Direct Healthcare Professional Communication (DHPC) - Carbamazepine (Tegretol 100 mg/5ml Oral Suspension): restriction of use in neonates as concentration of the excipient, propylene glycol, exceeds recommended threshold.

Tegretol syrup (carbamazepine 20 mg/ml) should not be used in newborns under 4 weeks of age (or in premature infants with a gestational age <44 weeks) because it contains a high amount of an excipient, propylene glycol, which can cause serious problems such as metabolic acidosis and renal and liverdysfunction .
Its use may be considered only if no other treatment option is available and the expected benefit outweighs the risks. In such cases, careful clinical monitoring of the newborn is recommended.
This restriction only affects to the syrup formulation, not to other Tegretol formulations.
 
Healthcare professionals are reminded of the importance of reporting suspected adverse reactions in order to monitoring drug safety and protecting patient health

The related document provides further information.

Published on: 19 December 2025