LAMICTAL 25 MG TABLETS

Active substance: LAMOTRIGINE

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Patient Information Leaflet
®

Lamictal 25 mg tablets
(lamotrigine)
This product is available in other strengths
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.
Your medicine is called Lamictal® 25 mg tablets but throughout this
leaflet will be referred to as Lamictal.
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:
Other 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. 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.
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
There may be an increased risk of birth defects in babies whose
mothers took Lamictal during pregnancy. These defects include cleft
lip or cleft palate. Your doctor may advise you to take extra folic acid if
you’re planning to become pregnant and while you’re pregnant.
Pregnancy may also alter the effectiveness of Lamictal, so you may
need blood tests and your dose of Lamictal may be adjusted.
 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.
 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’re 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 pharmacist immediately. If possible, show
them the Lamictal packet.
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)
• loss of consciousness or coma.
If you forget to take Lamictal
Don’t take extra tablets to make up for a missed dose. Just take
your next dose at the usual time.
 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)
• 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.
In many cases, these symptoms will be signs of less serious side
effects but you must be aware that they are potentially lifethreatening 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.

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
• 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 test, 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.
If you get 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.
5. How to store Lamictal
These are no special storage conditions required for Lamictal
Do not use after the expiry date. The expiry date refers to the last day
of the month.
Keep out of the sight and sight of children.
If your doctor tells you to stop taking the tablets, please take any
unused tablets back to your pharmacist to be destroyed. Do not throw
them away with your normal household water or waste. This will help
to protect the environment.
If your medicine show any sign of discolouration or deterioration,
please seek the advice of your pharmacist.
6. Further information
What Lamictal tablets contain:
Each tablet contains 25 mg of the active ingredient lamotrigine.
The other ingredients are: lactose monohydrate, microcrystalline
cellulose, povidone K30, sodium starch glycollate (type A), yellow iron
oxide (E172) and magnesium stearate.
What Lamictal tablets look like and the contents of the pack
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked
“GSEC7” on one side and “25” on the other.
Available in pack sizes of 28 and 56 tablets
Manufactured by:
Glaxo Operations UK Limited, Priory Street, Ware, Herfordshire,
SG12 0DJ, UK.
GlaxoSmithKline Pharmaceuticals S.A., Ulica, Grunwaldzka 189,
Poznan, PL-60-322, Poland.
Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32 – 36, Bad
Oldesloe D-23843, Germany.
Glaxo Wellcome S.A. Avda de Extremadura 3, Arenda De Duero,
Burgos 09400, Spain.
Procured within the EU
Product licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD
PL 19065/0363

POM

This leaflet was revised 11/06/2013
E0363/2
Lamictal® is a registered trade mark of GlaxoSmithKline Group of companies

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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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