LAMOTRIGINE 100MG DISPERSIBLE TABLETS

Active substance: LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Lamotrigine 25, 50, 100 and 200 mg Dispersible 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 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 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 Lamotrigine is and what it is used for
2. What you need to know before you take Lamotrigine
3. How to take Lamotrigine
4. Possible side effects
5. How to store Lamotrigine
6. Contents of the pack and other information

1

What Lamotrigine is and what it is used
for

Lamotrigine belongs to the group of medicines called
anti-epileptics. It is used to treat two conditions
• epilepsy and bipolar disorder.

Lamotrigine treats epilepsy by blocking the signals in the brain
that trigger epileptic seizures (fits).
• For adults and children aged 13 years and over, Lamotrigine
can be used on its own or with other medicines, to treat
epilepsy. Lamotrigine 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, Lamotrigine 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.
Lamotrigine 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, Lamotrigine 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 Lamotrigine works in the brain to have this effect.

2

What you need to know before you take
Lamotrigine

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 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.

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.

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.

Do not take Lamotrigine:
• 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 donʼt take Lamotrigine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lamotrigine:
• 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).
• if you are already taking medicine that contains lamotrigine.
If any of these apply to you:
Tell your doctor, who may decide to lower the dose, or that
Lamotrigine is not suitable for you.

Lamotrigine can also affect the way hormonal contraceptives
work, although itʼs 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
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 youʼre planning to become pregnant and
while youʼre pregnant.
Pregnancy may also alter the effectiveness of Lamotrigine, so
you may need blood tests and your dose of Lamotrigine may be
adjusted.

Important information about potentially life-threatening reactions
A small number of people taking Lamotrigine 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
Lamotrigine.

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.

Read the description of these symptoms in Section 4 of this
leaflet under ʻPotentially life-threatening reactions: get a
doctorʼs help straight awayʼ.
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 youʼre
taking Lamotrigine:
See a doctor as soon as possible or go to the nearest
hospital for help.

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 Lamotrigine passes into
breast milk and may affect your baby. Your doctor will discuss
the risks and benefits of breast feeding while youʼre taking
Lamotrigine, and will check your baby from time to time if you
decide to breast feed.

Driving and using machines
Lamotrigine can cause dizziness and double vision.
Donʼt drive or operate machines unless you are sure youʼre
not affected.

If you have epilepsy, talk to your doctor about driving and
using machines.

3

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 youʼre taking Lamotrigine for epilepsy
The seizures in some types of epilepsy may occasionally
become worse or happen more often while youʼre taking
Lamotrigine. 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
youʼre taking Lamotrigine: See a doctor as soon as possible.

How to take Lamotrigine

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.

How much Lamotrigine 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.

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.

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 than your doctor tells you to.

Other medicines and Lamotrigine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take other medicines including herbal
medicines or other medicines bought without a prescription.

The usual effective dose of Lamotrigine for adults and children
aged 13 years or over is between 100 mg and 400 mg each day.

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Rare side effects (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)

For children aged 2 to 12 years, the effective dose depends on
their body weight - usually, itʼs between 1 mg and 15 mg for
each kilogram of the childʼs weight, up to a maximum
maintenance dose of 200 mg daily.

Lamotrigine is not recommended for children aged under 2 years.
How to take your dose of Lamotrigine
Take your dose of Lamotrigine 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 youʼre being treated for
and the way you respond to treatment.

Very rare side effects (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 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,
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
• hallucinations (ʻseeingʼ or ʻhearingʼ things that arenʼt really
there)
• confusion
• feeling ʻwobblyʼ 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 Parkinsonʼs disease, worsening
of the symptoms.
• lupus-like reation (symptoms may include: back or joint pain
which sometimes may be accompanied by fever and/or
general ill health)

Lamotrigine dispersible tablets can either be swallowed whole
with a little water, or mixed with water to make a liquid medicine.
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 for about a minute, 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 Lamotrigine than you should
Contact a doctor or pharmacist immediately. If possible,
show them the Lamotrigine packet.

Someone who has taken too much Lamotrigine 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 Lamotrigine
Donʼt 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.
Itʼs important that you do this.
Donʼt stop taking Lamotrigine without advice
Lamotrigine must be taken for as long as your doctor
recommends. Donʼt stop unless your doctor advises you to.

If youʼre 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 youʼre 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.

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.

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4

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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

5

Potentially life-threatening reactions: get a doctorʼs help
straight away
A small number of people taking Lamotrigine 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 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.

How to store Lamotrigine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on
the carton or blister after EXP. The expiry date refers to the last
day of that month.

This medicinal product does not require any special storage
conditions.

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.

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. This measures will help protect the environment.

6

Contents of the pack and other
information

What Lamotrigine 25/50/100/200 contains
The active substance is: lamotrigine. Lamotrigine 25, 50, 100
and 200 contains 25, 50, 100 and 200 mg of lamotrigine,
respectively, per dispersible tablet.
The other ingredients are: microcrystalline cellulose (E460),
povidone (E1201), sodium starch glycolate,
hydroxypropylcellulose (E463), sodium saccharine (E954),
blackberry flavouring (one ingredient is maltodextrin), magnesium
stearate (E470b), anhydrous colloidal silicon dioxide (E551).

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 Lamotrigine.
In case you have developed Stevens-Johnson syndrome or
toxic epidermal necrolysis your doctor will tell you that you must
never use lamotrigine again.

What Lamotrigine dispersible tablets look like and contents
of the pack
Lamotrigine dispersible tablets are white to off-white, round and
flat with grooved edges.

Packaging
Contents of the packs:
PVC/PE/PVDC/Al blister: 14, 20, 28, 30, 50, 56, 60, 90, 100,
200 tablets
PVC/PE/PVDC/Al perforated unit dose blister: 100 x 1 tablets
PP container with LDPE lid: 90, 100, 200 tablets
Not all pack sizes may be marketed.

Very common side effects (may affect more than 1 in 10 people)
• headache
• skin rash.
Common side effects (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.

Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.

Manufacturer
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria or
Salutas Pharma GmbH, Dieselstrasse 5, D-70839, Gerlingen,
Germany or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Lek Pharmaceuticals d.d.,
Verovškova 57, Sl-1526 Ljubljana, Slovenia.

Uncommon side effects (may affect up to 1 in 100 people)
• clumsiness and lack of co-ordination (ataxia)
• double vision or blurred vision

This leaflet was last revised in 10/2013.

SZ00000LT000

Artwork Proof Box
Ref: V029 - SPC & PIL update in line with originator
Proof no.
008.0

Date prepared:
09/10/2013

Colours:
Black
Dimensions: 145 x 340 mm

Font size:
6pt
Fonts:
Helvetica

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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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