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Ilvico® Cold and Flu film-coated tablets contain Paracetamol 325 mg, Caffeine 30 mg and Brompheniramine maleate 3 mg.
There is a new contraindication for Ilvico® administration with monoamine oxidase inhibitors (MAOIs) concomitantly or within the last 14 days. This is due to the increased risk of serotonin syndrome. Furthermore, monoamine oxidase inhibitors enhance the anticholinergic effects of antihistamines such as brompheniramine.
This contraindication has been added to Section 4.3 of the SmPC and to the package leaflet.
Healthcare professionals are asked to report any suspected adverse reactions to HPRA Pharmacovigilance using the report form on the HPRA website, Adverse events should also be reported to P&G Health Germany GmbH, which can be contacted via the following call numbers in Ireland: 1800509242 and 1800509529, or by e-mail: consumerrelation.im@pg.com.
A copy of the HRPA Safety Notice can be downloaded here.
