RBX TOPIRAMATE topiramate 100 mg tablets bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

topiramate, Quantity: 100 mg

Διαθέσιμο από:

Sun Pharma ANZ Pty Ltd

INN (Διεθνής Όνομα):

Topiramate

Φαρμακοτεχνική μορφή:

Tablet

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

60

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

1. EPILEPSY. RBX TOPIRAMATE tablets are 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.. 2. MIGRAINE. RBX TOPIRAMATE tablets are indicated for the prophylaxis of migraine headache in adults.

Περίληψη προϊόντος:

Visual Identification: Yellow-coloured, film-coated, circular tablets debossed with 'TP3' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2010-05-10

Φύλλο οδηγιών χρήσης

RBX TOPIRAMATE
RBX TOPIRAMATE
_Topiramate 25/50/100/200 mg Tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RBX
TOPIRAMATE (topiramate). It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and
may contain important information
about the medicine and its use of
which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking RBX
TOPIRAMATE 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 RBX TOPIRAMATE
IS USED FOR
The name of your medicine is RBX
TOPIRAMATE. RBX TOPIRAMATE
contains topiramate.
Topiramate belongs to a group of
medicines called antiepileptics.
Topiramate prevents seizures and
migraines by affecting chemicals in
the brain that are involved in
sending signals to the nerves.
RBX TOPIRAMATE is used for the
treatment of various types of
epilepsy in adults and children over
2 years of age.
RBX TOPIRAMATE is also used for
the prevention of migraines in
adults.
Your doctor may prescribe RBX
TOPIRAMATE on its own, or in
combination with other medicine for
controlling your seizures or
migraines. Your doctor may have
prescribed RBX TOPIRAMATE for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RBX
TOPIRAMATE HAS BEEN
PRESCRIBED FOR YOU.
RBX TOPIRAMATE is available
only with a doctor’s prescription.
BEFORE YOU TAKE RBX
TOPIRAMATE
_WHEN YOU MUST NOT TAKE IT _
•
DO NOT TAKE RBX
TOPIRAMATE IF YOU ARE
ALLERGIC TO TOPIRAMATE OR ANY
OF THE INACTIVE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET. Symptoms of an allergic
reaction may include: wheezing,
swelling

Αρχείο Π.Χ.Π.

RBX TOPIRAMATE PI V6
Page 1 of 33
AUSTRALIAN PRODUCT INFORMATION – RBX TOPIRAMATE
(TOPIRAMATE) TABLETS
1
NAME OF THE MEDICINE
Topiramate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of RBX TOPIRAMATE contains 25 mg, 50 mg, 100
mg or 200 mg of
topiramate.
Excipient with known effect: Lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
RBX TOPIRAMATE 25 mg tablets are available as white, film-coated,
circular tablets debossed
with ‘TP1’ on one side and plain on the other side.
RBX TOPIRAMATE 50 mg tablets are available as yellow-coloured,
film-coated, circular tablets
debossed with ‘TP2’ on one side and plain on the other side.
RBX TOPIRAMATE 100 mg tablets are available as yellow-coloured,
film-coated, circular tablets
debossed with ‘TP3’ on one side and plain on the other side.
RBX TOPIRAMATE 200 mg tablets are available as peach-coloured,
film-coated, circular tablets
debossed with ‘TP4’ on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_EPILEPSY _
RBX TOPIRAMATE tablets are 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 _
RBX TOPIRAMATE tablets are indicated for the prophylaxis of migraine
headache in adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RBX TOPIRAMATE tablets should be swallowed whole.
RBX TOPIRAMATE PI V6
Page 2 of 33
RBX TOPIRAMATE tablets 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 c