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LAMOTRIGINE ACCORD 200 MG TABLETS

Active substance(s): LAMOTRIGINE

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happen more often, or if you experience a severe
seizure while you are taking Lamotrigine tablets.
See a doctor as soon as possible.
PACKAGE LEAFLET – INFORMATION FOR
THE USER

Lamotrigine Accord
25mg Tablets
Lamotrigine Accord
50mg Tablets
Lamotrigine Accord
100mg Tablets
Lamotrigine Accord
200mg 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, pharmacist or nurse.
• 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 side effects, talk to you doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Lamotrigine Tablets are and what they
are used for
2. What you need to know before you take
Lamotrigine Tablets
3. How to take Lamotrigine Tablets
4. Possible side effects
5. How to store Lamotrigine Tablets
6. Contents of the pack and other information

1. What Lamotrigine Tablets are
and what they are used for
Lamotrigine belongs to a group of medicines
called anti-epileptics. It is used to treat two
conditions-epilepsy and bipolar disorder.
Lamotrigine works by blocking the signals in the
brain that trigger epileptic seizures (fits).
Lamotrigine used to treat epilepsy.
• For adults and children aged 13 years and over,
Lamotrigine can be used alone or in
combination with other anti-epileptic medicines.
Lamotrigine can also be used with other
medicines to treat the seizures that occur with a
condition called Lennox-Gastaut Syndrome.
• For children aged 2 to 12 years, Lamotrigine
can be used with other medicines, to treat those
conditions. Lamotrigine can be used alone to
treat a type of epilepsy called typical absence
seizures.
Lamotrigine is also used to treat 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, Lamotrigine can be used alone or in
combination with other medicines, to prevent the
periods of depression that occur in bipolar
disorder. It is not yet known how Lamotrigine
works in the brain to have this effect.

2. What you need to know before
you take Lamotrigine Tablets
Do not take Lamotrigine if
• you are allergic (hypersensitive) to lamotrigine
or to any of the ingredients of lamotrigine
tablets (listed in section 6). An allergic reaction
may include rash, itching, swelling of face, lips,
tongue or hands/feet, or breathing difficulties.
If this applies to you, please contact your doctor
and don’t take Lamotrigine tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Lamotrigine tablets
• 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, please tell your
doctor, who may decide to lower the dose, or
decide whether Lamotrigine tablets is suitable for
you or not.
Important information about potentially life
threatening reactions
A small number of people taking Lamotrigine get
an allergic reaction or potentially serious skin
reaction, which may develop into more serious
problems if they are not treated. These can include
Stevens-Jonsons 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 Lamotrigine tablets.
Read the description of these symptoms in
Section 4 of this leaflet under ‘Potentially serious
reactions: Contact your doctor immediately.
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 Lamotrigine tablets.
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 lamotrigine have also had
thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately
contact your doctor.
If you are taking Lamotrigine for epilepsy
The seizures in some types of epilepsy may
occasionally become worse or happen more often
while you are taking Lamotrigine tablets. Some
patients may experience severe seizures, which
may cause serious health problems. If your seizures

Note: PIL is required centrally folded in bible paper

Lamotrigine 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 Lamotrigine tablets
Please inform your doctor or pharmacist if you
are taking, or have recently taken any other
medicines, even those not prescribed but bought/
obtained 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 Lamotrigine. These medicines
include:
• oxcarbazepine, felbamate, gabapentin,
levetiracetam, pregabalin, topiramate or
zonisamide, used to treat epilepsy.
• Lithium, Aripiprazole or olanzapine, 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
medicines.
Some medicines interact with Lamotrigine 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 of these
medicines.
Hormonal contraceptives (such as the Pill)
can affect the way Lamotrigine 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 Lamotrigine. 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.
Lamotrigine 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
Lamotrigine is affecting the way your
contraceptive is working.
Pregnancy and Breast-feeding
Contact your doctor if you are pregnant or might
become pregnant or planning to become
pregnant.
It’s important that you do this because there may
be an increased risk of birth defects in babies
whose mothers took Lamotrigine 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
Lamotrigine, so your doctor may take samples of
your blood to check the level of Lamotrigine, and
may adjust your dose.
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.
Talk to your doctor if you’re breast feeding or
planning to breast feed. Lamotrigine passes
into breast milk and may affect your baby. Your
doctor will discuss the risks and benefits of breast
feeding while you’re taking Lamotrigine, and will
check your baby from time to time if you decide
to breast feed.
Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Lamotrigine tablets can cause dizziness and
double vision.
Don’t drive or operate machines unless you
are sure you’re not affected.
If you have epilepsy, talk to your doctor about
driving and using machines.
Lamotrigine Tablets contains lactose
This medicine contains small amounts of an
inactive ingredient known as Lactose
monohydrate. If you have been told by your
doctor that you have an intolerance to some
sugars, contact your doctor before taking
Lamotrigine tablets.

3. How to take Lamotrigine
Tablets
Take this medicine exactly as instructed by your
doctor. Check the label carefully for how much
and how often to take this medicine. Check with
your doctor or pharmacist if you are not sure.
How much Lamotrigine tablets to take
It may take a while to find the best dose of
Lamotrigine for you. The dose you take will
depend on:
• your age.
• whether you are taking Lamotrigine 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 Lamotrigine
tablets than your doctor tells you to.
The usual effective dose of Lamotrigine 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 of 200 mg daily.
Lamotrigine tablets are not recommended for
children aged under 2 years.
How to take your dose of Lamotrigine tablets
Take your dose of Lamotrigine 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 have taken more Lamotrigine Tablets
than you should
If you or someone else swallows several of these
tablets all together, or you think a child has
swallowed any of these tablets, you should
consult the doctor or go to the nearest hospital
casualty department immediately. Take this
leaflet or some tablets with you so the doctor will
know what medicine has been taken.
If you take too much Lamotrigine Tablets you
may be more likely to have serious side effects
which may be fatal. Someone who has taken too
much Lamotrigine Tablets 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 Lamotrigine tablets
If you forget to take a dose, take it as soon as
you remember. However, if it is almost time for
the next dose, skip the missed dose and go back
to the regular dosing schedule. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Lamotrigine tablets
Lamotrigine tablets must be taken for as long as
your doctor recommends. Don’t stop unless your
doctor advises you to.
If you’re taking Lamotrigine for epilepsy
To stop taking Lamotrigine, it is important that
the dose is reduced gradually, over about 2
weeks. If you suddenly stop taking Lamotrigine,
your epilepsy may come back or get worse.
If you’re taking Lamotrigine for bipolar
disorder
Lamotrigine may take some time to work, so you
are unlikely to feel better straight away. If you
stop taking Lamotrigine, your dose will not need
to be reduced gradually. But you should still talk
to your doctor first, if you want to stop taking
Lamotrigine.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, Lamotrigine can cause side
effects, although not everybody gets them.
Potentially serious reactions: Contact your
doctor immediately.
A small number of people taking lamotrigine get
an allergic reaction or potentially serious 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
lamotrigine, especially if the starting dose is too
high or if the dose is increased too quickly, or if
lamotrigine 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 severe 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 the liver, blood and other
body organs involvement (DRESS).
• 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
• 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.
In many cases, these symptoms will be signs of
less serious side effects. but you must be
aware that they are potentially serious and
can develop into more serious problems, such
as organ failure, if they are not treated. If you
notice any of these symptoms:
Contact your doctor immediately. Your doctor
may decide to carry out tests on your liver,
kidneys or blood, and may tell you to stop taking
Lamotrigine tablets. 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:
• feeling dizzy
• feeling sleepy or drowsy
• feeling sick (nausea) or being sick (vomiting)
• feeling agitated
• aggression or irritability
• shaking or tremors
• difficulty in sleeping (insomnia)
• diarrhoea
• dry mouth
• feeling tired

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• pain in your back or joints, or elsewhere.
Uncommon side effects
These may affect up to 1 in 1,00 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:
• itchy eyes, with discharge and crusty eyelids
(conjunctivitis)
• 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)
• a life-threatening skin reaction
(Stevens-Johnson syndrome: see also the
information at the beginning of Section 4).
Very rare side effects
These may affect up to 1 in 10,000 people:
• 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
• a life-threatening skin reaction (toxic epidermal
necrolysis: see also the information at the
beginning of Section 4)
• in people who already have epilepsy, seizures
happening more often
• changes in liver function, which will show up in
blood tests, or liver failure) : 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, agranulo-cytosis),
reduced numbers of platelets (thrombocytopenia),
reduced numbers of all these types of cell
(pancytopenia), and a disorder of the bone
marrow called aplastic anaemia
• 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
• 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
• 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).
• Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS).
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
antiepileptic 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 Lamotrigine
Tablets
Keep this medicine out of the sight and reach
of children.
Do not store above 25ºC. Store in the original
package.
Do not use this medicine after the expiry date which
is stated on the label or carton after EXP. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater
or household waste household waste. Ask your
pharmacist how to throw away medicines you no
longer use. These measures will help protect the
environment.

6. Contents of the pack and
other information
What Lamotrigine tablet contains
• The active substance is Lamotrigine.
• The other ingredients are lactose monohydrate,
microcrystalline cellulose (Avicel PH 101 & 102),
povidone K30, sodium starch glycollate (Type A),
magnesium stearate, ferric oxide yellow (E172),
colloidal anhydrous silica and talc.(see section 2
for Important information about some of the
ingredients of Lamotrigine tablets).
What Lamotrigine Tablet looks like and
contents of the pack
Lamotrigine 25mg tablets are Light yellow to
yellow coloured, capsule shaped, biconvex,
uncoated tablets debossed with ‘E’ and ‘1’ on
either side of the scoreline on one side and
breakline on the other side.
Lamotrigine 50mg tablets are Light yellow to
yellow coloured, capsule shaped, biconvex,
uncoated tablets debossed with ‘E’ and ‘B’ on
either side of the scoreline on one side and
breakline on the other side.
Lamotrigine 100mg tablets are Light yellow to
yellow coloured, capsule shaped, biconvex,
uncoated tablets debossed with ‘E’ and ‘C’ on
either side of the scoreline on one side and
breakline on the other side.
Lamotrigine 200mg tablets are Light yellow to
yellow coloured, capsule shaped, biconvex,
uncoated tablets debossed with ‘E’ and ‘D’ on
either side of the scoreline on one side and
breakline on the other side.
Lamotrigine tablets are available as blister packs
in the pack sizes of 7, 14, 21, 28, 30, 56 and 100
tablets. (Not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
This leaflet was last revised in 10/2015.
10 00000 0 000000 INP001

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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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