LAMOTRIGINE 25MG TABLETS

Active substance: LAMOTRIGINE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Lamictal 25mg 50mg 100mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464 2785 2786 2787E

DATE OF PROOF:

21/05/13

DATE:

PROOF HISTORY:
v.2 - waymade - 21/05/13

DATE:

Leaflet Flat Size = 296 x 317
February 2013

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

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

5. How to store Lamictal
Do not store above 30˚C.
Store in a dry place.
Store in the original package.
Keep all medicines out of the sight and reach of children.
Do not take any tablets after the exp date shown on the pack. The expiry date refers to the last day of that
month.
If you doctor tells you to stop taking the tablets, please return any which are left over to your pharmacist. Only
keep them if your doctor tells you to.
If your tablets become discoloured or shown any signs of deterioration, you should seek the advice of your
pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. This will help protect the environment.

6. Further information
What Lamictal tablets contain
Each tablet contains 25 mg, 50mg or 100mg of the active ingredient lamotrigine. The other ingredients are
lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycollate, yellow iron oxide
(E172), and magnesium stearate.

LAMICTAL® 25mg
LAMICTAL® 50mg
LAMICTAL® 100mg

TABLETS/LAMOTRIGINE 25mg TABLETS
TABLETS/LAMOTRIGINE 50mg TABLETS
TABLETS/LAMOTRIGINE 100mg TABLETS
(Lamotrigine)
Patient Information leaflet

Your medicine is called by all the above names but will be referred to as Lamictal throughout this leaflet. Other
strengths are available.
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.
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. Further 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.

Each 50 mg tablet is pale yellow rounded-squared tablet and is marked ‘50’ on one side and ‘GSEE1’ on the
other.

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.

Each 100 mg tablets is a pale yellow rounded-squared tablet and is marked ‘100’ on one side and ‘GSEE5’ on
the other.

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.

Your medicine is available in packs of 28 and 56 tablets.

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 lifethreatening reactions: get a doctor’s help straight away’.

What Lamictal tablets look like and contents of the pack
Each 25mg tablet is a pale yellow rounded-squared tablet and is marked ‘25’ on one side and ‘GSEC7’ on the
other.

POM

PL No: 06464/2785
PL No: 06464/2786
PL No: 06464/2787

These products are manufactured by GlaxoSmithKline Pharmaceuticals S.A. Ul, Grunwaldzka 189, 60-322
Poznan, Poland and/or Glaxo Operations (trading as Glaxo Wellcome Operations) Priory Street, Ware,
Hertfordshire SG12 0DJ, United Kingdom, and/or Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36,
23843 Bad Odlesloe, Germany, and/or Glaxo Wellcome S.A., Avda. Extremadura, 3, Poligono Industrial
Allenduero, 09400 Aranda de Duero, (Burgos) Spain and are procured from within the EU and repackaged by
the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon Essex SS14 3FR
Leaflet revision and issue date (Ref.) 20.05.2013
Lamictal® is a registered trademark of Glaxo Group Limited
If you have any other questions about epilepsy, contact a doctor or pharmacist.
Alternatively, the British Epilepsy Association will try to answer them for you. You can telephone their National
Information Centre free from anywhere in the country on 0808 800 5050 or write to them at New Anstey
House, Gate Way Drive, Yeadon, Leeds LS19 7XY

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.
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.
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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Lamictal 25mg 50mg 100mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464 2785 2786 2787E

DATE OF PROOF:

21/05/13

DATE:

PROOF HISTORY:
v.2 - waymade - 21/05/13

DATE:

Leaflet Flat Size = 296 x 317
February 2013

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

Pg 2

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
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 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.


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.

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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 pharmacist immediately. If possible, show them the Lamictal packet.
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)

loss of consciousness 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

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).

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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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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