Ventolin 2 mg/5 ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ventolin 2 mg/5 ml syrup

salbutamol

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ventolin 2 mg/5 ml syrup is and what it is 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 adverse effects
5. How to store Ventolin 2 mg/5 ml syrup
6. Contents of the pack and other information

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

Ventolin belongs to a group of medicines called bronchodilators. It relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the air passages and relieves chest tightness, breathing difficulties, and coughing, making it easier to breathe.

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

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

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 to any of the other ingredients of this medicine (listed in section 6).
• to stop uncomplicated premature labour or threatened miscarriage.

Warnings and precautions

Talk to your doctor or pharmacist before using Ventolin if:

• you have previously had to stop using this or another medicine for treating this condition due to allergy or any other problem
• you have high blood pressure
• you have hyperthyroidism (overactivity of the thyroid gland)
• you have a history of heart problems such as fast or irregular heartbeat 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 for the treatment of asthma
• you are taking diuretics, 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.

Talk to your doctor if you think you may have any of these conditions.

Sometimes this medicine may not be suitable, and your doctor may want to switch you to a different treatment.

Other medicines and Ventolin 2 mg/5 ml syrup

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines (for example, treatments to remove fluid, other types of bronchodilator tablets, steroids, etc.), including those obtained without a prescription.

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

Pregnancy and breastfeeding

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.

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

Driving and using machines

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

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; that is, essentially “sodium-free”.

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

This medicine 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 of age).

This medicine 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 may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. 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 serious adverse effects including breathing problems ("gasping syndrome") in children.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Use in athletes

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

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

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long you should be treated with Ventolin. Do not stop treatment earlier.

If your doctor has diluted your Ventolin syrup, the resulting mixture must be protected from light and should be 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 daily.

Use in children and adolescents

Ages 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 daily.

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

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 daily.

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 medicines.

For children, elderly patients, and those who are particularly sensitive to this medicine, it is recommended to start treatment with 5 ml of Ventolin syrup (2 mg) three or four times daily.

IT IS VERY IMPORTANT that you follow exactly the instructions for use of the medicine contained in this leaflet or as indicated by your doctor regarding the amount you should take and how often. DO NOT TAKE MORE than you have been told. If in doubt, ask your doctor.

If you think that the effect of Ventolin is too strong or too weak, inform your doctor or pharmacist AS SOON AS POSSIBLE. Your asthma may begin to worsen and you may need different medication.

If you take more Ventolin 2 mg/5 ml syrup than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

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

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

Both at high doses and in cases of overdose, increased levels of lactic acid in the blood have been observed, which may 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 missed doses. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, wait and take the next dose at the scheduled time.

4. Possible adverse effects

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

Symptoms to watch for

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

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

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

The adverse effects associated with salbutamol, listed below, are classified by organ system and frequency.

The meaning of the terms used to describe the frequency of adverse effects is as follows:

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

Inform your doctor if you experience 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 bronchial walls leading to reduced airflow), hypotension, and collapse.

Metabolism and nutrition disorders

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

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

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 (irregular heart rhythms).

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 instructed to do so.

Vascular disorders

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

Musculoskeletal and connective tissue disorders

Common: muscle cramps.
Very rare: sensation of muscle tension.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ventolin 2 mg/5 ml syrup

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

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ventolin 2 mg/5 ml syrup

• The active substance 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 (containing benzyl alcohol, propylene glycol, isopropyl alcohol and orange bark extract), sodium chloride and purified water.

Appearance of the product and contents of the container

Ventolin syrup is a colourless to slightly straw-coloured, transparent, viscous liquid with an orange odour. 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 most recent revision of this leaflet: January 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/