TOPAMAX SPRINKLE

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Topiramate

Tilgjengelig fra:

Janssen-Cilag Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

TOPAMAX
®

TABLETS AND SPRINKLE CAPSULES

_Topiramate _
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about 
TOPAMAX
®
 tablets and Sprinkle capsules.  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 TOPAMAX against the 
benefits it is expected to have for you. 
If you have any concerns about taking TOPAMAX, ask 
your doctor or pharmacist.  
Keep this leaflet with the medicine.  You may need to read 
it again. 
WHAT TOPAMAX IS USED FOR 
TOPAMAX 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. 
TOPAMAX is not used to treat severe migraines that come 
on suddenly (acute). 
Your doctor may prescribe TOPAMAX on its own, or in 
addition to another medicine for controlling your seizures or 
migraines. 
Your doctor may have prescribed TOPAMAX for another 
reason.  Ask your doctor if you have any questions about 
why this medicine has been prescribed for you. 
BEFORE YOU TAKE TOPAMAX  
WHEN YOU MUST NOT TAKE IT 
Do not take TOPAMAX: 
•  if you have an allergy to it or to any of
the ingredients. 
See PRODUCT DESCRIPTION at the end of this leaflet for a 
list of ingredients. 
•  if the tablets or capsules are not as described under 
Product Description at the end of this leaflet. 
Do not take TOPAMAX if the packaging is torn or shows 
signs of tampering.  Do not take TOPAMAX 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. Topamax 
has

Preparatomtale

_____________________________________________________________________________________________________

jcptopam10513.docx

Page 1 of 27 
CCDS130204 

TOPAMAX
®

TABLETS AND SPRINKLE CAPSULES 
 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. 
It is most soluble in alkaline solutions containing sodium 
hydroxide or sodium phosphate and has 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. 

C
12
H
21
NO
8
S   

CAS-97240-79-4 

MW: 339.36 

TOPAMAX tablets contain topiramate, and the inactive ingredients lactose, pregelatinised 
maize starch, carnauba wax, microcrystalline cellulose, sodium starch glycollate, magnesium 
stearate, and the OPADRY
®
 coating and colouring for each
tablet comprising titanium dioxide, 
hypromellose, lauromacrogol 400 and polysorbate
80.  Additionally, in the coating, the 50 mg 
and 100 mg tablets contain iron oxide yellow, and the 200 mg and 300 mg tablets contain iron 
oxide red. 

TOPAMAX Sprinkle capsules consist of sugar spheres enclosed in a
gelatin capsule.  The 
sugar spheres contain topiramate, povidone, cellulose acetate and
sucrose.  The capsule 
shells contain gelatin and titanium dioxide, and are imprinted
with black ink. 

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 indicativ