Lamictal 25 mg chewable/dispersible tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Lamotrigine

Saatavilla:

PCO Manufacturing Ltd.

ATC-koodi:

N03AX09

INN (Kansainvälinen yleisnimi):

Lamotrigine

Annos:

25 milligram(s)

Lääkemuoto:

Chewable/dispersible tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

lamotrigine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2003-07-11

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 5 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 25 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 50 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 100 MG CHEWABLE/DISPERSIBLE TABLETS
LAMICTAL
® 200 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 dep

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25mg chewable/dispersible tablet contains 25 mg of
lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet.
_Product imported from Greece:_
White, square tablets with rounded corners with ‘Lamictal 25’ on
one side.
_Product imported from the Netherlands:_
White, square tablets with rounded corners with ‘25’ on one side
and ‘GSCL5’ 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
Calcium carbonate
Hyprolose
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K 30
Saccharin Sodium
Magnesium stearate
Blackcurrant flavouring
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 package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package in order to
protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 30 or 42 tablets in an over l