Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you use your medicine.

This leaflet answers some common questions about VENTOLIN NEBULES. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking VENTOLIN NEBULES against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What VENTOLIN NEBULES are used for

VENTOLIN NEBULES help you breathe more easily. When your chest is tight or when you are wheezing, Ventolin opens up the breathing tubes in your lungs.

Your medicine is known as a bronchodilator. Because the medicine in your VENTOLIN NEBULES gives fast relief from your chest symptoms, it is often called a 'reliever'. There are other types of medicines that prevent wheezing or chest tightness. These medicines are called 'preventers' and must be used every day. Your doctor may tell you to use a 'preventer' in addition to your VENTOLIN NEBULES.

VENTOLIN NEBULES are not the only form of VENTOLIN available. Your doctor will decide which form of VENTOLIN is right for you.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use VENTOLIN NEBULES

When you must not take it

Do not take VENTOLIN NEBULES if you have an allergy to salbutamol sulfate or any of the other ingredients in VENTOLIN NEBULES (see Ingredients).

Do not take VENTOLIN NEBULES to stop a miscarriage or premature labour.

Do not take this medicine after the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

You must tell your doctor if:

• you are allergic to foods, dyes, preservatives or any other medicines
• you have had to stop taking this or any other asthma medicine for any reason
• you have been diagnosed with a thyroid condition
• you have been diagnosed with high blood pressure
• you have a heart condition
• you have a liver condition
• you have a kidney condition
• you have diabetes.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

The ingredients of VENTOLIN NEBULES are known to cross the placenta during pregnancy. Your doctor can discuss with you the risks and benefits involved.

It is not known whether the ingredients of VENTOLIN NEBULES can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take VENTOLIN NEBULES.

If you have not told your doctor about any of the above, tell him/her before you start taking VENTOLIN NEBULES.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with VENTOLIN NEBULES. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take VENTOLIN NEBULES

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Take VENTOLIN NEBULES as directed by your doctor or pharmacist. The pharmacist's label will usually tell you how many VENTOLIN NEBULES should be taken. If you are not sure, ask your doctor or pharmacist.

Adults: one 5 mg Nebule via nebuliser every 4-6 hours as necessary.

Children (4-12 years): one 2.5 mg Nebule via nebuliser every 4-6 hours as necessary.

Initial doses in the elderly may be lower than the recommended adult dose.

If your condition suddenly gets worse, your doctor may tell you to increase your dose.

How to take it

VENTOLIN NEBULES must only be used by inhalation from a nebuliser and must not be injected or swallowed. The nebuliser produces a fine mist which you breathe in through a face mask or a mouthpiece. Make sure you know how to use it properly. If you have problems ask your doctor or pharmacist.

Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them.

Use your nebuliser in a well ventilated room as some of the mist will be released into the air and may be breathed in by others.

Any solution remaining in the nebuliser should be discarded after use.

How long to take it

Your doctor will decide how often and for how long you have to take VENTOLIN NEBULES. The pharmacist's label will usually tell you how often to take VENTOLIN NEBULES. If you are not sure, ask your doctor or pharmacist.

Do not stop taking VENTOLIN NEBULES, or change the dose without first checking with your doctor.

If you forget to take it

Do not take an extra dose to make up for a missed dose. This may increase the chance of you getting unwanted side effects. Just take your next dose at the usual time. If you become wheezy or develop other symptoms of an asthma attack you may need to take your next dose earlier.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (In Australia call 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too many VENTOLIN NEBULES. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

• rapid heart beat
• significant muscle tremor
• increased acid in the blood, which may cause an increased rate of breathing.

While you are using VENTOLIN NEBULES

Things you must do

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking VENTOLIN NEBULES.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

If your VENTOLIN NEBULES do not help your breathing as much as usual, tell your doctor as soon as possible.

If the effect of your VENTOLIN NEBULES does not last as long as usual, tell your doctor as soon as possible.

These may be signs that your chest condition is getting worse.

If your VENTOLIN NEBULES are not having the same effect as before, your doctor may decide to prescribe other forms of VENTOLIN, or another medicine, for you to use.

This medicine is only one part of a general plan to help you manage your asthma or other chest condition. You should discuss this plan with your doctor. Ask your doctor to check your treatment regularly.

Things you must not do

Do not take VENTOLIN NEBULES to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VENTOLIN NEBULES.

Like other medicines VENTOLIN NEBULES may have unwanted side effects in a few people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following side effects and they worry you.

Common side effects:

• headache
• nausea
• shaky or tense feeling
• irregular or fast heart beat
• 'warm' feeling or flushing.

Rare side effects:

• mouth and throat irritation
• muscle cramps
• restlessness in children.

Very rare side effects:

• feeling unusually active, such as restlessness and excitability.

If your breathing or wheezing gets worse straight after taking this medicine, stop using it immediately, and tell your doctor immediately. If available, try a different fast-acting asthma medicine as soon as possible.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

Allergic reactions have been very rarely reported. These symptoms may include a skin rash, angioedema (sudden swelling under the skin) or a faint or dizzy feeling.

Other side effects not listed above may also occur in some people.

Some of these side effects such as changes to blood potassium levels have been seen rarely and can only be found when your doctor does tests from time to time to check your progress.

After using VENTOLIN NEBULES

Storage

Keep your Nebules in the pack until it is time to take them. If you take the Nebules out of the pack they may not keep well.

Store VENTOLIN NEBULES below 30°C. Protect from light. Once the Nebules are removed from the foil overwrap, use within three months.

Do not store VENTOLIN NEBULES or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

VENTOLIN NEBULES are plastic containers that contain a liquid.

VENTOLIN NEBULES are supplied in packs of 20, arranged as four individually foil overwrapped pouches containing five Nebules linked together.

Ingredients

VENTOLIN NEBULES contain the active ingredient salbutamol sulfate.

Each 2.5 mL Nebule (0.1%) contains 2.5 mg of salbutamol (as salbutamol sulfate)

Each 2.5 mL Nebule (0.2%) contains 5 mg of salbutamol (as salbutamol sulfate)

The liquid in your VENTOLIN NEBULES also contains sodium chloride, sulfuric acid and water.

VENTOLIN NEBULES do not contain a preservative.

Supplier

VENTOLIN NEBULES are supplied in Australia by:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067
Australia

VENTOLIN NEBULES are registered trademarks of the GSK group of companies.

© 2022 GSK group of companies. All rights reserved.

This leaflet was prepared on 18 August 2022.

2.5 mg in 2.5 ml, AUST R 12533

5 mg in 2.5 ml, AUST R 12534

Version 6.0

Published by MIMS February 2023

1 Name of Medicine

Salbutamol sulfate.

2 Qualitative and Quantitative Composition

Nebuliser Solution.
2.5 mg: contain a concentration of salbutamol of 0.1% (1 mg salbutamol, as the sulfate, in 1 mL). Each nebule contains 2.5 mL of solution equivalent to 2.5 mg salbutamol.
5.0 mg: contain a concentration of salbutamol of 0.2% (2 mg salbutamol, as the sulfate, in 1 mL). Each nebule contains 2.5 mL of solution equivalent to 5.0 mg salbutamol.

List of excipients with known effect.

3 Pharmaceutical Form

Inhalation.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm.

4.2 Dose and Method of Administration

Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
Ventolin Nebules are to be used under the direction of a physician. The solution must not be injected or ingested.
2.5 mg/2.5 mL and 5 mg/2.5 mL may be delivered from any efficient nebulising device.
Ventolin Nebules may be used to achieve bronchodilatation as part of an inhalation therapy regime or for patients requiring assisted ventilation.
There is a large safety margin between therapeutic effects and unpleasant side effects. Nevertheless, because of the possibility of uncontrolled dosage associated with continuous administration, intermittent administration of appropriate amounts of Ventolin Nebules is preferred.

Adults and children.

Children 4 to 12 years.

Adults.

Elderly.

In impaired liver function.

In impaired renal function.

4.3 Contraindications

Hypersensitivity to any of the ingredients.
Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

4.4 Special Warnings and Precautions for Use

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they should seek medical advice at the earliest opportunity after increasing the dose.
Animal studies suggest that cardionecrotic effects may occur with high dosages of some sympathomimetic amines. On this evidence the possibility of the occurrence of myocardial lesions cannot be excluded subsequent to long term treatment with these drugs.
Care should be taken with patients who are known to have received large doses of salbutamol or other sympathomimetic drugs, or who are suffering from hypertension, hyperthyroidism, myocardial insufficiency, or diabetes mellitus.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes, for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Excessive use may induce a non-responsive state leading to a worsening of hypoxaemia.
Potentially serious hypokalaemia may result from beta-2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and hypoxia. It is recommended that serum potassium levels are monitored in such situations.
The possibility of cardiac arrhythmias arising as a consequence of salbutamol induced hypokalaemia should be borne in mind, especially in digitalised patients, following the administration of Ventolin Injection.
Addition of other active substances to Ventolin Nebules cannot be recommended.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. The specific salbutamol presentation should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Section 4.8 Adverse Effects (Undesirable Effects)). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Beta adrenergic blocking drugs inhibit the bronchodilator action of salbutamol and other sympathomimetic bronchodilators. However such drugs should not be used in asthmatic patients as they may increase airway resistance.
Care is recommended if it is proposed to administer salbutamol in concomitant therapy with other sympathomimetic amines as excess sympathetic stimulation may occur.
Animal studies have shown that large doses of salbutamol may interact with imipramine, chlordiazepoxide and chlorpromazine but any practical significance of these results in man remains to be established.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

A fine tremor of skeletal muscle has been reported in some patients when salbutamol is administered orally or by inhalation, and in about 20% of patients receiving Ventolin Injection; the hands being the most obviously affected with a few patients feeling tense. These effects are dose related and are caused by a direct action on skeletal muscle and not by direct CNS stimulation.
Increases in heart rate may occur in patients with normal heart rate after administration of Ventolin Nebules. These increases are dose dependent and are of the order of 9 beats/minute when 10 mg of salbutamol as 0.5% w/v solution is inhaled by adults over 3 minutes, 13 beats/minute when 20 mg of salbutamol as 0.1% w/v solution is inhaled by adults over 3 minutes. In patients with pre-existing sinus tachycardia, especially those in status asthmaticus, the heart rate tends to fall after the administration of Ventolin Nebules as the condition of the patient improves.
With higher doses than those recommended, or in patients who are unusually sensitive to beta-adrenergic stimulants, dilatation of some peripheral arterioles may occur leading to a small reduction in arterial pressure; a compensatory increase in cardiac output may then occur.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported. Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients. Tachycardia may occur in some patients.
Other reactions which may occur are headaches, nausea, palpitations and sensations of warmth. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. There have been very rare reports of muscle cramps. Mouth and throat irritation may occur with inhaled salbutamol.

Note.

Reporting suspected adverse effects.

4.9 Overdose

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)). The signs of salbutamol overdosage are significant tachycardia and/or significant muscle tremor.
Hypokalaemia may occur following overdosage with salbutamol. Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Consideration should be given to discontinuation of treatment and appropriate symptomatic treatment such as a cardio-selective beta-blocking agent given by intravenous injection in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Following inhalation, salbutamol acts topically in bronchial smooth muscle and initially the drug is undetectable in the blood. After 2 to 3 hours low concentrations are seen, due presumably to the portion of the dose which is swallowed and absorbed in the gut.
The elimination half-life of inhaled or oral salbutamol is between 2.7 and 5 hours. Salbutamol is not metabolized in the lung but is converted to the 4'-o-sulfate ester in the liver. Salbutamol is excreted in the urine as free drug and as the metabolite. After oral administration 58-78% of the dose is excreted in the urine in 24 hours, approximately 60% as metabolites. A small fraction is excreted in the faeces.
Impairment of liver or renal function may necessitate a reduction in dosage (see Section 4.2 Dose and Method of Administration).

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ventolin Nebules contains the excipients sodium chloride, sulfuric acid and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Ventolin Nebules should be stored below 30°C. Store protected from light. Once removed from the foil overwrap Nebules have a shelf-life of 3 months when stored below 30°C and should be protected from light.

6.5 Nature and Contents of Container

Ventolin Nebules are plastic ampoules containing a sterile preservative-free, isotonic, aqueous solution of salbutamol sulfate equivalent to either 2.5 mg salbutamol in 2.5 mL or 5 mg salbutamol in 2.5 mL. The nebules are supplied in packs of 5 and 20. The 20 pack size is arranged as four individually foil overwrapped pouches containing five Nebules linked together.
Not all strengths or pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Salbutamol sulfate is a white or almost white odourless powder. It is soluble in 4 parts of water; slightly soluble in 95% alcohol, in chloroform and solvent ether.
Chemical Name: 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino) ethanol sulfate.
Molecular Formula: (C₁₃H₂₁NO₃)₂H₂SO₄.
The molecular weight for salbutamol sulfate is 576.7.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes