Lamictal 2 mg chewable/dispersible tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Lamotrigine

Tilgjengelig fra:

GlaxoSmithKline (Ireland) Limited

ATC-kode:

N03AX; N03AX09

INN (International Name):

Lamotrigine

Dosering :

2 milligram(s)

Legemiddelform:

Chewable/dispersible tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other antiepileptics; lamotrigine

Autorisasjon status:

Marketed

Autorisasjon dato:

2001-10-19

Informasjon til brukeren

Reason for Update: Type IA – PRAC Recommendation
Market: IE
Agency Approval Date: 25-October-2023 (Type IAin artwork release date)
Text Date: 18/09/2023
Text Issue and Draft No: Issue 19 Draft 1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL 2 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
depression (dee

Preparatomtale

Health Products Regulatory Authority
16 January 2024
CRN00DYM7
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 2 mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 2 mg chewable/dispersible tablet contains 2 mg
lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet.
White to off‑white round tablets of 4.8 mm with a blackcurrant
odour. One side has a bevelled edge and is marked “LTG”
above the number 2. The other side is marked with two overlapping
super‑ellipses at right angles. The tablets may be slightly
mottled.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
_Adults and adolescents aged 13 years and above_
- Adjunctive or monotherapy treatment of partial seizures and
generalised seizures, including tonic‑clonic seizures.
- Seizures associated with Lennox‑Gastaut syndrome. Lamictal is
given as adjunctive therapy but may be the initial
antiepileptic drug (AED) to start with in Lennox‑Gastaut syndrome.
_Children and adolescents aged 2 to 12 years_
- Adjunctive treatment of partial seizures and generalised seizures,
including tonic‑clonic seizures and the seizures associated
with Lennox‑Gastaut syndrome.
- Monotherapy oftypical absence seizures.
Bipolar disorder
_Adults aged 18 years and above_
- Prevention of depressive episodes in patients with bipolar I
disorder who experience predominantly depressive episodes (see
section 5.1).
Lamictal is not indicated for the acute treatment of manic or
depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lamictal chewable/dispersible tablets may be chewed, dispersed in a
small volume of water (at least enough to cover the whole
tablet) or swallowed whole with a little water. Do not attempt to
administer partial quantities of the chewable/dispersible
tablets.
If the calculated dose of lamotrigine (for example for treatment of
children with epilepsy or patients with hepatic impairment)
does not equate