Lamictal 5 mg chewable/dispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lamotrigine

Available from:

PCO Manufacturing Ltd.

ATC code:

N03AX09

INN (International Name):

Lamotrigine

Dosage:

5 milligram(s)

Pharmaceutical form:

Chewable/dispersible tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

lamotrigine

Authorization status:

Authorised

Authorization date:

2003-07-11

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 5 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 25 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 50 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 100 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 200 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
dep

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2021
CRN00C4KV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 5 mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 5 mg chewable/dispersible tablet contains 5 mg of
lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet
_ _
_Product imported from Greece and Spain:_
White to off-white, elongated, biconvex tablets with a blackcurrant
odour, marked '5' on one side and 'GSCL2' on the other.
The tablets may be slightly mottled.
4 CLINICAL PARTICULARS
As per PA1077/061/006
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium carbonate
Low-substituted hydroxproylcellulose
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K30
Saccharin sodium
Blackcurrant flavour
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
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Blister: Do not store above 25 °C. Store in the original package in
order to protect from light and moisture.
Bottle: This medicinal product does not require any special storage
conditions.
Health Products Regulatory Authority
26 January 2021
CRN00C4KV
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 30 tablets in an overlabelled outer carton or
28 tablets in a carton.
_Product imported from Spain_: HDPE bottle containing 60 tablets with
a child resistant/tamper evident closure.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7