Lamictal 100 mg chewable/dispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lamotrigine

Available from:

PCO Manufacturing Ltd.

ATC code:

N03AX; N03AX09

INN (International Name):

Lamotrigine

Dosage:

100 milligram(s)

Pharmaceutical form:

Chewable/dispersible tablet

Therapeutic area:

Other antiepileptics; lamotrigine

Authorization date:

2012-09-14

Patient Information leaflet

_ _
_ _
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

Summary of Product characteristics

Health Products Regulatory Authority
19 July 2023
CRN00DPXD
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 and Germany_
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 PA1077/061/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/009
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.
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/dispersible tablets contained in an outer
carton.
Health Products Regulatory Authority
19 July 2023
CRN00DPXD
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/443/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Last of first authorisation: 14
th
December 2012
Last updated: April 2016
Last updated: September 2018
Last updated: May 2019
10 DATE OF REVISION OF THE TEXT
July 2023