/ml solution for inhalation by nebulizer (2.5 mg to 5.0 mg of salbutamol) to a final volume of 2.0 ml to 2.5 ml using a normal sterile saline solution as a diluent. Inhale the resulting solution with the help of a nebulizer of a suitable respirator until aerosol generation is complete. Using a suitable nebulizer, it should take around 10 minutes.

Ventolin 5 mg/ml solution for inhalation by nebulizer can be used undiluted when used through intermittent administration. In this case, 2.0 ml of Ventolin 5 mg/ml solution for inhalation by nebulizer (10.0 mg of salbutamol) are placed in a nebulizer and the patient is allowed to inhale the nebulized solution until the necessary degree of bronchodilation is reached. This usually takes between 3 and 5 minutes.

Some patients may require higher doses of salbutamol, up to 10 mg, in which case it is recommended to continue inhaling the nebulization of the undiluted solution until aerosol generation is complete.

Children

Ventolin 5 mg/ml solution for inhalation by nebulizer can be administered in the same way as intermittent administration for adults. The usual dose in children under 12 years is 0.5 ml (2.5 mg of salbutamol) diluted to 2.0 ml or 2.5 ml using a normal sterile saline solution as a diluent. However, some children (over 18 months) may require higher doses of salbutamol up to 5.0 mg.

Intermittent treatment can be repeated up to 4 times a day.

In children over 12 years: use the same dose as in the adult population.

The clinical efficacy of Ventolin 5 mg/ml solution for inhalation by nebulizer in children under 18 months of age is uncertain. As cases of transient hypoxemia may occur, the possibility of administering supplemental oxygen therapy should be considered.

Other pharmaceutical forms may be more suitable for administration in children under 4 years.

1. Through continuous administration:

Ventolin 5 mg/ml solution for inhalation by nebulizer is diluted with a normal sterile saline solution so that a content of 50 to 100 micrograms of salbutamol per ml (1 or 2 ml of Ventolin 5 mg/ml solution for inhalation by nebulizer diluted to 100 ml with the diluent) is obtained.

The diluted solution is administered in the form of aerosol generated by the nebulizer of a suitable respirator. In this way, it is administered at a rate of 1-2 mg of salbutamol per hour.