SmPC - Duloxetine 60mg hard Gastro-resistant Capsules: Change history

Section 4.4 – Deletion of “or buprenorphine, tramadol and pethidine”Addition of “SodiumThis medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.”Section 4.6 – Deletion of “There are no adequate data on the use of duloxetine in pregnant women”, “The potential risk for humans is unknown” and “Observational data have provided evidence of an increased risk (less than 2-fold) of postpartum haemorrhage following duloxetine exposure within the month prior to birth.”Addition of “Two large observational studies do not suggest an overall increased risk of major congenital malformation (one from the US including 2,500 exposed to duloxetine during the first trimester and one from the EU including 1,500 exposed to duloxetine during the first trimester). The analysis on specific malformations such as cardiac malformations shows inconclusive results.In the EU study, maternal exposure to duloxetine during late pregnancy (at any time from 20 weeks gestational age to delivery) was associated with an increased risk for preterm birth (less than 2-fold, corresponding to approximately 6 additional premature births per 100 women treated with duloxetine late in pregnancy). The majority occurred between 35 and 36 weeks of gestation. This association was not seen in the US study.The US observational data have provided evidence of an increased risk (less than 2-fold) of postpartum haemorrhage following duloxetine exposure within the month prior to birth.”