Lamictal 200 mg chewable/dispersible tablets.

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Lamotrigine

제공처:

IMED Healthcare Ltd.

ATC 코드:

N03AX; N03AX09

INN (국제 이름):

Lamotrigine

복용량:

200 milligram(s)

약제 형태:

Chewable/dispersible tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Other antiepileptics; lamotrigine

승인 상태:

Authorised

승인 날짜:

2012-08-03

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
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
depression (deep sadness or
despair). For adults aged 18 years and over, Lami

제품 특성 요약

Health Products Regulatory Authority
12 April 2022
CRN00CWLT
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 200 mg chewable/dispersible tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 200 mg chewable/dispersible tablet contains 200 mg
lamotrigine.
For a 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, tablet with a
blackcurrant odour, marked "GSEC5" on one side and "200" on
the other. The tablets may be slightly mottled.
4 CLINICAL PARTICULARS
As per PA1077/061/010
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/010
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium carbonate
Hyprolose
Aluminium magnesium silicate
Poly (O-carboxymethyl) starch, sodium salt
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 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
Carton containing 4 blister strips (14 tablets per strip).
Health Products Regulatory Authority
12 April 2022
CRN00CWLT
Page 2 of 2
Pack size of 56 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/066/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3
rd
August 2012
10 DATE OF REVISION OF THE TEXT
April 2022