NOUMED TOPIRAMATE topiramate 100 mg tablet bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

topiramate, Quantity: 100 mg

Boleh didapati daripada:

AVALLON PHARMACEUTICALS PTY LTD

INN (Nama Antarabangsa):

Topiramate

Borang farmaseutikal:

Tablet, film coated

Komposisi:

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

Laluan pentadbiran:

Oral

Unit dalam pakej:

60 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

EPILEPSY: Topiramate 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: Topiramate is indicated for the prophylaxis of migraine headache in adults.

Ringkasan produk:

Visual Identification: White, round shaped, film-coated tablet, plain on both sides.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2017-06-07

Risalah maklumat

NOUMED TOPIRAMATE
1
NOUMED TOPIRAMATE
_topiramate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
TOPIRAMATE.
It does not contain all of 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 taking this medicine
against the benefits it is expected to
have for you or your child.
IF YOUR CHILD IS BEING TREATED WITH
NOUMED TOPIRAMATE, FOLLOW
THE SAME INSTRUCTIONS IN THIS LEAFLET
AS YOU WOULD AS A PATIENT.
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 NOUMED
TOPIRAMATE IS USED
FOR
NOUMED TOPIRAMATE tablets
contain the active ingredient
topiramate.
Topiramate belongs to a group of
medicines called anti-epileptics.
These drugs prevent seizures and
migraines by acting on the nerves
and chemicals in the brain.
NOUMED TOPIRAMATE is used to
treat various types of epilepsy in
adults and children over 2 years of
age, and to prevent migraines in
adults.
This medicine is available only with
a doctor's prescription.
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 IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO TOPIRAMATE,
OTHER SIMILAR MEDICINES, OR TO ANY
OF THE OTHER INGREDIENTS LISTED AT
THE END OF THIS LEAFLET UNDER
PRODUCT DESCRIPTION.
Some of the symptoms of an allergic
reaction may include shortness of
breath; wheezing or difficulty in
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 TAMPERING.
If you take it after the expiry date has
passed, it may not work as well.
If it has expired or is damaged, retur

Ciri produk

Product Information - Australia
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION –
NOUMED TOPIRAMATE
(TOPIRAMATE FILM-COATED TABLETS)
1. NAME OF THE MEDICINE
Topiramate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NOUMED TOPIRAMATE tablets contain 25 mg, 50 mg, 100 mg or 200 mg
topiramate.
Excipients with known effects: sugars as lactose.
For the full list of excipients, see _Section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
NOUMED TOPIRAMATE tablets are available in the following
presentations:
25 mg, white, round shaped, film-coated tablet, plain on both sides.
50 mg, yellow, round shaped, film-coated tablet, plain on both sides.
100 mg, white, round shaped, film-coated tablet, plain on both sides.
200 mg, yellow, round shaped, film-coated tablet, plain on both sides
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPILEPSY
Topiramate 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
Topiramate is indicated for the prophylaxis of migraine headache in
adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
For optimum seizure control in both adults and children, it is
recommended that therapy should be initiated at a
low dose followed by slow titration to an effective dose. Dose
titration should be guided by clinical outcome.
The recommended dosages of topiramate in adults and children for
epilepsy are summarised in TABLE 1.
_MONOTHERAPY - EPILEPSY _
In newly diagnosed epileptic patients, topiramate monotherapy should
be initiated at a low dose (see TABLE 1).
In patients who are being converted to topiramate monotherapy,
consideration should be given to the effects of
seizure control when withdrawing concomitant antiepileptic agents
(AEDs). Unless safety concerns require an
abrupt with