Veltila-500 Special Precautions

Liver function tests should be carried out before therapy (see "Contraindications"), and periodically during the first 6 months especially in patients at risk (see "Warnings").
As with most anti-epileptic drugs, mild increased liver enzymes may be noted, particularly at the beginning of therapy; they are transient and isolated, without clinical sign.
More extensive biological investigations (including prothrombin rate) are recommended in those patients; an adjustment of dosage may be considered when appropriate and tests should be repeated as necessary.
Blood tests (blood cell count, including platelet count, bleeding time and coagulation tests) are recommended prior to initiation of therapy or before surgery, and in case of spontaneous bruising or bleeding (see "Side Effects").
In patients with renal insufficiency, it may be necessary to decrease dosage. As monitoring of plasma concentrations may be misleading, dosage should be adjusted according to clinical monitoring (see "Pharmacology: Pharmacokinetics under Actions").
Although immune disorders have been only exceptionally noted during the use of VELTILA, the potential benefit of VELTILA should be weighed against its potential risk in patients with systemic lupus erythematosus.
Exceptional cases of pancreatitis have been reported; therefore patients experiencing acute abdominal pain should have a prompt medical evaluation. In case of pancreatitis, valproate should be interrupted.
When a urea cycle enzymatic deficiency is suspected, metabolic investigations should be performed prior to treatment because of the risk of hyperammonemia with valproate.
Patients should be warned of the risk of weight gain at the initiation of therapy; and appropriate strategies should be adopted to minimise it (see "Side Effects").
Diabetic patients: VELTILA is eliminated mainly through the kidneys, partly in the form of ketone bodies, and this may give false positive readings in the urine testing of possible diabetics.
Effect on ability to drive and use machines: Patient should be warned of the risk of somnolence especially in cases of anticonvulsant polytherapy or association with benzodiazepines (see "Interactions").
Use in Children: Monotherapy is recommended in children under the age of 3 years when prescribing VELTILA, but the potential benefit of VELTILA should be weighed against the risk of liver damage or pancreatitis in such patients prior to initiation of therapy (see "Warnings").
The concomitant use of salicylates should be avoided in those children under 3 due to the risk of liver toxicity.