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LAMICTAL 5MG DISPERSIBLE/ CHEWABLE TABLETS

Active substance(s): LAMOTRIGINE

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What is in this leaflet
1 What Lamictal is and what it is used for
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.

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

Other formats
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

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



Reference number

Lamictal 2 mg
chewable/dispersible tablets
Lamictal 5 mg
chewable/dispersible tablets
Lamictal 25 mg
chewable/dispersible tablets
Lamictal 100 mg
chewable/dispersible tablets

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.

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2 What you need to know before you take Lamictal

1 What Lamictal is and what
it is used for

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.

3 How to take Lamictal
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.

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.
· Always take the full dose that your doctor has
prescribed. Never take only part of a tablet.
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.
Lamictal chewable/dispersible tablets can either be
swallowed whole with a little water, chewed or mixed with
water to make a liquid medicine.
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4 Possible side effects
To chew the tablet:
You may need to drink a little water at the same time
to help the tablet dissolve in the mouth. Then drink
some more water to make sure all the medicine has
been swallowed.
To make a liquid medicine:
· Put the tablet in a glass with at least enough
water to cover the whole tablet.
· Either stir to dissolve or wait until the tablet is
fully dissolved.
· Drink all the liquid.
· Add a little more water to the glass and drink
that, to make sure no medicine is left in the glass.

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.

Don’t stop taking Lamictal
without advice

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

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.

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.

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)
· 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

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6 Contents of the pack and other information
· 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

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).

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

· 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 this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date shown
on the blisters, carton or bottle. 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.

Other side effects have occurred in a small number of
people but their exact frequency is unknown:

What Lamictal chewable/
dispersible tablets contain

The active substance is lamotrigine. Each
chewable/dispersible tablet contains 2 mg, 5 mg,
25 mg or 100 mg lamotrigine.
The other ingredients are: calcium carbonate, low
substituted hydroxypropyl cellulose, aluminium
magnesium silicate, sodium starch glycolate (Type A),
povidone K30, saccharin sodium, magnesium
stearate, blackcurrant flavour.

What Lamictal chewable/
dispersible tablets look like and
contents of the pack

Lamictal chewable/dispersible tablets (all strengths)
are white to off-white and may be slightly mottled.
They smell of blackcurrant. Not all listed pack sizes
are marketed.
Lamictal 2 mg chewable/dispersible tablets are round.
They are marked ‘LTG’ above the number ‘2’ on one
side; and with two ovals overlapping at right angles
on the other. Each bottle contains 30 tablets.
Lamictal 5 mg chewable/dispersible tablets are
elongated with curved sides. They are marked
‘GS CL2’ on one side; and ‘5’ on the other. Each pack
contains blisters of 10, 14, 28, 30, 42, 50 or 56 tablets
or bottles contain 14, 28, 30, 42, 56 or 60 tablets.
Lamictal 25 mg chewable/dispersible tablets are square
with rounded corners. They are marked ‘GSCL5’ on one
side; and ‘25’ on the other. Each pack contains blisters
of 10, 14, 21, 28, 30, 42, 50, 56 or 60 tablets.
Lamictal 100 mg chewable/dispersible tablets are
square with rounded corners. They are marked
‘GSCL7’ on one side; and ‘100’ on the other. Each pack
contains blisters of 10, 14, 28, 30, 42, 50, 56, 60, 90,
98, 100, 196 or 200 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

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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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