LAMOTRIGINE TABLETS 200MG

Active substance: LAMOTRIGINE

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305-06-07 LEAFLET Lamictal 20120608

PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMICTAL TABLETS 50mg/
LAMOTRIGINE TABLETS 50mg
LAMICTAL TABLETS 100mg/
LAMOTRIGINE TABLETS 100mg
LAMICTAL TABLETS 200mg/
LAMOTRIGINE TABLETS 200mg
(lamotrigine)
Your medicine is known with either of the above names but will be
referred to as Lamictal throughout the following leaflet.
Information for other strength of Lamictal (Lamictal 25mg tablets) is
also present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.

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.
Taking other medicines
Tell your doctor or pharmacist if you’re taking any other
medicines, have taken any recently, or start taking new ones these include herbal medicines or other medicines you 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 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.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.

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

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.



carbamazepine, used to treat epilepsy and mental health
problems

In this leaflet



phenytoin, primidone or phenobarbitone, used to treat
epilepsy

2. Before you take Lamictal



risperidone, used to treat mental health problems

3. How to take Lamictal



rifampicin, which is an antibiotic

4. Possible side effects



6. Further information

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).

1. WHAT LAMICTAL IS AND WHAT IT IS USED FOR

 Tell your doctor if you are taking any of these, or if you start or
stop taking any.

1. What Lamictal is and what it is used for

5. How to store Lamictal

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. BEFORE YOU TAKE LAMICTAL
Do not take Lamictal:


if you are allergic (hypersensitive) to lamotrigine or any of the
other ingredients of Lamictal (listed in Section 6).

If this applies to you:
 Tell your doctor, and don’t take Lamictal.
Take special care with Lamictal
Your doctor needs to know before you take 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 serious reactions
A small number of people taking Lamictal get an allergic reaction or
potentially serious 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.

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
 Talk to your doctor if you’re pregnant, if you might be
pregnant, or if you’re 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 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 your
doctor may take samples of your blood to check the level of
Lamictal, and may adjust your dose.
 Talk to your doctor if you’re breast feeding or planning to
breast feed. 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 operate 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.

 Read the description of these symptoms in Section 4 of
this leaflet under ‘Potentially serious reactions: get a doctor’s
help straight away’.

3. HOW TO TAKE LAMICTAL

Thoughts of harming yourself or suicide

How much Lamictal to take

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:

It may take a while to find the best dose of Lamictal for you. The
dose you take will depend on:



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.

Always use Lamictal exactly as your doctor has told you to.
Check with your doctor or pharmacist if you’re not sure.



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 of 400 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.

If you take more Lamictal than you should



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)



a high temperature (fever)



swelling around the face (oedema) or swollen glands in the
neck, armpit or groin (lymphadenopathy)



in people who already have Parkinson’s disease, worsening of
the symptoms.

 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 or a double dose to make up for a
forgotten dose.
If you have missed taking a dose 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, Lamictal can cause side effects, but not
everyone gets them.

Other side effects
Other side effects have occurred in a small number of people but
their exact frequency is unknown:
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.
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 get side effects
 If any of the side effects becomes severe or troublesome, or if
you notice any side effects not listed in this leaflet please tell
your doctor or pharmacist.
5. HOW TO STORE LAMICTAL

Potentially serious reactions: get a doctor’s help straight away



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

A small number of people taking Lamictal get an allergic reaction or
potentially serious skin reaction, which may develop into more
serious problems if they are not treated.



Store in a dry place. Do not store above 30°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets 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 advise you what to do.



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.

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 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)



a sore mouth or eyes



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 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 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.
Very common side effects
These may affect more than 1 in 10 people:


headache



feeling dizzy



feeling sleepy or drowsy



clumsiness and lack of co-ordination (ataxia)



double vision or blurred vision



feeling sick (nausea) or being sick (vomiting)

 skin rash.
Common side effects
These may affect up to 1 in 10 people:

6. FURTHER INFORMATION
What Lamictal contains


The active substance in Lamictal Tablets 50mg is lamotrigine.
Each Lamictal 50mg tablet contains 50mg of the active
ingredient lamotrigine.



The active substance in Lamictal Tablets 100mg is lamotrigine.
Each Lamictal 100mg tablet contains 100mg of the active
ingredient lamotrigine.



The active substance in Lamictal Tablets 200mg is lamotrigine.
Each Lamictal 200mg tablet contains 200mg of the active
ingredient lamotrigine.



The other ingredients are: lactose, microcrystalline cellulose,
sodium starch glycollate, povidone, iron oxide (E172),
magnesium stearate.

What Lamictal looks like and contents of the pack
Lamictal Tablets 50mg are pale yellowish, rounded square tablets,
multi-faceted and marked ‘50’on one side, and flat with ‘GSEE1’
marked on the other. They are available as blister packs of 30
tablets.
Lamictal Tablets 100mg are pale yellowish, rounded square tablets,
multi-faceted and marked ‘100’ on one side, and flat with ‘GSEE5’
marked on the other. They are available as blister packs of 30
tablets.
Lamictal Tablets 200mg are pale yellowish, rounded square tablets,
multi-faceted and marked ‘200’ on one side, and flat with ‘GSEE7’
marked on the other. They are available as blister packs of 30
tablets.
Product Licence holder



aggression or irritability



rapid, uncontrollable eye movements (nystagmus)



shaking or tremors

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



difficulty in sleeping

Manufacturer



diarrhoea



dry mouth



This product is manufactured by Glaxo Wellcome Operations,
Ware, Hertfordshire, UK and The Wellcome Foundation Ltd,
Dartford, Kent.

feeling tired

 pain in your back or joints, or elsewhere.
Rare side effects

POM

PL No: 08747/0307 Lamictal Tablets 50mg
PL No: 08747/0306 Lamictal Tablets 100mg
PL No: 08747/0305 Lamictal Tablets 200mg

These may affect up to 1 in 1,000 people:


itchy eyes, with discharge and crusty eyelids (conjunctivitis)

Leaflet revision date: 8 June 2012



a severe skin reaction (Stevens-Johnson syndrome: see also
the information at the beginning of Section 4).

Lamictal is a registered trade mark of GlaxoSmithKline Group of
companies.

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 or agitation



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 severe 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

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
305-06-07 LEAFLET Lamictal 20120608

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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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