Lamictal 25 mg Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Lamotrigine

थमां उपलब्ध:

PCO Manufacturing Ltd.

ए.टी.सी कोड:

N03AX; N03AX09

INN (इंटरनेशनल नाम):

Lamotrigine

डोज़:

25 milligram(s)

फार्मास्यूटिकल फॉर्म:

Tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Other antiepileptics; lamotrigine

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2014-05-09

सूचना पत्रक

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25 MG TABLETS
LAMICTAL
® 50 MG TABLETS
LAMICTAL
® 100 MG TABLETS
LAMICTAL
® 200 MG 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 its own or
with other medicines, to p

उत्पाद विशेषताएं

Health Products Regulatory Authority
08 September 2022
CRN00D526
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25 mg tablet contains 25 mg lamotrigine.
Excipient(s) with known effect
Lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Czech Republic and Greece _
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked
“GSEC7” on one side and “25” on the other.
4 CLINICAL PARTICULARS
As per PA1077/061/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/061/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Povidone K30
Sodium starch glycolate (Type A)
Iron oxide yellow (E172)
Magnesium stearate.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container 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
_Product imported from Czech Republic _
Health Products Regulatory Authority
08 September 2022
CRN00D526
Page 2 of 2
PVC/Aluminium foil blister. Each pack contains 56 tablets.
_Product imported from Greece _
Blisters of 60 tablets.
Not all pack sizes may be marketed.
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
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/092/011
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09th May 2014
10 DATE OF REVISION OF THE TEXT
September 2022