Consumer medicine information

Bricanyl Turbuhaler

Terbutaline sulfate

BRAND INFORMATION

Brand name

Bricanyl Turbuhaler

Active ingredient

Terbutaline sulfate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Bricanyl Turbuhaler.

What is in this leaflet

This leaflet answers some common questions asked about Bricanyl Turbuhaler. It does not contain all the information that is known about Bricanyl Turbuhaler.

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

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

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

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

What Bricanyl Turbuhaler is used for

Bricanyl Turbuhaler contains terbutaline sulfate. Terbutaline is a bronchodilator and belongs to a group of medicines called beta-2-agonists.

Bricanyl Turbuhaler is used to open up the airways in people with asthma, bronchitis and other breathing problems so that they can breathe more easily. It can also be used before exercise to keep the airways open if you start to wheeze or have trouble breathing each time you exert yourself.

Bricanyl Turbuhaler is a reliever medicine and you should only use it when you need it.

Ask your doctor or pharmacist if you have any questions about why Bricanyl Turbuhaler has been prescribed for you. Your doctor/pharmacist may prescribe/recommend it for another reason.

Bricanyl Turbuhaler is available from a pharmacist without a doctor's prescription.

Bricanyl Turbuhaler is not addictive.

Before you use Bricanyl Turbuhaler

When you must not use it

Do not use Bricanyl Turbuhaler if you have an allergy to:

  • any medicine containing terbutaline
  • lactose (inactive ingredient in the 120 inhalations Bricanyl Turbuhaler only).

Some of the symptoms of an allergic reaction may include:

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

Do not use Bricanyl Turbuhaler after the expiry date (EXP) 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 or pharmacist.

Before you start to use it

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

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

  • heart problems
  • hypertension (high blood pressure)
  • diabetes
  • thyroid problems

It may not be safe for you to take Bricanyl Turbuhaler if you have any of these conditions.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant, or breastfeeding. Your doctor or pharmacist will advise you of the risks and benefits of using Bricanyl Turbuhaler during pregnancy and while breastfeeding.

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

Taking other medicines

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

Some medicines and Bricanyl Turbuhaler may interfere with each other. These include:

  • medicines used to treat heart problems or high blood pressure
  • medicines for glaucoma, including eye drops
  • medicines to treat asthma, bronchitis or breathing problems
  • some types of anaesthetics

These medicines may be affected by Bricanyl Turbuhaler, or may affect how well it works. You may need different amounts of your medicine, or you may need to use a different medicine. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while using Bricanyl Turbuhaler.

How to use Bricanyl Turbuhaler

You should only use Bricanyl Turbuhaler when you need it to ease your breathing. Unless your doctor or pharmacist has told you to, you should not use Bricanyl Turbuhaler regularly.

Each pack of Bricanyl Turbuhaler contains an instruction leaflet that tells you the correct way to use it. Please read it carefully.

If you are not sure how to use the Turbuhaler, ask your doctor or pharmacist.

ADULTS

The dose is one inhalation when needed up to every 4 to 6 hours. If you have severe breathing problems this may be increased to 3 inhalations.

You should not use more than 12 inhalations in any 24 hour period.

CHILDREN

Children are usually considered to be aged 12 years or less, but check with your doctor or pharmacist if you are at all worried about the dose that has been prescribed/recommended for your child.

Children should be 5 years or older before they use the Turbuhaler.

The dose is one inhalation when needed every 4 to 6 hours. If your child has severe breathing problems this may be increased to 2 inhalations.

A child should not take more than 8 inhalations in any 24-hour period.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (131 126), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Bricanyl Turbuhaler. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Bricanyl Turbuhaler you may experience shaky hands (tremor), headache, feel sick (nausea), anxious, tense, restless, excited and be unable to sleep, muscle twitching or cramps, fast or irregular heartbeats, dizziness or drowsiness.

While you are using Bricanyl Turbuhaler

Things you must do

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

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

If you find that the usual dose of Bricanyl Turbuhaler is not giving you 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 your breathing problem is controlled properly.

See your doctor regularly to ensure that your asthma is not getting worse.

It is recommended that you rinse your mouth out with water after each use if possible. Do not swallow the water.

Tell any other doctors, dentists and pharmacists who are treating you that you are using Bricanyl Turbuhaler.

If you are about to be started on a new medicine, tell your doctor or pharmacist that you are using Bricanyl Turbuhaler.

If you become pregnant while using Bricanyl Turbuhaler, tell your doctor or pharmacist.

Things you must not do

Do not use Bricanyl Turbuhaler to treat any other complaints unless your doctor tells you to.

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

Side effects

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

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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:

  • headache
  • tremor (shaky hands)
  • nervousness
  • increased heart rate or palpitations
  • nausea (feeling sick), vomiting or diarrhoea
  • a bad taste in your mouth
  • sweating, muscle twitching or cramps
  • drowsiness or dizziness
  • agitation, restlessness, hyperactivity, or disturbed sleep
  • skin rash

These side effects are usually mild.

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

  • fast or irregular heart beat
  • chest pain
  • difficulty breathing or worsening of your breathing problem

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

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

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

After using Bricanyl Turbuhaler

Cleaning

The Turbuhaler must be wiped with a clean dry tissue and must never get wet.

Full instructions on the right way to use and clean the Turbuhaler are inside each pack.

Storage

Keep your Bricanyl Turbuhaler in a cool dry place where the temperature stays below 30°C, with the cover firmly in place.

Do not store Bricanyl Turbuhaler or any other medicine in the bathroom or near a sink.

Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep it where young 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

Since some medicine may remain inside your Bricanyl Turbuhaler you should always return it to your pharmacist for disposal including:

  • when you have taken all your doses and the red mark is at the bottom of the dose indicator window (see instructions in the pack), or
  • it is damaged or past its expiry date, or
  • your doctor/pharmacist have told you to stop using it

Product description

There are two versions of Bricanyl Turbuhaler which both deliver the same amount of terbutaline sulfate (active ingredient) to the patient in each inhalation:

  • Original M2 version - 100 inhalations which contains the active ingredient only. It does not contain any other ingredients.
  • M3 version - 120 inhalations; Also contains lactose monohydrate (400 micrograms in each inhalation).

The Turbuhaler is a dry powder inhaler which is made up of plastic parts.

Supplier

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342

This leaflet was prepared 9 April 2020

Australian Registration Number:

  • AUST R 10278 (100 inhalation M2 version)
  • AUST R 315075 (120 inhalation M3 version)

Bricanyl and Turbuhaler are registered trade marks of the AstraZeneca group of companies.

© AstraZeneca, 2020

Doc ID-001914903 v5

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Bricanyl Turbuhaler

Active ingredient

Terbutaline sulfate

Schedule

S3

 

1 Name of Medicine

Terbutaline sulfate.

6.7 Physicochemical Properties

Chemical structure.

Terbutaline sulfate, 2-(tert-butylamino)-1-(3,5-dihydroxyphenyl) ethanol sulfate, a sympathomimetic bronchodilator with a degree of selective β2-stimulant activity on the respiratory system.

CAS number.

23031-32-5.

2 Qualitative and Quantitative Composition

There are two versions of Bricanyl Turbuhaler, each delivering (ex-mouthpiece) 400 microgram of terbutaline sulfate per inhalation (delivered dose):

Original M2 Turbuhaler version.

Labelled as the metered dose 500 microgram terbutaline sulfate per inhalation. It is free from propellant, lubricant, preservative, carrier substances or other additives.

M3 Turbuhaler version.

Labelled as the delivered dose 400 microgram terbutaline sulfate per inhalation (corresponding to 500 microgram metered dose). It is free from propellant, lubricant, preservative or carrier substances but contains the excipient, lactose monohydrate.

Excipient(s) with known effect.

Lactose monohydrate (M3 Turbuhaler). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for inhalation.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The tertiary butyl group attached to the terminal nitrogen of the terbutaline molecule is thought to confer selective stimulation of the pulmonary β2-receptors and only relatively minor stimulation of cardiac β1 receptors.
The potent bronchospasmolytic effect is rapid in onset and reaches a maximum about 30 minutes after subcutaneous injection, 1 hour after aerosol and 2-3 hours after oral administration. The duration of action is between 4 and 5 hours. In addition to its bronchospasmolytic effect, terbutaline has also been shown to improve mucociliary clearance.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The drug is absorbed unchanged from the respiratory tract.

Metabolism.

The presence of the two phenolic hydroxyl groups in the meta positions confers resistance to metabolism by the enzyme catechol-o-methyl transferase. Metabolism of terbutaline sulfate which is ingested orally or swallowed following inhalation is principally by conjugation in the gastrointestinal mucosa.

Excretion.

The drug is excreted mainly unchanged in the urine. Practically all of an administered dose of terbutaline is eliminated after 72 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

For 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.
Bricanyl Turbuhaler is intended for short-term management of bronchospasm.

4.3 Contraindications

Hypersensitivity to sympathomimetic amines or any other ingredient in the product (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

Treatment of asthma or COPD should be in accordance with current national treatment guidelines.
Patients with asthma should have a personal asthma action plan designed in association with their general practitioner. This plan should incorporate a stepwise treatment regimen which can be instituted if the patient's asthma improves or deteriorates.
Increasing use of short acting β2-agonists to control symptoms indicates deterioration of asthma control. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and consideration should be given to the need for starting or increasing therapy with corticosteroids.

Cardiovascular diseases and hyperthyroidism.

Caution is advised when terbutaline is administered to patients with thyrotoxicosis and to patients with hypertension, coronary artery disease, arrhythmias and tachyarrhythmia.
Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl, 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.

Arrhythmogenic potential.

β2-Stimulants have an arrhythmogenic potential which must be considered for each patient when receiving treatment for bronchospasm.

Diabetes.

Due to the blood-glucose increasing effects of β2-stimulants, extra blood glucose controls are initially recommended when diabetic patients are commenced on terbutaline.

Sensitivity to sympathomimetic amines.

Some patients may be unusually sensitive to β-adrenergic stimulants. Terbutaline should be used with caution when an increased susceptibility to sympathomimetic amines can be expected for instance in other patients with hyperthyroidism not yet adequately controlled.

Lack of response.

If the usual dose does not provide the usual relief, a non-responsive state may be developing. If a previously effective dose lasts less than usual, patients should be instructed to consult a doctor.

Hypokalaemia.

Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). It is recommended that serum potassium levels are monitored in such situations.

Acute asthma.

If patients with an acute attack of asthma fail to respond to a dry powder inhaler of β2-agonist they should be advised to follow their personal asthma action plan. Failure to respond to β2-agonists in general can be due to various reasons related to drug administration or the disease itself. Particularly in children 5 years or younger, and exceptionally in other cases, inspiratory flow through a dry powder inhaler may not be sufficient for optimal drug delivery. If a non-response occurs, medical help should be sought while a β2-agonist treatment is continued. In such a situation, and if available, a nebuliser or pressurised metered dose inhaler with spacer should be used. (see Lack of response above).

Lactose.

Bricanyl Turbuhaler (M3 version only) contains lactose monohydrate (approximately 400 microgram/inhalation delivered dose) which may contain small amounts of milk protein residues. This amount does not normally cause problems in lactose intolerant people. In patients with hypersensitivity to milk protein, these small amounts may cause allergic reactions.

Cardionecrosis.

Animal studies suggest that cardionecrotic lesions may occur with high doses of some sympathomimetic amines. On this evidence, it is not possible to exclude myocardial lesions as a possible hazard resulting from long-term treatment.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other sympathomimetic amines.

Care is recommended if it is proposed to administer terbutaline in concomitant therapy with other sympathomimetic amines as excess sympathetic stimulation may occur.

β-adrenergic blocking drugs.

β-adrenergic blocking drugs, including eye drops, may inhibit the bronchodilating effect of sympathomimetic bronchodilators and may increase airways resistance in asthmatic patients.

Halogenated anaesthetics.

Halothane anaesthesia should be avoided during β2-agonists treatment, since it increases the risk of cardiac arrhythmias. Other halogenated anaesthetics should be used cautiously together with β2-agonists.

Potassium depleting agents and hypokalaemia.

Owing to the hypokalaemic effect of β-agonists, concurrent administration with Bricanyl of serum potassium depleting agents known to exacerbate the risk of hypokalaemia (such as diuretics, methyl xanthines and corticosteroids) should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see Section 4.4 Special Warnings and Precautions for Use, Hypokalaemia). Hypokalaemia also predisposes to digoxin toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Although no adverse effects in pregnant women or their foetuses have been reported, care with Bricanyl, as with all other drugs, is recommended during the first 3 months of pregnancy.
Although terbutaline is secreted into breast milk, and milk concentrations are approximately those in maternal plasma, two individual case studies indicate that the infant is likely to receive 0.2-0.7% of the maternal dose (0.4 and 0.7 microgram/kg/day respectively), depending (for example) on the time of feeding in relation to administration of the drug. In the 4 infants studied this did not result in any signs of β-adrenoceptor stimulation.
Transient hypoglycaemia has been reported in newborn preterm infants after maternal β2-agonist treatment.

4.8 Adverse Effects (Undesirable Effects)

Most of the side effects are characteristic of sympathomimetic amines. The incidence and severity of particular side effects depends on the dose and rate of administration. An initial dose-titration will often reduce side effects. At recommended therapeutic doses, the frequency of side-effects is minimal.

More common reactions.

More commonly observed side effects include tremor and headache. Commonly observed side effects include nervousness, tachycardia, palpitations, tonic muscle cramps and hypokalaemia.

Less common reactions.

See Table 1.

Serious or life threatening reactions.

Cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles) and myocardial ischaemia have been rarely reported.
Overdose of terbutaline preparations may produce significant tachycardia, arrhythmia and hypotension (see Section 4.9 Overdose). In rare cases, through unknown mechanisms, drugs for inhalation may cause bronchospasm.

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

Inhaled bronchodilators should be used as required rather than regularly.
Dosage should be individualised. If long-term use of terbutaline is proposed, particularly if the patient is asked to take terbutaline in conjunction with other medications, objective pulmonary function testing (for example, by peak flow meter or spirometer) may be useful as part of assessment of the efficacy or treatment.

Adults and children over 12 years.

1 inhalation as required up to every 4 to 6 hours. In severe cases the single dose may be increased to 3 inhalations. The total daily dose should not exceed 12 inhalations per 24 hours.

Paediatric.

1 inhalation as required up to every 4 to 6 hours. In severe cases the single dose may be increased to 2 inhalations. The total daily dose should not exceed 8 inhalations per 24 hours.

Special patient populations.

Renal impairment.

As terbutaline sulfate is largely excreted in urine, caution should be exercised in patients with renal impairment.

Hepatic impairment.

Hepatic failure has not been shown to influence the metabolism of terbutaline. However, caution should be exercised in patients with impaired liver function.

Use in paediatric patients.

Bricanyl Turbuhaler is suitable for use by children since it is breath activated and does not require coordination of dose release and inhalation as with use of aerosol inhalers.

Method of administration.

For detailed instructions, see the Turbuhaler instructions leaflet provided in each pack of Bricanyl Turbuhaler. Patients should be instructed on how to administer the product correctly and advised to read the instruction leaflet carefully.

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. However, adverse effects of terbutaline sulfate include dizziness and drowsiness which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
There is a potential for progressive accumulation of dry powder in the mouthpiece of the Bricanyl Turbuhaler that could be released if dropped (for example, from a table) towards the end of inhaler life. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use.

Possible symptoms and signs.

Too frequent administration, as with other sympathomimetic agents, may cause nausea, headaches, changes in blood pressure, anxiety, tension, restlessness, insomnia, tremor, excitement, tonic muscle cramps, palpitations, tachycardia and cardiac arrhythmias. The symptoms and signs are those characteristic of excessive sympathetic stimulation.

Laboratory findings.

Hyperglycaemia and lactacidosis (see Section 4.4 Special Warnings and Precautions for Use) sometimes occur. β2-agonists may cause hypokalemia as a result of redistribution of potassium.

Treatment.

The specific antidote for accidental overdosage with terbutaline sulfate is a cardio-selective β-adrenergic blocking drug such as metoprolol (5-10 mg by slow intravenous injection, repeated if necessary after 5 minutes). β-blockers should be used with care because of the possibility of inducing bronchospasm in sensitive individuals.

7 Medicine Schedule (Poisons Standard)

S3.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate (Bricanyl Turbuhaler M3 version only). See Section 2 Qualitative and Quantitative Composition.

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

Store below 30°C. Replace cap firmly after use.

6.5 Nature and Contents of Container

Bricanyl Turbuhaler is a breath activated multiple dose dry powder inhaler available* as single inhaler packs:

Original M2 Turbuhaler (AUST R 10278).

100 inhalations.

M3 Turbuhaler (AUST R 315075).

120 inhalations.
* Not all presentations may be supplied in Australia.

6.6 Special Precautions for Disposal

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

Summary Table of Changes