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LAMICTAL 100MG TABLETS

Active substance(s): LAMOTRIGINE

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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.
5. How to store Lamictal






KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Lamictal does not require any special storage
conditions.
Do not take Lamictal after the expiry date which
is stated on the blister and carton.
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.

• If your medicine becomes discoloured or show


any other signs of deterioration, ask your
pharmacist who will advise you what to do.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

6. Contents of the pack and other information
What Lamictal contains
• The active substance is lamotrigine.
Each tablet contains 100mg lamotrigine.
• The other ingredients are:
lactose monohydrate, microcrystalline cellulose,
povidone K30, sodium starch glycolate (type A),
yellow iron oxide (E172) and magnesium
stearate.
What Lamictal looks like and contents of the
pack
• Lamictal tablets are pale, yellowish-brown
tablet, marked GSEE5 on on side and 100 on
the reverse.
• Each pack contains 56 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Wellcome
S.A., Avda. Extremadura, 3, Poligono Industrial
Allenduero, 09400 Aranda de Duero (Burgos),
Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 15184/1435 - Lamictal 100mg Tablets
Lamictal is a registered trademark of the
GlaxoSmithKline group of companies.
Leaflet revision date: 25/07/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Lamictal ®100mg

Ref: 1435/250716/1/F

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.
Your medicine is called Lamictal 100mg Tablets
but will be referred to as Lamictal throughout the
rest of this leaflet.
Please note that the leaflet also contains
information about other strengths of the medicine,
Lamictal 25mg Tablets, Lamictal 50mg Tablets and
Lamictal 200mg Tablets.
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.

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.
3. How to take 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.

• ulcers in the mouth, throat, nose or genitals
• a sore mouth or red or swollen eyes

If you take too much Lamictal you may be more
likely to have serious side effects which may
be fatal.

• swelling around your face or swollen glands

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.

• a sore throat or more infections (such as colds)

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.

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.

(conjunctivitis)

• a high temperature (fever), flu-like symptoms or
drowsiness

in your neck, armpit or groin

• unexpected bleeding or bruising, or the
fingers turning blue

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
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)

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.

Very common side effects
These may affect more than 1 in 10 people:
• headache
• skin rash.
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).

Ref: 1435/250716/1/B

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.
5. How to store Lamictal






KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Lamictal does not require any special storage
conditions.
Do not take Lamictal after the expiry date which
is stated on the blister and carton.
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.

• If your medicine becomes discoloured or show


any other signs of deterioration, ask your
pharmacist who will advise you what to do.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

6. Contents of the pack and other information
What Lamictal contains
• The active substance is lamotrigine.
Each tablet contains 100mg lamotrigine.
• The other ingredients are:
lactose monohydrate, microcrystalline cellulose,
povidone K30, sodium starch glycolate (type A),
yellow iron oxide (E172) and magnesium
stearate.
What Lamictal looks like and contents of the
pack
• Lamictal tablets are pale, yellowish-brown
tablet, marked GSEE5 on on side and 100 on
the reverse.
• Each pack contains 56 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by
GlaxoSmithKline Pharmaceuticals S.A., Ul
Grunwaldzka 189, 60-322 Poznan, Poland and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 15184/1435 - Lamictal 100mg Tablets
Lamictal is a registered trademark of the
GlaxoSmithKline group of companies.
Leaflet revision date: 25/07/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Lamictal ®100mg

Ref: 1435/250716/1/F

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.
Your medicine is called Lamictal 100mg Tablets
but will be referred to as Lamictal throughout the
rest of this leaflet.
Please note that the leaflet also contains
information about other strengths of the medicine,
Lamictal 25mg Tablets, Lamictal 50mg Tablets and
Lamictal 200mg Tablets.
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.

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.
3. How to take 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.

• ulcers in the mouth, throat, nose or genitals
• a sore mouth or red or swollen eyes

If you take too much Lamictal you may be more
likely to have serious side effects which may
be fatal.

• swelling around your face or swollen glands

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.

• a sore throat or more infections (such as colds)

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.

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.

(conjunctivitis)

• a high temperature (fever), flu-like symptoms or
drowsiness

in your neck, armpit or groin

• unexpected bleeding or bruising, or the
fingers turning blue

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
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)

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.

Very common side effects
These may affect more than 1 in 10 people:
• headache
• skin rash.
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).

Ref: 1435/250716/1/B

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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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