TOPIRAMATE GH topiramate 50 mg tablet bottle

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

topiramate

Fáanlegur frá:

Sandoz Pty Ltd

INN (Alþjóðlegt nafn):

Topiramate

Leyfisstaða:

Registered

Upplýsingar fylgiseðill

Topiramate GH CMI v1 Oct13
Page 1 of 5
CONSUMER MEDICINE INFORMATION
TOPIRAMATE GH
_TOPIRAMATE FILM-COATED TABLETS _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Topiramate GH. 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 risk of you taking
Topiramate GH 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 GH IS USED FOR
Topiramate GH is used for the
treatment of various types of
seizures in adults and children,
aged 2 years and over.
This medicine can also be used
for the prevention of migraines in
adults. Topiramate GH is not
used to treat severe migraines
that come on suddenly (acute).
Topiramate GH contains the
active ingredient topiramate.
Topiramate belongs to a group of
medicines known as anti-
epileptics. It prevents seizures
and migraines by acting on the
nerves and chemicals in the
brain.
Your doctor may prescribe
Topiramate GH on its own, or in
addition to another medicine for
controlling your seizures or
migraines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
BEFORE YOU TAKE TOPIRAMATE GH
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
the active ingredient
topiramate or to any of the
other ingredients listed at the
end of this leaflet under
Product Description
•
any other similar medicines.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF

Vara einkenni

Topiramate GH PI April 2016 v5
Page 1 of 32
_ _
PRODUCT INFORMATION
TOPIRAMATE GH
TOPIRAMATE FILM-COATED TABLETS
NAME OF THE MEDICINE
_ _
Generic name: topiramate.
Chemical name:
2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate.
Chemical structure:
_ _
CAS: 97240-79-4
Empirical formula: C
12
H
21
NO
8
S
MW: 339.36
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 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.
Topiramate GH tablets contain 25 mg, 50 mg, 100 mg or 200 mg
topiramate. All tablets contain the
inactive ingredients lactose, pregelatinised maize starch,
microcrystalline cellulose, sodium starch
glycollate, magnesium stearate, titanium dioxide, hypromellose,
macrogol 400 and polysorbate 80.
In addition, Topiramate GH 50 mg and 200 mg tablets contain iron oxide
yellow.
_ _
_ _
PHARMACOLOGY
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 markedly enhances the activity of gamma-aminobutyric acid
(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
Topiramate GH PI April 2016 v5
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_ _
differs markedly from that of the benzodiazepines, it may modulate a
benzodiazepine-insensitive
subtype of GABA
A
receptor.
Topiramate GH