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LAMICTAL 200MG TABLETS

Active substance(s): LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamictal® 200mg Tablets
(lamotrigine)
This product is available as the above name but will be referred to as Lamictal
throughout the following leaflet. Please note that the leaflet also contains information
about other strengths (Lamictal 25mg, 50mg and 100mg Tablets).
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.
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 lifethreatening 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.
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 lifethreatening 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.

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
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.

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
■ 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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.

6. Contents of the pack and other information

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.

5. How to store Lamictal






Keep out of the sight and reach of children.
Lamictal should be stored below 30°C and in a dry place.
Do not use after the expiry date printed on the carton label or blister strip. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

Each tablet contains 200mg of the active ingredient lamotrigine.
The tablets are pale yellow, rounded square tablets, multi-faceted on one side and
impressed ‘200’ on one side and ‘GSEE7’ on the reverse.
Lamictal is available as blister packs of 30 tablets.
Lamictal also contains the following:
lactose, microcrystalline cellulose, sodium starch glycollate, povidone, yellow iron
oxide (E172) and magnesium stearate.
POM

PL No: 15814/0247

This product is manufactured by GlaxoSmithKline Pharmaceuticals S.A., Poznan,
Poland and is procured from within the EU and repackaged by the Product Licence
holder: O.P.D. Laboratories Ltd., 6 Colonial Way, Watford, Herts, WD24 4PR.
Leaflet revision and issue date (Ref): 27.06.2016.
Lamictal is a registered trademark of the GSK group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.

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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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