LAMOTRIGINE 100MG DISPERSIBLE TABLETS

Active substance: LAMOTRIGINE

View full screen / Print PDF » Download PDF ⇩

Transcript
S299 LEAFLET Lamictal 20130228

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. Store in a dry place. Protect from
light.



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



Your medicine is known as Lamictal 100mg Dispersible Tablets but
will be referred to as Lamictal throughout the remainder of the
leaflet.

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.



Please note that information regarding Lamictal 25mg Dispersible
Tablets, Lamictal 2mg Dispersible Tablets and Lamictal 5mg
Dispersible Tablets may also be present in the below leaflet.

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.

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



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

LAMICTAL 100mg DISPERSIBLE TABLETS
(lamotrigine)

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 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’.
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:

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.



when you first start treatment



if you have previously had thoughts about harming yourself or
about suicide
if you are under 25 years old.

What Lamictal contains


Each 100mg dispersible tablet contains 100mg lamotrigine.

What is in this leaflet



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



1. What Lamictal is and what it is used for

If you have distressing thoughts or experiences, or if you notice that
you feel worse or develop new symptoms while you’re taking
Lamictal:

2. What you need to know before you take Lamictal
3. How to take Lamictal
4. Possible side effects
5. How to store Lamictal

What Lamictal looks like and contents of the pack
The tablets are white multifaceted, round tablets marked ‘GSCL7’
on one side and ‘100’ on the other.
Lamictal 100mg dispersible Tablets are available as blister packs of
56 tablets.

6. Contents of the pack and other 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).

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



Manufacturer
This product is manufactured by Glaxo Operations UK Ltd, Priory
Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI
Grunwaldzka 189, 60-322 Poznan, Poland.
POM



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.

PL No: 19488/0299

Leaflet revision date: 28 February 2013
Lamictal is a registered trade mark of GlaxoSmithKline Group of
companies.
S299 LEAFLET Lamictal 20130228

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

 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.
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

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 if you are taking any of these.

 Tell your doctor and don’t take Lamictal.

Some medicines interact with Lamictal or make it more likely that
people will have side effects. These include:

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.



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.

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.

S299 LEAFLET Lamotrigine 20130228

5. How to store Lamotrigine Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

LAMOTRIGINE 100mg DISPERSIBLE TABLETS



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



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

Your medicine is known as Lamotrigine 100mg Dispersible Tablets
but will be referred to as Lamotrigine Tablets throughout the
remainder of the leaflet.



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 Lamotrigine 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 Lamotrigine Tablets contain

Please note that information regarding Lamotrigine 25mg
Dispersible Tablets, Lamotrigine 2mg Dispersible Tablets and
Lamotrigine 5mg Dispersible Tablets may also be present in the
below leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Each 100mg dispersible tablet contains 100mg lamotrigine.



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

Thoughts of harming yourself or suicide

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:

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.



2. What you need to know before you take Lamotrigine Tablets
3. How to take Lamotrigine Tablets
4. Possible side effects
5. How to store Lamotrigine Tablets

1. What Lamotrigine Tablets are and what they are used for
Lamotrigine Tablets belong to a group of medicines called antiepileptics. It is used to treat two conditions – epilepsy and bipolar
disorder.

Product Licence holder

Lamotrigine Tablets treat epilepsy by blocking the signals in the
brain that trigger epileptic seizures (fits).


Manufacturer

POM

when you first start treatment



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



if you are under 25 years old.

1. What Lamotrigine Tablets are and what they are used for

Lamotrigine Tablets are available as blister packs of 56 tablets.

This product is manufactured by Glaxo Operations UK Ltd, Priory
Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI
Grunwaldzka 189, 60-322 Poznan, Poland.

A small number of people taking Lamotrigine Tablets 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 Tablets.

If you have any further questions, ask your doctor or pharmacist.

What Lamotrigine Tablets look like and contents of the pack

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

Important information about potentially life-threatening
reactions

Keep this leaflet. You may need to read it again.

6. Contents of the pack and other information
The tablets are white multifaceted, round tablets marked ‘GSCL7’
on one side and ‘100’ on the other.

 Tell your doctor, who may decide to lower the dose or that
Lamotrigine Tablets are not suitable for you.

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

What is in this leaflet



If any of these applies to you:



For adults and children aged 13 years and over, Lamotrigine
Tablets can be used on its own or with other medicines, to treat
epilepsy. Lamotrigine Tablets 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 Tablets
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.

PL No: 19488/0299

If you have distressing thoughts or experiences, or if you notice that
you feel worse or develop new symptoms while you’re taking
Lamotrigine Tablets:
 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
Lamotrigine Tablets 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 Lamotrigine Tablets for epilepsy
The seizures in some types of epilepsy may occasionally become
worse or happen more often while you’re taking Lamotrigine
Tablets. 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
Lamotrigine Tablets:
 See a doctor as soon as possible.
Lamotrigine Tablets 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 Lamotrigine Tablets

Lamotrigine Tablets also treat bipolar disorder.
Leaflet revision date: 28 February 2013
S299 LEAFLET Lamotrigine 20130228

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 Tablets
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 Tablets work in the brain to have this effect.
2. What you need to know before you take Lamotrigine Tablets
Do not take Lamotrigine Tablets:


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 Lamotrigine Tablets.

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 Lamotrigine Tablets. 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 Lamotrigine Tablets or make it more
likely that people will have side effects. These include:

Take special care with Lamotrigine Tablets



valproate, used to treat epilepsy and mental health problems

Talk to your doctor or pharmacist before taking Lamotrigine
Tablets:



carbamazepine, used to treat epilepsy and mental health
problems



if you have any kidney problems





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

phenytoin, primidone or phenobarbitone, used to treat
epilepsy



risperidone, used to treat mental health problems



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



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).



if you are already taking medicine that contains
lamotrigine.

 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 Tablets work
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 Tablets. 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.
Lamotrigine Tablets 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 Lamotrigine Tablets
are affecting the way your contraceptive is working.

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.
Lamotrigine Tablets are not recommended for children aged under
2 years.
How to take your dose of Lamotrigine Tablets
Take your dose of Lamotrigine Tablets 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.
Lamotrigine dispersible/chewable tablets can either be swallowed
whole with a little water, chewed or mixed with water to make a
liquid medicine.

4. Possible side effects

Rare side effects

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

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

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



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).

A small number of people taking Lamotrigine Tablets 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 Tablets, especially if the
starting dose is too high or if the dose is increased too quickly or if
Lamotrigine Tablets are 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:


There may be an increased risk of birth defects in babies whose
mothers took Lamotrigine Tablets 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 Lamotrigine Tablets,
so you may need blood tests and your dose of Lamotrigine Tablets
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 Lamotrigine Tablets passes
into breast milk and may affect your baby. Your doctor will
discuss the risks and benefits of breast-feeding while you’re
taking Lamotrigine Tablets and will check your baby from time
to time if you decide to breast-feed.
Driving and using machines

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.

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



a sore mouth or red or swollen eyes (conjunctivitis)

To make a liquid medicine:



a high temperature (fever), flu-like symptoms or drowsiness



Put the tablet in a glass with at least enough water to cover the
whole tablet.



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



Either stir to dissolve or wait until the tablet is fully dissolved.



unexpected bleeding or bruising, or the fingers turning blue



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 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).

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:

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

ulcers in the mouth, throat, nose or genitals







To chew the tablet:
Pregnancy and breast-feeding

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)

Very rare side effects



If you take more Lamotrigine Tablets than you should
 Contact a doctor or pharmacist immediately. If possible,
show them the Lamotrigine Tablets packet.
Someone who has taken too much Lamotrigine Tablets may have
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 Tablets. In case you have developed
Stevens-Johnson syndrome or toxic epidermal necrolysis your
doctor will tell you that you must never use lamotrigine again.



rapid, uncontrollable eye movements (nystagmus)



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

Very common side effects



loss of consciousness or coma.

These may affect more than 1 in 10 people:

Lamotrigine Tablets can cause dizziness and double vision.



headache

 Don’t drive or use machines unless you are sure you’re not
affected.

If you forget to take Lamotrigine Tablets



skin rash.

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

Common side effects

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

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

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

Don’t stop taking Lamotrigine Tablets without advice
Lamotrigine Tablets must be taken for as long as your doctor
recommends. Don’t stop unless your doctor advises you to.

How much Lamotrigine Tablets to take

If you’re taking Lamotrigine Tablets for epilepsy

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

To stop taking Lamotrigine Tablets, it is important that the dose
is reduced gradually, over about 2 weeks. If you suddenly stop
taking Lamotrigine Tablets, your epilepsy may come back or get
worse.



your age



whether you are taking Lamotrigine Tablets 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 Lamotrigine Tablets
than your doctor tells you to.
The usual effective dose of Lamotrigine Tablets for adults and
children aged 13 years or over is between 100 mg and 400 mg
each day.

If you’re taking Lamotrigine Tablets for bipolar disorder
Lamotrigine Tablets may take some time to work, so you are
unlikely to feel better straight away. If you stop taking Lamotrigine
Tablets, 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 Tablets.

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

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



diarrhoea





dry mouth



feeling sick (nausea) or being sick (vomiting)



feeling tired



pain in your back or joints, or elsewhere.

Other side effects

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
Uncommon side effects
These may affect up to 1 in 100 people:


clumsiness and lack of co-ordination (ataxia)



double vision or blurred vision.

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

Expand view ⇕

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.

Hide
(web5)