VALPROATE WINTHROP EC 500 sodium valproate 500mg Tablet

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

sodium valproate, Quantity: 500 mg

Tersedia dari:

Sanofi-Aventis Australia Pty Ltd

INN (Nama Internasional):

Sodium valproate

Bentuk farmasi:

Tablet, enteric coated

Komposisi:

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

Rute administrasi :

Oral

Unit dalam paket:

100 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Epilepsy: Primary generaliszed epilepsies (petit mal absences, various forms of myoclonic epilepsies and tonic-clonic grand mal seizures). Partial (focal) epilepsies either alone or as adjuvant therapy. Mania: For the treatment of mania where other therapy has proved inadequate or is inappropriate.

Ringkasan produk:

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

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2007-04-04

Selebaran informasi

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

Karakteristik produk

valproate-winthrop-ccdsv31-34-35-piv25-30aug22
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION
VALPROATE WINTHROP
® (SODIUM VALPROATE)
ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Sodium valproate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enteric-coated tablets, Sodium valproate 200 mg.
Enteric-coated tablets, Sodium valproate 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
Valproate Winthrop tablets may be given twice daily.
Valproate Winthrop should preferably be taken with or after food: the
enteric-coated tablet
(lilac) must be swallowed whole, if necessary with a little water.
Valproate Winthrop 500 mg enteric-coated tablets are recommended for
patients requiring
high doses. Valproate Winthrop 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.
valproate-winthrop-ccdsv31-34-35-piv25-30aug22
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