SODIUM VALPROATE SANDOZ sodium valproate 500mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium valproate, Quantity: 500 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Sodium valproate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: hyprolose; calcium silicate; amaranth aluminium lake; titanium dioxide; polyvinyl acetate phthalate; diethyl phthalate; stearic acid; purified talc; povidone; hypromellose; magnesium stearate; macrogol 6000; indigo carmine aluminium lake; citric acid monohydrate

Administration route:

Oral

Units in package:

100 tablets

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: Circular biconvex tablet with a lilac matt finish; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-04-23

Patient Information leaflet

SODIUM VALPROATE SANDOZ
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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 SODIUM VALPROATE SANDOZ?
Sodium Valproate Sandoz contains the active ingredient sodium
valproate. Sodium Valproate Sandoz is used to treat epilepsy in
adults and children.
For more information, see Section 1. Why am I using Sodium Valproate
Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM VALPROATE SANDOZ?
Do not use if you have ever had an allergic reaction to Sodium
Valproate Sandoz 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
Sodium Valproate Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sodium Valproate Sandoz 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 SODIUM VALPROATE SANDOZ?
•
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 Sodium
Valproate Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM VALPROATE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sodium Valproate Sandoz.
•
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 t

Summary of Product characteristics

sodium-valproate-sdz-ccdsv31-34-35-piv27-30aug22
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION
SODIUM VALPROATE SANDOZ
® (SODIUM VALPROATE)
ENTERIC COATED TABLETS
1
NAME OF THE MEDICINE
Sodium valproate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium valproate 200 mg or 500 mg.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Tablets, 200 mg (lilac, enteric-coated)
Tablets, 500 mg (lilac enteric-coated)
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.
_MANIA _
For the treatment of mania where other therapy has proved inadequate
or is inappropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
Sodium Valproate Sandoz tablets may be given twice daily.
Sodium Valproate Sandoz should preferably be taken with or after food:
the enteric-coated
tablet (lilac) must be swallowed whole, if necessary with a little
water.
Sodium Valproate Sandoz 500 mg enteric-coated tablets are recommended
for patients
requiring high doses.
Sodium Valproate Sandoz may take several days to show an initial
effect and in some cases
may take from 2 to 6 weeks to exhibit its maximum effect.
sodium-valproate-sdz-ccdsv31-34-35-piv27-30aug22
Page 2 of 36
_EPILEPSY _
Monotherapy
Usual requirements are as follows:
Adults
Dosage should start with 600 mg daily increasing by 200 mg/day at
three-day intervals until
control is achieved. This is generally within the range 1,000 to 2,000
mg/day, (i.e. 20 to
30 mg/kg/day). Where adequate control is not achieved within this
range the dose may be
further increased to 2,500 mg/day.
Children > 20 kg
Initial dosage should be 400 mg/day (irrespective of weight) with
spaced increases until
control is achieved; this is usually within the range 20 to 30
mg/kg/day.
Children < 20 kg
20 mg/kg/day: in severe cases this may be increased but only in
patients in whom plasma
valproic acid leve