Lamictal 2mg dispersible tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Lamotrigine

Verfügbar ab:

GlaxoSmithKline UK Ltd

ATC-Code:

N03AX09

INN (Internationale Bezeichnung):

Lamotrigine

Dosierung:

2mg

Darreichungsform:

Dispersible tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04080100; GTIN: 5010706010147

Gebrauchsinformation

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
Other formats
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print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
PRODUCT NAME
LAMICTAL 2 MG
CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL 5 MG
CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL 25 MG
CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL 100 MG
CHEWABLE/DISPERSIBLE TABLETS
Reference number
00003/0375
This is a service provided by the Royal National Institute of
Blind People.
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 how Lamictal
works in the brain to have this effect.
Do not take Lamictal:
•
IF YOU ARE ALLERGIC (_hypersensitive_) to lamotrigine or any of
the other ingredients of this medicine (listed in Section 6

Fachinformation

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
Tablet.
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 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.
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 escal