Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Terbutaline sulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Bricanyl Respules contain a medicine called terbutaline. This belongs to a group of medicines called 'beta-agonists'. These work by relaxing certain muscles and opening up the airways in the lungs.
2.
e Bricanyl Respules
Do not use Bricanyl Respules:
3.
Bricanyl Respules
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Bricanyl Respules should be used as required rather than regularly. Seek medical attention right away if your asthma symptoms (cough, breathlessness, wheezing or tight chest) are getting worse or if you are too breathless to speak, eat or sleep. You must contact your doctor as soon as possible if you need higher doses of Bricanyl Respules than usual to relieve your breathing problems. You may then need extra medication to control your asthma.
If you use Bricanyl Respules more than twice a week to treat your asthma symptoms, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can have serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment. If you use a medicine against inflammation of your lungs daily, e.g., "inhaled corticosteroid", it is important to continue using it regularly, even if you feel better. The solution in a Respule must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section 'How much to take. Children under 18 years should only use a nebuliser to take reliever medications under the care of a doctor with expertise in the management of asthma so that deterioration in asthma control can be detected and treated without delay. Only use the nebuliser recommended by your doctor and supervise your child while they are using the nebuliser. Seek urgent medical assistance if the nebulised medication is not working, even if there is short-term recovery following use of prescribed nebulised medication. How much to take The recommended dose is:
Talk to your doctor straight away if:
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Important side effects to look out for:
• • • •
Feeling sick (nausea). Mouth and throat irritation. Changes in sleeping patterns and changes in behaviour, such as feeling agitated, restless or hyperactive. Lactic acidosis is caused by a build-up of lactic acid in your blood. Symptoms of lactic acidosis include recurrent nausea and vomiting, abdominal pain and hyperventilation.
Do not be concerned by this list of side effects. You may not get any of them. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
Bricanyl Respules
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Keep this medicine out of the sight and reach of children.
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Once a foil envelope has been opened, the Respules inside should be used within 3 months. Note: It is best to mark the opening date on the foil envelope to help you remember.
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Once you have opened a single Respule, any remaining product cannot be regarded as sterile. This must be considered if the intention is to use the remaining content at a later occasion.
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Each single Respule should be used within 24 hours after it is opened. After this time the Respule and any remaining contents should be thrown away.
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Do not store above 30C. Store Bricanyl Respules in their original carton and foil, and out of direct sunlight.
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Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
What Bricanyl Respules contains The active substance is terbutaline sulfate. Each Bricanyl Respule contains 5 mg of the active ingredient, terbutaline sulfate (equivalent to 2.5 mg/ml). The other ingredients are sodium chloride, disodium edetate, hydrochloric acid and water. What Bricanyl Respules look like and the contents of the pack Respules are single dose plastic units containing 2 millilitres (ml) of solution.
The solution must be nebulised (made into a fine mist) before it can be breathed in. Bricanyl Respules are available in boxes of 20. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Bricanyl Respules is held by AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK. Bricanyl Respules are manufactured by AstraZeneca AB, SE-151 36, Södertälje, Sweden.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Bricanyl Respules 2.5 mg/ml Nebuliser Solution Reference number 17901/0114 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in: February 2026 Bricanyl and Respules are trade marks of the AstraZeneca group of companies. © AstraZeneca 2026 RSP 26 0001
Bricanyl Respules 2.5 mg/ml Nebuliser Solution comes as inhaler containing 2.5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Bricanyl Respules 2.5 mg/ml Nebuliser Solution is terbutaline sulfate.
This leaflet reproduces the patient information leaflet approved for Bricanyl Respules 2.5 mg/ml Nebuliser Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Terbutaline is a selective beta2-adrenergic agonist recommended for the relief of severe bronchospasm in bronchial asthma and in chronic bronchitis and other bronchopulmonary disorders in which bronchospasm is a complicating factor.
Posology
When used as maintenance therapy the patient should also receive optimal anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene receptor antagonists.
In most patients, the use of terbutaline sulfate, based on the doses below, given 2-4 times daily will be sufficient to relieve bronchospasm. In acute, severe asthma, additional doses may be necessary.
Bricanyl Respules:
Adults:
1 or 2 Respules (5 or 10mg)
Children:
(>25kg) 1 Respule (5mg)
Children:
(<25kg) use multidose bottles.
Multidose Bottles:
Adults: 0.5 to 1 ml (5 to 10mg) diluted to required nebuliser volume with sterile physiological saline.
Children: 0.2 to 0.5ml (2 to 5mg), see table, diluted to required nebuliser volume with sterile physiological saline.
Table illustrating ml undiluted solution from multidose bottle required for administration to children
Age
Average kg
weight lb
mg terbutaline
ml undiluted solution
<3
10
22
2.0
0.2
3
15
33
3.0
0.3
6
20
44
4.0
0.4
8+
25+
55+
5.0
0.5
Elderly: Dosage as for adults.
Method of administration
Instructions for use and cleaning are provided in the Patient Information Leaflet which can be found in each pack.
Private purchase of nebuliser devices for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended.
Only specialists in respiratory medicine should initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents.
Children should be trained in the correct use of their device to deliver rescue therapy and use should be supervised by a responsible adult.
Urgent medical assistance should be sought if worsening asthma symptoms are not relieved by rescue medicines, even if there is short-term recovery following use of prescribed medication.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Patients should be instructed in proper use and their inhalation technique checked regularly.
Patients who are prescribed regular anti-inflammatory therapy should be advised to continue taking their anti-inflammatory medication even when symptoms decrease and they do not require Bricanyl.
If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should seek medical advice as soon as possible as this could be a sign of worsening asthma and warrants a reassessment of the asthma therapy.
Patients with persistent asthma who require maintenance therapy with beta2-agonists should also receive optimal anti-inflammatory therapy e.g. inhaled corticosteroids, leukotriene receptor antagonists. These patients must be advised to continue taking their anti-inflammatory therapy after the introduction of Bricanyl even when symptoms decrease. Should symptoms persist, or if treatment with beta2-agonists needs to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the therapy. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner.
Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality.
Patients who take more than twice a week additional “as needed” terbutaline should be re-evaluated for proper treatment adjustment as these patients are at risk for overuse of terbutaline.
As for all beta2-agonists caution should be observed in patients with thyrotoxicosis.
Due to the positive inotropic effect of the beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy.
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.
Due to the hyperglycaemic effects of beta2-agonists, additional blood glucose controls are recommended initially in diabetic patients.
Potentially serious hypokalaemia may result from beta2-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). It is recommended that serum potassium levels are monitored in such situations.
Lactic acidosis has been reported in association with high therapeutic doses of parenteral and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see section 4.8 & 4.9). In patients not adequately responding to acute Bricanyl therapy, consideration should be given to the presence of lactic acidosis as a possible contributing factor to ongoing respiratory symptoms.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per respule.
Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants. Therefore, Bricanyl preparations and non-selective beta-blockers should not normally be administered concurrently. Bricanyl should be used with caution in patients receiving other sympathomimetics.
Halogenated anaesthetics
Halothane anaesthesia should be avoided during Beta2-agonists treatment, since it increases the risk of cardiac arrhythmias. Other halogenated anaesthetics should be used cautiously together with Beta2-agonists.
Potassium depleting agents and hypokalemia
Owing to the hypokalaemic effect of beta-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). Hypokalaemia also predisposes to digoxin toxicity.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
Although no teratogenic effects have been observed in animals or in patients, Bricanyl should only be administered with caution during the first trimester of pregnancy.
If used in maintenance therapy for asthma and other pulmonary diseases, Bricanyl respules should be used with caution at the end of pregnancy because of the potential tocolytic effect.
Breast-feeding
Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.
Bricanyl has no or negligible influence on the ability to drive and use machines.
Summary of safety profile
The frequency of adverse reactions is low at the recommended dose. Terbutaline given by inhalation is unlikely to produce significant systemic effects when given in recommended doses. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.
The frequency of side-effects is low at the recommended doses.
Tabulated list of adverse reaction
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
System Organ Class (SOC)
Frequency Classification
Adverse Drug Reaction
Preferred term (PT)
Immune system disorders
Not known^
Hypersensitivity reactions including angioedema, bronchospasm, hypotension and collapse
Metabolism and nutritional disorders
Common
Hypokalaemia (See section 4.4)
Not known^
Lactic acidosis
Psychiatric disorders
Not known^
Sleep disorder and Behavioural disturbances, such as agitation and restlessness
Nervous system disorders
Very Common
Tremor
Headache
Cardiac disorders
Common
Tachycardia
Palpitations
Not known^
Arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles
Myocardial ischaemia (See section 4.4)
Vascular disorders
Not known^
Peripheral vasodilation
Respiratory, thoracic and mediastinal Disorders
Not known^
Paradoxical bronchospasm*
Gastrointestinal disorders
Not known^
Nausea
Mouth and throat irritation
Skin and subcutaneous tissue disorders
Not known^
Urticaria
Rash
Musculoskeletal and connective tissue disorders#
Common
Muscle spasms
# A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.
^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown
* In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator. Bricanyl therapy should be discontinued and after assessment, an alternative therapy initiated.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
i) Possible symptoms and signs
Headache, anxiety, tremor, nausea, tonic cramp, palpitations, tachycardia and arrhythmia. A fall in blood pressure sometimes occurs. Laboratory findings; hypokalaemia, hyperglycaemia and metabolic acidosis sometimes occur (see section 4.4).
ii) Treatment
Mild and moderate cases: Reduce the dose.
Severe cases: Gastric lavage, administration of activated charcoal, (where suspected that significant amounts have been swallowed). Determination of acid-base balance, blood sugar and electrolytes, particularly serum potassium levels. Monitoring of heart rate and rhythm and blood pressure. Metabolic changes should be corrected. A cardioselective beta-blocker (e.g. metoprolol) is recommended for the treatment of arrhythmias causing haemodynamic deterioration. The beta-blocker should be used with care because of the possibility of inducing bronchoconstriction: use with caution in patients with a history of bronchospasm. If the beta-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.
Ask anything about Bricanyl Respules 2.5 mg/ml Nebuliser Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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