VENTOLIN 2 mg/5 ml SYRUP

Introduction

Leaflet: information for the patient

Ventolin 2 mg/5 ml syrup

salbutamol

Read the entire leaflet carefully before starting to take this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Ventolin 2 mg/5 ml syrup and what is it used for
2. What you need to know before taking Ventolin 2 mg/5 ml syrup
3. How to take Ventolin 2 mg/5 ml syrup
4. Possible side effects
5. Storage of Ventolin 2 mg/5 ml syrup
6. Package contents and additional information

1. What is Ventolin 2 mg/5 ml syrup and what is it used for

Ventolin belongs to a group of medications called bronchodilators. It relaxes the muscles of the walls of the small airways in the lungs. This facilitates the opening of the airways and helps to relieve chest tightness, difficulty breathing, and coughing, so that you can breathe more easily.

Ventolin is indicated for the prevention and treatment of bronchospasm (closure of airways in the lungs) associated with asthma attacks and other processes associated with reversible obstruction of the airways. These are a group of lung diseases that cause inflammation of the airways, resulting in a blockage of airflow in the lungs.

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

2. What you need to know before taking Ventolin 2 mg/5 ml syrup

Do not take Ventolin 2 mg/5 ml syrup

• if you are allergic to salbutamol or any of the other components of this medication (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 another medication for the treatment of this disease due to an allergy or 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 heartbeat or angina (chest pain)
• you have low potassium levels 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, which are sometimes used 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 medication may not be suitable, and your doctor may want to change it to a different one.

Other medications and Ventolin 2 mg/5 ml syrup

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication (e.g., treatments to eliminate fluids, any other type of bronchodilator tablets, steroids...), including those purchased without a prescription.

Also, inform your doctor if you are being treated with non-selective β-blockers (used mainly for the treatment of 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

If it is necessary to administer Ventolin during pregnancy or breastfeeding, your doctor will carefully weigh the benefits and potential risks based on the severity of the clinical condition.

Driving and using machines

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

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

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

This medication contains 1.9 mg of propylene glycol in each 5 ml of syrup.

This medication contains 10 mg of sodium benzoate in each 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 medication contains less than 1 mg of benzyl alcohol in each 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 can accumulate in your body and cause side effects (metabolic acidosis).

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

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

This medication should not be used for more than one week in children under 3 years old unless directed by your doctor or pharmacist.

Use in athletes

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

3. How to take Ventolin 2 mg/5 ml syrup

Follow the administration instructions for this medication exactly as indicated by your doctor. If in 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 stop treatment before.

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

Adults

The recommended dose is 5 ml (half a tablespoon) to 10 ml (one tablespoon) (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 a teaspoon) to 5 ml (half a tablespoon) (1 to 2 mg) 3 or 4 times a day.

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

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

Your doctor may have prescribed a higher dose than 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 the administration instructions for this medication exactly as contained in this leaflet or as indicated by your doctor regarding the amount you should take and how often. DO NOT TAKE more than indicated. If in doubt, ask your doctor.

If you think the effect of Ventolin is too strong or too weak, tell 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 Toxicology 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 department of the nearest hospital. It is recommended to bring the packaging and leaflet of the medication 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.

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 forget to take Ventolin 2 mg/5 ml syrup

Do not take a double dose to make up for forgotten 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Symptoms to be aware of

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

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

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

The following are side effects associated with salbutamol, classified by organ, system, and frequency.

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).

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

Disorders of the immune system

Very rare: hypersensitivity reactions (allergic) including angioedema (skin reactions with redness, swelling, and itching), urticaria, bronchospasm (narrowing of the bronchi with decreased air intake), hypotension, and collapse.

Metabolic and nutritional disorders

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

Therapy with β2 agonists, such as salbutamol, may lead to potentially serious hypokalemia.

Nervous system disorders

Very common: tremor.

Common: headache.

Very rare: hyperactivity.

Cardiac disorders

Common: 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). Tell 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

Common: muscle cramps.

Very rare: muscle tension sensation.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ventolin 2 mg/5 ml syrup

Keep this medication out of sight and reach of children.

Do not store above 30°C. Keep in the outer packaging to protect from light.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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 package contents

Ventolin syrup is a viscous, transparent, colorless to slightly amber liquid with an orange odor. Each bottle contains 150 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: 900 202 700

[email protected]

Manufacturer

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe (Germany)

Date of the last revision of this leaflet:January 2022

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/