Lamictal 5mg dispersible/chewable tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Lamotrigine

Διαθέσιμο από:

Imbat Limited

Φαρμακολογική κατηγορία (ATC):

N03AX; N03AX09

INN (Διεθνής Όνομα):

Lamotrigine

Δοσολογία:

5 milligram(s)

Φαρμακοτεχνική μορφή:

Dispersible tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Other antiepileptics; lamotrigine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-05-20

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 5mg dispersible/chewable tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 5mg dispersible/chewable tablet contains 5mg
lamotrigine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible/chewable tablet.
_Product imported from Italy :_
White to off-white, elongated, biconvex tablet with a blackcurrant
odour, marked ‘GSCL2’ on one side, and ‘5’ 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_
o
Adjunctive or
monotherapy treatment
of
partial
seizures
and generalised seizures,
including tonic
-
clonic
seizures.
o
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_
o
Adjunctive treatment
of
partial
seizures
and generalised seizures,
including tonic
-
clonic seizures
and the
seizures associated with Lennox
-
Gastaut syndrome.
o
Monotherapy of typical absence seizures.
Bipolar disorder
_Adults aged 18 years and above_
o
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 dispersible/chewable 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.
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