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LAMICTAL 200 MG TABLETS

Active substance(s): LAMOTRIGINE

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Ref: 1742/060218/1/F

Lamictal 200 mg tablets
(lamotrigine)
Patient Information Leaflet
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 200 mg tablets but will be referred to as
Lamictal throughout the leaflet.
What is in this leaflet

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

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

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).

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’.

Tell your doctor if you are taking any of these.

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.

*

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.

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.

Ref: 1742/060218/1/B

Lamictal 200 mg tablets
(lamotrigine)
Patient Information Leaflet (continued)
If you take more Lamictal than you should
* Contact a doctor or nearest hospital emergency department
immediately. If possible, show them the Lamictal packet.
If you take too much Lamictal you may be more likely to have serious
side effects which may be fatal.
Someone who has taken too much Lamictal may have any of these
symptoms:
* rapid, uncontrollable eye movements (nystagmus)
* clumsiness and lack of co-ordination, affecting their balance (ataxia)
* heart rhythm changes (detected usually on ECG)
* loss of consciousness, fits (convulsions) or coma.
If you forget to take a single dose of Lamictal
* Don’t take extra tablets to make up for a missed dose. Just take your
next dose at the usual time. In case you forget to take multiple doses
of Lamictal
* Ask your doctor for advice on how to start taking it again. It’s
important that you do this.
Don’t stop taking Lamictal without advice
Lamictal must be taken for as long as your doctor recommends. Don’t stop
unless your doctor advises you to.
If you’re taking Lamictal for epilepsy
To stop taking Lamictal, it is important that the dose is reduced gradually,
over about 2 weeks. If you suddenly stop taking Lamictal, your epilepsy
may come back or get worse.
If you’re taking Lamictal for bipolar disorder
Lamictal may take some time to work, so you are unlikely to feel better
straight away. If you stop taking Lamictal, your dose will not need
to be reduced gradually. But you should still talk to your doctor first, if you
want to stop taking Lamictal.

4

Possible side effects

Like all medicines, this medicine can cause side effects, but not everyone
gets them.
Potentially life-threatening reactions: get a doctor’s help straight away
A small number of people taking Lamictal get an allergic reaction or
potentially life-threatening skin reaction, which may develop into more
serious problems if they are not treated.
These symptoms are more likely to happen during the first few months of
treatment with Lamictal, especially if the starting dose is too high or if the
dose is increased too quickly or if Lamictal is taken with another medicine
called valproate. Some of the symptoms are more common in children, so
parents should be especially careful to watch out for them.
Symptoms of these reactions include:
* skin rashes or redness, which may develop into life-threatening skin
reactions including widespread rash with blisters and peeling skin,
particularly occurring around the mouth, nose, eyes and genitals
(Stevens-Johnson syndrome), extensive peeling of the skin (more than
30% of the body surface - toxic epidermal necrolysis) or extended rashes
with liver, blood and other body organs involvement (Drug Reaction with
Eosinophilia and Systemic Symptoms which is also known as DRESS
hypersensitivity syndrome)
ulcers
in the mouth, throat, nose or genitals
*
* a sore mouth or red or swollen eyes (conjunctivitis)
* a high temperature (fever), flu-like symptoms or drowsiness
* swelling around your face or swollen glands in your neck, armpit or
groin
* unexpected bleeding or bruising, or the fingers turning blue
* a sore throat or more infections (such as colds) than usual
* increased levels of liver enzymes seen in blood tests
* an increase in a type of white blood cell (eosinophils)
* enlarged lymph nodes
* involvement of the organs of the body including liver and kidneys.
In many cases, these symptoms will be signs of less serious side effects but
you must be aware that they are potentially life-threatening and can
develop into more serious problems, such as organ failure, if they are not
treated. If you notice any of these symptoms:
* Contact a doctor immediately. Your doctor may decide to carry out tests
on your liver, kidneys or blood and may tell you to stop taking Lamictal.
In case you have developed Stevens-Johnson syndrome or toxic
epidermal necrolysis your doctor will tell you that you must never use
lamotrigine again.
Very common side effects
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
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 on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the
safety of this medicine.

How to store Lamictal

5

*
*
*
*
*
*
*
*

Store in the original package.
Do not chew or crush
Oral use
Keep out of the sight and reach of children.
Do not take Lamictal after the expiry date which is stated on the blister
label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

6

Contents of the pack and other information

What Lamictal contains:
Each tablet contains 200mg lamotrigine.
Also contains lactose monohydrate, microcrystalline cellulose, povidone K30,
sodium starch glycolyte (Type A), iron oxide yellow (E172), magnesium
stearate.
What Lamictal looks like and contents of the pack
Lamictal tablets are pale, yellowish brown, multifaceted, super elliptical
tablets of 10.2 mm, marked GSEE7 on one side and 200 on the other.
Each pack contains 60 Tablets.
Manufacturer and Licence Holder
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 15184/1742

Lamictal 200 mg tablets

Lamictal is a registered trademark of Glaxo Group Limited.
Revision date: 06/02/18

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,Tel: 01527
505414 to obtain the leaflet in a
format suitable for you

+ Expand Transcript

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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