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CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, an

Taking into account the PRAC Assessment Report on the PSUR(s) for furosemide / spironolactone, the scientific conclusions are as follows: Both spironolactone and trimethoprim can cause hyperkalaemia. In a case control study that compared with amoxicillin, trimethoprim / sulfamethoxazole was associated with a more than two fold increase in the risk of sudden death when co-administered with spironolactone. Whilst the PRAC agrees that the study had some limitations, which impede the judgment of causality, it nevertheless considers the theoretic biological mechanism of additive hyperkalaemia as strongly compelling for the causality.

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