Leaflet: information for the patient

Ventolin 2 mg/5 ml syrup

salbutamol

Read this leaflet carefully before you start taking 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 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.

Ventolin belongs to a group of medicines called bronchodilators. It relaxes the muscles of the walls of the small airways in the lungs. This makes it easier for the airways to open and helps to relieve chest tightness, difficulty breathing, and cough, making it easier to breathe.

Ventolin is indicated for the prevention and treatment of bronchial spasm (closure of airways 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.

Ventolin syrup is indicated for adults, adolescents, and children aged 2 to 12 years.

Do not take Ventolin 2 mg/5 ml syrup

- if you are allergic to salbutamol or to 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 this condition due to an allergy or any other problem.
• You have high blood pressure problems.
• 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 have diabetes mellitus (Ventolin may increase blood sugar levels).
• 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.

Sometimes this medicine may not be suitable and your doctor may want to change it for another one.

Other medicines and Ventolin 2 mg/5 ml syrup

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

Also, inform your doctor if you are being treated with non-selective β-blockers (used mainly to treat heart rhythm disorders), such as propranolol, as these should not be administered normally with salbutamol.

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 medicine.

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 machines

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

Ventolin 2 mg/5 ml syrup contains sodium, propylene glycol, sodium benzoate, and benzyl alcohol

This medicine contains less than 23 mg of sodium (1 mmol) per 5 ml of syrup; it is essentially "sodium-free".

This medicine contains 1.9 mg of propylene glycol per 5 ml of syrup.

This medicine contains 10 mg of sodium benzoate per 5 ml of syrup.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medicine contains less than 1 mg of benzyl alcohol per 5 ml of syrup.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("choking syndrome") in children.

This medicine should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist advises you to do so.

Use in athletes

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

Follow exactly the administration instructions for 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.

If your doctor has diluted your Ventolin syrup, the resulting mixture must be protected from light and must be used within 28 days.

Adults

The recommended dose is 5 ml (half teaspoon) to 10 ml (one teaspoon) (2 to 4 mg) administered 3 or 4 times a day.

Use in children and adolescents

Two to six years:The recommended dose is 2.5 ml (half teaspoon) to 5 ml (half teaspoon) (1 to 2 mg) 3 or 4 times a day.

Six to twelve years:The recommended dose is 5 ml (half teaspoon) (2 mg) 3 or 4 times a day.

Over twelve years:The recommended dose is 5 ml (half teaspoon) to 10 ml (one teaspoon) (2 to 4 mg) administered 3 or 4 times a day.

Your doctor may have prescribed a higher dose than the one recommended above.

Ventolin syrup is suitable for adults and children who prefer to take liquid medications.

For children, elderly people, and those with marked sensitivity to this medication, it is recommended to start treatment with 5 ml of Ventolin syrup (2 mg) three or four times a day.

IT IS VERY IMPORTANT that you follow exactly the administration instructions for the medication contained in this leaflet or indicated by your doctor as to the amount you should take and how often. DO NOT TAKE more than what you have been told. In case of doubt, ask your doctor.

If you estimate that the action of Ventolin is too strong or too weak, inform your doctor or pharmacist AS SOON AS POSSIBLE. Your asthma may start to worsen and you may need another type of medication.

If you take more Ventolin 2 mg/5 ml syrup 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.

However, if the amount ingested is significant, you should go to the doctor immediately or to the emergency service of the nearest hospital. It is recommended to bring the packaging and the leaflet 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.

In cases of overdose with salbutamol administered orally, nausea, vomiting, and hyperglycemia have been reported, especially in children.

Both at high doses and in overdose, an increase in blood lactate levels has been identified, which can cause difficulty breathing and hyperventilation.

If you forgot to take Ventolin 2 mg/5 ml syrup

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, take another as soon as you remember, but if it is close to the time for your next dose, wait until then.

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

Symptoms to be aware of

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

• Sudden onset of "pings" 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 (which 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),

• Rare(may affect up to 1 in 100 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 redness, swelling, and itching), urticaria, bronchospasm (narrowing of the bronchial walls with reduced airflow), hypotension, and collapse.

Metabolism and nutrition disorders

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

The therapy with agonists?2, such as salbutamol, may lead to potentially severe hypokalemia.

Nervous system disorders

Very frequent: tremor.

Frequent: headache.

Very rare: hyperactivity.

Cardiac disorders

Frequent: tachycardia (increased heart rate), palpitations.

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

Although the exact frequency is not known, 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 vessels).

Musculoskeletal and connective tissue disorders

Frequent: muscle cramps.

Very rare: feeling of muscle tension.

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 Vigilance of Medicinal Products 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 above30°C. Store in the outer packaging to protect it from light.

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 of 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 2 mg/5 ml syrup

-The active ingredient is salbutamol (as salbutamol sulfate). Each 5 ml of syrup contains 2 mg of salbutamol.

-The other components are sodium citrate dihydrate, citric acid monohydrate, hypromellose, sodium benzoate (E211), sodium saccharin, orange flavor IFF 17.42.8187 (contains benzyl alcohol, propylene glycol, isopropyl alcohol, and orange peel extract), sodium chloride, and purified water.

Appearance of the product and contents of the packaging

Ventolin syrupis presented in the form of a viscous, transparent, colorless to slightly yellowish liquid with an orange odor.Each bottle contains 150 ml.

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)

Tel: 900 202 700

[email protected]

Responsible for manufacturing

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe (Germany)

Date of the last review of this leaflet:January 2022

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