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LAMICTAL 5MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE

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LAMICTAL® 5mg DISPERSIBLE TABLETS
(lamotrigine)
MOCK UP
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. 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.
The name of your medicine is Lamictal 5mg Dispersible Tablets. Throughout the rest of this
leaflet your medicine 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

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.

Lamictal belongs to a group of medicines called anti-epileptics. It is used to treat two conditions
– epilepsy and bipolar disorder.

Hormonal contraceptives (such as the Pill) can affect the way Lamictal
works

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.

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:

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’.

→ 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 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.

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.

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 are 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:



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.
• 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 you’re being treated for and the way you respond to treatment.

See a doctor as soon as possible.
Lamictal dispersible/chewable tablets can either be swallowed whole with a little water, chewed,
or mixed with water to make a liquid medicine.

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.

To chew the tablet:
You may need to drink a little water at the same time to help the tablet dissolve in the mouth.
Then drink some more water to make sure all the medicine has been swallowed.

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 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.






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)

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 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 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

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).

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 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.

If you get side effects
ÆIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.

Reporting 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 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 Lamictal
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30° C. Store in original container to protect from light and moisture. If your
doctor decides to stop treatment, return any remaining tablets to your pharmacist for safe
disposal. Only keep them if your doctor tells you to.
Do not use Lamictal after the expiry date shown on the blisters, carton or bottle. The expiry date
refers to the last day of that month.
If you have any unwanted Lamictal tablets, don’t dispose of them in your waste water or your
household rubbish. Take them back to your pharmacist, who will dispose of them in a way that
won’t harm the environment

6. Contents of the pack and other Information
What Lamictal dispersible tablets contain
The active substance is lamotrigine. Each dispersible/chewable tablet contains 5 mg
Lamotrigine.
The other ingredients are: calcium carbonate, hydroxypropyl cellulose, aluminium magnesium
silicate, sodium starch glycolate, povidone K30, saccharin sodium, magnesium stearate,
blackcurrant flavour.

What Lamictal dispersible/chewable tablets look like and contents of the
pack
The tablets are white, elongated, impressed with ‘GS CL2’ on one side; and ‘5’ on the reverse.
Each pack contains 56 tablets in four blister strips of 14 or 28 tablets in two blister strips.

Marketing Authorisation Holder and Manufacturer
Lamictal tablets are manufactured by GlaxoSmithKline Pharmaceuticals S.A., UI. Grunwaldzka
189, 60-322 Poznan, Poland and procured within the EU by the Product Licence holder Stephar
(UK) Limited, 3 Waveney Park, Hewett Road, Great Yarmouth, Norfolk NR31 0NN.
Lamictal® is the registered trademark of the GlaxoSmithKline group of companies.
PRODUCT LICENCE NUMBER:
Lamictal 5mg Dispersible Tablets – PL 10256/0797
POM

Leaflet Ref: LAMICT 5 Disp/E/S
Revision Date: 14.05.2014-T

© STEPHAR (UK) LTD

Print Date: xx/xx/xxxx
Note: If you have any other questions about epilepsy, contact a doctor or pharmacist.
Alternatively, the British Epilepsy Association will be happy to try and answer them for
you. You can telephone their National Information Centre free from anywhere in the
country on 0808 8005050 or write to them at New Anstey House, Gate Way Drive,
Yeadon, Leeds, LS19 7XY.

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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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