SEAZE 25 lamotrigine 25mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

lamotrigine, Quantity: 25 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; saccharin sodium; purified talc; magnesium stearate; mannitol; Flavour

Vía de administración:

Oral

Unidades en paquete:

56 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Seaze is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. There is extensive experience with lamotrigine used initially as add-on therapy. The use of Lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. Initial monotherapy therapy in newly diagnosed paediatric patients is not recommended.( See Pharmacology, Clinical trials.)

Resumen del producto:

Visual Identification: White to off-white, shield-shaped tablet, embossed with 'LI25' on one one side and bisect on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2005-02-16

Información para el usuario

SEAZE (lamotrigine) – CMI
Page 1 of 4
SEAZE
lamotrigine
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take SEAZE tablets.
This leaflet answers some common
questions about SEAZE. 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 benefits and
risks. Your doctor has weighed the
expected benefits of you taking
SEAZE tablets against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT SEAZE IS USED
FOR
Lamotrigine (the active ingredient in
SEAZE tablets) belongs to a group
of medicines called “anti-epileptic
drugs”.
SEAZE tablets are used to treat
epilepsy in adults and children.
Usually SEAZE tablets are initially
used in addition to other medicines
for the treatment of epilepsy.
SEAZE is used in partial or
generalised seizures including
Lennox-Gastaut Syndrome.
An epileptic seizure, fit or turn
results when abnormal electrical
impulses occur in nerve cells in the
brain. These abnormal electrical
impulses are believed to be due to
altered levels of some chemicals in
the brain.
It is thought to work by changing
the levels of some of the chemicals
associated with seizures.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SEAZE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
SEAZE is available only with a
doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE SEAZE IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
LAMOTRIGINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives; swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing; wheezing or shortness of
breath.
DO NOT TAKE SEAZE IF THE

Ficha técnica

SEAZE (lamotrigine) – Product Information
Page 1 of 20
PRODUCT INFORMATION
Seaze
Severe, potentially life-threatening rashes have been reported in
association with the use of
lamotrigine, particularly in children. Accordingly, lamotrigine should
be discontinued at the first sign
of rash unless the rash is clearly not drug related. (See DOSAGE AND
ADMINISTRATION).
NAME OF THE MEDICINE
Lamotrigine. The chemical name for lamotrigine is 3,5-diamino-6-
(2,3-dichlorophenyl)- 1,2,4-
triazine. Its structural formula is:
C
9
H
7
Cl
2
N
5
Molecular weight: 256.09
CAS No.: 84057-84-1
DESCRIPTION
Lamotrigine is a substituted asymmetric triazine. It is a white to
off-white crystalline powder and is
slightly soluble in ethanol and chloroform and very slightly soluble
in water.
Seaze tablets are dispersible and come in five strengths and contain 2
mg, 25 mg, 50 mg, 100 mg
or
200
mg
of
lamotrigine.
The
tablets
also
contain
the
following
excipients:
mannitol,
microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous
silica, povidone, saccharin
sodium, purified talc, magnesium stearate and blackcurrant flavour
(ARTG No. 10975). The tablets
are gluten free.
PHARMACOLOGY
The precise mechanism of the anticonvulsant action of lamotrigine is
not certain. The results of
neurochemical and electrophysiological studies with various
in vitro
and
in vivo
preparations indicate
that lamotrigine can inhibit voltage gated sodium channels and reduce
the release of glutamate, an
excitatory amino acid implicated in the pathophysiology of epilepsy.
It is possible that these effects
underlie inhibition of the sustained repetitive firing of action
potentials characteristic of neurons in
epileptic foci, thereby limiting the spread of seizures.
In tests designed to evaluate the CNS effects of drugs, the results
obtained using doses of
lamotrigine 240 mg administered to healthy adult volunteers did not
differ from placebo, whereas
both phenytoin 1,000 mg and diazepam 10 mg each significantly impaired
fine visual motor
coordination and eye