Lamictal 100 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lamotrigine

Available from:

Lexon (UK) Ltd

ATC code:

N03AX; N03AX09

INN (International Name):

Lamotrigine

Dosage:

100 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; lamotrigine

Authorization status:

Authorised

Authorization date:

2017-05-05

Patient Information 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
What Lamictal is and what it is used for
What you need to know before you take Lamictal
How to take Lamictal
Possible side effects
How to store Lamictal
Contents of the pack and other information
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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMICTAL
DO NOT TAKE LAMIC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 100 mg tablet contains 100 mg lamotrigine
Excipient(s) with known effect:
lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Czech Republic_
Light brown square tablets with rounded corners marked “GSEE5” on
one side and "100" on the other.
4 CLINICAL PARTICULARS
As per PA1077/061/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/003
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 for this product shall be the date shown on
the blister 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.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 56 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE