Lamictal 200 mg chewable/dispersible tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Lamotrigine

Dostopno od:

PCO Manufacturing Ltd.

Koda artikla:

N03AX09

INN (mednarodno ime):

Lamotrigine

Odmerek:

200 milligram(s)

Farmacevtska oblika:

Chewable/dispersible tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

lamotrigine

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-03-16

Navodilo za uporabo

_ _
_ _
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

Lastnosti izdelka

Health Products Regulatory Authority
02 March 2022
CRN00CSTN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 200 mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 200 mg chewable/dispersible tablet contains 200 mg
lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet
_Product imported from Italy and Germany:_
White, rounded-square tablets branded with '200' on one side and
'GSEC5' on the other.
4 CLINICAL PARTICULARS
As per PA1077/061/010
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/010
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
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
Do not store above 25°C. Store in the original package in order to
protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 56 dispersible/chewable tablets.
Health Products Regulatory Authority
02 March 2022
CRN00CSTN
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
PPA0465/092/009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
March 2007
Date of last renewal: May 2019
10 DATE OF REVISION OF THE TEXT
March 2022