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Pregnancy: Since Tramadol HCl + Paracetamol (Tramadin Plus) is a fixed combination of active ingredients including tramadol, it should not be used during pregnancy. Data regarding paracetamol: Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosages. Data regarding tramadol: Tramadol should not be used during pregnancy as there is inadequate evidence available to assess the safety of tramadol in pregnant women. Tramadol administered before or during birth does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Long-term treatment during pregnancy may lead to withdrawal symptoms in the newborn after birth, as a consequence of habituation.
Lactation: Since Tramadol HCl + Paracetamol (Tramadin Plus) is a fixed combination of active ingredients including tramadol, it should not be ingested during breast feeding. Data regarding paracetamol: Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding by women using single ingredient medicinal products containing only paracetamol. Data regarding tramadol: Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest about 0.1% of the dose given to the mother. Tramadol should not be ingested during breast feeding.
