TOPAMAX topiramate 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

topiramate, Quantity: 100 mg

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; Carnauba Wax; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EPILEPSY TOPAMAX is indicated in 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 TOPAMAX is indicated for the prophylaxis of migraine headache in adults. The usefulness of TOPAMAX in the acute treatment of migraine headache has not been studied.

Product summary:

Visual Identification: round, yellow biconvex, film-coated tablet embossed "TOP" on one side and "100" on the other.; 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:

1998-01-30

Patient Information leaflet

TOPAMAX (220525) CMI
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 they expect it
will 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 TOPAMAX IS
USED FOR
The name of your medicine is
TOPAMAX. It contains the active
ingredient topiramate.
TOPAMAX belongs to a group of
medicines known as antiepileptics.
TOPAMAX is used for the treatment
of various types of seizures in adults
and children, aged 2 years and over.
It can also be used for the prevention
of migraines in adults. TOPAMAX is
not used to treat severe migraines
that come on suddenly (acute).
It prevents seizures and migraines by
acting on the nerves and chemicals in
the brain.
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 (HYPERSENSITIVITY)
TO:
•
topiramate
•
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.
Symptoms of an allergic or
hypersensitivity reaction may
include:
•
rash, itching or hives on the skin
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
DO NOT TAKE TOPAMAX IF THE
PACKAGING

Summary of Product characteristics

CCDS211019v24
Page 1 of 30
TOPAMAX(220517)API
AUSTRALIAN PRODUCT INFORMATION
TOPAMAX®
(
TOPIRAMATE
)
TABLETS AND SPRINKLE CAPSULES
1. NAME OF THE MEDICINE
Topiramate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_TOPAMAX 25 MG, 50 MG, 100 MG & 200 MG FILM-COATED TABLETS _
Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.
Excipient(s) with known effect: sugars as lactose
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
_TOPAMAX SPRINKLE 15 MG, 25 MG & 50 MG HARD CAPSULES _
Each capsule consists of sugar spheres enclosed in a gelatin capsule.
The sugar spheres contain
15 mg, 25 mg or 50 mg of topiramate.
Excipient with known effect: sugars
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
TABLETS
TOPAMAX film-coated tablets are supplied in blisters:
•
25 mg, round and white, marked “TOP” on one side and “25” on
the other
•
50 mg, round and light-yellow, marked “TOP” on one side and
“50” on the other
•
100 mg, round and yellow, marked “TOP” on one side and “100”
on the other
•
200 mg, round and salmon, marked “TOP” on one side and “200”
on the other
CAPSULES
TOPAMAX Sprinkle capsules contain small, white to off-white spheres
and are supplied in bottles.
Each capsule consists of a clear capsule cap and a white capsule body:
•
15 mg, imprinted “TOP” on cap and “15 mg” on body
•
25 mg, imprinted “TOP” on cap and “25 mg” on body
•
50 mg, imprinted “TOP” on cap and “50 mg” on body
Product Information - Australia
CCDS211019v24
Page 2 of 30
TOPAMAX(220517)API
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPILEPSY
TOPAMAX is indicated in 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-Gastau