LAMICTAL DISPERSIBLECHEWABLE TABLETS 100 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

LAMOTRIGINE

Tilgængelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

N03AX09

Lægemiddelform:

DISPERSIBLE/CHEWABLE TABLETS

Sammensætning:

LAMOTRIGINE 100 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Terapeutisk gruppe:

LAMOTRIGINE

Terapeutisk område:

LAMOTRIGINE

Terapeutiske indikationer:

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.

Autorisation dato:

2020-09-30

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
Lamictal Dispersible/Chewable Tablets 5 mg
Each Lamictal Dispersible/Chewable Tablet 5 mg contains 5 mg
lamotrigine.
Lamictal Dispersible/Chewable Tablets 25 mg
Each Lamictal Dispersible/Chewable Tablet 25 mg contains 25 mg
lamotrigine.
Lamictal Dispersible/Chewable Tablets 50 mg
Each Lamictal Dispersible/Chewable Tablet 50 mg contains 50 mg
lamotrigine.
Lamictal Dispersible/Chewable Tablets 100 mg
Each
Lamictal
Dispersible/Chewable
Tablet
100
mg
contains
100
mg
lamotrigine.
Lamictal Dispersible/Chewable Tablets 200 mg
Each
Lamictal
Dispersible/Chewable
Tablet
200
mg
contains
200
mg
lamotrigine.
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 – "Important information about some of the ingredients in the
medicine" and
section 6 – "Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Lamictal
is
intended
for
the
treatment
of
epilepsy
(Lamictal
Dispersible/Chewable Tablets: 5, 25, 50, 100, 200 mg)
In adults and adolescents aged 13 years and above:
•
Lamictal is given as monotherapy or in combination with other
medicines to
treat
partial
seizures
and
generalized
seizures,
including
tonic-clonic
seizures.
•
Seizures that occur with Lennox-Gastaut syndrome. Lamictal is given as
combination therapy with other medicines but may be used as the
initial
antiepileptic drug to start treatment in Lennox-Gastaut syndrome.
In children and adolescents aged 2 to 12 years:
•
Lamictal is given as combination therapy with other medicines to treat
partial
seizures a

Produktets egenskaber

1
1.
NAME OF THE MEDICINAL PRODUCT
Lamictal Dispersible/Chewable Tablets 5mg
Lamictal Dispersible/Chewable Tablets 25mg
Lamictal Dispersible/Chewable Tablets 50mg
Lamictal Dispersible/Chewable Tablets 100mg
Lamictal Dispersible/Chewable Tablets 200mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamictal Dispersible/Chewable Tablets 5mg: contain 5mg lamotrigine.
Lamictal Dispersible/Chewable Tablets 25mg: contain 25mg lamotrigine.
Lamictal Dispersible/Chewable Tablets 50mg: contain 50mg lamotrigine.
Lamictal Dispersible/Chewable Tablets 100mg: contain 100mg
lamotrigine.
Lamictal Dispersible/Chewable Tablets 200mg: contain 200mg
lamotrigine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable/Dispersible tablet.
Lamictal Dispersible/Chewable Tablets 5mg are white to off-white,
elongated, biconvex, tablets, with a
blackcurrant odour, marked “GS CL2” on one side and “5” on the
other. The tablets may be slightly
mottled.
Lamictal Dispersible/Chewable Tablets 25mg are white to off-white,
multifaceted, super elliptical tablets
with a blackcurrant odour, marked “GSCL5” on one side “25” on
the other. The tablets may be slightly
mottled.
Lamictal Dispersible/Chewable Tablets 50mg are white to off-white,
multifaceted, super elliptical tablets
with a blackcurrant odour, marked “GSCX7” on one side and “50”
on the other. The tablets may be slightly
mottled.
Lamictal Dispersible/Chewable Tablets 100mg are white to off-white,
multifaceted, super elliptical tablets
with a blackcurrant odour, marked “GSCL7” on one side and
“100” on the other. The tablets may be slightly
mottled.
Lamictal Dispersible/Chewable Tablets 200mg are white to off-white,
multifaceted, super elliptical tablets
with a blackcurrant odour, marked “GSEC5” on one side and
“200” on the other. The tablets may be slightly
mottled
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy
(Lamictal Disp/Chewable Tablets: 5MG, 25MG, 50MG, 100MG, 200MG)
_Adults and adolescents aged 13 years and a