23 Sep DHCPL – Tegretol S 100 mg Per 5 ml Carbamazepine Suspension
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Novartis, during its portfolio review (Tegretol S® oral suspension included) observed the possibility of exceeding defined permitted daily exposure (PDE) when the product is taken above 1200 mg/day in adult patients because of the quantity of sorbitol in the formulation. Sorbitol is one of the major potential sources of ethylene glycol (EG) because of its quantity in the formulation of Tegretol S® oral suspension.
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Document Number:
DHCPL
Version:
1
Date Updated:
23/09/2024
File Type:
pdf
Category:
Communication To Health Care Professionals