Lamictal 100 mg tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Lamotrigine

Dostopno od:

Originalis B.V.

Koda artikla:

N03AX; N03AX09

INN (mednarodno ime):

Lamotrigine

Farmacevtska oblika:

Tablet

Terapevtsko območje:

Other antiepileptics; lamotrigine

Datum dovoljenje:

2022-08-12

Navodilo za uporabo

Package leaflet: Information for the User
Lamictal
®
100 mg tablets
lamotrigine
O1769A3-IE-1.1
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 prevent the periods of depression
that occur in bipolar disorder. It is not yet known

Lastnosti izdelka

Health Products Regulatory Authority
12 August 2022
CRN00CY76
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 100 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg lamotrigine.
Excipient(s) with known effect: Each tablet contains lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Portugal and Czech Republic_
Pale, yellowish‑brown, multifaceted, super‑elliptical tablets of
9.4 mm 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.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/aluminium foil blister. Packs of 56 tablets.
Health Products Regulatory Authority
12 August 2022
CRN00CY76
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.,
Joop Geesinkweg 901,
1114 AB Amsterdam-Duivendrecht,
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/024/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
August 2022
10 DATE OF REVISION OF THE TEXT