Lamictal 25mg dispersible/chewable Tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Lamotrigine

Saadav alates:

Profind Wholesale Ltd

ATC kood:

N03AX09

INN (Rahvusvaheline Nimetus):

Lamotrigine

Annus:

25 milligram(s)

Ravimvorm:

Chewable/dispersible tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

lamotrigine

Volitamisolek:

Authorised

Loa andmise kuupäev:

2010-04-23

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25mg dispersible/chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible/chewable tablet contains 25mg lamotrigine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible/chewable tablet
_Product imported from the UK:_
White to off white square tablet with rounded corners marked
‘GSCL5’ on one side and ‘25’ on the other. The tablets
have a blackcurrant odour and 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.
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