Lamictal 25 mg chewable/dispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lamotrigine

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

N03AX; N03AX09

INN (International Name):

Lamotrigine

Dosage:

25 milligram(s)

Pharmaceutical form:

Chewable/dispersible tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; lamotrigine

Authorization status:

Marketed

Authorization date:

1994-05-16

Patient Information leaflet

Reason for Update: Type IAIN – PRAC recommendation
Market: IE
Agency Approval Date: 25/10/2023 – Type IA – Implementation date
Text Date: 18/09/2023
Text Issue and Draft No.: Issue 24 Draft 1
1
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.
Peopl

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2024
CRN00DYM7
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25 mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25 mg chewable/dispersible tablet contains 25 mg
lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet.
White to off‑white multi‑faceted, super‑elliptical, tablets of
5.2 mm with a blackcurrant odour, marked GSCL5 on one side 25
on the other. 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 of typical 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 to whole tablets, the dose to be administered is that
equal to the lower nu