EPILIM LIQUID sodium valproate 40 mg/mL sugar free oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium valproate, Quantity: 40 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); sodium methyl hydroxybenzoate; citric acid; brilliant scarlet 4R; hyetellose; sodium propyl hydroxybenzoate; saccharin sodium; Flavour

Administration route:

Oral

Units in package:

300mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

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. Mania: For the treatment of mania where other therapy has proved inadequate or is inappropriate

Product summary:

Visual Identification: Clear cherry-red slightly viscous liquid; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2000-06-30

Patient Information leaflet

EPILIM
®
E
p
i
l
i
m
®
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.
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.
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.
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 instructions can be found in Section 4. How do I use Epilim? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EPILIM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Epilim.
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are taking
this medicine.
•
If you become pregnant while you are taking this medicine, tell your
doctor immediately
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dosage, without
checking with your doctor.
•
Do not take more than the recommended dose unless your doctor tells
you to.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Epilim
affects you.
•
Children should not ride a bike, climb trees or do anything else that
could be d

Summary of Product characteristics

epilim-ccdsv31-34-35-piv26-30aug22
Page 1 of 37
AUSTRALIAN PRODUCT INFORMATION
EPILIM
® (SODIUM VALPROATE) CRUSHABLE TABLETS, ENTERIC-
COATED TABLETS, SYRUP, LIQUID
1
NAME OF THE MEDICINE
Sodium valproate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Crushable tablets, Sodium valproate 100 mg.
Enteric-coated tablets, Sodium valproate 200 mg.
Enteric-coated tablets, Sodium valproate 500 mg.
Syrup, Sodium valproate 200 mg/5 mL. Excipients of known effects:
sucrose, saccharin
sodium and sorbitol.
Sugar free liquid, Sodium valproate 200 mg/5 mL. 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 Tablets, 100 mg (white, scored)
Tablets, 200 mg (lilac, enteric-coated)
Tablets, 500 mg (lilac enteric-coated)
Syrup, 200 mg/5 mL (red, cherry flavoured)
Sugar free liquid, 200 mg/5 mL (red, cherry flavoured)
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.
epilim-ccdsv31-34-35-piv26-30aug22
Page 2 of 37
_MANIA _
For the treatment of mania where other therapy has proved inadequate
or is inappropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
Epilim tablets may be given twice daily. Uncoated tablets may be
crushed if necessary.
Epilim Syrup and Sugar-Free Liquid should be given in divided doses.
Epilim should preferably be taken with or after food: the
enteric-coated tablet (lilac) must be
swallowed whole, if necessary with a little water; the plain tablet
(white, 100 mg) may be
taken whole or crushed and swallowed with water (not aerated).
Epilim 500 mg enteric-coated tablets are recommended for patients
requiring high doses.
Where the possibility of dental caries represents a risk through
long-term therapy with Epilim
Syrup, it ma