Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Asmol uni-dose.

It does not contain all of 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 using Asmol uni-dose against the benefits they expect it will have for you.

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

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

What Asmol uni-dose is used for

Asmol uni-dose are plastic ampoules which contain a medicine called salbutamol, as a liquid. The liquid is changed into a fine mist of droplets by the nebuliser.

Asmol uni-dose is used for the treatment of asthma, bronchitis and other breathing problems.

In people who have difficulty breathing during exercise, Asmol uni-dose may also be used before exercise to keep the air passages open.

Your doctor may have prescribed Asmol uni-dose for another purpose. Ask your doctor if you have any questions about why Asmol uni-dose has been prescribed for you.

It belongs to a group of medicines called bronchodilators or beta-2 agonists. When your chest is tight or when you are wheezing, Asmol uni-dose is inhaled into the lungs and works rapidly to open up the air passages in your lungs to help you breathe more easily.

The medicine in Asmol uni-dose gives fast relief from your chest symptoms and is often called a 'reliever' medicine.

There is no evidence that Asmol uni-dose is addictive.

Before you use Asmol uni-dose

When you must not use it

Do not use Asmol uni-dose if you have an allergy to any medicine containing salbutamol.

Do not take Asmol uni-dose to stop a miscarriage or premature labour.

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 if the packaging is torn or shows signs of tampering.

Do not take use this medicine if the expiry date (Exp.) printed on the pack has passed. Once a foil pack has been opened, the ampoules must be used within three months.

Before you start to use it

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

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

• high blood pressure
• heart problems
• liver problems
• kidney problems
• thyroid conditions
• diabetes.

Tell your doctor if you had to stop taking this or any other asthma medicine for any reason.

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

The ingredients of Asmol uni-dose are known to cross the placenta during pregnancy.

Your doctor will discuss the risks and benefits of using Asmol uni-dose when pregnant. It is important that asthma is managed well during pregnancy and you should not stop your medicine without asking your doctor.

Tell your doctor if you are breastfeeding or wish to breastfeed.

Your doctor will discuss the risks and benefits of using Asmol uni-dose when breastfeeding.

If you have not told your doctor about any of the above, tell him/her before you start using Asmol uni-dose.

Taking other medicines

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

Some medicines may interfere with Asmol uni-dose. These include:

• medicines used to treat high blood pressure or other heart conditions
• medicines used to treat glaucoma, including those that are eye drops
• some cough and cold preparations
• some weight reducing medicines
• medicines used to treat depression or other mood disorders.

These medicines may be affected by Asmol or may affect how well it works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while using Asmol uni-dose.

How to use Asmol uni-dose

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

Your doctor will tell you how much to use and when to use it.

How much to use

The dose varies from patient to patient.

The pharmacist label will usually tell you how many ampoules to use and how often to use them. If you are not sure, ask your doctor or pharmacist.

Adults: The usual dose is one 5 mg ampoule every four to six hours.

Elderly patients may need smaller doses.

Children: The usual dose is one 2.5 mg ampoule every four to six hours.

Your doctor will decide what dose you should take, how often you should take it and what strength of ampoule you should use.

If your chest condition suddenly gets worse, your doctor may tell you to increase your dose. IMPORTANT: Tell your doctor as soon as possible if:

• your Asmol uni-dose does not help your breathing as much as usual
• the effect of your Asmol uni-dose does not last as long as usual or lasts less than 3 hours
• you need more ampoules than usual of Asmol uni-dose to get relief.

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

How to use it

Do not swallow or inject the liquid in Asmol uni-dose.

Asmol uni-dose is for inhalation only, using a nebuliser. A nebuliser delivers the medicine in the form of a mist which you breathe into your lungs. You breathe in the mist through the face mask which is connected to the nebuliser.

Instructions on how to use Asmol uni-dose are included in the pack.

Read these instructions carefully before using Asmol.

It is wise to visit your doctor or pharmacist from time to time to check that you are using your nebuliser in the right way. If you are not breathing the medicine in correctly, the medicine may not be helping you as much as it could.

If you forget to use it

If you are using this medicine regularly and you miss a dose, take it as soon as you remember.

Do not take a double dose to make up for the dose you missed.

If you miss more than one dose, or are not sure what to do, check with your doctor or pharmacist.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 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 used too much Asmol. Do this even if there are no signs of discomfort or poisoning.

If you use too much Asmol uni-dose, you may feel shaky, tremble, have a fast heart beat or have increased acid in the blood, which may cause an increased rate of breathing. These symptoms are usually mild side effects of using Asmol uni-dose. However, if they are severe or do not go away, it may be that you have taken too much Asmol uni-dose.

While you are using Asmol uni-dose

Things you must do

IMPORTANT: If your breathing suddenly becomes more difficult or you get an immediate increase in wheezing just after using Asmol uni-dose, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

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

If Asmol uni-dose does not help your breathing as much as usual, tell your doctor as soon as possible. If the effect of Asmol uni-dose does not last as long as usual or lasts less than three hours, tell your doctor as soon as possible.

These may be signs that your condition is getting worse.

If you are about to start taking a new medicine, tell your doctor or pharmacist that you are using Asmol uni-dose.

If you become pregnant while using Asmol uni-dose, tell your doctor.

Tell all the doctors, dentists and pharmacists who are treating you that you are using Asmol uni-dose.

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.

Visit your doctor regularly so that they can check on your condition.

Things you must not do

Do not stop using Asmol uni-dose or lower the dose without checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

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

Do not use Asmol uni-dose to treat any other complaints unless your doctor says to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

If you are mixing Asmol uni-dose with ipratropium bromide (another medicine for asthma) in your nebuliser, be careful not to let the mist get into your eyes. If the mist does get in your eyes and you get a headache with eye pain, red eyes or blurred vision, tell your doctor immediately.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Asmol uni-dose.

Like all other medicines, Asmol uni-dose may have unwanted side effects in some people. Most of the side effects will be minor and temporary, but some may be serious. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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

If you have any of the following side effects, tell your doctor or pharmacist but do not stop using your Asmol uni-dose.

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

• muscle cramps
• mouth or throat irritation
• headache
• feeling shaky or tense
• fine tremors, especially of the hands
• fast heart beat
• restlessness in children
• nausea, feeling sick
• unusual feelings of warmth.

Tell your doctor immediately if any of the following happen:

• skin rash, hives or itching
• irregular heart beat, palpitations.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if any of the following happen:

• severe dizziness, fainting or collapse
• swelling of the face, lips, mouth, throat and neck which may cause difficulty in swallowing or breathing
• increased wheezing or difficulty breathing after using Asmol.

Very rarely, in people receiving high dose treatment with this medicine and in patients with an acute exacerbation of asthma, a serious condition called lactic acidosis, which affects the blood, may occur because of the build up of lactic acid. Your doctor may do tests to check this.

Asmol uni-dose may cause a fall in potassium levels in a few people. Your doctor may also do tests to check this.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell while you are using, or soon after you have finished using Asmol uni-dose, even if it is not on this list.

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

After using Asmol uni-dose

Storage

Keep Asmol uni-dose in a cool dry place where the temperature stays below 30°C.

Keep the ampoules in the foil pack, with the foil lid closed, inside the box, until it is time to use them.

If you take the ampoules out of the foil pack and box, they may not keep well.

Once a foil pack has been opened, the ampoules must be used within 3 months. Discard any ampoules left after this time.

After using the nebuliser, discard any liquid left in the nebuliser bowl, rinse and dry.

Do not keep Asmol uni-dose or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep your medicine 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 your medicine has passed its expiry date, ask your pharmacist what to do with any ampoules that are left over.

Product description

What it looks like

Asmol uni-dose comes in two strengths:

• Asmol 2.5 uni-dose
• Asmol 5 uni-dose

Each pack of Asmol uni-dose contains 30 plastic ampoules. Each ampoule contains 2.5 mL of clear and colourless liquid.

Ingredients

The active ingredient in Asmol uni-dose is salbutamol (as salbutamol sulfate).

• Asmol 2.5 uni-dose contains 2.5 mg of salbutamol in 2.5 mL of liquid
• Asmol 5 uni-dose contains 5 mg of salbutamol in 2.5 mL of liquid

Asmol uni-dose also contains:

• sodium chloride
• water for injections

Asmol uni-dose is preservative free.

Supplier

Asmol uni-dose is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Australian Registration Numbers:
Asmol 2.5 uni-dose: Aust R 54719
Asmol 5 uni-dose: Aust R 54720

This leaflet was prepared on 7 October 2014.

Asmol unidose_cmi\Oct14/00

Name of the medicine

Salbutamol (as sulfate).

Description

Chemical name: 1-(4-hydroxy- 3-hydroxymethylphenyl)- 2-(t-butylamino) ethanol sulfate. Molecular formula: (C₁₃H₂₁NO₃)₂H₂SO₄. MW: 288.4. CAS: 51022-70-9. Salbutamol sulfate is a white or almost white odourless powder. It is soluble in 4 parts of water; slightly soluble in 95% alcohol, chloroform and solvent ether.

Pharmacology

Salbutamol is a relatively selective β₂-adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic β₂-receptors.
After oral and parenteral administration, stimulation of the β-receptors in the body, both β₁ and β₂, occurs because:
(a) β₂ selectivity is not absolute, and
(b) because higher concentrations of salbutamol occur in the regions of these receptors with these modes of administration.
This results in the β₁ effect of cardiac stimulation, though not so much as with isoprenaline, and β₂ effects of peripheral vasodilatation and hypotension, skeletal muscle tremor and uterine muscle relaxation.
Metabolic effects such as hyperinsulinaemia and hyperglycaemia, may also occur, although it is not known whether these effects are mediated by β₁ or β₂-receptors. The serum potassium levels have a tendency to fall.

Pharmacokinetics.

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.

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 program, and patient response should be monitored clinically and by lung function tests. Increasing use of short acting inhaled β₂-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 doses 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 β-adrenoreceptor 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 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 and diuretics, and by hypoxia. It is recommended that serum potassium levels be 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 Asmol uni-dose solution 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 β-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 β-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

β-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.

Adverse 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 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 may occur in patients with normal heart rate after administration of Asmol uni-dose. 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 and 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 Asmol uni-dose as the condition of the patient improves.
With higher doses than those recommended, or in patients who are unusually sensitive to β-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.

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.
Asmol uni-dose is to be used under the direction of a physician. The solution must not be injected or ingested.
The 2.5 mg/2.5 mL and 5 mg/2.5 mL presentations may be delivered from any efficient nebulising device.
Asmol uni-dose may be used to achieve bronchodilatation as part of an inhalational 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 Asmol uni-dose is preferred.

Adults and children.

Children 4 to 12 years.

Adults.

Geriatric.

In impaired liver function.

In impaired renal function.

Overdosage

In cases of overdosage, it is advisable to contact the Poisons Information Centre (131 126) for recommendation on the management and treatment of overdosage.
The most common signs and symptoms of overdose with salbutamol are transient beta-agonist pharmacologically mediated events (see Precautions and Adverse 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 cardioselective β-blocking agent given by intravenous injection in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). In general, beta-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals.

Presentation

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

Storage

Asmol uni-dose ampoules have a shelf life of 3 years when stored below 30°C. Store protected from light. Once removed from the foil overwrap ampoules have a shelf life of three months when stored below 30°C.

Poison Schedule

S4.