Lamictal

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lamotrigine 5mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Lamotrigine 5 mg

Dosage:

5 mg

Pharmaceutical form:

Chewable/dispersible tablet

Composition:

Active: Lamotrigine 5mg Excipient: Aluminium magnesium silicate Blackcurrant flavour 502009 AP0551 Calcium carbonate Hyprolose Magnesium stearate Povidone Saccharin sodium Sodium starch glycolate

Units in package:

Blister pack, 28 tablet pack, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

Epilepsy Adults (over 12 years of age) Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome. Children (2 to 12 years of age) Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gaustaut syndrome.

Product summary:

Package - Contents - Shelf Life: Blister pack, Child Resistant PVC/PVdC - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, Child Resistant PVC/PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, HDPE, child resistant/tamper evident closure - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1994-05-31

Patient Information leaflet

LAMICTAL
1
LAMICTAL
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LAMICTAL?
LAMICTAL contains the active ingredient lamotrigine. LAMICTAL tablets
are used to treat epilepsy in adults and children aged 2
years and over.
For more information, see Section 1. Why am I using LAMICTAL?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LAMICTAL?
Do not use if you have ever had an allergic reaction to LAMICTAL or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
LAMICTAL?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LAMICTAL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE LAMICTAL?
•
It is usual for the dose of LAMICTAL tablets to start at quite a low
level and be slowly increased during the first few weeks of
treatment.
•
The doses that your doctor prescribes will generally depend on any
other anti-epileptic medications you are taking and your
response to LAMICTAL tablets.
More instructions can be found in Section 4. How do I use LAMICTAL?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LAMICTAL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using LAMICTAL.
•
Tell your doctor immediately if you become pregnant or intend to
become pregnant whilst using
LAMICTAL.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly without checking with your
doctor.
•
Do not use LAMICTAL tablets to treat any other complaints unless your
doctor says to.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how LAMICT

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
LAMICTAL lamotrigine 2 mg, 5 mg, 25 mg, 50 mg, 100 mg
dispersible/chewable
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg, 5 mg, 25 mg, 50 mg, or 100 mg of
lamotrigine.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Dispersible/chewable tablets.
_2 mg:_ white to off-white, round tablets with ‘LTG’ over ‘2’
on one side and scored on
the other.
_5 mg:_ white to off-white, elongated, biconvex, unscored tablets with
'GS CL2' on one
side and ‘5’ on the other.
_25 mg:_ white to off-white, multi-faceted, superelliptical, unscored
tablet with ”GSCL5”
on one side and “25” on the other. The tablets may be slightly
mottled.
_50 mg:_ white to off-white, multi-faceted, superelliptical, unscored
tablet with ”GSCX7”
on one side and “50” on the other. The tablets may be slightly
mottled.
_100 mg:_ white to off-white, multi-faceted, superelliptical, unscored
tablet with
”GSCL7” on one side and “100” on the other. The tablets may be
slightly mottled.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy
_Adults and Adolescents (over 12 years of age) _
LAMICTAL is indicated as adjunctive therapy in the treatment of
epilepsy, for partial
seizures and generalised seizures, including tonic-clonic seizures and
the seizures
associated with Lennox-Gastaut syndrome.
_Children (2 to 12 years of age) _
LAMICTAL is indicated as adjunctive therapy in the treatment of
epilepsy, for partial
seizures and generalised seizures including tonic-clonic seizures and
the seizures
associated with Lennox-Gastaut syndrome.
2
Bipolar Disorder (Adults 18 years of age and over)
LAMICTAL is indicated for the prevention of mood episodes in patients
with bipolar
disorder, predominantly by preventing depressive episodes.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
RESTARTING THERAPY
Prescribers should assess the need for escalation to maintenance dose
when
restarting lamotrigine in patients who have discon