Lamictal 50 mg Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Lamotrigine

Saatavilla:

Primecrown 2010 Limited

ATC-koodi:

N03AX; N03AX09

INN (Kansainvälinen yleisnimi):

Lamotrigine

Annos:

50 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Other antiepileptics; lamotrigine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-11-03

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25 MG TABLETS
LAMICTAL
® 50 MG TABLETS
LAMICTAL
® 100 MG TABLETS
lamotrigine
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 its own or with
other medicines, to prevent the periods of depression that occur in
bipolar
disorder. It is not yet known how Lamictal works in the brain to have
this
effect.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMICTAL
DO NOT TAKE LAMICTAL:
 IF YOU ARE ALLERGIC _ (hypersensitive) _ to lamotrigine or any of the
other
ingredients of this medicine (listed in Section 6).
If this applies to you:

TELL YOUR DOCTOR, and don’t take Lamictal.
TAKE SPECIAL CARE WITH LAMICTAL
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING LAMICTAL:
 IF YOU HAVE ANY KIDNEY PROBLEMS
 IF YOU HAVE EVER DEVELOPED A RASH after taking lamotri

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 50 mg tablet contains 50 mg lamotrigine.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Romania:_
Pale, yellowish
-
brown, multifaceted, super
-
elliptical tablet, marked “GSEE1” on one side and “50” on the
other.
4 CLINICAL PARTICULARS
As per PA1077/061/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/002
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 shall be the date shown on
the container and outer package of the product on
the market 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_
_4_
_/_
_0_
_7_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_2_
_4_
_9_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/aluminium foil blister. Packs of 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Nor