Berodual Special Precautions

Prolonged Use: In patients with bronchial asthma, Berodual should be used only on an as needed basis. In patients with mild COPD, on demand treatment (symptom-oriented) may be preferable to use regularly. The addition or the increase of anti-inflammatory therapy to control airway inflammation and to prevent the deterioration of disease control should be considered for patients with bronchial asthma and steroid-responsive COPD.
The use of increasing amounts of β₂-agonists-containing products eg, 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 β₂-agonist-containing products eg, 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.
Other sympathomimetic bronchodilators should only be used with Berodual under strict medical supervision.
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 and pheochromocytoma or with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-neck obstruction).
Cardiovascular effects may be seen with sympathomimetic drugs, including Berodual. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with β-agonists. Patients with underlying severe heart disease (eg, 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 the assessment of symptoms eg, dyspnoea and chest pain, as they may be of either respiratory or cardiac origin. Potentially serious hypokalemia may result from β₂-agonist therapy.
Berodual should be used with caution in patients predisposed to narrow-angled glaucoma, or with preexisting urinary outflow tract obstruction (eg, prostatic hyperplasia or bladder-neck obstruction).
There have been isolated reports of ocular complications (ie, mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolized ipratropium bromide, either alone or in combination with an adrenergic β₂-agonist, has come in contact with. Thus, patients must be instructed in the correct administration of Berodual metered aerosol.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion an 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.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Immediate hypersensitivity reactions may occur after administration of Berodual as demonstrated by rare cases of urticaria, angiooedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
The use of Berodual may lead to positive result with regard to fenoterol in tests for nonclinical substance abuse eg, in the context of athletic performance enhancement (doping).
Paradoxical bronchospasm: if paradoxical bronchospasm occurs BERODUAL should be discontinued immediately and alternative therapy substituted.
Doping warning: may lead to positive results with regard to fenoterol in tests for nonclinical substance abuse.
Effects on the Ability to Drive or Operate Machinery: 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 eg, dizziness, tremor accomodation disorder, mydriasis and blurred vision during treatment with Berodual. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects, they should avoid potentially hazardous tasks eg, driving or operating machinery.