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LAMICTAL TABLETS 50MG

Active substance(s): LAMOTRIGINE

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25 mg, 50 mg, 100 mg and
200 mg tablets

25 mg, 50 mg, 100 mg and 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.

1 What Lamictal is and what
it is used for

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

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.

Other formats
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large print or audio please call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Lamictal 25 mg tablets

Lamictal 50 mg tablets

Lamictal 100 mg tablets

Lamictal 200 mg tablets
Reference number 00003/0272
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lamotrigine

Package Leaflet: Information for the User

What is in this leaflet

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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.

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
lamotrigine or other medicines for bipolar disorder or
epilepsy
• 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 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’.

Thoughts of harming yourself or suicide

Anti-epileptic medicines are used to treat several
conditions, including epilepsy and bipolar disorder. People
with bipolar disorder can sometimes have thoughts of
harming themselves or committing suicide. If you have
bipolar disorder, you may be more likely to think like this:
• when you first start treatment
• if you have previously had thoughts about harming
yourself or about suicide
• if you are under 25 years old.
If you have distressing thoughts or experiences, or if you
notice that you feel worse or develop new symptoms
while you’re taking Lamictal:
➔ See a doctor as soon as possible or go to the nearest
hospital for help.
You may find it helpful to tell a family member, caregiver
or close friend that you can become depressed or have
significant changes in mood, and ask them to read this
leaflet. You might ask them to tell you if they are worried
about your depression or other changes in your behaviour.
A small number of people being treated with anti-epileptics
such as Lamictal have also had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.

If you’re taking Lamictal for epilepsy

The seizures in some types of epilepsy may occasionally
become worse or happen more often while you’re taking
Lamictal. Some patients may experience severe seizures,
which may cause serious health problems. If your seizures
happen more often or if you experience a severe seizure
while you’re taking Lamictal:
➔ See a doctor as soon as possible.
Lamictal should not be given to people aged under
18 years to treat bipolar disorder. Medicines to treat
depression and other mental health problems increase the
risk of suicidal thoughts and behaviour in children and
adolescents aged under 18 years.

Other medicines and Lamictal

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including herbal medicines or other medicines bought
without a prescription.
Your doctor needs to know if you are taking other
medicines to treat epilepsy or mental health problems.
This is to make sure you take the correct dose of Lamictal.
These medicines include:
• oxcarbazepine, felbamate, gabapentin, levetiracetam,
pregabalin, topiramate or zonisamide, used to treat
epilepsy
• lithium, olanzapine or aripiprazole used to treat
mental health problems
• bupropion, used to treat mental health problems or to
stop smoking
➔ Tell your doctor if you are taking any of these.
Some medicines interact with Lamictal or make it more
likely that people will have side effects. These include:
• valproate, used to treat epilepsy and mental health
problems
• carbamazepine, used to treat epilepsy and mental
health problems
• phenytoin, primidone or phenobarbitone, used to
treat epilepsy
• risperidone, used to treat mental health problems
• rifampicin, which is an antibiotic
• medicines used to treat Human Immunodeficiency
Virus (HIV) infection (a combination of lopinavir and
ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the Pill (see below).
➔ Tell your doctor if you are taking any of these or if you
start or stop taking any.

Hormonal contraceptives (such as the Pill)
can affect the way Lamictal works

Your doctor may recommend that you use a particular
type of hormonal contraceptive or another method of
contraception, such as condoms, a cap or coil. If you are
using a hormonal contraceptive like the Pill, your doctor
may take samples of your blood to check the level of
Lamictal. If you are using a hormonal contraceptive or if
you plan to start using one:
➔ Talk to your doctor, who will discuss suitable methods
of contraception with you.
Lamictal can also affect the way hormonal contraceptives
work, although it’s unlikely to make them less effective. If
you are using a hormonal contraceptive and you notice
any changes in your menstrual pattern, such as
breakthrough bleeding or spotting between periods:
➔ Tell your doctor. These may be signs that Lamictal is
affecting the way your contraceptive is working.

Pregnancy and breast-feeding

➔ If you are pregnant, think you may be pregnant or
are planning to have a baby ask your doctor or
pharmacist for advice before taking this medicine.
• You should not stop treatment without discussing this
with your doctor. This is particularly important if you
have epilepsy.
• Pregnancy may alter the effectiveness of Lamictal, so
you may need blood tests and your dose of Lamictal
may be adjusted.
• There may be a small increased risk of birth defects,
including a cleft lip or cleft palate, if Lamictal is taken
during the first 3 months of pregnancy.
• Your doctor may advise you to take extra folic acid if
you’re planning to become pregnant and while you’re
pregnant.

➔ If you are breast-feeding or planning to breast-feed
ask your doctor or pharmacist for advice before taking
this medicine. The active ingredient of Lamictal passes
into breast milk and may affect your baby. Your doctor
will discuss the risks and benefits of breast-feeding
while you’re taking Lamictal and will check your baby
from time to time if you decide to breast-feed.

Driving and using machines

Lamictal can cause dizziness and double vision.
➔ Don’t drive or use machines unless you are sure you’re
not affected.
If you have epilepsy, talk to your doctor about driving
and using machines.

Important information about some of the
ingredients of Lamictal

Lamictal tablets contain small amounts of a sugar called
lactose. If you have an intolerance to lactose or any
other sugars:
➔ Tell your doctor and don’t take Lamictal.

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3 How to take Lamictal

5 How to store Lamictal

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

How much Lamictal to take

It may take a while to find the best dose of Lamictal
for you. The dose you take will depend on:
• your age
• whether you are taking Lamictal with other
medicines
• whether you have any kidney or liver problems.
Your doctor will prescribe a low dose to start and
gradually increase the dose over a few weeks until
you reach a dose that works for you (called the
effective dose). Never take more Lamictal than
your doctor tells you to.
The usual effective dose of Lamictal for adults and
children aged 13 years or over is between 100 mg
and 400 mg each day.
For children aged 2 to 12 years, the effective dose
depends on their body weight - usually, it’s
between 1 mg and 15 mg for each kilogram of the
child’s weight, up to a maximum maintenance dose
of 200 mg daily.
Lamictal is not recommended for children aged
under 2 years.

How to take your dose of Lamictal

Take your dose of Lamictal once or twice a day, as
your doctor advises. It can be taken with or
without food.
Your doctor may also advise you to start or stop
taking other medicines, depending on what
condition you’re being treated for and the way you
respond to treatment.
• Swallow your tablets whole. Don’t break, chew
or crush them.
• Always take the full dose that your doctor has
prescribed. Never take only part of a tablet.

If you take more Lamictal than you
should

➔ Contact a doctor or nearest hospital emergency
department immediately. If possible, show them
the Lamictal packet.
If you take too much Lamictal you may be more
likely to have serious side effects which may be
fatal.
Someone who has taken too much Lamictal may
have any of these symptoms:
• rapid, uncontrollable eye movements
(nystagmus)
• clumsiness and lack of co-ordination, affecting
their balance (ataxia)
• heart rhythm changes (detected usually on ECG)
• loss of consciousness, fits (convulsions) or coma.

If you forget to take a single dose of
Lamictal

➔ Don’t take extra tablets to make up for a
missed dose. Just take your next dose at the
usual time.
In case you forget to take multiple doses of Lamictal
➔ Ask your doctor for advice on how to start
taking it again. It’s important that you do this.

Don’t stop taking Lamictal without
advice

Lamictal must be taken for as long as your doctor
recommends. Don’t stop unless your doctor advises
you to.

If you’re taking Lamictal for epilepsy
To stop taking Lamictal, it is important that the
dose is reduced gradually, over about 2 weeks. If
you suddenly stop taking Lamictal, your epilepsy
may come back or get worse.

If you’re taking Lamictal for bipolar
disorder

Lamictal may take some time to work, so you are
unlikely to feel better straight away.
If you stop taking Lamictal, your dose will not need
to be reduced gradually. But you should still talk to
your doctor first, if you want to stop taking
Lamictal.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, but not everyone gets them.

Potentially life-threatening reactions:
get a doctor’s help straight away
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 symptoms are more likely to happen during
the first few months of treatment with Lamictal,
especially if the starting dose is too high or if the
dose is increased too quickly or if Lamictal is taken
with another medicine called valproate. Some of the
symptoms are more common in children, so parents
should be especially careful to watch out for them.
Symptoms of these reactions include:
• skin rashes or redness, which may develop into
life-threatening skin reactions including
widespread rash with blisters and peeling skin,
particularly occurring around the mouth, nose,
eyes and genitals (Stevens-Johnson syndrome),
extensive peeling of the skin (more than 30% of
the body surface - toxic epidermal necrolysis) or

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extended rashes with liver, blood and other
body organs involvement (Drug Reaction with
Eosinophilia and Systemic Symptoms which is
also known as DRESS hypersensitivity syndrome)
• ulcers in the mouth, throat, nose or genitals
• a sore mouth or red or swollen eyes (conjunctivitis)
• a high temperature (fever), flu-like symptoms or
drowsiness
• swelling around your face or swollen glands in
your neck, armpit or groin
• unexpected bleeding or bruising, or the fingers
turning blue
• a sore throat or more infections (such as colds)
than usual
• increased levels of liver enzymes seen in blood
tests
• an increase in a type of white blood cell
(eosinophils)
• enlarged lymph nodes
• involvement of the organs of the body including
liver and kidneys.
In many cases, these symptoms will be signs of less
serious side effects but you must be aware that
they are potentially life-threatening and can
develop into more serious problems, such as organ
failure, if they are not treated. If you notice any of
these symptoms:
➔ Contact a doctor immediately. Your doctor may
decide to carry out tests on your liver, kidneys or
blood and may tell you to stop taking Lamictal.
In case you have developed Stevens-Johnson
syndrome or toxic epidermal necrolysis your
doctor will tell you that you must never use
lamotrigine again.

Very common side effects

Common side effects

These may affect up to 1 in 10 people:
• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• shaking or tremors
• difficulty in sleeping (insomnia)
• feeling agitated
• diarrhoea
• dry mouth
• feeling sick (nausea) or being sick (vomiting)
• feeling tired
• pain in your back or joints, or elsewhere.

Uncommon side effects

These may affect up to 1 in 100 people:
• clumsiness and lack of co-ordination (ataxia)
• double vision or blurred vision
• unusual hair loss or thinning (alopecia)

Rare side effects

These may affect up to 1 in 1,000 people:
• a life-threatening skin reaction (Stevens-Johnson
syndrome): (see also the information at the
beginning of Section 4)
• a group of symptoms together including: fever,
nausea, vomiting, headache, stiff neck and
extreme sensitivity to bright light. This may be
caused by an inflammation of the membranes
that cover the brain and spinal cord (meningitis).
These symptoms usually disappear once
treatment is stopped however if the symptoms
continue or get worse contact your doctor
• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crusty eyelids
(conjunctivitis).

These may affect more than 1 in 10 people:
• headache
• skin rash.

Very rare side effects

These may affect up to 1 in 10,000 people:
• a life-threatening skin reaction (toxic epidermal
necrolysis): see also the information at the
beginning of Section 4
• Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS): (see also the information at
the beginning of Section 4)
• a high temperature (fever): (see also the
information at the beginning of Section 4)
• swelling around the face (oedema) or swollen
glands in the neck, armpit or groin
(lymphadenopathy): (see also the information at
the beginning of Section 4)
• changes in liver function, which will show up in
blood tests, or liver failure: (see also the
information at the beginning of Section 4)
• a serious disorder of blood clotting, which can
cause unexpected bleeding or bruising
(disseminated intravascular coagulation): (see also
the information at the beginning of Section 4)
• changes which may show up in blood
tests - including reduced numbers of red blood
cells (anaemia), reduced numbers of white blood
cells (leucopenia, neutropenia, agranulocytosis),
reduced numbers of platelets (thrombocytopenia),
reduced numbers of all these types of cell
(pancytopenia) and a disorder of the bone
marrow called aplastic anaemia
• hallucinations (‘seeing’ or ‘hearing’ things that
aren’t really there)
• confusion
• feeling ‘wobbly’ or unsteady when you move
about
• uncontrollable body movements (tics),
uncontrollable muscle spasms affecting the eyes,
head and torso (choreoathetosis) or other
unusual body movements such as jerking,
shaking or stiffness

• in people who already have epilepsy, seizures
happening more often
• in people who already have Parkinson’s disease,
worsening of the symptoms.
• lupus-like reaction (symptoms may include: back
or joint pain which sometimes may be
accompanied by fever and/or general ill health).

Other side effects

Other side effects have occurred in a small number
of people but their exact frequency is unknown:
• There have been reports of bone disorders
including osteopenia and osteoporosis (thinning
of the bone) and fractures. Check with your
doctor or pharmacist if you are on long-term
anti-epileptic medication, have a history of
osteoporosis or take steroids
• Nightmares.

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
shown on the blisters or carton. The expiry date
refers to the last day of that month.
Lamictal does not require any special storage
conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. This will
help protect the environment.

6 Contents of the pack

and other information

What Lamictal tablets contain

The active substance is lamotrigine. Each tablet
contains 25 mg, 50 mg, 100 mg or 200 mg
lamotrigine.
The other ingredients are: lactose monohydrate,
microcrystalline cellulose, povidone K30, sodium
starch glycolate (Type A), iron oxide yellow (E172)
and magnesium stearate.

Lamictal 100 mg tablets are marked ‘GSEE5’ on one
side and ‘100’ on the other. Each pack contains
blisters of 28, 30, 42, 50, 56, 60, 90, 98 or 100 tablets.
Lamictal 200 mg tablets are marked ‘GSEE7’ on one
side and ‘200’ on the other. Each pack contains
blisters of 28, 30, 42, 56 or 100 tablets.

Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder:
The Wellcome Foundation Ltd., Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer: GlaxoSmithKline Pharmaceuticals
S.A., Ul. Grunwaldzka 189, 60-322 Poznań, Poland
This leaflet was last revised in March 2016
Lamictal is a registered trade mark of the GSK
group of companies
© 2016 GSK group of companies. All rights reserved

What Lamictal tablets look like and
contents of the pack

Lamictal tablets (all strengths) are square with
rounded corners and pale, yellowish brown in
colour. Not all listed pack sizes may be marketed.
Lamictal 25 mg tablets are marked ‘GSEC7’ on one
side and ‘25’ on the other. Each pack contains
blisters of 14, 21, 28, 30, 42, 50, 56 or 100 tablets.
Lamictal 50 mg tablets are marked ‘GSEE1’ on one
side and ‘50’ on the other. Each pack contains
blisters of 14, 28, 30, 42, 56, 90, 98 or 100 tablets.

123368

8.0pt
8.4pt
90%
8.0pt
No

K

Poznan – Additional Artwork Information Panel
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Leaflet / dimensions after folding

148 x 608 mm

Carton dimensions

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

Tube dimensions

N/A

Replacement No.:

121786

Point of sale code No.:

N/A

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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