Revised SPCs: Zydol (tramadol) products

SPC now notes regular use during pregnancy may cause drug dependency in the foetus and withdrawal symptoms in the neonate; administration to nursing women is not recommended as it may be secreted in breast milk and cause respiratory depression in the infant.

SPS commentary:

The following statements have also been added:

 - Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome

 - Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.


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