Ventolin 0.5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ventolin 0.5 mg/ml injection solution

salbutamol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ventolin 0.5 mg/ml injection solution is and what it is used for

2. What you need to know before you use Ventolin 0.5 mg/ml injection solution

3. How to use Ventolin 0.5 mg/ml injection solution

4. Possible side effects

5. How to store Ventolin 0.5 mg/ml injection solution

6. Contents of the pack and other information

1. What Ventolin 0.5 mg/ml injectable solution 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 the air passages to open up and helps relieve chest tightness, shortness of breath, and cough, making it easier to breathe.

Ventolin is indicated for the relief of severe bronchospasm associated with asthma or bronchitis, and for the treatment of status asthmaticus.

Injectable Ventolin is indicated in adults and adolescents.

2. What you need to know before using Ventolin 0.5 mg/ml injection solution

Do not use Ventolin 0.5 mg/ml injection solution

• if you are allergic to salbutamol or to any of the other ingredients of this medicine (listed in section 6).
• Non-intravenous preparations of Ventolin must not be used 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 your condition due to allergy or another 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 have lactic acidosis (increased production of lactic acid)
• 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.

• Consult your doctor if you think you may have any of these conditions.

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

Symptoms to watch for

High doses of this medicine may very rarely cause a condition known as lactic acidosis. You should be aware of certain symptoms while taking this medicine to reduce the risk of any problems. See "Symptoms to watch for" in section 4.

Use of Ventolin 0.5 mg/ml injection solution with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines (e.g. treatments for fluid removal, 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 together with salbutamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 clinical condition.

Driving and use of machines

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

Important information about some of the components of Ventolin 0.5 mg/ml injectable solution

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule; that is, it is essentially "sodium-free".

Use in athletes

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

3. How to use Ventolin 0.5 mg/ml injectable solution

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

Ventolin injectable solution is normally administered by a doctor or healthcare professional. It may be given under the skin (subcutaneously), directly into a vein (intravenously), or into a muscle (intramuscularly).

The recommended dose administered subcutaneously or intramuscularly is 1 ampoule of 0.5 mg (500 micrograms).

The recommended intravenous dose is 0.25 mg (250 micrograms) injected very slowly.

Your doctor will advise you on the duration of your treatment with Ventolin. Do not stop the treatment early.

If you use more Ventolin 0.5 mg/ml injectable solution 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.

Both at high doses and in overdose, increased levels of lactic acid in the blood have been observed, which may cause difficulty in breathing and hyperventilation.

If you forget to use Ventolin 0.5 mg/ml injectable solution

Do not use a double dose to make up for forgotten doses.

4. Possible adverse effects

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

Symptoms to be aware of

The following adverse reactions are very rare (may affect fewer than 1 in 10,000 patients) but very serious. Contact your doctor immediately if you experience any of these symptoms. Stop using Ventolin.

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

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

Lactic acidosis: a very rare adverse effect of intravenously administered Ventolin is an increase in lactic acid levels in the blood (lactic acidosis). This occurs more frequently in patients with severe kidney problems. Symptoms of lactic acidosis include:

• rapid breathing, difficulty breathing
• feeling cold
• stomach pain, nausea, and vomiting.

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 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).

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

Immune system disorders

Very rare: hypersensitivity reactions including angioedema (skin reactions with erythema, edema, and itching), urticaria, bronchospasm (narrowing of the bronchial walls with reduced airflow), hypotension, and collapse.

Metabolism and nutrition disorders

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

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

Very rare: lactic acidosis.

Very rare cases of lactic acidosis have been reported in patients receiving salbutamol intravenously or by nebulization for the treatment of acute asthma exacerbations.

Nervous system disorders

Very common: tremor.

Common: headache.

Very rare: hyperactivity.

Cardiac disorders

Very common: tachycardia (increased heart rate), palpitations.

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

Uncommon: pulmonary edema (fluid accumulation in the lungs).

Gastrointestinal disorders

Very rare: nausea, vomiting.

Musculoskeletal and connective tissue disorders

Common: muscle cramps.

Injury, poisoning, and procedural complications

Very rare: mild pain or pricking sensation following intramuscular administration of undiluted injectable solution.

Reporting of adverse effects

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

5. Storage of Ventolin 0.5 mg/ml solution for injection

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

Store below 30°C.

Keep in the outer packaging to protect from light.

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 should not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ventolin 0.5 mg/ml injectable solution

• The active substance is salbutamol (as salbutamol sulfate). Each 1 ml ampoule contains 0.5 mg (500 micrograms) of salbutamol.

• The other components are sodium chloride, sulfuric acid or sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Ventolin injectable solution is a sterile normal saline solution. Each pack contains 5 or 6 ampoules of 1 ml.

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
[email protected]

Manufacturer:

GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90 - 43056 San Polo di Torrile (Parma), Italy

Date of the most recent revision of this summary: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Dosage

Adults

Subcutaneous and intramuscular route: the usual dose is 1 ampoule containing 0.5 mg (500 micrograms), equivalent to 8 micrograms/kg. The dose may be repeated every 4 hours, if necessary.

Intravenous route: the usual dose is 0.25 mg (250 micrograms), equivalent to 4 micrograms/kg, administered very slowly. The dose may be repeated if necessary.

Use in children

The safety and efficacy have not yet been established in children under 12 years of age.

In children aged 12 years and older: use the same dose as in adults.

Method of administration

Ventolin injectable solution may be diluted to facilitate administration. The only suitable diluents for this purpose are: water for injections, sodium chloride injection solution, glucose injection solution, or sodium chloride and glucose injection solution.

All unused mixtures of parenteral preparations of Ventolin 0.5 mg/ml solution for infusion must be discarded 24 hours after preparation.

Whenever possible, administration of oxygen together with injectable Ventolin is recommended, especially in hypoxic patients.

Do not mix with other medicines in the same syringe.

Instructions for opening the Ventolin injectable ampoule:

The ampoules are equipped with the "Single Point Cut" (SPC) opening system and should be opened according to the following instructions:

• Hold the lower part of the ampoule with one hand, as shown in Figure 1.
• Place the other hand on the upper part of the ampoule, positioning the thumb on the coloured dot and press, as shown in Figure 2.

Figure 1

Figure 2

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/