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Pregnancy and Breast-feeding: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or post-natal development (see Pharmacology: Toxicology: Non-clinical Information: Preclinical Safety Data under Actions). Tramadol has been shown to cross the placenta. There is inadequate evidence available on the safety of tramadol in human pregnancy. Therefore TRAMAPAN should not be used in pregnant women. The effect of TRAMAPAN if any, on the later growth, development, and functional maturation of the child is unknown.
The use of opioids during childbirth might result in respiratory depression in the newborn infant.
Prolonged use of TRAMAPAN, or other opioids, during pregnancy may lead to neonatal opioid withdrawal syndrome. This risk is particularly increased during the last trimester of pregnancy.
TRAMAPAN is not recommended for breast feeding mothers because its safety in infants and newborns has not been studied.
Tramadol is subject to the same polymorphic metabolism as codeine, with ultra-rapid metabolizers of CYP2D6 substrates being potentially exposed to life-threatening levels of O-desmethyltramadol (M1). At least one death was reported in a breast-feeding infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine. A baby breast-feeding from an ultra-rapid metabolizer mother taking TRAMAPAN could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression. For this reason, breast-feeding is not recommended during treatment with TRAMAPAN.
Fertility: The effect of tramadol or tramadol/paracetamol combination on human fertility has not been evaluated.
