All forms of epilepsy

Child 1 month–11 years: Initially 10–15 mg/kg daily in 1–2 divided doses (max. per dose 600 mg); maintenance 25–30 mg/kg daily in 2 divided doses, doses up to 60 mg/kg daily in 2 divided doses may be used in infantile spasms; monitor clinical chemistry and haematological parameters if dose exceeds 40 mg/kg daily

Child 12–17 years: Initially 600 mg daily in 1–2 divided doses, increased in steps of 150–300 mg every 3 days; maintenance 1–2 g daily in 2 divided doses; maximum 2.5 g per day

Adult: Initially 600 mg daily in 1–2 divided doses, then increased in steps of 150–300 mg every 3 days; maintenance 1–2 g daily, alternatively maintenance 20–30 mg/kg daily; maximum 2.5 g per day

Migraine prophylaxis

Adult: Initially 200 mg twice daily, then increased if necessary to 1.2–1.5 g daily in divided doses.

Mania

Adult: Initially 750 mg daily in 1–2 divided doses, adjusted according to response, usual dose 1–2 g daily in 1–2 divided doses, doses greater than 45 mg/kg daily require careful monitoring.

Valproate Medicines: Contra-Indicated in Women and Girls of Childbearing Potential Unless Conditions of Pregnancy Prevention Programme are met

Valproate is highly teratogenic and evidence supports that use in pregnancy leads to neurodevelopmental disorders (approx. 30–40% risk) and congenital malformations (approx. 10% risk).Valproate must not be used in women and girls of childbearing potential unless the conditions of the Pregnancy Prevention Programme are met and only if other treatments are ineffective or not tolerated, as judged by an experienced specialist. Use of valproate in pregnancy is contra-indicated for migraine prophylaxis and bipolar disorder; it must only be considered for epilepsy if there is no suitable alternative treatment. Women and girls (and their carers) must be fully informed of the risks and the need to avoid exposure to valproate medicines in pregnancy

Further Information

Acute porphyrias known or suspected mitochondrial disorder (liver failure and liver-related deaths). Personal or family history of severe hepatic dysfunction. Urea cycle disorders (risk of hyperammonaemia)

Conception and Contraception advised that all women and girls of childbearing potential be in treated with valproate medicines must be supported on a Pregnancy Prevention Programme- pregnancy should be excluded before treatment initiation and highly effective

Contraception must be used during treatment.

Pregnancy For migraine prophylaxis [unlicensed] and bipolar disorder, it is advised that valproate must not be used. For epilepsy, the MHRA advises valproate must not be used unless there is no suitable alternative treatment; in such cases, access to counselling about the

Common or very common abdominal pain, Agitation, alopecia (regrowth may be curly), Anaemia, Behaviour abnormal, Concentration impaired, Confusion, Deafness, Diarrhoea, Drowsiness, Haemorrhage, Hallucination, headache, Hepatic disorders, Hypersensitivity, Hyponatraemia, Memory loss, Menstrual cycle irregularities, Movement disorders, Nail disorder, Nausea, Nystagmus, Oral disorders, Seizures, Stupor, thrombocytopenia, Tremor, Urinary disorders, Vomiting, weight increased

Uncommon Androgenetic alopecia, Angioedema, Bone disorders, Bone fracture, Bone marrow disorders, Coma, encephalopathy, Hair changes, Hypothermia, Leukopenia pancreatitis anesthesia, Parkinsonism, Peripheral oedema, Pleural effusion, Renal failure SIADH, Skin reactions, Vasculitis, Virilise

Rare or very rare Agranulocytosis, Cerebral atrophy, Cognitive disorder, Dementia, Diplopia gynaecomastia, hyperammonaemia, Hypothyroidism, Infertility male, learning disability, Myelodysplastic syndrome, Nephritis tubulointerstitial, Obesity, Polycystic ovaries, Red blood cell abnormalities, Rhabdomyolysis, Severe cutaneous adverse reactions (SCARs), Systemic lupus erythematosus (SLE), Urine abnormalities Frequency not known Alertness increased, Suicidal behaviours

 Specific Side-Effects

Hepatic dysfunction Withdraw treatment immediately if persistent vomiting and abdominal pain, anorexia, jaundice, oedema, malaise, drowsiness, or loss of seizure control, Pancreatitis Discontinue treatment if symptoms of pancreatitis develop

Store in a cool and dry place

10×10 Tablets