TOPIRAMATE AN topiramate 100 mg tablets bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

topiramate

Disponible depuis:

Sun Pharma ANZ Pty Ltd

DCI (Dénomination commune internationale):

Topiramate

Statut de autorisation:

Registered

Notice patient

TOPIRAMATE AN
TOPIRAMATE 25/50/100/200 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Topiramate AN
(topiramate).
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet.
More recent information may be available. The latest Consumer Medicine
Information is available from https://www.ebs.tga.gov.au/ and may
contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking Topiramate AN against the benefits it is expected
to have for you.
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 TOPIRAMATE AN IS USED FOR
The name of your medicine is Topiramate AN
.
Topiramate AN contains
topiramate.
Topiramate
belongs
to
a
group
of
medicines
called
antiepileptics. Topiramate prevents seizures and migraines by
affecting
chemicals in the brain that are involved in sending signals to the
nerves.
Topiramate AN is used for the treatment of various types of epilepsy
in
adults and children over 2 years of age.
Topiramate AN is also used for the prevention of migraines in adults.
Your doctor may prescribe Topiramate AN on its own, or in combination
with other medicine for controlling your seizures or migraines. Your
doctor may have prescribed Topiramate AN for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TOPIRAMATE AN HAS
BEEN PRESCRIBED FOR YOU.
Topiramate AN is available only with a doctor’s prescription.
Topiramate AN CMI v3.0
Page 1 of 9
BEFORE YOU TAKE TOPIRAMATE AN
_WHEN YOU MUST NOT TAKE IT_
_ _
•
DO NOT TAKE TOPIRAMATE AN IF YOU ARE ALLERGIC TO TOPIRAMATE OR
ANY
OF THE INACTIVE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction may include: wheezing, swellin

Résumé des caractéristiques du produit

PRODUCT INFORMATION
TOPIRAMATE AN
TOPIRAMATE 25/50/100/200 MG TABLETS
NAME OF THE MEDICINE
Topiramate
Structural formula:
Molecular formula
_: _
C
12
H
21
NO
8
S
Chemical name:
2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Molecular weight: 339.36
CAS Number: 97240-79-4
DESCRIPTION
Topiramate is a white crystalline powder with a bitter taste. It is
most soluble in alkaline
solutions containing sodium hydroxide or sodium phosphate and having a
pH of 9 to 10.
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.
Each film-coated tablet of
TOPIRAMATE AN
contains 25 mg, 50 mg, 100 mg or 200
mg of topiramate, and the inactive ingredients microcrystalline
cellulose, lactose,
pregelatinised maize starch, sodium starch glycollate type A and
magnesium stearate. In
addition the 25 mg tablet contains OPADRY complete film coating system
12B58956
White (Proprietary ingredient no. 13153), the 50 mg and 100 mg tablets
contain
OPADRY complete film coating system 12B52749 Yellow (Proprietary
ingredient no.
13152), and the 200 mg tablet contains OPADRY complete film coating
system
12B56662 Brown (Proprietary ingredient no. 13151). OPADRY complete
film coating
system 12B58956 White contains hypromellose, titanium dioxide,
macrogol 400 and
polysorbate 80. OPADRY complete film coating system 12B52749 Yellow
contains
hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and iron
oxide yellow.
Topiramate AN v3.0
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OPADRY complete film coating system 12B56662 Brown contains
hypromellose,
titanium dioxide, macrogol 400, polysorbate 80 and iron oxide red.
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,