Immediate hypersensitivity reactions may occur after administration of COMBIVENT, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.
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 escaped into the eyes.
Eye pain or discomfort, blurred vision, visual halos or colored 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.
Patients must be instructed in the correct administration of COMBIVENT.
Care must be taken not to expose the eyes to the aerosol or solution of COMBIVENT.
Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
In the following conditions COMBIVENT 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, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, tachyarrhythmia or severe heart failure) who are receiving salbutamol for respiratory disease, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.
Potentially serious hypokalaemia may result from beta2-agonist therapy. Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm.
Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances.
In the case of acute, rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.
If higher than recommended doses of COMBIVENT are required to control symptoms, the patient's therapy plan should be reviewed by a doctor.
Unit dose vials: It is recommended that the nebulised solution be administered via a mouth piece. If this is not available and a nebuliser mask is used, it must fit properly.