Lamictal 25 mg chewable/dispersible tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Lamotrigine

Dostopno od:

Lexon Pharmaceuticals (Ireland) Limited

Koda artikla:

N03AX; N03AX09

INN (mednarodno ime):

Lamotrigine

Odmerek:

25 milligram(s)

Farmacevtska oblika:

Chewable/dispersible tablet

Terapevtsko območje:

Other antiepileptics; lamotrigine

Datum dovoljenje:

2017-02-16

Navodilo za uporabo

*
IF YOU EXPERIENCE A RASH OR SUNBURN AFTER TAKING LAMOTRIGINE AND HAVING BEEN EXPOSED TO SUN OR ARTIFICIAL LIGHT (E.G. SOLARIUM). Your
doctor will check your treatment and may advise you to avoid sunlight
or
protect yourself against the sun (e.g. use of a sunscreen and/or to
wear
protective clothing)
*
IF YOU HAVE EVER DEVELOPED MENINGITIS AFTER TAKING LAMOTRIGINE (_read
_
_ the description of these symptoms in Section 4 of this leaflet: Rare
side _
_ effects_)
*
IF YOU ARE ALREADY TAKING MEDICINE THAT CONTAINS LAMOTRIGINE.
*
IF YOU HAVE A CONDITION CALLED BRUGADA SYNDROME, OR OTHER HEART PROBLEMS. Brugada syndrome is a genetic disease that results in
abnormal
electrical activity within the heart. ECG abnormalities which may lead
to
arrhythmias (abnormal heart rhythm) can be triggered by lamotrigine.
If any of these applies to you:
TELL YOUR DOCTOR, who may decide to lower the dose, or that Lamictal
is not suitable for you.
IMPORTANT INFORMATION ABOUT POTENTIALLY LIFE-THREATENING REACTIONS
A small number of people taking Lamictal get an allergic reaction or
potentially life-threatening skin reaction, which may develop into
more serious
problems if they are not treated. These can include Stevens - Johnson
syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction
with
Eosinophilia and Systemic Symptoms (DRESS). You need to know the
symptoms to look out for while you are taking Lamictal. READ THE DESCRIPTION OF THESE SYMPTOMS IN SECTION 4 OF THIS
LEAFLET under ‘_Potentially life-threatening reactions: get a
doctor’s help _
_straight away’_.
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)_ _
There have been reports of a rare but very serious immune system
reaction,
in patients taking lamotrigine.
CONTACT YOUR DOCTOR OR PHARMACIST IMMEDIATELY if you experience
any of the following symptoms while taking lamotrigine: fever, rash,
neurological symptoms (e.g. shaking or tremor, confusional state,
disturbances of brain function)._ _
_ _
THOUGHTS OF HARMING YOURSELF OR SUICIDE
Anti-epileptic medicines are used to

Lastnosti izdelka

Health Products Regulatory Authority
10 February 2022
CRN00CSP3
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamictal 25 mg chewable/dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lamictal 25 mg chewable/dispersible tablet contains 25 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 tablets of 5.2 mm with a blackcurrant odour, marked
GSCL5 on one side 25 on the other. The tablets may be
slightly mottled.
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
Low-substituted hydroxypropyl cellulose
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K30
Saccharin sodium
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
PPA23176/003/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
February 2017
10 DATE OF REVISION OF THE TEXT
October 2021