Lamictal 25 mg tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Lamotrigine

Saadav alates:

Merit Pharmaceuticals Limited

ATC kood:

N03AX; N03AX09

INN (Rahvusvaheline Nimetus):

Lamotrigine

Annus:

25 milligram(s)

Ravimvorm:

Tablet

Terapeutiline ala:

Other antiepileptics; lamotrigine

Loa andmise kuupäev:

2014-11-03

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL
® 25 MG TABLETS
LAMICTAL
® 100 MG TABLETS
lamotrigine
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 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMICTAL
DO NOT TAKE LAMICTAL:
• IF YOU ARE ALLERGIC _ (hypersensitive) _ to lamotrigine or any of the
other
ingredients of this medicine (listed in Section 6).
If this applies to you:

TELL YOUR DOCTOR, and don’t take Lamictal.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH LAMICTAL
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING LAMICTAL:
• IF YOU HAVE ANY KIDNEY PROBLEMS
• IF YOU HAVE EVER DEVELOPED A RASH after taking lamotri

Toote omadused

Health Products Regulatory Authority
21 May 2021
CRN00C2T0
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 with known effect: lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Romania:_
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
PVC/aluminium foil blister. Packs of 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Health Products Regulatory Authority
21 May 2021
CRN00C2T0
Page 2 of 2
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Merit Pharmaceuticals Limited
Unit C4 Metropoint Business Park
Kettles Lane
Swords
Co Dublin
K67 RH92
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23080/014/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3
rd
November 2014
10 DATE OF REVISION OF THE TEXT
May 2021