Topamax Sprinkle

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Topiramate 15mg;  ;  

Διαθέσιμο από:

Janssen-Cilag (New Zealand) Ltd

INN (Διεθνής Όνομα):

Topiramate 15 mg

Δοσολογία:

15 mg

Φαρμακοτεχνική μορφή:

Capsule

Σύνθεση:

Active: Topiramate 15mg     Excipient: Cellulose acetate Gelatin Opacode black S-1-17822 Opacode black S-1-17823 Povidone Sucrose

Μονάδες σε πακέτο:

Bottle, plastic, HDPE, 60 capsules

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Siegfried Ltd

Θεραπευτικές ενδείξεις:

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, generalised tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 60 capsules - 24 months from date of manufacture stored at or below 25°C

Ημερομηνία της άδειας:

1998-03-27

Φύλλο οδηγιών χρήσης

TOPAMAX
®
230323 ACMI
1
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
PACKAG

Αρχείο Π.Χ.Π.

26.221109
1
TOPAMAX (230323) ADS
TOPAMAX
®
TABLETS AND SPRINKLE CAPSULES
TOPIRAMATE
NEW
ZEALAND
DATA
SHEET
1. PRODUCT NAME
TOPAMAX
®
25 mg, 50 mg, 100 mg & 200 mg film-coated tablets
TOPAMAX
®
Sprinkle 15 mg, 25 mg & 50 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_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.
_SPRINKLE CAPSULES _
Each capsule contains 15 mg, 25 mg or 50 mg of topiramate.
Excipients with known effect: Sugar
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
_TABLETS _
25 mg: Round, white, film-coated tablets, marked “TOP” on one side
and “25” on the other.
50 mg: Round, light-yellow, film-coated tablets, marked “TOP” on
one side and “50” on the other
100 mg: Round, yellow, film-coated tablets, marked “TOP” on one
side and “100” on the other
200 mg: Round, salmon, film-coated tablets, marked “TOP” on one
side and “200” on the other.
_SPRINKLE CAPSULES _
Hard capsules enclosing small, white to off-white spheres. Each
gelatin capsule consists of a clear
(natural) capsule cap and a white capsule body.
15 mg: imprinted with “TOP” on cap and “15 mg” on body
25 mg: imprinted with “TOP” on cap and “25 mg” on body
50mg: imprinted with “TOP” on cap and “50mg” on body (not
marketed).
26.221109
2
TOPAMAX (230323) ADS
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, generalised tonic-clonic
seizures or seizures
associated with Lennox-Gastaut syndrome.
MIGRAINE
TOPAMAX is indicated in adults for the prophylaxis of migraine
headache. The usefulness of
TOPAMAX in the acute treatment of migraine headache has not been
studied.
4.2 DOSE AND METHOD OF AD