Epilim 100 Crushable

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium valproate 100mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Sodium valproate 100 mg

Dosage:

100 mg

Pharmaceutical form:

Tablet

Composition:

Active: Sodium valproate 100mg Excipient: Hydrated silica Light kaolin Magnesium stearate Maize starch Purified water

Units in package:

Blister pack, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Therapeutic indications:

Epilepsy: Primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). Partial (focal) epilepsy either alone or as adjuvant therapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1986-03-17

Patient Information leaflet

Epilim®
1
EPILIM
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING EPILIM?
Epilim contains the active ingredient sodium valproate. Epilim is used
to treat epilepsy in adults and children and bipolar disorder
in adults.
For more information, see Section 1. Why am I using Epilim?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EPILIM?
Do not use if you have ever had an allergic reaction to Epilim or any
of the ingredients listed at the end of the CMI.
EPILIM CAN SERIOUSLY HARM AN UNBORN CHILD WHEN TAKEN DURING PREGNANCY.
IF YOU ARE A FEMALE ABLE TO HAVE A BABY, YOU MUST USE
AN EFFECTIVE METHOD OF BIRTH CONTROL (CONTRACEPTION) DURING YOUR
ENTIRE TREATMENT WITH EPILIM. RISK OF PATERNAL EXPOSURE, RISK
OF NEURODEVELOPMENT DISORDERS IN CHILDREN BORN TO MEN TREATED WITH
VALPROATE CANNOT BE EXCLUDED. ENSURE THAT YOUR DOCTOR
HAS ADVISED YOU OF THE RISKS, ALTERNATIVE TREATMENT OPTIONS, OR IF
REMAINING ON EPILIM THE NEED FOR EFFECTIVE CONTRACEPTION.
SCHEDULE AN URGENT APPOINTMENT WITH YOUR DOCTOR IF YOU WANT TO BECOME
PREGNANT OR IF YOU THINK YOU BECAME PREGNANT. DO
NOT STOP TAKING EPILIM UNLESS YOUR DOCTOR TELLS YOU TO, AS IT MAY BE
DANGEROUS FOR YOU.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Epilim?
in the full CMI and read the patient guide available
electronically through QR code on the carton
(www.sanofi.com.au/valproate)
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Epilim and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE EPILIM?
•
Your doctor will tell you how much to take. This may depend on your
age, your condition and whether or not you are taking
any other medicines.
More in

Summary of Product characteristics

epilim-ccdsv38-dsv28-24nov23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Epilim 100 crushable tablet, 100 mg
Epilim EC modified release tablet, 200 mg
Epilim EC modified release tablet, 500 mg
Epilim Syrup, 200 mg/5 mL
Epilim Liquid oral solution (sugar free), 200mg/5mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epilim 100 Crushable Tablets contain 100 mg sodium valproate.
Epilim EC Modified Release Tablets contain 200 mg sodium valproate.
Epilim EC Modified Release Tablets contain 500 mg sodium valproate.
Epilim Syrup, each 5 mL of syrup contains 200 mg sodium valproate.
Excipients of known
effects: sucrose, saccharin sodium and sorbitol.
Epilim Liquid Oral Solution (sugar free), each 5mL of liquid contains
200 mg sodium valproate.
Excipients of known effects: saccharin sodium, sorbitol solution (70%)
(non-crystallising),
sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Crushable tablet, 100 mg (white, scored).
Modified release tablet, 200 mg (lilac, enteric-coated).
Modified release tablet, 500 mg (lilac enteric-coated).
Syrup, 200 mg/5 mL (red, cherry flavoured).
Oral solution sugar free liquid, 200 mg/5 mL (red, cherry flavoured)
epilim-ccdsv38-dsv28-24nov23
Page 2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_EPILEPSY _
Primary generalised epilepsy (petit mal absences, various forms of
myoclonic epilepsy and tonic-
clonic grand mal seizures). Partial (focal) epilepsy either alone or
as adjuvant therapy. In women
of child bearing potential effective contraception must also be
prescribed.
_BIPOLAR DISORDER _
For the treatment of manic episodes, maintenance and prophylactic
treatment of bipolar disorder
when other treatments have failed. In women of child bearing potential
effective contraception
must also be prescribed. The safety and efficacy of sodium valproate
for the treatment of manic
episodes in bipolar disorder have not been evaluated in patients aged
less than 18 years.
4.2
DOSE AND METHOD