EPISENTA®CAPSULESContents of capsule may be mixed
with cold soft food or drink and swallowed immediately
without chewing.
EPILIM®SYRUPMay be diluted, preferably in Syrup BP;
use within 14 days.
EPISENTA®GRANULESGranules may be mixed with cold
soft food or drink and swallowed immediately without
chewing.
EPILIM CHRONOSPHERE®Granules may be mixed with
soft food or drink that is cold or at room temperature, and
swallowed immediately without chewing.
lPRESCRIBING AND DISPENSING INFORMATIONThe
Pregnancy Prevention Programme is supported by the
following materials provided by the manufacturer:Patient
Guide,Guide for Healthcare Professionals,Risk
Acknowledgement Form, and for pharmacists,Patient Cards
andStickers with warning symbols; the MHRA has also
produced a patient information sheet providing advice for
women and girls taking valproate medicines.
Switching between formulationsCare should be taken when
switching between oral formulations in the treatment of
epilepsy. The need for continued supply of a particular
manufacturer’s product should be based on clinical
judgement and consultation with the patient or their
carer, taking into account factors such as seizure
frequency and treatment history.
Patients being treated for epilepsy may need to be
maintained on a specific manufacturer’s branded or
generic oral sodium valproate product.
EPILIM CHRONOSPHERE®Prescribe dose to the nearest
whole 50 -mg sachet.
lPATIENT AND CARER ADVICE
Valproate use by women and girlsThe MHRA advises women
and girls shouldnotstop taking valproate withoutfirst
discussing it with their doctor.
Blood or hepatic disordersPatients or their carers should be
told how to recognise signs and symptoms of blood or liver
disorders and advised to seek immediate medical attention
if symptoms develop.
PancreatitisPatients or their carers should be told how to
recognise signs and symptoms of pancreatitis and advised
to seek immediate medical attention if symptoms such as
abdominal pain, nausea, or vomiting develop.
Pregnancy Prevention ProgrammePharmacists must ensure
that female patients have a patient card—see also
Important safety information.
Medicines for Children leaflet: Sodium valproate for preventing
seizureswww.medicinesforchildren.org.uk/sodium-valproate-
for-preventing-seizures
EPISENTA®CAPSULESPatients and carers should be
counselled on the administration of capsules.
EPISENTA®GRANULESPatients and carers should be
counselled on the administration of granules.
EPILIM CHRONOSPHERE®Patients and carers should be
counselled on the administration of granules.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution,
suppository
Modified-release tablet
CAUTIONARY AND ADVISORY LABELS8, 10, 21, 25
▶Epilim Chrono(Sanofi)A
Sodium valproate 200 mgEpilim Chrono 200 tablets|
100 tabletP£ 11. 65 DT = £ 11. 65
Sodium valproate 300 mgEpilim Chrono 300 tablets|
100 tabletP£ 17. 47 DT = £ 17. 47
Sodium valproate 500 mgEpilim Chrono 500 tablets|
100 tabletP£ 29. 10 DT = £ 29. 10Gastro-resistant tablet
CAUTIONARY AND ADVISORY LABELS5, 8, 10, 25
▶Sodium valproate (non-proprietary)A
Sodium valproate 200 mgSodium valproate 200 mg gastro-
resistant tablets| 100 tabletP£ 7. 70 DT = £ 4. 04
Sodium valproate 500 mgSodium valproate 500 mg gastro-
resistant tablets| 100 tabletP£ 19. 25 DT = £ 7. 50
▶Epilim(Sanofi)A
Sodium valproate 200 mgEpilim 200 gastro-resistant tablets|
100 tabletP£ 7. 70 DT = £ 4. 04
Sodium valproate 500 mgEpilim 500 gastro-resistant tablets|
100 tabletP£ 19. 25 DT = £ 7. 50
Tablet
CAUTIONARY AND ADVISORY LABELS8, 10, 21
▶Epilim(Sanofi)A
Sodium valproate 100 mgEpilim 100 mg crushable tablets|
100 tabletP£ 5. 60 DT = £ 5. 60
Powder and solvent for solution for injection
▶Sodium valproate (non-proprietary)A
Sodium valproate 400 mgSodium valproate 400 mg powder and
solvent for solution for injection vials| 4 vialP£ 49. 00
Solution for injection
▶Sodium valproate (non-proprietary)A
Sodium valproate 100 mg per 1 mlSodium valproate 400 mg/ 4 ml
solution for injection ampoules| 5 ampouleP£ 57. 90
Modified-release capsule
CAUTIONARY AND ADVISORY LABELS8, 10, 21, 25
▶Episenta(Desitin Pharma Ltd)A
Sodium valproate 150 mgEpisenta 150 mg modified-release
capsules| 100 capsuleP£ 7. 00
Sodium valproate 300 mgEpisenta 300 mg modified-release
capsules| 100 capsuleP£ 13. 00 DT = £ 13. 00
Oral solution
CAUTIONARY AND ADVISORY LABELS8, 10, 21
▶Sodium valproate (non-proprietary)A
Sodium valproate 40 mg per 1 mlSodium valproate 200 mg/ 5 ml
oral solution sugar free sugar-free| 300 mlP£ 4. 46 – £ 7. 78 DT =
£ 4. 46
▶Epilim(Sanofi)A
Sodium valproate 40 mg per 1 mlEpilim 200 mg/ 5 ml liquid sugar-
free| 300 mlP£ 7. 78 DT = £ 4. 46
Epilim 200 mg/ 5 ml syrup| 300 mlP£ 9. 33 DT = £ 9. 33
Modified-release granules
CAUTIONARY AND ADVISORY LABELS8, 10, 21, 25
▶Epilim Chronosphere MR(Sanofi)A
Sodium valproate 50 mgEpilim Chronosphere MR 50 mg granules
sachets sugar-free| 30 sachetP£ 30. 00
Sodium valproate 100 mgEpilim Chronosphere MR 100 mg granules
sachets sugar-free| 30 sachetP£ 30. 00 DT = £ 30. 00
Sodium valproate 250 mgEpilim Chronosphere MR 250 mg granules
sachets sugar-free| 30 sachetP£ 30. 00 DT = £ 30. 00
Sodium valproate 500 mgEpilim Chronosphere MR 500 mg granules
sachets sugar-free| 30 sachetP£ 30. 00 DT = £ 30. 00
Sodium valproate 750 mgEpilim Chronosphere MR 750 mg granules
sachets sugar-free| 30 sachetP£ 30. 00 DT = £ 30. 00
Sodium valproate 1 gramEpilim Chronosphere MR 1000 mg
granules sachets sugar-free| 30 sachetP£ 30. 00 DT = £ 30. 00
▶Episenta(Desitin Pharma Ltd)A
Sodium valproate 500 mgEpisenta 500 mg modified-release
granules sachets sugar-free| 100 sachetP£ 21. 00 DT = £ 21. 00
Sodium valproate 1 gramEpisenta 1000 mg modified-release
granules sachets sugar-free| 100 sachetP£ 41. 00 DT = £ 41. 00Stiripentol 26-Oct-2017
lINDICATIONS AND DOSE
Adjunctive therapy of refractory generalised tonic-clonic
seizures in children with severe myoclonic epilepsy in
infancy (Dravet Syndrome) in combination with
clobazam and valproate (under expert supervision)
▶BY MOUTH
▶Child 3–17 years:Initially 10 mg/kg daily in 2 – 3 divided
doses, increased to up to 50 mg/kg daily in 2 – 3 divided
doses, titrated over minimum of 3 dayslCONTRA-INDICATIONSHistory of psychosis
lINTERACTIONS→Appendix 1 : antiepileptics210 Epilepsy and other seizure disorders BNFC 2018 – 2019
Nervous system4