LAMOTRIGINE GH lamotrigine 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamotrigine, Quantity: 50 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Lamotrigine

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lamotrigine GH (lamotrigine) is an anti-epileptic 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 anti-epileptic drugs (AEDs).,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 '50' 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:

2016-08-05

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
LAMOTRIGINE GH
(LAMOTRIGINE) UNCOATED TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
Lamotrigine GH.
This leaflet answers some
common questions about
Lamotrigine GH. 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
Lamotrigine GH against the
benefits this medicine is
expected to 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 GH IS
USED FOR
Lamotrigine (the active
ingredient in Lamotrigine GH)
belongs to a group of medicines
called "anti-epileptic drugs".
Lamotrigine GH are used for the
treatment of epilepsy in adults
and children over 12 years of
age.
Lamotrigine GH is initially used
in addition to other medicines for
the treatment of epilepsy.
Lamotrigine GH is also used in
partial or generalised seizures
including tonic-clonic seizures
and seizures associated with
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 that Lamotrigine GH
work by changing the levels of
some of the chemicals
associated with seizures.
Your doctor may have
prescribed Lamotrigine GH for
another reason. Ask your doctor
if you have any questions about
why Lamotrigine GH has been
prescribed for you.
There is no evidence that
Lamotrigine GH is addictive.
BEFORE YOU TAKE
LAMOTRIGINE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LAMOTRIGINE GH 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 be mild or severe. They
usually include some or all of the
following:
•
whe

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – LAMOTRIGINE GH
(LAMOTRIGINE) UNCOATED TABLETS
Severe
life-threatening
rashes
have
been
reported
with
lamotrigine
treatment,
particularly
in
children. It is recommended that lamotrigine treatment be discontinued
at the first sign of rash unless
the rash is clearly not related to lamotrigine treatment. (See SECTION
4.2 DOSE AND METHOD OF
ADMINISTRATION)
1
NAME OF THE MEDICINE
Lamotrigine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamotrigine GH tablets containing 25 mg, 50 mg, 100 mg or 200 mg
lamotrigine.
List of excipients with known effect: sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lamotrigine GH 25 mg tablets are uncoated white, circular, flat
bevelled tablets, with ‘25’ debossed on
one side and a central breakline on the other side.
Lamotrigine GH 50 mg tablets are uncoated white, circular, flat
bevelled tablets, with ‘50’ debossed on
one side and a central breakline on the other side.
Lamotrigine GH 100 mg tablets are uncoated white, circular, flat
bevelled tablets, with ‘100’ debossed
on one side and a central breakline on the other side.
Lamotrigine GH 200 mg tablets are uncoated, white, capsule-shaped,
biconvex tablets with ‘200’
debossed on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lamotrigine GH (lamotrigine) is an 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).
Lamotrigine GH v2
Page 2 of 24
(lamotrigine) uncoated tablets
4.2 DOSE AND METHOD OF ADMINISTRATION
RESTARTING THERAPY
Prescribers should assess the need f