Lamictal 25mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lamotrigine

Available from:

Imbat Limited

ATC code:

N03AX; N03AX09

INN (International Name):

Lamotrigine

Dosage:

25 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; lamotrigine

Authorization status:

Authorised

Authorization date:

2014-01-24

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25MG TABLETS
lamotrigine
Your medicine is available using the above name but will be
referred to as Lamictal throughout this leaflet.
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 the same as yours.

If you get any of the 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 LEAFLET
1.
What Lamictal is and what it is used for
2.
What you need to know before you take Lamictal
3.
How to take Lamictal
4.
Possible side effects
5.
How to store Lamictal
6.
Contents of the pack and other information
1.
WHAT LAMICTAL IS AND WHAT IT IS USED FOR
Lamictal belongs to a group of medicines called _anti-_
_epileptics_. It is used to treat two conditions - EPILEPSY and
BIPOLAR DISORDER.
LAMICTAL TREATS EPILEPSY by blocking the signals in the brain
that trigger epileptic seizures (fits).

For adults and children aged 13 years and over, Lamictal
can be used on its own or with other medicines, to treat
epilepsy. Lamictal can also be used with other medicines
to treat the seizures that occur with a condition called
Lennox-Gastaut syndrome.

For children aged between 2 and 12 years, Lamictal can
be used with other medicines, to treat those conditions.
It can be used on its own to treat a type of epilepsy
called typical absence seizures.
LAMICTAL ALSO TREATS BIPOLAR DISORDER.
People with bipolar disorder (sometimes called _manic _
_depression_) have extreme mood swings, with periods of
mania (excitement or euphoria) alternating with periods of
depression (deep sadness or despair). For adults aged 18
years and over, Lamictal can be used on

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25mg tablet contains 25mg lamotrigine.
Excipient: Each tablet contains lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK_
Pale yellowish-brown, square tablets with rounded corners, marked
‘GSEC7’ on one side and ‘25’ on the other.
4 CLINICAL PARTICULARS
As per PA1077/061/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Povidone K30
Sodium starch glycolate (Type A)
Iron oxide yellow (E172)
Magnesium stearate.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_5_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_2_
_1_
_7_
_2_
_2_
_8_
_0_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labeled outer carton containing blister strips.
Pack size: 56
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PROD