Consumer medicine information

Asmol Inhaler CFC-Free

Salbutamol

BRAND INFORMATION

Brand name

Asmol CFC-free Inhaler

Active ingredient

Salbutamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Asmol Inhaler CFC-Free.

What is in this leaflet

This leaflet answers some common questions about Asmol inhaler.

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 taking Asmol inhaler against the benefits they expect it will have for you.

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

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

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

What Asmol inhaler is used for

Asmol inhaler is used to help treat the symptoms of:

  • asthma
  • bronchitis
  • emphysema
  • other breathing problems.

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

Asmol inhaler contains a medicine called salbutamol. Each dose (puff) contains 100 micrograms of salbutamol. There are 200 doses in each Asmol inhaler.

Salbutamol belongs to a group of medicines called bronchodilators or beta-2 agonists. When your chest is tight or when you are wheezing, Asmol is inhaled into the lungs and works rapidly to open up the air passages in your lungs, helping you breathe more easily. Asmol inhaler gives fast relief from your chest symptoms and is often called a "reliever" medicine. You may also know it as a "reliever puffer".

Some people start wheezing or their chest starts to feel tight when they exercise. This is called exercise-induced asthma. If you have exercise-induced asthma, your doctor may tell you to take one or two puffs of your Asmol inhaler before you exercise. This can help prevent the symptoms of exercise-induced asthma.

Asmol inhaler helps to control your condition but does not cure it.

Your doctor may have prescribed Asmol inhaler for another reason. Ask your doctor if you have any questions about why Asmol inhaler has been prescribed for you.

There is no evidence that Asmol inhaler is addictive.

Before you use Asmol inhaler

When you must not use it

Do not use Asmol inhaler if you are allergic to medicines containing salbutamol or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not use your Asmol inhaler to control miscarriage or premature labour.

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.

Before you start to use it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

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

The ingredients of Asmol inhaler are known to cross the placenta during pregnancy. Your doctor will discuss the risks and benefits of using Asmol inhaler during pregnancy.

It is important that asthma is managed well during pregnancy and you should not stop taking 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 inhaler when breastfeeding.

Tell your doctor if you have any medical conditions, especially the following:

  • 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. Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor about any of the above, tell them before you start using Asmol inhaler.

Taking other medicines

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

Some medicines may be affected by Asmol inhaler, or may affect how well it works. These include:

  • beta-blockers, medicines used to treat high blood pressure or heart conditions
  • some cough and cold preparations
  • some weight reducing medicines
  • some medicines used to treat depression or other mood disorders.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Asmol inhaler.

How to use Asmol inhaler

How much to use

The usual Asmol inhaler dose is one or two puffs every four hours if needed. Your doctor may advise you to take a different dose. This depends on your condition and whether or not you are taking any other medicine.

Elderly patients may need smaller doses. If you have an Asthma Action Plan that you have agreed with your doctor, follow it closely at all times.

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

How to use it

Instructions on how to use Asmol inhaler are included in the pack.

Read these instructions carefully before using Asmol inhaler. The pharmacist's label will usually tell you how many puffs to take and how often to use your Asmol inhaler. If you are not sure, ask your doctor or pharmacist.

Children may require adult supervision when using their Asmol inhaler.

If your Asmol inhaler is new, or if you have not used it for 5 days or more, point the mouthpiece away from you and spray two puff into the air before using it.

This will ensure that your inhaler will work properly.

You should visit your doctor or pharmacist regularly to check that you are using your Asmol inhaler 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 be.

If you have trouble using your Asmol inhaler, talk to your doctor or pharmacist.

You may find using a spacer device with your Asmol inhaler helpful.

To use a spacer device, fit your Asmol inhaler into the spacer, spray one puff of Asmol into the spacer and then slowly breathe in as far as possible. Hold your breath for as long as comfortable, before breathing out slowly. Repeat this for each puff of your Asmol inhaler.

Most people will benefit from the use of a spacer device with their Asmol inhaler.

Use of a spacer will help more of the drug to reach your lungs and reduce the amount of drug deposited in the mouth and back of the throat. This will help to lessen your chance of getting local side effects such as mouth and throat irritation and hoarse voice.

Your pharmacist or doctor can help you with more information about spacer devices.

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

If you have any questions about this, check with your doctor or pharmacist.

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 taken too much Asmol inhaler. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too many puffs of your Asmol inhaler, you may have a fast heart beat, feel shaky or have a headache. You may also have increased acid in the blood, which may cause an increased rate of breathing. These symptoms are usually mild side effects of using Asmol inhaler. However, if they are severe or do not go away, it may be that you have used too much Asmol.

While you are using Asmol inhaler

Things you must do

IMPORTANT: If your breathing suddenly becomes more difficult just after using Asmol inhaler, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

Your doctor may tell you to take extra puffs of your Asmol inhaler if your chest condition suddenly gets worse. If you take extra puffs and do not get relief, tell your doctor immediately.

Tell your doctor as soon as possible if:

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

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

Your doctor may decide to add another medicine to your treatment if your Asmol puffer is not having the same effect as before.

Make sure you keep your Asmol inhaler with you at all times.

Before starting any new medicine, tell your doctor or pharmacist that you are using Asmol inhaler.

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

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

If you become pregnant while taking Asmol inhaler, tell your doctor.

Visit your doctor regularly so they can check on your condition. Your doctor or pharmacist may recommend the use of a peak flow meter to help monitor your condition at home.

Things you must not do

Do not stop using Asmol inhaler 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 inhaler to treat any other conditions unless your doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how Asmol inhaler affects you. Asmol inhaler may cause fine tremors, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Asmol inhaler. Like all other medicines, Asmol inhaler may have unwanted side effects in some people. Most of the side effects will be minor and temporary, but sometimes they are 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.

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

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

Tell your doctor immediately if you notice any of the following:

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

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

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

In a few people, Asmol may cause a fall in potassium levels in a few people. Your doctor may do blood tests to check this.

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

After using Asmol inhaler

Straight after use, replace the mouthpiece cover firmly and click it into position.

Cleaning

Regular cleaning is required.

It is recommended that you clean your Asmol inhaler once a week.

Follow these steps to clean your inhaler:

  1. Remove the metal can from the plastic holder of your inhaler and remove the mouthpiece cover.
  2. Rinse the plastic holder and mouthpiece cover under warm running water.
  3. Dry the plastic holder and mouthpiece cover thoroughly inside and out.
  4. Put the can back into the plastic holder and replace the mouthpiece cover.

Do not put the metal can in water.

If you use a spacer device, clean it once each month. Wash the spacer in warm water and detergent then rinse clean with water. Allow it to air dry; do not use a cloth to dry it.

Storage

Keep Asmol inhaler 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.

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

Do not store Asmol inhaler or any other medicine in the bathroom or near a sink.

Do not leave Asmol inhaler in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop using Asmol inhaler, or your medicine has passed its expiry date, ask your pharmacist what to do with the inhaler.

Do not burn or puncture the metal can, even when it is empty. The metal can is pressurised and may explode when punctured or burned.

You can recycle the plastic holder and the mouthpiece cover of your inhaler with other plastic things.

If you have any other questions, ask your doctor or pharmacist.

Product description

What it looks like

Asmol inhaler consists of a metal can inside a blue plastic holder with a dark blue mouthpiece cover.

Each Asmol inhaler contains 200 puffs.

Ingredients

The active ingredient in Asmol inhaler is salbutamol (sulfate). Each puff contains 100 micrograms of salbutamol.

Asmol inhaler also contains HFA-134a as the propellant. Asmol inhaler has no other additives.

Asmol inhaler is CFC-free.

Supplier

Asmol inhaler is supplied by:

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

This leaflet was prepared in May 2020.

AUST R 65639.

AsmolCFC_cmi\May20/00

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Asmol CFC-free Inhaler

Active ingredient

Salbutamol

Schedule

S3

 

1 Name of Medicine

Salbutamol sulfate B.P.

6.7 Physicochemical Properties

Chemical Name: di[(RS)-2-(1,1-dimethylethyl)amino-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol]sulfate.
Molecular Formula: C26H44N2O10S.
Molecular Weight: 288.4.

Chemical structure.


CAS number.

51022-70-9.

Description.

Salbutamol sulfate is a white or almost white crystalline powder, freely soluble in water, practically insoluble or very slightly soluble in ethanol (96 per cent) and in methylene chloride.

2 Qualitative and Quantitative Composition

Asmol inhaler is a pressurised metered dose inhaler which delivers 100 micrograms of salbutamol (as sulfate) per actuation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pressurised inhalation.

Asmol inhaler (without dose counter).

Suspension contained in an aluminium alloy can, sealed with a metering valve. The canister is fitted with a plastic actuator incorporating an atomising nozzle and fitted with a mouthpiece cover.

Asmol inhaler (with dose counter).

Suspension contained in an aluminium alloy can, sealed with a metering valve. The canister has a counter attached to it and is fitted with a plastic actuator incorporating an atomising nozzle and fitted with a mouthpiece cover.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Salbutamol is a relatively selective beta-2 adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic beta-2 receptors.

Pharmacodynamics.

After oral and parenteral administration, stimulation of the beta receptors in the body, both beta-1 and beta-2, occurs because (a) beta-2 selectivity is not absolute, and (b) higher concentrations of salbutamol occur in the regions of these receptors with these modes of administration. This results in the beta-1 effect of cardiac stimulation, though not so much as with isoprenaline, and beta-2 effects of peripheral vasodilatation and hypotension, skeletal muscle tremor and uterine muscle relaxation.
Metabolic effects such as hyperinsulinaemia and hyperglycaemia also may occur, although it is not known whether these effects are mediated by beta-1 or beta-2 receptors. The serum potassium levels have a tendency to fall.

Clinical trials.

Salbutamol, delivered from a pressurised metered dose inhaler using chlorofluorocarbon (CFC) propellants, has been used for over 20 years in clinical practice and has been demonstrated to be safe and effective in the treatment of reversible obstructive airways disease. The following section describes clinical studies conducted to assess the therapeutic equivalence of salbutamol reformulated using a nonchlorofluorocarbon propellant, with the established product.
A clinical program was devised that included paediatric and adult patients, smokers and patients aged over 65 years. A total of 1064 patients were randomised and received study medication in six clinical studies. Of these, 586 received the CFC-free inhaler (approx. 81 patient years) and 572 received CFC containing product (approx. 79 patient years). All studies compared the CFC-free product against CFC product.
Three single dose crossover studies, two bronchial provocation studies with histamine and a dose ranging bronchodilatation study, in adults demonstrated the efficacy of salbutamol formulated with the nonchlorofluorocarbon propellant. Another bronchial provocation study demonstrated efficacy in paediatric patients.
Two randomised, double blind, parallel group multiple dosing studies were also conducted in adults. In a four week '100 microgram prn' dosing study (n = 423), patients with mild to moderate reversible airways obstruction demonstrated equivalent usage of inhaled salbutamol (daily median usage of 4 actuations/day) in both treatment groups. In a twelve week 200 microgram qds dosing study (n = 547), patients with moderate reversible airways obstruction recorded no change in heart rate (as a measure of tolerability) following the treatment period, and no detrimental effect was seen as a result of 'switching' from the CFC containing inhaler to the CFC-free inhaler.
These studies in both adult and paediatric patients showed that the CFC-free inhaler at the same dose is clinically equivalent to, and is as well tolerated as, the CFC containing inhaler. There was no evidence to suggest any possible interactions between salbutamol and nonchlorofluorocarbon propellant. There were no reports of hypokalaemia or paradoxical bronchospasm in the clinical programme. No new or unexpected adverse events were highlighted when compared to the CFC containing inhaler.

5.2 Pharmacokinetic Properties

Following inhalation, salbutamol acts topically on 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 metabolised in the lung but is converted to the 4'-o-sulphate 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 and carcinogenicity.

Salbutamol sulfate caused a significant dose related increase in the incidence of benign leiomyomas of the mesovarium in a 2 year study in the rat at oral doses of 2, 10 and 50 mg/kg. In another study this effect was blocked by the coadministration of propranolol. These findings are a drug class effect and are thought not to be relevant to the clinical use of the drug. An 18 month study in mice and a lifetime study in hamsters revealed no evidence of tumorigenicity. Studies with salbutamol revealed no evidence of mutagenesis.

4 Clinical Particulars

4.1 Therapeutic Indications

Asmol inhaler is indicated for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma and other stimuli known to induce bronchospasm.

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 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.
Asmol inhaler contains a hydrofluoroalkane (norflurane) propellant. In animal studies, norflurane has been shown to have no significant pharmacological effects, except at very high exposure concentrations when narcosis and a relatively weak sensitisation to the arrhythmogenic effects of catecholamines were found. The potency of the cardiac sensitisation was less than that of trichloromethane (CFC-11).
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
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.
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.

Spacer devices.

Most patients, particularly those with poor inhaler technique, will benefit from the consistent use of a spacer device with their metered dose inhaler (MDI or "puffer"). Use of a spacer will also decrease the amount of drug deposited in the mouth and back of the throat, and therefore reduce the incidence of local side effects such as "thrush" and a hoarse voice.
In those people using a spacer, a change in formulation of the drug used, or a change in the make of spacer, may be associated with alterations in the amount of drug delivered to the lungs. The clinical significance of these alterations is uncertain. However, in these situations, patients should be monitored for any loss of asthma control.
If using a spacer, the patient should be instructed to actuate the inhaler into the spacer and then slowly breathe in as far as possible. The patient should hold their breath for as long as comfortable, before breathing out slowly. This should be repeated for each actuation of the drug into the spacer. Any delays between actuation and inhalation should be kept to a minimum.
Static on the walls of the spacer may cause variability in drug delivery. Patients should be advised to wash the spacer in warm water and detergent and allow it to air dry without rinsing or drying with a cloth. This should be performed before initial use of the spacer and at least monthly thereafter.

Use in the elderly.

See Section 4.2 Dose and Method of Administration, Geriatric for dosage requirements.

Paediatric use.

There are no special precautions for use in children.

Effects on laboratory tests.

No data available.

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. Salbutamol and nonselective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no information on the effects of salbutamol on human fertility. Reproductive studies in rats revealed no evidence of impaired fertility.
(Category A)
Salbutamol is known to cross the placental barrier in humans. Safety for use in pregnancy has not been demonstrated, therefore the drug should not be used in pregnant women, or those likely to become pregnant, unless the expected benefit outweighs any potential risk.
Oral administration of salbutamol to rats and rabbits during pregnancy showed no teratogenic effects in offspring, but evidence of retardation of fetal development was recorded in an inhalational teratology study in rabbits at an estimated dose of 149 microgram/kg/day.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol.
Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of uncomplicated premature labour, Asmol presentations should not be used for threatened abortion during the first or second trimesters of pregnancy. Intravenous salbutamol is contraindicated in cases of antepartum haemorrhage because of the risk of further haemorrhage from an atonic uterus and there is the risk of the same problem arising inadvertently in asthmatics using salbutamol. Profuse uterine bleeding following spontaneous abortion has been reported after the use of salbutamol. Special care is required in pregnant diabetic women.
 As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefit to the mother is greater than any possible risk to the infant.

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, 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.
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. Tachycardia may occur in some patients.
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.
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.

The incidence and severity of particular side effects depends on the dosage and route of administration. Asmol does not cause difficulty in micturition because, unlike sympathomimetic drugs such as ephedrine, therapeutic doses have no alpha-adrenergic receptor stimulant activity.
Potentially serious hypokalaemia may result from beta 2 agonist therapy.
As with other inhalation therapy the potential for paradoxical bronchospasm should be kept in mind, resulting in an immediate increase in wheezing after dosing (see Section 4.4 Special Warnings and Precautions for Use).
As with other beta 2 agonists, hyperactivity has been reported rarely in children.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Asmol inhaler is administered by the inhaled route only, to be breathed in through the mouth.
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.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.

Adults and children.

If required, one or two inhalations, repeated four hourly. The bronchodilator effect of each administration of Asmol inhaler lasts for at least four hours and more frequent use should be unnecessary. The patient can readily recognise any reduction in the length of action and should be instructed to consult a doctor if the effect of a previously adequate dose lasts for less than three hours.
For detailed instructions on how to use Asmol inhaler refer to the patient information leaflet.

Note 1.

Failure to obtain relief from the inhaler may be a medical emergency. Other appropriate treatment must be instituted without delay.

Note 2.

It is important that the patient be instructed in the proper use of the pressurised aerosol.

Geriatric.

Initial doses of salbutamol in the elderly should be lower than the recommended adult dosage. The dose may then be gradually increased if sufficient bronchodilatation is not achieved.

In impaired liver function.

As about 60% of orally administered salbutamol (this includes not only tablet and syrup preparations but also approximately 90% of an inhaled dose) is metabolised to an inactive form, impairment of liver function may result in accumulation of unchanged salbutamol.

In impaired renal function.

About 60-70% of salbutamol administered by inhalation or intravenous injection is excreted in urine unchanged. Impairment of renal function may, therefore, require a reduction in dosage to prevent exaggerated or prolonged effects.

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.

4.9 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 cardioselective 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.
In treating overdosage with Asmol inhaler, it is to be remembered that forty 100 microgram puffs of the inhaler contain as much salbutamol as one 4 mg salbutamol tablet.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist Only Medicine).

6 Pharmaceutical Particulars

6.1 List of Excipients

Non-chlorofluorocarbon propellant 1,1,1,2-tetrafluoroethane (GR106642X or HFA-134a or norflurane).

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

Replace the mouthpiece cover firmly and snap it into position.
Store below 30°C. Protect from frost and direct sunlight. As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold.

6.5 Nature and Contents of Container

Asmol inhaler comprises of a suspension of salbutamol sulfate in the propellant HFA-134a.
Container type: the suspension is contained in an aluminium alloy can, sealed with a metering valve.
Pack sizes: each canister contains at least 200 actuations.
Asmol inhaler is available with or without a counter (see Section 3 Pharmaceutical Form). The counter shows how many actuations of medicine are left. The number is visible through a window in the back of the plastic actuator.
Some container types may not be marketed.

6.6 Special Precautions for Disposal

The canister should not be punctured, broken or burnt even when apparently empty.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes