Consumer medicine information

What is in this leaflet?

This leaflet answers some common questions about Salbutamol AN.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Salbutamol AN against the benefits this medicine is expected to have for you.

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

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

Keep this leaflet. You may need to read it again.

What Salbutamol AN is used for

The name of your medicine is Salbutamol AN. The medicine in your Salbutamol AN ampoules is delivered through a device called a nebuliser.

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

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 may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed salbutamol.

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

Before you use Salbutamol AN

When you must not be given it

Do not use Salbutamol AN if you have an allergy to:

• salbutamol or any other medicines used to treat breathing problems
• any other beta-2-agonist medicine
• any of the ingredients listed at the end of this leaflet

If you are not sure whether any of these apply to you, check with your doctor before you are given it.

Before you are given it:

Tell your doctor if:

1. you have any allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes

2. you are pregnant or intend to become pregnant
3. you are breast-feeding or plan to breast feed
4. you have or have had any medical conditions, especially the following:

• thyroid problems
• heart problems
• high blood pressure
• diabetes
• glaucoma

Taking other medicines

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

Some medicines and Salbutamol AN may interfere with each other. These include medicines used to treat:

• heart problems
• depression or other mood disorders
• hayfever, coughs and colds
• high blood pressure
• weight reduction

Your doctor will advise you about continuing to take other medicines while you are receiving salbutamol.

How to use Salbutamol AN properly

The contents of Salbutamol AN ampoules are 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.

The usual dose is 5 mg for an adult and 2.5 mg for a child over four years, given every four to six hours. Your doctor will decide what dose and how often you should use Salbutamol AN. The dosage you will be given will depend on your condition, what it is being used for and other factors, such as your age, and whether or not other medicines are being given at the same time.

Opening instructions for the ampoules:

STEP 1: Remove the strip of Salbutamol AN ampoules 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 the ampoule upright and twisting the top off.

STEP 3: The contents 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.

If you forget to take a dose:

If you miss a dose, do not worry. Just take the next dose at the normal time or earlier if you become wheezy or feel tight in your chest.

Important:
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 manufacturer's instructions.

While you are using Salbutamol AN

Things you must do

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

If you find that the usual dose of salbutamol is not giving as much relief as before, or you are needing 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.

If you become pregnant while using Salbutamol AN tell your doctor.

Tell any other doctors, dentists or pharmacists who are treating you that you are using Salbutamol AN.

Things you must not do

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

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

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

Side effects

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

Like other medicines, Salbutamol AN can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

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

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor immediately 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

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor if you notice any of the following and they worry you:

• sore mouth, throat or tongue
• dry mouth
• coughing
• headache
• drowsiness
• feeling anxious, nervous, restless or upset
• difficulty sleeping
• dizziness
• sweating
• trembling or shakiness
• 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. Mostly these are mild and short-lived.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.

If you take too much (overdose)

Immediately telephone your doctor, pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident & Emergency at your nearest hospital, if you think that you or anyone else may have used too much salbutamol. Do this even if there are no signs of discomfort or poisoning. You may need medical attention. If you inhale too much salbutamol, you may experience some of the effects listed under ‘Side Effects’ below.

After you use Salbutamol AN

Storage

Salbutamol AN should be kept in a cool, dry place where the temperature stays below 25°C.

Salbutamol AN must be protected from light.

Do not store in direct sunlight or heat.

Do not leave in the car on hot days.

Keep your Salbutamol AN ampoules in a place where children cannot reach them.

Do not use after the expiry date on the carton.

Once you have opened each foil pack, you need to note down the date of opening the foil lid. Add three to this date and write it down in the space provided on the foil pack.

Do not use the Salbutamol AN ampoules left in the tray after this date.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Do not store Salbutamol AN or any other medicine in the bathroom or near a sink.

Disposal

If your doctor tells you to stop using Salbutamol AN or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Where to go for further information

Further information can be requested from your doctor or pharmacist.

Product Description

What it looks like

Salbutamol AN contains salbutamol for inhalation. It is a clear, colourless, preservative free solution and comes in sterile plastic unit dose ampoules.

Salbutamol AN comes in two strengths:

• 2.5 mg salbutamol sulfate in 2.5 mL of solution. Available in packs of 30 (6 foil pouches of 5 ampoules) AUST R 135467
• 5 mg salbutamol sulfate in 2.5 mL of solution, Available in packs of 30 (6 foil pouches of 5 ampoules) AUST R 135469

Ingredients

Salbutamol AN contains salbutamol sulfate as the active ingredient.

Salbutamol AN ampoules also contain water for injections and sodium chloride.

Sponsor

Amneal Pharma Australia Pty Ltd
12 River Street
South Yarra VIC 3141
Australia

This Consumer Medicine Information was prepared in Dec 2015.

Salbutamol AN 2.5mg/2.5mL (AUST R 135467)

Salbutamol AN 5mg/2.5mL (AUST R 135469).

Name of the medicine

Salbutamol sulfate BP.

Excipients.

Description

Chemical name: di[(RS)-2-(1,1-dimethylethyl)amino-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol]sulfate. Molecular formula: (C₁₃H₂₁NO₃)₂, H₂SO₄. CAS number: 51022-70-9. MW: 576.7.
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.
Inactive ingredients: Sodium chloride, sulfuric acid (for pH adjustment), water for injection.

Pharmacology

Action.

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.

Precautions

The management of asthma should normally follow a stepwise program, 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.
Excessive use may induce a non-responsive state leading to a worsening of hypoxaemia.
Potentially serious hypokalaemia may result from β₂-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 AN ampoules cannot be recommended.

Use in pregnancy.

Use in lactation.

Interactions

Beta-adrenergic blocking drugs inhibit the bronchodilator action of salbutamol and other sympathomimetic bronchodilators. Such drugs should not be used in asthmatic patients as they may increase airway resistance.
Beta-adrenergic stimulants or sympathomimetic amines such as ephedrine should not be given concomitantly. Salbutamol should not be given to patients who have already received large doses of sympathomimetics.

Antidepressants.

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 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 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 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 extra systoles) 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 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 rare reports of muscle cramps and restlessness.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

Note.

Dosage and Administration

Increasing use of β₂-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 AN is to be used under the direction of a doctor. The solution must not be injected or ingested.
Salbutamol AN 2.5 mg/2.5 mL and 5 mg/2.5 mL may be delivered from any efficient nebulising device.
Salbutamol AN may be used to achieve bronchodilation as part of an inhalation therapy regimen 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 AN is preferred.

Children 4 to 12 years.

Adults.

Important.

Use in the elderly.

Impaired hepatic function.

Impaired renal function.

Overdosage

In general, β-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals. Hypokalaemia may occur following overdosage with salbutamol. Serum potassium levels should be monitored.
Please contact the Poisons Information Centre (telephone 131 126) regarding overdose management.
The signs of overdosage are significant tachycardia and/or significant muscle tremor.

Treatment.

Presentation

Salbutamol AN ampoules contain 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: 30’s (6x5’s).
The ampoules are made of PE (LDPE - low density polyethylene).

Storage

Store below 25°C. Protect from light.

Shelf life.

Poison Schedule

S4.