LAMICTAL lamotrigine 100 mg dispersible/chewable tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamotrigine, Quantity: 100 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: calcium carbonate; hyprolose; aluminium magnesium silicate; sodium starch glycollate; povidone; saccharin sodium; magnesium stearate; Flavour

Administration route:

Oral

Units in package:

56 tablets, 60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lamictal is an anti-epileptic drug for the treatment of partial and generalised seizures in adults and children. There is extensive experience with Lamictal used initially as ?add-on? therapy. The use of Lamictal has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see CLINICAL TRIALS). Lamictal is indicated for the prevention of depressive episodes in patients with bipolar disorder.

Product summary:

Visual Identification: White to off-white tablet multifaceted super elliptical unscored plain on one side and '100' on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-04-26

Patient Information leaflet

LAMICTAL
(lamotrigine)
dispersible/chewable
tablets – Consumer Medicine Information
Page 1 of 5
LAMICTAL
DISPERSIBLE/CHEWABLE TABLETS
_lamotrigine _
CONSUMER MEDICINE INFORMATION (CMI)
There are reports of severe, potentially life-threatening rashes
associated with Lamictal treatment, particularly in
children. Lamictal 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
Lamictal tablets. 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 risks and
benefits. Your doctor has
weighed the risks of you taking
Lamictal 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 LAMICTAL IS USED
FOR
Lamictal tablets contain
lamotrigine as the active
ingredient and belongs to a group
of medicines called "anti-epileptic
drugs".
Anti-epileptic drugs such as
Lamictal are used to treat several
conditions, including epilepsy and
bipolar disorder.
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.
Lamictal is also used to help
prevent depression in adults over
18 years of age with bipolar
disorder.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
LAMICTAL HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
This medicine is only available
with a doctor’s prescription.
It is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LAMICTAL IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:

lamotrigine

any of the ingredients liste

Summary of Product characteristics

LAMICTAL (lamotrigine) – Product Information
Page 1 of 35
AUSTRALIAN PRODUCT INFORMATION
LAMICTAL (LAMOTRIGINE) DISPERSIBLE/CHEWABLE TABLETS
LAMICTAL (LAMOTRIGINE) TABLETS
1
NAME OF THE MEDICINE
Lamotrigine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LAMICTAL dispersible/chewable tablets and LAMICTAL tablets (uncoated)
contain
lamotrigine.
List of excipients with known effect: saccharin (for LAMICTAL
dispersible/chewable tablets)
and sugars as lactose (for LAMICTAL uncoated tablets)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
LAMICTAL DISPERSIBLE/CHEWABLE TABLETS*
2 MG BOTTLES [AUST 77098]: White to off-white round tablets with an
odour of blackcurrant.
They are marked "LTG2" on one side and engraved with two overlapping
super-ellipses on
the other.
5 MG BLISTER PACKS [AUST R 51547]: White to off-white, elongated,
biconvex, unscored
tablets with an odour of blackcurrant. They are marked "GSCL2” on
one side and ‘5’ on the
other. The tablets may be slightly mottled.
5 MG BOTTLES [AUST R 51718]: White to off-white caplet shaped biconvex
tablet embossed
with ‘5’ on one side and plain on the other side.
25 MG BLISTER PACKS [AUST R 51548]: White to off-white tablet
multifaceted super elliptical
unscored plain on one side and ‘25’ on the other side.
25 MG BOTTLES [AUST R 51739]: White to off-white, multi-faceted,
superelliptical, unscored
tablets with an odour of blackcurrant. They are marked "GSCL5" on one
side and “25” on the
other. The tablets may be slightly mottled.
50 MG BLISTER PACKS [AUST R 57190]: White to off-white tablet
multifaceted super elliptical
unscored plain on one side and ‘50’ on the other side.
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.)
LAMICTAL (lamotrigine) – Product I