LAMOTRIGINE ACTAVIS 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:

LAMOTRIGINE ACTAVIS (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 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:

Registered

Authorization date:

2006-09-25

Patient Information leaflet

Lamotrigine Actavis
1
LAMOTRIGINE ACTAVIS
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.
There are reports of severe, potentially life threatening rashes
associated with Lamotrigine treatment, particularly in
children. LAMOTRIGINE ACTAVIS should be discontinued at the first sign
of rash unless the rash is clearly not drug related.
1.
WHY AM I USING LAMOTRIGINE ACTAVIS?
LAMOTRIGINE ACTAVIS contains the active ingredient lamotrigine.
LAMOTRIGINE ACTAVIS is used to treat epilepsy.
For more information, see Section 1. Why am I using LAMOTRIGINE
ACTAVIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LAMOTRIGINE ACTAVIS?
Do not use if you have ever had an allergic reaction to lamotrigine 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 MEDICINE, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
LAMOTRIGINE ACTAVIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with lamotrigine 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 LAMOTRIGINE ACTAVIS?
•
LAMOTRIGINE ACTAVIS tablets may be swallowed whole or dispersed in a
small volume of water (at least enough to cover
the whole tablet).
•
LAMOTRIGINE ACTAVIS tablets are not chewable tablets.
More instructions can be found in Section 4. How do I use LAMOTRIGINE
ACTAVIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LAMOTRIGINE ACTAVIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using LAMOTRIGINE ACTAVIS.
•
Contact your doctor immediately if you develop any skin rash such as
spots or 'hives' during
LAMOTRIGINE ACTAVIS treatment.
THINGS YOU
SHOULD NOT DO
•
For epilepsy patients, do not stop tak