APO-TOPIRAMATE topiramate 25 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

topiramate, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Topiramate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; croscarmellose sodium; hypromellose; colloidal anhydrous silica; titanium dioxide; magnesium stearate; methylcellulose; macrogol 8000

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Epilepsy. 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. Prophylaxis of migraine headache in adults.

Product summary:

Visual Identification: White to off-white, round, unscored, film coated tablet, imprinted "APO" on one side and "TP" over "25" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2007-07-20

Patient Information leaflet

APO-TOPIRAMATE
TABLETS
_Topiramate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about topiramate. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Topiramate is used to:
•
treat various types of epilepsy in
adults and children over 2 years
of age
•
prevent migraines in adults – it is
not used to treat severe migraines
that come on suddenly (acute)
Topiramate belongs to a group of
medicines called antiepileptic drugs.
_HOW IT WORKS_
Topiramate prevents seizures and
migraines by acting on the nerves
and chemicals in the brain.
Your doctor may prescribe
topiramate 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 this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
This medicine may be used to treat
epilepsy in children aged 2 years or
older.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
topiramate
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT BREASTFEED IF YOU ARE TAKING
THIS MEDICINE.
It is not recommended to breastfeed
whilst taking this medicine,

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-TOPIRAMATE (TOPIRAMATE) TABLETS
1
NAME OF THE MEDICINE
Topiramate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate, as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-TOPIRAMATE TABLETS:
25 MG TABLETS:
White to off-white, round, unscored, film coated tablet, imprinted
“APO” on one side and “TP
over “25” on the other side.
50 MG TABLETS:
Light-yellow, round, unscored, film coated tablet, imprinted “APO”
on one side and “TP over
“50” on the other side.
100 MG TABLETS:
Mustard yellow, round, unscored, film coated tablet, imprinted
“APO” on one side and “TP over
“100” on the other side.
200 MG TABLETS:
Reddish-brown, round, unscored, film coated tablet, imprinted
“APO” on one side and “TP over
“200” on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPILEPSY
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
Prophylaxis of migraine headache in adults. The usefulness of
topiramate in the acute
treatment of migraine headache has not been studied.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Topiramate tablets are intended for oral administration
DOSAGE
Topiramate tablets should be swallowed whole.
Topiramate can be taken without regard to meals.
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 n