Ventolin 100 micrograms/inhalation suspension for inhalation in pressurized container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ventolin 100 micrograms/inhalation suspension for inhalation, pressurised container
salbutamol
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Ventolin is and what it is used for
- What you need to know before using Ventolin
- How to use Ventolin
- Possible adverse effects
- How to store Ventolin
- Contents of the pack and other information
1. What Ventolin is and what it is used for
Ventolin 100 micrograms/inhalation suspension for inhalation under pressure 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 prior to exposure to a known and unavoidable allergenic stimulus.
2. What you need to know before using Ventolin
Do not use Ventolin
- 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 threat of abortion.
Warnings and precautions
Consult 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 another problem
- you have high blood pressure
- you have hyperthyroidism (increased activity 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 are taking xanthine derivatives (such as theophylline) or steroids to treat 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 medicine.
Your inhaler contains enough medicine for only 200 doses (either inhaled and/or released into the air as a test spray) and contains a propellant gas to deliver the medicine. However, after 200 doses, your inhaler may still release gas, but without the correct dose of salbutamol, so you cannot be assured of receiving the medicine after 200 doses. The inhaler does not have a dose counter. Methods to determine whether the inhaler is empty, such as shaking it, weighing it, or submerging the inhaler in water, are not accurate and are not recommended. Cases of severe worsening of asthma symptoms have been reported due to accidental use of empty inhalers. You may consider keeping a record of the number of doses used. It is recommended to have a spare inhaler available. If you are using more than one inhaler, it is recommended to keep a separate record of the number of doses for each inhaler.
Other medicines and Ventolin
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Some medicines may affect how Ventolin works or make it more likely that you will experience side effects. These include:
- Non-selective β-blockers such as propranolol, used to treat high blood pressure or heart problems.
- Monoamine oxidase inhibitors (MAOIs), used to treat depression.
Your doctor or pharmacist will decide whether you should use Ventolin with these medicines.
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 have been conducted on the ability to drive or operate machinery.
Important information about some of the ingredients of Ventolin
Some patients may notice a different taste or sensation compared to the previous formulation of the Ventolin inhaler, because the propellant has been replaced with a new one that does not contribute to ozone layer depletion.
Use in athletes
This medicine contains salbutamol, which may result in a positive doping test.
3. How to use Ventolin
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine.
Your doctor will tell you how long your treatment with Ventolin should last. Do not stop the treatment prematurely.
This medicine produces 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.
If your inhaler does not provide rapid relief lasting at least 3 hours after administration, seek medical advice immediately.
Inform your doctor if your asthma worsens or if this medicine no longer provides you with the same relief from your asthma symptoms as before.
The recommended starting dose to relieve symptoms or acute asthma attacks is:
Adults: one puff (100 micrograms) or two puffs (200 micrograms), once daily.
Children aged 12 years and older: one puff (100 micrograms) or two puffs (200 micrograms), once daily.
Children under 12 years: one puff (100 micrograms) once daily. Your doctor may increase this to two puffs (200 micrograms) once daily.
The as-needed use of Ventolin should not exceed four times per day. The need for additional use or a sudden increase in dose indicates worsening of asthma.
The recommended starting dose to prevent symptoms or asthma attacks triggered by allergens or exercise is:
Adults: two puffs (200 micrograms) 10 to 15 minutes before exercise or exposure to an allergen.
Children aged 12 years and older: two puffs (200 micrograms) 10 to 15 minutes before exercise or exposure to an allergen.
Children under 12 years: one puff (100 micrograms) 10 to 15 minutes before exercise or exposure to an allergen. Your doctor may increase this to two puffs (200 micrograms) before exercise or allergen exposure.
The recommended starting dose for regular use (in addition to your usual anti-inflammatory asthma medication, such as inhaled corticosteroids) is:
Adults, children aged 12 years and older, and children under 12 years: one puff (100 micrograms) or two puffs (200 micrograms), once daily.
The maximum dose is 800 micrograms (two puffs up to four times within a 24-hour period).
Do not inhale more puffs or use your inhaler more frequently than instructed by your doctor.
Your doctor may instruct you to inhale additional puffs as emergency treatment if your "wheezing" or breathing worsens. It is important that you follow your doctor's instructions regarding the number of puffs and their frequency.
Some people may find it difficult to release a puff just before inhaling. Spacer devices can help overcome this problem. Your doctor or pharmacist will advise you.
Infants and young children may benefit from using Ventolin with a pediatric spacer device equipped with a mask (such as a Babyhaler). Your doctor or pharmacist will advise you.
If your breathing or difficulty breathing begins to worsen immediately after taking the medicine, stop using it immediately and inform your doctor as soon as possible.
Ventolin should be used on an as-needed basis and not regularly.
If your asthma is active (for example, you have frequent symptoms or attacks such as difficulty breathing that interferes with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or limited physical capacity), inform your doctor immediately. Your doctor may start you on additional medication or increase your treatment dose, such as an inhaled corticosteroid, to control your asthma.
Inform your doctor as soon as possible if your medicine appears not to be working as well as usual (for example, if you need higher doses to relieve breathing problems or if your inhaler does not provide relief for at least 3 hours), as your asthma may be worsening and you may require different medication.
If you use Ventolin more than twice 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 can lead to serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.
If you are taking daily medication for lung inflammation, e.g., an "inhaled corticosteroid," it is important that you continue to use it regularly, even if you feel better.
If you feel that the effect of Ventolin is too strong or too 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 should show you how to use the inhaler device. If in doubt, consult your doctor or pharmacist.
Checking the inhaler:
Before using the inhaler for the first time, remove the mouthpiece cap by gently pressing the sides, shake the inhaler well, and release two doses into the air to ensure the inhaler is working properly. If the inhaler has not been used for 5 or more days, shake it well and release two doses into the air to ensure it is functioning.
Using the inhaler:
- Remove the mouthpiece cap by gently pressing the sides.
- Check that there are no foreign particles inside or outside the inhaler, including the mouthpiece.
- Shake the inhaler well to ensure any foreign particles are removed and the contents are properly mixed.
- Hold the inhaler vertically between your index finger and thumb, placing your thumb on the base below the mouthpiece. Breathe out as fully as reasonably possible.
- Then place the mouthpiece in your mouth, between your teeth, sealing your lips around it without biting it.
- Immediately after starting to inhale through your mouth, press down on the inhaler to release the salbutamol, and continue inhaling deeply and steadily.
- Hold your breath, remove the inhaler from your mouth, and remove your index finger from the top of the inhaler. Continue holding your breath as long as reasonably possible.
- If a second inhalation is needed, keep the inhaler upright and wait about half a minute before repeating steps 4 to 7.
- Replace the mouthpiece cap by firmly pushing and snapping it closed so the cover is securely in place.
Important
Do not perform steps 5, 6, and 7 too quickly. It is important to begin inhaling as slowly as possible, just before pressing the inhaler. Practice in front of a mirror the first few times. If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth, start again from step 2.
Patients who have difficulty coordinating the use of the inhaler with inhalation may benefit from using an appropriate spacer device: Volumatic (for adults and children over 5 years) or Babyhaler (for children aged 1 to 5 years).
If your doctor gives different instructions, follow them carefully. Consult your doctor or pharmacist if you experience any difficulties.
Children:
Young children may need help, with an adult operating the inhaler for them. Encourage the child to breathe out and activate the inhaler just after the child begins to inhale. Practice the technique together.
Older children or people with weak hands should hold the inhaler with both hands: place both index fingers on top of the inhaler and both thumbs on the base below the mouthpiece.
Cleaning the inhaler
Clean the inhaler at least once a week.
- Remove the metal cartridge from the plastic casing of the inhaler and take off the mouthpiece cap.
- Rinse the plastic casing with lukewarm water.
- Allow the plastic casing to dry thoroughly inside and out in a warm place, avoiding excessive heat.
- Reinsert the metal cartridge and replace the mouthpiece cap.
A mild detergent or a solution of the type used for cleaning baby bottles may be added 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you accidentally take more than the recommended dose, you are more likely to experience adverse effects such as increased heart rate, headache, tremors, or muscle cramps (see Possible adverse effects). Inform your doctor as soon as possible if you have taken more than the recommended dose.
If you forget to use Ventolin
Do not take a double dose to make up for a missed dose. Simply inhale the next dose at the usual time, or earlier if you start to feel short of breath. Your doctor will have advised you whether to use your inhaler regularly every day or only when your breathing worsens.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse 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 contact your doctor as soon as possible.
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 (hives) or urticaria anywhere on the body
- sudden feeling of weakness or dizziness (which 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, classified by organ system and frequency, are listed below. 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.
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 erythema, edema and itching), urticaria, bronchospasm (narrowing of bronchial walls with reduced airflow), hypotension and collapse.
Metabolism and nutrition disorders
Rare: hypokalaemia (low potassium levels in the blood).
Beta-2 agonist therapy may lead to potentially serious hypokalaemia.
Nervous system disorders
Common: tremor, headache.
Very rare: hyperactivity (agitation and excitability).
Cardiac disorders
Common: tachycardia (increased heart rate).
Uncommon: palpitations (irregular heartbeat).
Very rare: cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystoles (abnormal 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 peripheral blood vessels).
Respiratory, thoracic and mediastinal disorders
Very rare: paradoxical bronchospasm (narrowing of the bronchial walls with reduced airflow).
Gastrointestinal disorders
Uncommon: irritation of mouth and throat.
Musculoskeletal and connective tissue disorders
Uncommon: muscle cramps.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not freeze. Store in the outer packaging to protect from direct sunlight.
Replace the mouthpiece cap firmly and secure it in place.
If the inhaler is very cold, remove the cartridge and warm it in your hand for a few minutes before use. Do not use any other method to warm it.
The cartridge contains a pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce, break, or burn the cartridge, even if it is empty.
Do not use this medicine after the expiry date stated on the packaging 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. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ventolin 100 micrograms/inhalation suspension for inhalation in pressurised container
- The active substance is 100 micrograms of salbutamol (as salbutamol sulfate) per dose.
- The other component is norflurane (HFA134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 18 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0257 tonnes of CO2 (global warming potential GWP = 1,430).
Appearance of the product and contents of the pack
Each pack contains one inhaler delivering 200 doses.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
Manufacturer:
Glaxo Wellcome, S.A.
Avda. de Extremadura, 3
09400 – Aranda de Duero (Burgos)
Or
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
Date of latest revision of this leaflet: 10/2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/