Hypersensitivity: Immediate hypersensitivity reactions may occur after administration of BERODUAL, as demonstrated by rare cases of urticaria, angio-oedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
Paradoxical bronchospasm: As with other inhaled medicines BERODUAL may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs BERODUAL should be discontinued immediately and substituted with an alternative therapy.
Ocular complications: BERODUAL should be used with caution in patients predisposed to narrow-angle glaucoma.
There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide either alone or in combination with an adrenergic beta2-agonist, has come in contact with the eyes.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Thus patients must be instructed in the correct administration of BERODUAL. Care must be taken not to allow the product to enter the eyes.
For BERODUAL solution for inhalation, it is recommended that the nebulised solution is administered via a mouth piece. If this is not available and a nebuliser mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Systemic effects: In the following conditions BERODUAL should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used: Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, or with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-neck obstruction).
Cardiovascular effects: Cardiovascular effects may be seen with sympathicomimetic drugs, including BERODUAL. 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 BERODUAL, 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.
Hypokalaemia: Potentially serious hypokalaemia may result from beta2-agonist therapy (see also Overdosage).
Gastro-intestinal motility disturbances: Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances.
Dyspnoea: In the case of acute, rapidly worsening dyspnoea, a physician should be consulted immediately.
Prolonged use: In patients with bronchial asthma BERODUAL should be used only on an as-needed basis. In patients with mild COPD on demand (symptom-oriented) treatment may be preferable to regular use.
The addition or the increase of anti-inflammatory therapy to control airway inflammation and to prevent deterioration of disease control should be considered for patients with bronchial asthma and with steroid-responsive COPD.
The use of increasing amounts of beta2-agonists containing products such as BERODUAL on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. If bronchial obstruction deteriorates it is inappropriate and possibly hazardous to simply increase the use of beta2-agonist containing products such as BERODUAL beyond the recommended dose over extended periods of time. In this situation, the patient's therapy plan, and in particular the adequacy of anti-inflammatory therapy with inhaled corticosteroids, should be reviewed to prevent potentially life threatening deterioration of disease control.
Concomitant use with other sympathomimetic bronchodilators: Other sympathomimetic bronchodilators should only be used with BERODUAL under medical supervision (see Interactions).
Doping warning: The use of BERODUAL may lead to positive results with regard to fenoterol in tests for nonclinical substance abuse, e.g. in the context of athletic performance enhancement (doping).
Excipients: This product contains 0.1mg benzalkonium chloride in each mL. Benzalkonium chloride may cause wheezing and breathing difficulties, Patients with asthma are at an increased risk for these adverse events.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that they may experience undesirable effects such as dizziness, tremor, accommodation disorder, mydriasis and blurred vision during treatment with BERODUAL. Therefore, caution should be recommended when driving a car or operating machinery.