Lamictal tablets chewable/dispersible

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

lamotrigine

Saadav alates:

GlaxoSmithKline Pharmaceuticals S.A.

ATC kood:

N03AX09

INN (Rahvusvaheline Nimetus):

lamotrigine

Annus:

5mg

Ravimvorm:

tablets chewable/dispersible

Ühikuid pakis:

(28/2x14/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2016-07-27

Infovoldik

Reason for update: 2015-12-17 UKIE-TII-WS158-GDS 42-alopecia
Text Date: 09 March 2016
MHRA Approval: 8 March 2016
Text Issue and Draft No.: Issue 10 Draft 3
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
®
2 MG, 5 MG, 25 MG AND 100 MG
CHEWABLE/DISPERSIBLE TABLETS
LAMOTRIGINE
LAMICTAL
®
2 MG, 5 MG, 25 MG AND 100 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
B
EFORE 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
To listen to or request a copy of this leaflet in Braille, large 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.
1
WHAT LAMICTAL IS AND WHAT IT IS USED FOR
Reason for update: 2015-12-17 UKIE-TII-WS158-GDS 42-alopecia
Text Date: 09 March 2016
MHRA Approval: 8 March 2016
Text Issue and Draft No.: Issue 10 Draft 3
2
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 epile

Toote omadused

Reason for update:
TII-WS158-GDS 42-alopecia
Agency approval date: 8 March 2016
Text Date: 22 March 2016
SPC Issue 19 Draft 1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lamictal 5 mg chewable/dispersible tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 5 mg chewable/dispersible tablet contains 5 mg
lamotrigine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable/dispersible tablet.
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.
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.
Reason for update:
TII-WS158-GDS 42-alopecia
Agency approval date: 8 March 2016
Text Date: 22 March 2016
SPC Issue 19 Draft 1
2
If the calculated dose of lamotrigine (for example for treatment of
children with epilepsy or patients