Lamictal 25 mg chewable/dispersible tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LAMOTRIGINE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

N03AX09

INN (International Name):

LAMOTRIGINE 25 mg

Pharmaceutical form:

CHEWABLE/DISPERSIBLE TABLET

Composition:

LAMOTRIGINE 25 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Authorised

Authorization date:

2006-03-17

Patient Information leaflet

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PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL 5 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL 25 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 (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
perio

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lamictal 25 mg tablets.
Lamictal 50 mg tablets.
Lamictal 100 mg tablets.
Lamictal 5 mg chewable/dispersible tablets.
Lamictal 25 mg chewable/dispersible tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamictal tablets
Each Lamictal 25 mg tablet contains 25 mg lamotrigine.
Excipient with known effect: Each tablet contains 23.5 mg lactose.
Each Lamictal 50 mg tablet contains 50 mg lamotrigine.
Excipient with known effect: Each tablet contains 46.9 mg lactose.
Each Lamictal 100 mg tablet contains 100 mg lamotrigine.
Excipient with known effect: Each tablet contains 93.9 mg lactose.
Lamictal chewable/dispersible tablets
Each Lamictal 5 mg chewable/dispersible tablet contains 5 mg
lamotrigine.
Each Lamictal 25 mg chewable/dispersible tablet contains 25 mg
lamotrigine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Chewable/dispersible tablet.
25 mg tablets:
Pale, yellowish-brown, multifaceted, super-elliptical tablets of 6.0
mm marked “GSEC7” on one side and
“25” on the other.
50 mg tablets:
Pale, yellowish-brown, multifaceted, super-elliptical tablets of 7.4
mm marked “GSEE1” on one side and
“50” on the other.
100 mg tablets:
Pale, yellowish-brown, multifaceted, super-elliptical tablets of 9.4
mm marked “GSEE5” on one side and
“100” on the other.
5 mg chewable/dispersible tablets:
White to off-white, elongated, biconvex tablets (major axis 8.0 mm;
minor axis 4.0 mm) with a blackcurrant
odour, marked “GS CL2” on one side and “5” on the other. The
tablets may be slightly mottled.
25 mg chewable/dispersible tablets:
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.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy
_Adults and adolescents aged 13 years and above _
-
Adjunctive or monotherapy treatment of partial seizures and
general