Answer
Pregnancy requires an individual specialist benefit–risk assessment because evidence is limited and neonatal withdrawal or breathing suppression may occur. The selected product information advises against use while breastfeeding because infant respiratory depression cannot be excluded.
Sources for this answer
- Tapentadol Aspire 250 mg prolonged-release tablets — Current selected SmPCemc · Summary of Product Characteristics
- Tapentadol Neuraxpharm 150 mg prolonged-release capsules, hard — Current selected SmPC