Hypersensitivity: Immediate hypersensitivity reactions may occur after administration of ATROVENT, as demonstrated by rare cases of rash, urticaria, angioedema, oropharyngeal oedema, bronchospasm and anaphylaxis.
Paradoxical bronchospasm: As with other inhaled medicines ATROVENT may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs ATROVENT should be discontinued immediately and substituted with an alternative therapy.
Renal and urinary effects: ATROVENT should be used with caution in patients with micturition disorders (such as in prostatic hypertrophy or bladder neck obstruction), the benefit of treatment with ipratropium bromide must be carefully weighed against the potential risk of aggravating urinary retention.
Gastro-intestinal motility disturbances: Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances.
Ocular complications: ATROVENT 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 into 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 should be sought immediately.
Patients must be instructed in the correct administration of ATROVENT.
Metered Dose Inhaler: Care must be taken not to allow the mist to enter into the eyes. Since the metered dose aerosol is applied via mouth piece and manually controlled, the risk for the mist entering the eyes is limited.
Solution for inhalation: Care must be taken not to allow the solution or mist to enter into the eyes. 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. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Local effects: Solution for inhalation: This product contains the preservative benzalkonium chloride and the stabiliser disodium edetate dihydrate. When inhaled these components may cause bronchospasm in sensitive patients with hyper reactive airways.
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, accommodation disorder, mydriasis and blurred vision during treatment with ATROVENT. Therefore, caution should be recommended when driving a car or operating machinery.