Lamictal 100 mg chewable/dispersible tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Lamotrigine

Tilgængelig fra:

PCO Manufacturing

ATC-kode:

N03AX; N03AX09

INN (International Name):

Lamotrigine

Dosering:

100 milligram(s)

Lægemiddelform:

Chewable/dispersible tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other antiepileptics; lamotrigine

Autorisation dato:

2012-09-14

Indlægsseddel

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 50 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 100 MG CHEWABLE/DISPERSIBLE 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 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

Produktets egenskaber

Health Products Regulatory Authority
07 December 2018
CRN008N1N
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 100 mg chewable/dispersible tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 100 mg
chewable/dispersible
tablet contains 100 mg lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet.
_Product imported from Spain:_
White to off‑white square tablet with rounded corners with a
blackcurrant odour,
marked “GSCL7” on one side and “100” on the other. The tablets
may be slightly
mottled.
4 CLINICAL PARTICULARS
As per PA 1077/061/009
5 PHARMACOLOGICAL PROPERTIES
As per PA 1077/061/009
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.
Health Products Regulatory Authority
07 December 2018
CRN008N1N
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container 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.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 56 chewable tablets/dispersible contained in an
overlabelled outer
carton
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA465/443/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
September 2012
10 DATE OF REVISION OF THE TEXT
December 2018