Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Tropex should not be used in patients who have perforated eardrums.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Tropex should not be used in patients who have perforated eardrums.
Oral phenazone affects the metabolism of drugs broken down by liver enzymes. However, little absorption is expected from topical application into the auditory canal.
There is no information to contraindicate the use of Tropex during pregnancy or lactation.
None known.
Phenazone may give rise to skin eruptions and hypersensitivity reactions.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +353 1 6764971; Fax +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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