Lamictal 50 mg tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Lamotrigine

Boleh didapati daripada:

GlaxoSmithKline (Ireland) Limited

Kod ATC:

N03AX; N03AX09

INN (Nama Antarabangsa):

Lamotrigine

Dos:

50 milligram(s)

Borang farmaseutikal:

Tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Other antiepileptics; lamotrigine

Status kebenaran:

Marketed

Tarikh kebenaran:

1990-11-05

Risalah maklumat

Reason for Update: Type IA – PRAC Recommendation
Market: IE
Agency Approval Date: 25-Oct-2023(Type IAin artwork release date)
Text Date: 18/09/2023
Text Issue and Draft No.: Issue 17 Draft 1
1
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 euphor

Ciri produk

Health Products Regulatory Authority
16 January 2024
CRN00DYM7
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 50 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 50 mg tablet contains 50 mg lamotrigine.
Excipient with known effect: Each tablet contains 46.9 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
50 mg tablets:
Pale, yellowish‑brown, multifaceted, super‑elliptical tablets of
7.4 mm marked "GSEE1" on one side and "50" on the other.
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
Posology
Lamictal tablets should be swallowed whole, and should not be chewed
or crushed.
Health Products Regulatory Authority
16 January 2024
CRN00DYM7
Page 2 of 23
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 number of whole tablets.
_Restarting therapy_
Prescribers should assess the need for escalation to maintenance dose
when re