TOPIRAMATE SANDOZ topiramate 50 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

topiramate, Quantity: 50 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Topiramate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; sodium starch glycollate; magnesium stearate; 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: 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, and - 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.

Product summary:

Visual Identification: Yellow, 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; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2008-05-02

Patient Information leaflet

TOPIRAMATE SANDOZ
®
1
TOPIRAMATE
SANDOZ
®
_topiramate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Topiramate Sandoz.
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
Sandoz 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
SANDOZ IS USED
FOR
Topiramate Sandoz 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 Sandoz is not used to
treat severe migraines that come on
suddenly (acute).
Topiramate Sandoz contains the
active ingredient topiramate.
Topiramate belongs to a group of
medicines known as antiepileptics. It
prevents seizures and migraines by
acting on the nerves and chemicals in
the brain.
Your doctor may prescribe
Topiramate Sandoz 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
SANDOZ
_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
SIGN

Summary of Product characteristics

220729-topiramate-sandoz-pi
Page 1 of 34
AUSTRALIAN PRODUCT INFORMATION
TOPIRAMATE SANDOZ
® (TOPIRAMATE) TABLETS
1
NAME OF THE MEDICINE
Topiramate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Topiramate Sandoz 25 mg tablet contains 25 mg of topiramate.
Each Topiramate Sandoz 50 mg tablet contains 50 mg of topiramate.
Each Topiramate Sandoz 100 mg tablet contains 100 mg of topiramate.
Each Topiramate Sandoz 200 mg tablet contains 200 mg of topiramate.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect:_
_contains sugars (as lactose)_
.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Topiramate Sandoz 25 mg tablets are white, round shaped, film-coated
tablets, plain on both
sides.
Topiramate Sandoz 50 mg tablets are yellow, round shaped, film-coated
tablets, plain on both
sides.
Topiramate Sandoz 100 mg tablets are white, round shaped, film-coated
tablets, plain on both
sides.
Topiramate Sandoz 200 mg tablets are yellow, round shaped, film-coated
tablets, plain on both
sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_EPILEPSY _
Topiramate Sandoz 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 Sandoz is indicated for the prophylaxis of migraine
headache in adults. The
usefulness of topiramate in the acute treatment of migraine headache
has not been studied.
220729-topiramate-sandoz-pi
Page 2 of 34
4.2
D
OSE 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