Lamictal 100 mg Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Lamotrigine

Dostupné z:

PCO Manufacturing Ltd.

ATC kód:

N03AX; N03AX09

INN (Medzinárodný Name):

Lamotrigine

Dávkovanie:

100 milligram(s)

Forma lieku:

Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Other antiepileptics; lamotrigine

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2013-05-31

Príbalový leták

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25 MG TABLETS
LAMICTAL
® 50 MG TABLETS
LAMICTAL
® 100 MG TABLETS
LAMICTAL
® 200 MG 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 its own or
with other medicines, to p

Súhrn charakteristických

Health Products Regulatory Authority
13 December 2018
CRN008QS3
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 100 mg 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 Portugal, Czech Republic and Greece_
Pale, yellowish-brown, multifaceted, super-elliptical tablet, 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.
Health Products Regulatory Authority
13 December 2018
CRN008QS3
Page 2 of 3
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.
6.5 NATURE AND CONTENTS OF CONTAINER
_Product imported from Portugal and Czech Republic _
Each pack contains 56 tablets.
_Product imported from Greece _
Blisters of 60 tablets.
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
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/092/010
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31st May 2013
10 DATE OF REVISION OF THE TEXT
Health Products Regulatory Authority
13 December 2018
CRN0