TOPIRAMATE-GA topiramate 50 mg tablet blister

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

topiramate, Quantity: 50 mg

Disponible depuis:

Medis Pharma Pty Ltd

DCI (Dénomination commune internationale):

Topiramate

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; pregelatinised maize starch; sodium starch glycollate; colloidal anhydrous silica; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia

Mode d'administration:

Oral

Unités en paquet:

60 tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Epilepsy. Adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome.. Migraine. Prophylaxis of migraine headache in adults.

Descriptif du produit:

Visual Identification: Light yellow, circular, biconvex film-coated tablets, imprinted with "50" in black ink on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2010-04-19

Notice patient

TOPIRAMATE-GA
_topiramate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Topiramate-GA. It does not
contain all 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 you taking
Topiramate-GA against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING TOPIRAMATE-GA,
ASK YOUR DOCTOR OR
PHARMACIST. KEEP THIS LEAFLET
WITH THE MEDICINE. You may
need to read it again.
WHAT TOPIRAMATE-GA IS USED
FOR
Topiramate-GA is used for the
treatment of various types of
epilepsy in adults and children
over 2 years of age, and for
the prevention of migraines in
adults. It prevents seizures
and migraines by acting on the
nerves and chemicals in the
brain.
Your doctor may prescribe
Topiramate-GA on its own, or
in addition to another medicine
for controlling your seizures or
migraines.
Your doctor may have
prescribed Topiramate-GA for
another reason. Ask your
doctor if you have any
questions about why this
medicine has been prescribed
for you.
BEFORE YOU TAKE TOPIRAMATE-
GA
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE TOPIRAMATE-GA:
•
if you have an allergy to
topiramate or to any of the
ingredients listed at the end
of this leaflet
•
if the tablets do not look
right
•
if the packaging is torn or
shows signs of tampering.
•
after the expiry date (month
and year) printed on the
pack.
_BEFORE YOU START TO TAKE IT _
_ _
YOU MUST TELL YOUR DOCTOR IF
YOU:
•
ARE PREGNANT OR PLANNING
TO BECOME PREGNANT.
Topiramate has caused
harm to the developing
foetus when administered
to a pregnant woman.
Information available
suggests that there may be
an association between the
use of topiramate in
humans during pregnancy
and birth defects including
cleft lip/palate. However, it
is very important to control
your fits while you are
pregnant. If it is necessary
for you to take topiramate,
your doctor can help you
decide whether or not to
t

Résumé des caractéristiques du produit

Topiramate-GA PI v5 120907
- 1 -
TOPIRAMATE-GA
PRODUCT INFORMATION
NAME OF THE MEDICINE
Topiramate
DESCRIPTION
Topiramate
[2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose
sulfamate]
is
a
white
crystalline powder with a bitter taste. Solubility of topiramate is
approximately 10 mg/mL over
the physiological pH range. It is freely soluble in acetone,
chloroform, dimethylsulfoxide and
ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution
has a pH of 6.3.
Empirical formula: C
12
H
21
NO
8
S
CAS-97240-79-4
Molecular weight: 339.36
Topiramate-GA tablets contain topiramate, and the inactive ingredients
lactose, pregelatinised
maize
starch,
microcrystalline
cellulose,
sodium
starch
glycollate,
colloidal
silicon
dioxide,
magnesium stearate, and the Opadry White, Yellow, Pink, depending on
the colour, contains
Hypromellose, Titanium dioxide, Macrogol, Iron Oxide and polysorbate
80.
Topiramate-GA tablets 25 mg, 50 mg, 100 mg & 200 mg also contains
Opacode S-1-17823
Black. Opacode S-1-17823 Black contains, Shellac Glaze- 45% (20 %
esterified) in Ethanol,
Iron Oxide Black JPE, N-Butyl Alcohol NF, Propylene Glycol, Ammonium
Hydroxide 28%,
Isopropyl alcohol.
PHARMACOLOGY
PHARMACODYNAMICS
Topiramate is classified as a sulfamate substituted monosaccharide.
Three pharmacological
properties of topiramate have been identified that may contribute to
its anticonvulsant activity:

Topiramate reduces the frequency at which action potentials are
generated when
neurons are subjected to a sustained depolarisation, which is
indicative of a state-
dependent blockade of voltage-sensitive sodium channels.
Topiramate-GA PI v5 120907
- 2 -

Topiramate markedly enhances the activity of GABA at some types of
GABA
A
receptors.
This
effect
was
not
blocked
by
flumazenil,
a
benzodiazepine
antagonist,
nor
did
topiramate increase the duration of the channel open time,
differentiating topiramate
from barbiturates that modulate GABA
A
receptors. Because the antiepileptic profile of
topiramate differs
markedly
from that of the