LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
lamotrigine
Available from:
Sandoz Pty Ltd
INN (International Name):
Lamotrigine
Authorization status:
Registered
Patient Information leaflet
LAMOTRIGINE
SANDOZ
®
_Lamotrigine dispersible/chewable tablets_
CONSUMER MEDICINE INFORMATION
THERE ARE REPORTS OF SEVERE, POTENTIALLY LIFE-THREATENING RASHES
ASSOCIATED WITH
LAMOTRIGINE TREATMENT, PARTICULARLY IN CHILDREN. LAMOTRIGINE SHOULD BE
DISCONTINUED AT THE FIRST SIGN OF RASH UNLESS THE RASH IS CLEARLY NOT
DRUG RELATED.
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take Lamotrigine Sandoz
tablets.
This leaflet answers some common
questions about Lamotrigine Sandoz
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. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the risks of you
taking Lamotrigine Sandoz 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 LAMOTRIGINE
SANDOZ IS USED FOR
Lamotrigine Sandoz tablets contain
lamotrigine as the active ingredient
and belongs to a group of medicines
called "anti-epileptic drugs".
Lamotrigine Sandoz tablets are 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 Lamotrigine
Sandoz 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 LAMOTRIGINE SANDOZ 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
m
Read the complete document
Summary of Product characteristics
_Product Information _
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_Lamotrigine 25, 50, 100 & 200 mg Dispersible_
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_Chewable Tablets _
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_01/2017 _
_Sandoz Pty Ltd _
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_Version 02 _
PRODUCT INFORMATION
LAMOTRIGINE SANDOZ 25MG, 50MG, 100MG, 200MG,
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
DOSAGE
AND
ADMINISTRATION
)
NAME OF THE MEDICINE
lamotrigine.
CHEMICAL NAME:
3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine
MOLECULAR FORMULA:
C
9
H
7
Cl
2
N
5
MOLECULAR WEIGHT:
256.1
CAS REGISTRY NUMBER: _[84057-84-1] _
DESCRIPTION
Lamotrigine is a white or almost white powder. Slightly soluble in
anhydrous ethanol, practically
insoluble in water. The pKa of lamotrigine at 25°C is 5.7.
Lamotrigine Sandoz dispersible/chewable tablets contain lamotrigine.
Lamotrigine Sandoz dispersible/chewable tablets contain the following
inactive ingredients:
Microcrystalline
cellulose,
magnesium
carbonate
hydrate,
polacrilin
potassium,
sucralose,
povidone, magnesium stearate, black currant flavour 501017 AP0551 (PI
ARTG No. 106513).
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 neurones in epileptic foci, thereby limiting the
spread of seizures.
_Product Information _
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_Lamotrigine 25, 50, 100 & 200 mg Dispersible_
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_Chewable Tablets _
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_Sandoz Pty Ltd _
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_Version 02
Read the complete document
