Summary of safety profile
The intensity of the adverse reactions depends on dosage and route of administration. 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 reactions
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 |
Immune System Disorders | Not Known ^ | Hypersensitivity reactions including angioedema, bronchospasm, hypotension and collapse |
Metabolism and Nutrition Disorders | Common | Hypokalaemia (see section 4.4) |
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 spasm |
^ 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.
# A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.
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