Veltila-500 Warnings

Liver dysfunction: Conditions of occurrence: Cases of severe liver damage resulting sometimes in fatalities have been reported.
Experience in epilepsy has indicated that patients most at risk especially in cases of multiple anticonvulsant therapy are infants and young children under the age of 3 with severe seizure disorders, particularly those with brain damage, mental retardation and (or) congenital metabolic or degenerative disease.
After the age of 3, the incidence of occurrence is reduced and decreases with age.
In most cases, such liver damage occurred during the first 6 months of therapy.
Suggestive signs: Clinical symptoms are essential for early diagnosis. In particular, the following conditions, which may precede jaundice, should be taken into consideration, especially in patients at risk (see "Conditions of occurrence" as previously mentioned): non-specific symptoms, usually of sudden onset, such as asthenia, anorexia, lethargy, drowsiness, which are sometimes associated with repeated vomiting and abdominal pain; in patients with epilepsy, recurrence of seizures.
Patients (or their family for children) should be instructed to report immediately any such signs to a physician should they occur. Investigations including clinical examination and biological assessment of liver function should be undertaken immediately.
Detection: Liver function should be performed before and then periodically monitored during the first 6 months of therapy. Amongst usual investigations, tests which reflect protein synthesis, particularly prothrombin rate, are most relevant. Confirmation of an abnormally low prothrombin rate, particularly in association with other biological abnormalities (significant decrease in fibrinogen and coagulation factors; increased bilirubin level and raised transaminases) requires cessation of VELTILA therapy. As a matter of precaution and in case they are taken concomitantly salicylates should also be discontinued since they employ the same metabolic pathway.
Pancreatitis: Severe pancreatitis, which may result in fatalities, has been rarely reported. Young children are at particular risk. This risk decreased with increasing age. Severe seizures, neurological impairment or anticonvulsant therapy may be risk factors. Hepatic failure with pancreatitis increases the risk of fatal outcome.