VALPREASE 200 sodium valproate 200 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium valproate, Quantity: 200 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Sodium valproate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: purified talc; triethyl citrate; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; povidone; magnesium stearate; citric acid; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; indigo carmine; sunset yellow FCF; allura red AC; polyvinyl alcohol; macrogol 3350; xanthan gum; lecithin

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: Round, purple, coated, biconvex tablet, approximately 9.7 mm in diameter; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-06-30

Patient Information leaflet

VALPREASE
®
1
VALPREASE
_Sodium Valproate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Valprease.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your taking Valprease
against the benefits they expect it
will have for you.
PLEASE READ THIS LEAFLET VERY
CAREFULLY BEFORE YOU START TO TAKE
YOUR VALPREASE, EVEN IF YOU HAVE
episodes of overactivity, elation or
irritability.
Valprease may be used alone or in
combination with other medicines to
treat your condition.
Your doctor, however, may have
prescribed Valprease for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
There is no evidence that
Valprease is addictive.
This medicine is available only with
a doctor's prescription.
•
known or suspected of having a
genetic problem causing a
mitochondrial disorder.
•
you are pregnant, unless your
doctor has determined no
alternative treatment works for
you.
If you are a girl or woman of
childbearing age, you must not take
Valprease unless you use an effective
method of birth control
(contraception) at all times during
your treatment with Valprease. Do
not stop taking Valprease or your
contraception until you have
discussed this with your doctor. Your
doctor will advise you further (see
TAKEN VALPREASE BEFORE.
'Before you start to take it').
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VALPREASE IS
USED FOR
Valprease is a medicine used to for
the treatment of epilepsy in adults
and children.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of seizures,
ranging from mild to severe.
Valprease belongs to a group of
medicines called anticonvulsants.
These medicines are thought to work
by controlling brain chemica

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – VALPREASE (SODIUM
VALPROATE) ENTERIC COATED TABLETS
1
NAME OF THE MEDICINE
Sodium valproate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valprease tablets come in two strengths and contain either 200 mg or
500 mg of sodium valproate.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
VALPREASE 200
A purple, round, coated, biconvex tablet, approximately 9.7 mm in
diameter.
VALPREASE 500
A purple, round, coated, biconvex tablet, approximately 13 mm in
diameter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
Valprease tablets may be given twice daily.
Valprease tablets should preferably be taken with or after food; it
must be swallowed whole, if
necessary with a little water.
Valprease 500 mg enteric coated is recommended for patients requiring
high dosages.
Valprease may take several days to show an initial effect and in some
cases may take from two to six
weeks to exhibit its maximum effect.
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.
2
Children <20 kg. 20 mg/kg/day; in severe cases this may be increased
but only in patients in whom
plasma
valproic
acid
levels
can
be
monitored.
Above
40
mg/kg/day,
clinical
chemistr