Package Insert: Information for the Patient

Ventolin 100 micrograms/inhalation suspension for inhalation in a pressurized container

salbutamol

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 package insert. See section 4.

Ventolin 100 micrograms/inhalation suspension for inhalation in a pressurized container, is indicated in adults, adolescents and children aged 4 to 11 years (for children under 4 years see section 3), in the following cases:

• Rescue medication for mild, moderate or severe asthma.
• Prevention of bronchospasm (difficulty breathing or wheezing) induced by physical exercise or before exposure to a known unavoidable allergenic stimulus.

Do not use Ventolin

• if you are allergic to salbutamol or any of the other ingredients of this medication (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 medication for this condition due to allergy or any other problem
• you have high blood pressure
• you have hyperthyroidism (increased activity 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.

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.

If the use of this medication does not provide relief for at least three hours, consult your doctor. Sometimes this medication may not be suitable and your doctor may want to change it for another one.

Other medications and Ventolin

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of Ventolin or make it more likely that you will have adverse effects. Among these medications are:

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

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

Pregnancy and breastfeeding

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 medication.

If Ventolin needs to be administered during pregnancy or breastfeeding, your doctor will carefully evaluate the potential benefits and risks based on the severity of the clinical condition.

Driving and operating machinery

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

Important information about some of the components of Ventolin

Some patients may notice some sensation or different taste with respect to the Ventolin inhaler formulation they previously used, due to the fact that the propellant has been replaced with a new one that does not contribute to the depletion of the ozone layer.

Use in athletes

This medication 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 use your medication.

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

This medicationproduces a fine mist that must be inhaled into the lungs. Make sure you know how to use the inhaler correctly. If you have any problems, ask your doctor or pharmacist.

The recommended dose forrelieving an acute attackis:

Adults:one application (100 micrograms) or two applications (200 micrograms).

Children 12 years and older:one application (100 micrograms) or two applications (200 micrograms).

Children under 12 years:one application (100 micrograms). Your doctor may increase it to two applications (200 micrograms).

The use of Ventolin on demand should not exceed four times a day. The need for additional use or a sudden increase in dose indicates a worsening of asthma disease.

The recommended dose forpreventing an attack during exerciseis:

Adults:one application (100 micrograms) or two applications (200 micrograms) before exercise.

Children 12 years and older:one application (100 micrograms) or two applications (200 micrograms) before exercise.

Children under 12 years:one application (100 micrograms) before exercise. Your doctor mayincrease it to two applications (200 micrograms) before exercise.

The recommended dose forcontinuous useis:

Adults, children 12 years and older, and children under 12 years:up to two applications (200 micrograms) four times a day.

Generally, the maximum dose taken in 24 hours is 8 applications (800 micrograms).

Do not inhale more applications or use your inhaler more frequently than your doctor indicates.

Your doctor may indicate that you inhale more applications as emergency treatment if your "wheezes" or breathing worsen. It is essential to follow your doctor's instructions regarding the number of applications and frequency.

Some people may find difficulty in releasing a dose just before inhaling. Chamber inhalers help solve this problem. Your doctor or pharmacist will advise you.

Babies and small children may benefit from using Ventolin with a pediatric patient inhalation chamber with a mask (such asBabyhaler).Your doctor or pharmacist will advise you.

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

Ventolin should be used on demand and not regularly.

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 ability), you must inform your doctor immediately, 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 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.

If you estimate that the action of Ventolin is too strong or weak, inform your doctor or pharmacist.

Read these instructions carefully before using your medication.

Instructions for use:

Ventolin produces a fine mist that is inhaled through the mouth into the lungs. Your doctor or pharmacist must indicate how to use the inhaler device. In case of doubt, consult your doctor or pharmacist.

Checking the inhaler:

Before using the inhaler for the first time, remove the cap from the mouthpiece by pressing it gently on both sides, shake the inhaler thoroughly, and release two doses into the air to ensure the inhaler is functioning properly. If the inhaler has not been used for 5 or more days, shake it thoroughly and release two doses into the air to ensure it is working.

Using the inhaler:

1. Remove the cap from the mouthpiece by pressing it gently on both sides.

1. Check that there are no foreign particles inside and outside the inhaler, including the mouthpiece.
2. Shake the inhaler well to ensure that any foreign particles are eliminated and the contents of the inhaler are mixed properly.

1. Hold the inhaler vertically between your index and middle fingers, placing your thumb on the base, below the mouthpiece. Breathe out as much as reasonably possible.

1. Insert the mouthpiece into your mouth, between your teeth, closing your lips over the device, but not biting it.

1. Immediately after starting to breathe in, press the inhaler to release the salbutamol, and continue breathing in deeply and constantly.

1. Hold your breath, remove the inhaler from your mouth, and release your index finger from the top of the inhaler. Continue holding your breath as long as reasonably possible.

1. If you are to administer another inhalation, hold the inhaler vertically and wait for approximately half a minute before repeating steps 3 to 7.
2. Replace the cap on the mouthpiece by pressing it firmly and closing it with a snap to secure it in place.

Important

Do not perform steps 5, 6, and 7 quickly. It is essential to start breathing slowly as possible, just before pressing the inhaler. Practice in front of a mirror the first few times. If you see a "mist" coming out of the top of the inhaler or from the sides of your mouth, start again from step 2.

Patients who find difficulty in coordinating the use of the inhaler with inhalation may use an appropriate inhalation chamber, such asVolumatic(adults and children over 5 years) orBabyhaler(children 1 to 5 years).

If your doctor gives you different instructions, follow them carefully. Consult your doctor or pharmacist if you have difficulties.

Children:

Small children may need help, with an adult handling the inhaler for them. Encourage the child to breathe out and press the inhaler just after the child starts breathing in. Practice together the technique.

Older children or people with fragile hands should hold the inhaler with both hands; for this, they will place their two index fingers on the top of the inhaler and their two thumbs on the base, below the mouthpiece.

Cleaning the inhaler

Clean the inhaler at least once a week.

1.Remove the metal cartridge from the plastic casing of the inhaler and remove the cap from the mouthpiece.

2.Wash the plastic casing with warm water.

3.Allow the plastic casing to dry thoroughly inside and out in a warm place, avoiding excessive heat.

4.Replace the metal cartridge and the cap on the mouthpiece.

You can add a mild detergent or a solution of the type used to clean baby bottles to the water. Rinse thoroughly with clean water before drying.

Do not immerse the metal cartridge in water.

If you use more Ventolin 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.

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). Inform your doctor as soon as possible if the dose you have taken is higher than recommended.

If you forgot to use Ventolin

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 difficulty breathing. Your doctor will have indicated that you use your inhaler regularly every day or only when your breathing worsens.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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:

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).

Contact your doctor immediatelyif you experience any of these symptoms.Stop using Ventolin.

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.

Very rare: may affect up to 1 in 10,000 patients.

Inform your doctor if you have any of the following symptoms:

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).

Salbutamol therapy may lead to potentially severe hypokalemia.

Nervous system disorders

Frequent: tremor, headache.

Very rare: hyperactivity (agitation and excitability).

Cardiac disorders

Frequent: tachycardia (increased heart rate).

Infrequent: palpitations (irregular heart rhythm).

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, 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 above 86°F (30°C). Do not freeze. Store in the outer packaging to protect it from direct sunlight.

Place the mouthpiece protector firmly and snap it into place.

If the inhaler is very 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.

The cartridge contains a pressurized liquid.Do not expose to temperatures above 122°F (50°C).Do not pierce, break, or burn the cartridge even if it is empty.

Do not use this medication after the expiration date that appears 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ventolin 100 micrograms/inhalation suspension for inhalation in pressurized container

• The active ingredient is 100 micrograms ofsalbutamol (as salbutamol sulfate) per dose.
• The other components are norflurane (HFA134a).

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 18 g of HFC-134a (also known as norflurane or HFA 134a) corresponding to 0.0257 tons of CO2equivalent (global warming potential PCG = 1,430).

Appearance of the product and contents of the packaging

Each package contains an inhaler that provides 200 doses.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturer:

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

09400 – Aranda de Duero (Burgos)

O

Glaxo Wellcome Production

Zone Industrielle nº 2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France.

Tel: + 33 2 3223 5500

Fax: +33 2 3223 5558

Last review date of this leaflet:01/2025

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