Contraindications
Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Adverse reactions (frequency and seriousness)
Dog, cat:
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Deafness1
Undetermined frequency (cannot be estimated from the available data):
Local immune deficiency2,3
Skin thinning2
Delayed healing2
Teleangiectasia2
Increased vulnerability of the skin (with bleeding)2
Reference
1 In animals treated for otitis externa, especially in older dogs. Treatment should be discontinued.
2 With prolonged use due to the contained glucocorticoid.
3 Associated with increased susceptibility to infection.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay Pregnancy and lactation:
Corticosteroids are not recommended for use in pregnant animals.
Interaction with other medicinal products and other forms of interaction
Do not use concomitantly with medicines that induce ototoxicity.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, no other adverse events are known other than those mentioned in section 4.6. In case of accidental ingestion by licking, no toxic effects were observed.