Leaflet: information for the patient

Ventolin 5 mg/ml solution for inhalation by nebulizer

salbutamol

Read this 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 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ventolin belongs to a group of medicines called rapid-acting bronchodilators. Rapid-acting bronchodilators relax the muscles of the walls of the small airways in the lungs within a few minutes. This facilitates the opening of the airways and helps to alleviate chest tightness, difficulty breathing, and cough, making it easier to breathe.

Ventolin is used in the treatment of severe bronchial spasm (airway closure in the lungs) associated with asthma attacks and other processes associated with reversible obstruction of the respiratory tract. These are a group of lung diseases that cause inflammation of the respiratory tract, resulting in a blockage of airflow in the lungs. It is usually administered to people who suffer from these situations to a great extent when other forms of treatment do not provide sufficient relief.

Ventolin solution for inhalation by nebulizer is indicated for adults, adolescents, and children aged 4 to 11 years.For babies and children under 4 years, consult your doctor.

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 that is not complicated or a threat of abortion.

Warnings and precautions

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

• you have had to stop using this or another medicine for treating this condition due to an allergy or any other problem
• you have high blood pressure
• you have hyperthyroidism (excess function of the thyroid gland)
• you have a history of heart problems such as rapid or irregular heart rhythm or angina (chest pain)
• you have low levels of potassium in your blood
• you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma
• you are taking diuretics, used sometimes to treat high blood pressure or heart problems
• you have diabetes
• you are using inhaled anticholinergic medicines (such as ipratropium bromide) in combination with salbutamol. Make sure the nebulization does not penetrate into your eyes.
• you have taken other medicines used for relieving nasal congestion (such as ephedrine or pseudoephedrine) or other medicines 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 watch out for

High doses of this medicine may occasionally cause a condition known as lactic acidosis. Be aware of the appearance of certain symptoms while taking this medicine to reduce the risk of any problems. See “Symptoms to watch out for” in section 4.

Other medicines and Ventolin 5 mg/ml solution for inhalation by nebulizer

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine (for example, treatments to remove fluids, any other type of bronchodilator tablets, steroids…), even those bought without a prescription.

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

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

Your doctor or pharmacist will decide whether to use Ventolin with these medicines.

Pregnancy and breastfeeding

Normally, Ventolin is not recommended for use during pregnancy.If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess the benefit of treating you with Ventolin 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 operating machinery

No studies have been conducted on the ability to drive and operate machinery.

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 coughing and breathing difficulties (bronchospasm), especially in patients with asthma.

Use in athletes

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

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

Remember to take your medication.

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

Instructions for use:

Important information

Ventolin solution for inhalation by nebulizershould only be used by inhalation using a nebulizer. Do not inject or swallow.

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). Use only normal sterile saline solution to dilute the solution.
4. Put the lid on the nebulizer container and gently shake to mix the contents.
5. Attach the nebulizer and use as indicated.
6. After use, discard any remaining solution in the nebulizer container. Clean the

nebulizer in the recommended manner.

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 prospectus.

Avoid letting Ventolin, or the mist produced by the nebulizer, come into contact with your eyes.

You should use the nebulizer in a well-ventilated room since part 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 told 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 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 should immediately inform your doctor, who may start administering a medication or increase 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 3hours), 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 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 medication to reduce inflammation in your lungs, e.g., an inhaled corticosteroid, it is essential to continue using it regularly, even if you feel better.

If after administering the medication your breathing or difficulty breathing worsens, 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 medication and the amount used.

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

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

If you forgot to use Ventolin 5 mg/ml solution for inhalation by nebulizer

Do not take a double dose to compensate for the missed doses. Simply inhale the next dose when due, or before if you start to feel short of breath.

Most people who take this medication do not have any problems. Like all medications, this medication can produce side effects, although not everyone will experience them.

Some people may be allergic to medications. 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 "pops" or chest tightness
• Swelling of eyelids, face, or lips
• Rash on the skin (hives) or urticaria in any part of the body
• Sudden feeling of weakness or dizziness (may lead to collapse or loss of consciousness)

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

• Accelerated breathing, difficulty breathing despite improvement in wheezing
• Sensation of cold
• Abdominal pain, nausea, and vomiting

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

• Very frequent(may affect more than 1 in 10 patients),
• Frequent(may affect up to 1 in 10 patients),
• Infrequent(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) including angioedema (skin reactions with erythema, edema, and pruritus), urticaria, bronchospasm (narrowing of the walls of the bronchi with decreased air entry), hypotension, and collapse.

Metabolism and nutrition disorders

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

Therapy with agonists?2beta may lead to potentially severe hypokalemia.

Very rare: lactic acidosis.

There have been reports of very rare cases of lactic acidosis in patients receiving salbutamol by intravenous or nebulization for the treatment of acute asthma exacerbations.

Nervous system disorders

Frequent: tremor, headache.

Very rare: hyperactivity (agitation and excitability).

Cardiac disorders

Frequent: tachycardia (rapid heart rate).

Infrequent: palpitations (irregular heart rate).

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 told to do so.

Vascular disorders

Rare: peripheral vasodilation (dilation of peripheral blood vessel size).

Respiratory, thoracic, and mediastinal disorders

Very rare: paradoxical bronchospasm (narrowing of the walls of the bronchi with decreased air entry).

Gastrointestinal disorders

Infrequent: mouth and throat irritation.

Musculoskeletal and connective tissue disorders

Infrequent: muscle cramps.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es Reporting side effects can help provide 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 25°C. Store in the outer packaging to protect it from light.

Do not leave any remaining solution in the nebulizer after completing treatment.

Once the bottle is opened, do not use the product after one month has passed.

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

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 contents of the container

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Spain

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

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

Last review date of this leaflet: April 2024

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

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This information is intended solely for doctors or healthcare professionals

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

MEASURE VENTOLIN 5 mg/ml SOLUTION FOR INHALATION BY NEBULIZER AND THE SALINE SOLUTION ONLY IN MILLILITERS. To measure 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 how it is used:

1. By 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 suitable nebulizer and respirator until the aerosol is finished. Using a suitable nebulizer, it should take around 10 minutes.

Ventolin 5 mg/ml solution for inhalation by nebulizer can be used without dilution when used by intermittent administration. In this case, 2.0 ml of Ventolin 5 mg/ml solution for inhalation by nebulizer (10.0 mg of salbutamol) is placed in a nebulizer and the patient inhales the nebulized solution until the necessary bronchodilation is reached. This usually takes between 3 and 5 minutes.

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

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 need higher doses of salbutamol up to 5.0 mg.

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

In children 12 years and older: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 is uncertain. As transient hypoxemia may occur, it is essential to consider the possibility of administering supplementary oxygen therapy.

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

1. By continuous administration:

Ventolin 5 mg/ml solution for inhalation by nebulizer is diluted with a normal sterile saline solution to obtain 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).

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