APX-LAMOTRIGINE lamotrigine 25 mg dispersible/chewable tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

lamotrigine, Quantity: 25 mg

Beschikbaar vanaf:

Arrotex Pharmaceuticals Pty Ltd

farmaceutische vorm:

Tablet, chewable

Samenstelling:

Excipient Ingredients: calcium carbonate; microcrystalline cellulose; crospovidone; maize starch; purified talc; saccharin sodium; sodium stearylfumarate; colloidal anhydrous silica; sorbitol; Flavour

Toedieningsweg:

Oral

Eenheden in pakket:

56

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Lamotrigine 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 treatment in newly diagnosed paediatric patients is not recommended.

Product samenvatting:

Visual Identification: White to off-white, modified square shape, engraved with 'L' and '25' on one side, plain on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2020-08-27

Bijsluiter

APX-LAMOTRIGINE (lamotrigine) dispersible tablets – Consumer
Medicine Information
Page 1 of 5
APX-LAMOTRIGINE
25 MG, 50 MG, 100 MG & 200 MG DISPERSIBLE TABLETS
_lamotrigine _
CONSUMER MEDICINE INFORMATION (CMI)
There are reports of severe, potentially life-threatening rashes
associated with lamotrigine treatment, particularly in
children. APX-LAMOTRIGINE should be discontinued at the first sign of
rash unless the rash is clearly not drug related.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-
LAMOTRIGINE. 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
risks of you taking APX-
LAMOTRIGINE tablets against the
benefits they expect it will 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 APX-
LAMOTRIGINE IS USED
FOR
APX-LAMOTRIGINE tablets contain
lamotrigine as the active ingredient
and belongs to a group of
medicines called "anti-epileptic
drugs".
Anti-epileptic drugs such as APX-
LAMOTRIGINE are used to treat
epilepsy.
It is used for the treatment of
epilepsy in patients over 2 years of
age. In general, it is initially used in
addition to other medicines, for the
treatment of epilepsy including
partial or generalized seizures and
Lennox-
Gastaut syndrome. It is
thought that this medicine works by
changing the levels of some
chemicals associated with seizures.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY APX-
LAMOTRIGINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available 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 APX-LAMOTRIGINE IF
YOU ARE ALLERGIC TO LAMOTRIGINE OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic r

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION
APX-LAMOTRIGINE (LAMOTRIGINE) DISPERSIBLE/CHEWABLE
TABLETS
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 SECTION 4.2
DOSE AND METHOD OF
ADMINISTRATION).
1
NAME OF THE MEDICINE
Lamotrigine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-LAMOTRIGINE dispersible/chewable tablets come in four strength and
contain 25mg, 50mg,
100mg and 200mg of Lamotrigine.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APX-LAMOTRIGINE 25MG_ (AUST R340907)_: White to off-white, modified
square shape, engraved
with “L” and “25” on one side, plain on the other side.
APX-LAMOTRIGINE 50MG _(AUST R340908)_: White to off-white, modified
square shape, engraved
with “L” and “50” on one side, plain on the other side.
APX-LAMOTRIGINE 100MG_ (AUST R340909)_: White to off-white, modified
square shape, engraved
with “L” and “100” on one side, plain on the other side.
APX-LAMOTRIGINE 200MG _(AUST R340910)_: White to off-white, modified
square shape, engraved
with “L” and “200” on one side, plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
2
APX-LAMOTRIGINE 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 treatment in newly diagnosed paediatric patients
is not recommended. (See
SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS)
4.2
D
OSE AND METHOD OF ADMINISTRATION
RESTARTING THERAPY
Prescribers should assess the need for escalation to maintenance dose
when restarting lamotrigine
in patients who have discontinued lamotri