Package Insert: Information for the Patient

Ventolin 0.5 mg/ml Injectable Solution

salbutamol

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Ventolin belongs to a group of medicines 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 alleviate chest tightness, difficulty breathing, and cough, so that breathing can be done more easily.

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

Ventolin injectable is indicated for adults and adolescents.

Do not use Ventolin 0.5 mg/ml injectable solution

• if you are allergic to salbutamol or any of the other components of this medication (listed in section 6).
• Non-intravenous preparations of Ventolin cannot be used to stop uncomplicated 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 this condition due to an allergy or 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 have lactic acidosis (increased production of lactic acid)
• 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 doctor if you think you may have any of these problems.

This medication may not be suitable for you and your doctor may want to change it for another one.

Be aware of the following symptoms

High doses of this medication may occasionally cause a rare condition known as lactic acidosis. Be aware of the appearance of certain symptoms while taking this medication to reduce the risk of any problems. See “Be aware of the following symptoms” in section 4.

Using Ventolin 0.5 mg/ml injectable solution with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication (for example, treatments to remove fluids, other types of bronchodilator tablets, steroids…), even those purchased 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 normally be administered 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 evaluate the potential benefits and risks based on the severity of the clinical condition.

Driving and operating machinery

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

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

This medication contains less than 23 mg (1 mmol) of sodium per ampoule; this is, essentially “sodium-free”.

Use in athletes

This medication 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. If in doubt, consult your doctor or pharmacist again.

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

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

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

Your doctor will indicate the duration of your treatment with Ventolin. Do not discontinue treatment prematurely.

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

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 use Ventolin 0.5 mg/ml injectable solution

Do not use a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side 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 immediatelyif you experience any of these symptoms.Stop using Ventolin.

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

• Sudden onset of "pops" or chest tightness
• Swelling of eyelids, face, or lips
• Rash (hives) or urticaria in any part of the body
• Sudden feeling of weakness or dizziness (may lead to collapse or loss of consciousness).

Lactic acidosis: a very rare adverse effect of Ventolin administered intravenously is an increase in the amount of lactic acid in the blood (lactic acidosis). This affects more often patients with severe kidney problems. The symptoms of lactic acidosis include:

• Accelerated breathing, difficulty breathing
• Sensation of cold
• Abdominal pain, nausea, and vomiting.

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

The meaning of the terms used to describe the frequency of adverse 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 1,000 patients), andVery rare adverse effects(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 pruritus), urticaria, bronchospasm (narrowing of the bronchial walls with decreased air entry), hypotension, and collapse.

Metabolism and nutrition disorders

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

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

Very rare: lactic acidosis.

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

Nervous system disorders

Very frequent: tremor.

Frequent: headache.

Very rare: hyperactivity.

Cardiac disorders

Very 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).

Respiratory, thoracic, and mediastinal disorders

Rare:pulmonary edema (accumulation of fluid in the lungs).

Gastrointestinal disorders

Very rare:nausea, vomiting.

Musculoskeletal and connective tissue disorders

Frequent:muscle cramps.

Accidents, poisoning, and complications of therapeutic procedures

Very rare:mild pain or stinging sensation in the case of intramuscular administration of the 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse 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.

Store below 30°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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofVentolin 0.5 mg/ml injectable solution

• The active ingredient is salbutamol (as salbutamol sulfate). Each ampoule of 1 ml 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 injection.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90 -43056 San Polo di Torrile (Parma) Italy

Date of the last review of this leaflet: October 2024

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

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This information is intended solely for doctors or healthcare professionals

Dosage

Adults

Subcutaneous and intramuscular route: the usual dose is 1 ampoule with 0.5 mg (500 micrograms) at a rate of 8 micrograms/kg. The dose can be repeated every 4 hours if necessary.

Intravenous route: the usual dose is 0.25 mg (250 micrograms) at a rate of 4 micrograms/kg injected very slowly. If necessary, the dose can be repeated.

Use in children

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

In children 12 years and older: use the same dose as in the adult population.

Administration form

Ventolin injectable can be diluted to facilitate administration. For this, the only suitable solvents are: water for injection, injectable solution of sodium chloride, injectable solution of glucose or injectable solution of sodium chloride and glucose.

All unused preparations of Ventolin 0.5 mg/ml injectable solution for fluid perfusion must be discarded 24 hours after preparation.

When possible, it is recommended to administer oxygen together with Ventolin injectable, mainly in hypoxic patients.

Do not mix in the same syringe with other medications.

Instructions for opening the Ventolin injectable ampoule:

The ampoules have the "One Point of Cut" (UPC) opening system and must be opened following the instructions below:

• Hold with one hand the lower part of the ampoule, as indicated in Figure 1.
• Place the other hand on the upper part of the ampoule, positioning the thumb above the colored point and press, as indicated in Figure 2.

Figure 1

Figure 2

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