LAMOTRIGINE AUROBINDO 200 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LAMOTRIGINE

Available from:

Aurobindo Pharma Limited

ATC code:

N03AX09

INN (International Name):

LAMOTRIGINE

Dosage:

200 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics

Authorization status:

Authorised

Authorization date:

2010-08-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

LAMOTRIGINE AUROBINDO 25 MG TABLETS 
LAMOTRIGINE AUROBINDO 50 MG TABLETS 
LAMOTRIGINE AUROBINDO 100 MG TABLETS 
LAMOTRIGINE AUROBINDO 200 MG TABLETS 
Lamotrigine 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
_- _
Keep this leaflet. You may need to read it again. 
_- _
If you have
any further questions, ask your doctor or pharmacist. 
_- _
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, 
even if their signs of illness are same as yours. 
_- _
If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side 
effects not listed in this leaflet. See section 4..  

WHAT IS IN THIS LEAFLET1  What Lamotrigine Aurobindo is and
what it is used for 
2      What you need to knowbBefore you take Lamotrigine
Aurobindo 
3       How to take Lamotrigine Aurobindo 
4       Possible side effects 
5       How to store Lamotrigine Aurobindo 
6       Contents of the pack and other information 

1.      WHAT LAMOTRIGINE AUROBINDO IS AND WHAT IT IS
USED FOR 

Lamotrigine Aurobindo belongs to a group
of medicines called _anti-epileptics_. It is
used to treat two 
conditions — EPILEPSY and BIPOLAR DISORDER. 

LAMOTRIGINE AUROBINDO TREATS EPILEPSY by blocking the
signals in the brain that trigger epileptic 
seizures (fits). 
•  For adults and children aged 13 years and over, Lamotrigine
Aurobindo can be used  on its 
own or with other  medicines, to treat epilepsy. Lamotrigine
Aurobindo can also be used with 
other medicines to treat the seizures that occur with
a condition called Lennox-Gastaut 
syndrome. 
Lamotrigine Aurobindo can be used  with other 
medicines, to treat  those conditions. It can be used on its
ow

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamotrigine Aurobindo 200 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg lamotrigine.
Excipient with known effect::
Lactose: 152 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Blue coloured, mottled, shield shaped uncoated tablets debossed with
‘D’ and ‘96’on one sideand scoreline on the other
side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy:
_Adults and adolescents aged 13 years and above_
•
Adjunctive or monotherapy treatment of partial seizures and
generalized seizures, including tonic-clonic
seizures.
•
Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given
as an adjunctive therapy but may
be the initial antiepileptic drug (AED) to start with in
Lennox-Gastaout syndrome.
_Children and adolescents aged 2 to 12 years_
•
Adjunctive treatment of partial seizures and generalized seizures,
including tonic-clonic seizures and the
seizures associated with Lennox-Gastaut syndrome.
•
Monotherapy of typical absence seizures.
Bipolar disorder:
_Adults aged 18 years and above_
•
Prevention of depressive episodes in patients with bipolar I disorder
who experience predominantly
depressive episodes (see section 5.1).
Lamotrigine is not indicated for the acute treatment of manic or
depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lamotrigine tablets should be swallowed whole. If the tablets require
halving (to facilitate ease of swallowing), the
halves should also be swallowed whole and not be chewed or crushed.
Use a tablet cutter to halve tablets. Alternatively,
keeping the score-line side facing upwards, hold both the upper and
lower sides of the tablet, on either side of the
score-line, using the thumb and index finger of both hands (fig. A)
and halve the tablet by pressing down and away
from the score-line so that the t