APO-LAMOTRIGINE lamotrigine 100mg chewable and dispersible tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

lamotrigine, Quantity: 100 mg

Prieinama:

Arrotex Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

Calcium carbonate,Lamotrigine

Vaisto forma:

Tablet, chewable

Sudėtis:

Excipient Ingredients: microcrystalline cellulose; hyprolose; povidone; purified talc; crospovidone; magnesium stearate; colloidal anhydrous silica; aspartame; calcium carbonate; maltodextrin; Flavour

Vartojimo būdas:

Oral

Vienetai pakuotėje:

56 tablets per pack

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

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.

Produkto santrauka:

Visual Identification: White to off-white, uncoated, circular flat beveled tablets debossed with "LI4" on one side and plain on the other side having characteristic fruity odour.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

2010-01-20

Pakuotės lapelis

APO-LAMOTRIGINE
1
APO-LAMOTRIGINE
_Lamotrigine _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about lamotrigine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Lamotrigine. It contains the active
ingredient lamotrigine.
Lamotrigine belongs to a group of
medicines called "anti-epileptic
drugs".
It is used to treat epilepsy in adults
and children aged 2 years and over.
Usually lamotrigine is used in
addition to other medicines for the
treatment of epilepsy. Lamotrigine is
used in partial seizures (seizures that
affect only one part of the brain) or
generalised seizures (seizures that
affect the whole brain), including
Lennox-Gastaut Syndrome (a severe
form of epilepsy characterised by
several seizure types).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
This medici

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION
APO-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 tablet contains lamotrigine 25 mg, 50 mg, 100 mg or 200 mg as the
active ingredient.
EXCIPIENT WITH KNOWN EFFECT
Aspartame.
For a complete list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
25 MG TABLETS:
White to off-white, uncoated, circular flat beveled tablets debossed
with “LI2” on one side, plain
on the other side having a characteristic fruity odour.
50 MG TABLETS:
White to off-white, uncoated, circular flat beveled tablets debossed
with “LI3” plain on the other
side having a characteristic fruity odour.
100 MG TABLETS:
White to off-white, uncoated, circular flat beveled tablets debossed
with “LI4” on one side, plain
on the other side having a characteristic fruity odour.
200 MG TABLETS:
White to off-white, uncoated, circular flat beveled tablets debossed
with “LI5” on one side, plain
on the other side having a characteristic fruity odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
APO-Lamotrigine tablets are intended for oral administration.
APO-Lamotrigine tablets have been