SANDOZ LAMOTRIGINE lamotrigine 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamotrigine, Quantity: 25 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Lamotrigine

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; maize starch

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Antiepileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,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).

Product summary:

Visual Identification: Uncoated white, circular, flat bevelled tablets with '25' debossed on one side and central breakline on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-09-14

Patient Information leaflet

CMI – Sandoz Lamotrigine
Page 1 of 6
SANDOZ LAMOTRIGINE TABLETS
LAMOTRIGINE 25 MG, 50 MG, 100 MG, 200 MG
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common
questions
about
Sandoz Lamotrigine 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
Sandoz
Lamotrigine
tablets
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
SANDOZ
LAMOTRIGINE
TABLETS ARE USED FOR?
Sandoz
Lamotrigine
tablets
contains
Lamotrigine
as
the
active
ingredient
and
belongs
to a group of medicines called
"anti-epileptic drugs".
Anti-epileptic
drugs
used
to
treat epilepsy.
It is used for the treatment of
epilepsy
in
patients
over
2
years
of
age.
Lamotrigine
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
work
by
changing
the
levels
of
some
chemicals
associated
with
seizures.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
SANDOZ
LAMOTRIGINE
TABLETS
HAVE 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
SANDOZ
LAMOTRIGINE
TABLETS
IF
YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION TO

lamotrigine

any of the ingredients
listed at the end of this
leaflet.
Symptoms of an allergic
reaction may include shortness
of breath, wheezing or
difficulty in breathing; swelling
of the face, lips, tongue or any
other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE LAMOTRIGINE THIS
MEDICINE
AFTER
THE
EXPIRY
(EXP)
PRINTED
ON
THE
PACK
HAS PASSED
.
DO
NOT
TAKE
SAN

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –SANDOZ
® LAMOTRIGINE (LAMOTRIGINE)
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
Each SANDOZ
®
LAMOTRIGINE 25 tablet contain 25 mg lamotrigine
Excipient with known effects: lactose monohydrate
Each SANDOZ
®
LAMOTRIGINE 50 tablet contain 50 mg lamotrigine
Excipient with known effects: lactose monohydrate
Each SANDOZ
®
LAMOTRIGINE 100 tablet contain 100 mg lamotrigine
Excipient with known effects: lactose monohydrate
Each SANDOZ
®
LAMOTRIGINE 200 tablet contain 200 mg lamotrigine
Excipient with known effects: lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White round flat tablets, with a breakline on one side and 25, 50 or
100 debossed on the other, containing
25, 50 or 100 mg lamotrigine respectively; or capsule-shaped biconvex
tablets with 200 debossed on one
side and plain on the other containing 200 mg lamotrigine.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antiepileptic drug for the treatment of partial and generalised
seizures in adults and children over 12 years
of age.
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
DOSE AND METHOD OF ADMINISTRATION
Restarting Therapy
Prescribers should assess the need for escalation to maintenance dose
when restarting lamotrigine in
patients who have discontinued lamotrigine for any reason, since the
risk of se