Lamictal 100 mg chewable/dispersible tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Lamotrigine

Доступна з:

Lexon Pharmaceuticals (Ireland) Limited

Код атс:

N03AX; N03AX09

ІПН (Міжнародна Ім'я):

Lamotrigine

Дозування:

100 milligram(s)

Фармацевтична форма:

Chewable/dispersible tablet

Терапевтична области:

Other antiepileptics; lamotrigine

Дата Авторизація:

2017-05-19

інформаційний буклет

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
What Lamictal is and what it is used for
What you need to know before you take Lamictal
How to take Lamictal
Possible side effects
How to store Lamictal
Contents of the pack and other information
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 its own or with
other
medicines, to prevent the periods of depression that occur in bipolar
disorder.
It is not yet known how Lamictal works in the brain to have this
effect.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMICTAL
DO NOT TAKE

Характеристики продукта

Health Products Regulatory Authority
10 February 2022
CRN00CSP3
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 100 mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 100 mg chewable/dispersible tablet contains 100 mg
lamotrigine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable/dispersible tablet.
_Product imported from Germany_
White to off-white multi-faceted, super-elliptical, tablets with a
blackcurrant odour, marked GSCL7 on one side and 100 on the
other. The tablets may be slightly mottled.
4 CLINICAL PARTICULARS
As per PA1077/061/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/009
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium carbonate
Low-substituted hydroxypropyl cellulose
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K30
Sodium saccharine
Magnesium stearate (Ph. Eur.)
Blackcurrant flavour
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 56 tablets.
Health Products Regulatory Authority
10 February 2022
CRN00CSP3
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/003/005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19
th
May 2017
10 DATE OF REVISION OF THE TEXT
October 2021