Lamictal 50mg Dispersible/Chewable Tablet

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Lamotrigine

Διαθέσιμο από:

Imbat Limited

Φαρμακολογική κατηγορία (ATC):

N03AX; N03AX09

INN (Διεθνής Όνομα):

Lamotrigine

Δοσολογία:

50 milligram(s)

Φαρμακοτεχνική μορφή:

Dispersible tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Other antiepileptics; lamotrigine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-02-25

Φύλλο οδηγιών χρήσης

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 50MG DISPERSIBLE/CHEWABLE 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, L

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 50mg Dispersible/Chewable Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 50mg dispersible/chewable tablet contains 50mg
lamotrigine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible/chewable tablet.
_Product imported from Italy_
The tablets are white to off-white, multi-faceted, super-elliptical,
with a blackcurrant odour, marked “GSCX7” on one
side and “50” on the other. The tablets may be slightly mottled.
4 CLINICAL PARTICULARS
As per PA1077/061/008
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/61/008
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium carbonate
Low-substituted hydroxypropyl cellulose
Aluminium magnesium silicate
Sodium starch glycolate (Type A)
Povidone K30
Saccharin sodium
Magnesium stearate
Blackcurrant flavour
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package 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_
_ _
_2_
_2_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_2_
_1_
_4_
_5_
_9_
_3_
_4_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled outer carton containing blister strips.
Pack size: 56
6.6 SPECIAL PR