Lamictal 25mg dispersible/chewable tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Lamotrigine

Disponible depuis:

Imbat Limited

Code ATC:

N03AX; N03AX09

DCI (Dénomination commune internationale):

Lamotrigine

Dosage:

25 milligram(s)

forme pharmaceutique:

Dispersible tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Other antiepileptics; lamotrigine

Statut de autorisation:

Authorised

Date de l'autorisation:

2009-08-21

Notice patient

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25MG DISPERSIBLE/CHEWABLE TABLETS
(lamotrigine)
Your medicine is available using the above name but will be
referred to as Lamictal throughout this leaflet.
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, L

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25mg dispersible/chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25mg 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 Germany and Italy:_
White to off-white multi-faceted, super-elliptical tablet with a
blackcurrant odour marked ‘GSCL5’ on one side and
‘25’ on the other.
4 CLINICAL PARTICULARS
As per PA1077/061/007
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Germany:_
Calcium carbonate
hydroxypropyl cellulose
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K30
Saccharin sodium
Magnesium stearate
Blackcurrant flavour
_Product imported from Italy:_
Calcium carbonate
Low-substituted hydroxypropyl cellulose
Aluminium magnesium silicate
Sodium starch glycolate (Type A)
Povidone K30
Saccharin sodium
Magnesium stearate
Blackcurrant flavour
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6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strip and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
T