LAMICTAL 25 Milligram Chewable/Dispersible tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LAMOTRIGINE

Commercializzato da:

WPR Healthcare Limited

Codice ATC:

N03AX09

INN (Nome Internazionale):

LAMOTRIGINE

Dosaggio:

25 Milligram

Forma farmaceutica:

Chewable/Dispersible tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Other antiepileptics

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2012-09-14

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 50 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 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 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
1.
WHAT LAMICTAL IS AND WHAT IT IS USED FOR
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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25 mg chewable/dispersible tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25 mg chewable/dispersible tablets contains 25 mg lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet.
_Product imported from Spain:_
White to off
-white square tablet with rounded corners with a blackcurrant odour, marked “GSCL5” on one side “25”
on the other. The tablets may be slightly mottled.
4 CLINICAL PARTICULARS
As per PA 1077/061/007
5 PHARMACOLOGICAL PROPERTIES
As per PA 1077/061/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium carbonate
Low-substituted hydroxypropyl cellulose
Aluminium magnesium silicate
Sodium starch glycolate (Type A)
Povidone K30
Saccharin sodium
Magnesium stearate
Blackcurrant flavour
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the container and outer carton of the product as marketed
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage conditions.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/04/2016_
_CRN 2174571_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 56 chewable/dispersible tablets contained in an overlabelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
WPR Healthcare Limited
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA 0565/050/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first�