Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Salbutamol Sandoz.

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 using this medicine against the benefits they expect it will have for you.

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

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

What Salbutamol Sandoz is used for

The name of your medicine is Salbutamol Sandoz. The medicine in your Salbutamol Sandoz is delivered through a device called a nebuliser. It contains the active ingredient salbutamol sulfate.

Salbutamol is inhaled into the lungs for the treatment of asthma. Asthma is a disease where the lining of the lungs become inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke, air-borne pollution and other irritants. Salbutamol opens up the air passages in people suffering from asthma, bronchitis and other breathing problems. It may also be used before exercise to keep your air passages open if you start to wheeze or have difficulty breathing each time you exert yourself.

Salbutamol Sandoz belongs to a group of medicines called beta-2-agonists. These work rapidly to open up the air passages in your lungs.

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.

This medicine is available only with a doctor's prescription.

Before you use Salbutamol Sandoz

When you must not use it

Do not use this medicine if you have an allergy to:

• salbutamol, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
• any other medicines used to treat breathing problems or any other beta-2-agonist medicine.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not use this medicine after the expiry date printed on the pack 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 using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• thyroid problems
• heart disease, irregular heart rhythm or angina
• high blood pressure
• diabetes
• glaucoma.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using Salbutamol Sandoz.

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 and Salbutamol Sandoz may interfere with each other. These include:

• some medicines used to treat high blood pressure or heart conditions
• some hay fever, cough and cold preparations
• medicines used to treat depression or other mood disorders.

These medicines may be affected by Salbutamol Sandoz, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Salbutamol Sandoz

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, ask your doctor or pharmacist for help.

How much to use

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly what dose and how often you should use this medicine. Your dose will depend on your condition, what it is being used for and other factors, such as your age, and whether or not you are taking other medicines at the same time.

Follow the instructions they give you. If you use the wrong dose, Salbutamol Sandoz may not work as well and your problem may not improve.

The usual dose is 5mg for an adult and 2.5mg for a child over 4 years, given every four to six hours.

How to use it

The content of Salbutamol Sandoz is inhaled through a nebuliser according to the manufacturer's instructions. The nebuliser changes the solution into a fine mist and delivers the medicine to your lungs when you inhale the mist through the mask.

Step 1: Remove the strip of Salbutamol Sandoz from the carton and tear one ampoule from the strip. Open only one foil pack at a time, and use all 5 ampoules before opening the next foil pack.

Step 2: Never use an ampoule that has previously been opened. The ampoule may be opened by carefully holding it upright and twisting the top off.

Step 3: The content of the ampoule should be squeezed out into the nebuliser bowl.

The nebuliser should be assembled and used as directed by your doctor. After using the nebuliser, discard any solution remaining in the nebuliser bowl. Follow the manufacturer's instructions on how to clean your nebuliser.

Fresh solution must be used for each dose. After the full dose has been given, any solution remaining in the nebuliser must be thrown away. Nebulisers must be cleaned after use according to the manufacturer's instructions.

If you miss a dose

Use your next dose at the normal time or earlier if you become wheezy or feel tight in your chest.

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

If you have trouble remembering when to use your medication, ask your pharmacist for some hints.

If you use too much (overdose)

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

If you inhale too much salbutamol, you may experience some of the effects listed under Side effects below.

While you are using Salbutamol Sandoz

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Salbutamol Sandoz.

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

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

Always follow your doctor's instructions carefully.

If you have an Asthma Action Plan that you have agreed on with your doctor, follow it closely at all times.

If you find that the usual dose of Salbutamol Sandoz is not providing as much relief as before, or you need to use it more often, please contact your doctor so that your condition can be checked. This is important to ensure that your breathing problem is controlled properly.

Continue using salbutamol for as long as your doctor tells you.

Visit your doctor regularly to check on your condition.

Things you must not do

Do not use Salbutamol Sandoz to treat any other complaints unless your doctor tells you to.

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

Do not stop using your medicine or lower the dose without checking with your doctor.

Do not take any other medicines for your breathing problems without checking with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Salbutamol Sandoz.

All medicines can have side effects. 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 and they worry you:

• sore mouth, throat or tongue
• dry mouth
• coughing
• chest pain (due to heart problems such as angina)
• headache
• drowsiness
• feeling anxious, nervous, restless or upset
• difficulty sleeping
• dizziness
• sweating
• trembling or shaking
• aching or weak muscles
• cramps
• tingling or numbness in the hands or feet ('pins and needles')
• unpleasant taste in your mouth
• nausea or vomiting
• diarrhoea
• rash or itchy skin
• sore or puffy eyes.

These are the more common side effects of Salbutamol Sandoz. Mostly, these are mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

• a feeling of warmth
• difficulty breathing or worsening of your breathing problems
• swelling or severe rash
• fast or irregular heart beat
• pounding heart beat.

The above list includes serious side effects that may require urgent medical attention. Serious side effects are rare.

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

• swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

After using Salbutamol Sandoz

Storage

Keep your medicine in the original container.

Keep Salbutamol Sandoz ampoules in the foil pack until it is time to use them. If you take the ampoules out of the foil pack they may not keep well.

Once a foil pack has been opened, the ampoules must be used within 3 months.

Discard any ampoules remaining after this time.

Store below 25°C in a cool dry place, protected from light.

Do not store Salbutamol Sandoz 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 using 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

Salbutamol Sandoz comes in:

• Salbutamol Sandoz 5mg/2.5mL.

Each pack of Salbutamol Sandoz contains 30 (6x5) plastic ampoules. Each ampoule contains 2.5mL of clear, colourless, preservative free solution.

The ampoules are for inhalational use only.

Ingredients

Active ingredient:

• Salbutamol Sandoz 5 mg/2.5 mL - 5 mg salbutamol in 2.5 mL of solution.

Inactive ingredients:

• sodium chloride
• water.

The solution is sterile and preservative free.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park NSW 2113
Australia
Tel: 1800 726 369

This leaflet was revised in October 2019.

Australian Register Numbers

Salbutamol Sandoz 5 mg/2.5 mL inhalation ampoules: AUST R 140695

Published by MIMS December 2019

Name of the medicine

Salbutamol sulfate BP.

Excipients.

Description

Chemical name: di[(RS)-2-(1,1-dimethyl) ethylamino-1-[4-hydroxy-3-(hydroxymethyl)phenyl] ethanol] sulfate. Molecular formula: (C₁₃H₂₁NO₃)₂, H₂SO₄. MW: 576.7. CAS: 51022-70-9. Salbutamol sulfate is a white or almost white, crystalline, odourless powder with a slightly bitter taste. It is freely soluble in water, slightly soluble in alcohol, chloroform and ether, very slightly soluble in methylene chloride. Salbutamol sulfate 1.2 mg is approximately equivalent to salbutamol 1 mg.

Pharmacology

Selective beta-2 adrenoceptor agonist.

Pharmacodynamics.

Pharmacokinetics.

Absorption.

Distribution.

Metabolism.

Excretion.

Indications

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.

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.

Precautions

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing uses 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.
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from postmarketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
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 nonresponsive 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 salbutamol injection.
Addition of other active substances to Salbutamol Sandoz 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 Adverse 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.

Effects on fertility.

Use in pregnancy.

Use in lactation.

Interactions

Beta-adrenergic blocking drugs.

Beta-adrenergic stimulants or sympathomimetic amines.

Antidepressant.

Anticholinergics (ipratropium).

Cardiac glycosides.

Corticosteroids.

Diuretics.

Adverse Effects

Adverse events are described according to the CIOMS classification:
very common ≥ 10%; common ≥ 1% and < 10%; uncommon ≥ 0.1% and < 1%; rare ≥ 0.01% and < 0.1%; very rare < 0.01%.
Very common: 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 salbutamol injection, the hands being the most obviously affected; a few patients feel 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 are common in patients with normal heart rate after administration of salbutamol respirator solution. 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 salbutamol respirator solution as the condition of the patient improves.
With higher doses than those recommended, or in patients who are usually 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) and myocardial ischaemia have been reported (see Precautions). Peripheral vasodilatation and a compensatory small increase in heart rate may occur in some patients.
Tachycardia may occur in some patients.
Other common side effects which may occur are headaches, nausea, palpitations and sensations of warmth. Mouth and throat irritation may occur with inhaled salbutamol.
There have been reports of muscle cramps and restlessness.
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.

Dosage and 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.
Salbutamol Sandoz is to be used under the direction of a doctor.
The solution must not be injected or ingested.
Salbutamol Sandoz 2.5 mg/2.5 mL and 5 mg/2.5 mL ampoules may be delivered from any efficient nebulising device.
Salbutamol Sandoz 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 Salbutamol Sandoz is preferred.

Children 4-12 years.

Adults.

Important.

Use in the elderly.

Impaired hepatic function.

Impaired renal function.

Overdosage

Contact the Poisons Information Centre on 131 126 for advice on management of overdose.
In general, beta-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals.

Symptoms.

Signs.

Treatment.

Presentation

Inhalation solution (sterile, aqueous, isotonic, preservative free), salbutamol 2.5 mg/2.5 mL, 5 mg/2.5 mL: 30's (6 x 5, foil wrapped ampoules).

Storage

Store below 25°C. Protect from light.

Shelf life.

Poison Schedule

S4.