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LAMOTRIGINE 5MG DISPERSIBLE TABLETS

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S121-122 LEAFLET Lamictal 20130513

5. How to store Lamictal

PACKAGE LEAFLET: INFORMATION FOR THE USER



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Protect from light. Protect from
moisture.



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



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



If you have any unwanted Lamictal, 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 contains


Each 5mg dispersible tablet contains 5mg of the active
ingredient, lamotrigine.



Lamictal also contain the following inactive ingredients calcium
carbonate, hydroxypropylcellulose, aluminium magnesium
silicate, sodium starch glycollate, povidone K30, saccharin
sodium, magnesium stearate and blackcurrant flavouring.

LAMICTAL 5mg DISPERSIBLE TABLETS
LAMOTRIGINE 5mg DISPERSIBLE TABLETS
(lamotrigine)

 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

Your medicine is known as either of the above names but will be
referred to as Lamictal throughout the following patient information
leaflet.

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.

Please note that information regarding Lamictal 25mg Dispersible
Tablets, Lamictal 2mg Dispersible Tablets and Lamictal 100mg
Dispersible Tablets may also be present in the below leaflet.

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

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Thoughts of harming yourself or suicide

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.

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:

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



Lamictal 5mg Dispersible Tablets are white, elongated tablets
marked ‘GS CL2’ on one side and ‘5’ on the other.

5. How to store Lamictal



Lamictal 5mg Dispersible Tablets are available as blister packs
of 28 or 56.

6. Contents of the pack and other information
1. What Lamictal is and what it is used for



when you first start treatment



if you have previously had thoughts about harming yourself or
about suicide



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 Lamictal looks like and contents of the pack

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

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

Lamictal treats epilepsy by blocking the signals in the brain that
trigger epileptic seizures (fits).

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:



Product Licence holder

 See a doctor as soon as possible.

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

This product is manufactured by


Glaxo Operations UK Ltd, Ware, UK.



GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189,
60-322, Poznan, Poland.

POM

If any of these applies to you:



PL No: 19488/0121 Lamictal 5mg Dispersible Tablets
PL No: 19488/0122 Lamictal 5mg Dispersible Tablets

Leaflet revision date 13 May 2013
Lamictal is a registered trade mark of GlaxoSmithKline Group of
companies.
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

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.

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

2. What you need to know before you take Lamictal
Do not take Lamictal:


S121-122 LEAFLET Lamictal 20130513

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:

 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



if you have any kidney problems



if you have ever developed a rash after taking lamotrigine or
other medicines for bipolar disorder or epilepsy



risperidone, used to treat mental health problems





rifampicin, which is an antibiotic

if you have ever developed meningitis after taking
lamotrigine (read the description of these symptoms in Section
4 of this leaflet: Other side effects)





medicines used to treat Human Immunodeficiency Virus
(HIV) infection (a combination of lopinavir and ritonavir or
atazanavir and ritonavir)

if you are already taking medicine that contains
lamotrigine.



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.

How to take your dose of Lamictal

Symptoms of these reactions include:

Very rare side effects

Take your dose of Lamictal once or twice a day, as your doctor
advises. It can be taken with or without food.



These may affect up to 1 in 10,000 people:



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.
Lamictal dispersible/chewable tablets can either be swallowed
whole with a little water, chewed or mixed with water to make a
liquid medicine.
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:

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.



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.

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 breastfeed.

skin rashes or redness, which may develop into lifethreatening 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 high temperature (fever), flu-like symptoms or drowsiness



unexpected bleeding or bruising, or the fingers turning blue





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

swelling around your face or swollen glands in your neck,
armpit or groin



a life-threatening skin reaction (toxic epidermal necrolysis): see
also the information at the beginning of Section 4

a sore mouth or red or swollen eyes (conjunctivitis)





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 lifethreatening 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 StevensJohnson syndrome or toxic epidermal necrolysis your doctor will
tell you that you must never use lamotrigine again.

If you take more Lamictal than you should

Very common side effects



feeling ‘wobbly’ or unsteady when you move about

 Contact a doctor or pharmacist immediately. If possible,
show them the Lamictal packet.

These may affect more than 1 in 10 people:



Someone who has taken too much Lamictal may have any of these
symptoms:



headache



skin rash.

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).



rapid, uncontrollable eye movements (nystagmus)



clumsiness and lack of co-ordination, affecting their balance
(ataxia)



loss of consciousness or coma.

Common side effects
These may affect up to 1 in 10 people:

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.

aggression or irritability



feeling sleepy or drowsy

If you forget to take Lamictal
Driving and using machines




feeling dizzy

Don’t take extra tablets to make up for a missed dose. Just
take your next dose at the usual time.



shaking or tremors
difficulty in sleeping (insomnia)

Other side effects

 Ask your doctor for advice on how to start taking it again.
It’s important that you do this.




feeling agitated



diarrhoea

Other side effects have occurred in a small number of people but
their exact frequency is unknown:



dry mouth



feeling sick (nausea) or being sick (vomiting)

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.



feeling tired

3. How to take Lamictal

If you’re taking Lamictal for epilepsy



pain in your back or joints, or elsewhere.

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

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.

Uncommon side effects

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.

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.

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).

4. Possible side effects
Like all medicines, this medicine can cause side effects, but not
everyone gets them.

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

Potentially life-threatening reactions: get a doctor’s help
straight away

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.

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.

Lamictal is not recommended for children aged under 2 years.

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.



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.

Expand Transcript

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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