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LAMOTRIGINE MYLAN 100 MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE / LAMOTRIGINE / LAMOTRIGINE

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Package leaflet: Information for the patient

Lamotrigine Mylan 25 mg
Dispersible Tablets
Lamotrigine Mylan 100 mg
Dispersible Tablets
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 side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet

1. What Lamotrigine Mylan is and what it is used for
2. What you need to know before you take
Lamotrigine Mylan
3. How to take Lamotrigine Mylan
4. Possible side effects
5. How to store Lamotrigine Mylan
6. Contents of the pack and other information.

1. What Lamotrigine Mylan is and what it is
used for
Lamotrigine belongs to a group of medicines called
anti-epileptics. It is used to treat two conditions epilepsy and bipolar disorder.
Lamotrigine Mylan treats epilepsy by blocking the
signals in the brain that trigger epileptic seizures (fits):
• For adults and children aged 13 years and over,
Lamotrigine Mylan can be used on its own or with
other medicines, to treat epilepsy. Lamotrigine Mylan
can also be used with other medicines to treat the
seizures that occur with a condition called LennoxGastaut syndrome.
• For children aged between 2 and 12 years,
Lamotrigine Mylan 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.

Lamotrigine Mylan 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, Lamotrigine Mylan 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 Mylan works in the brain to
have this effect.

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

• if you are allergic to lamotrigine or any of the other
ingredients of this medicine (listed in section 6).
If this applies to you, tell your doctor, and do not take
Lamotrigine Mylan.

Warnings and precautions:

Talk to your doctor or pharmacist before taking
Lamotrigine Mylan if any of the following applies to you,
who may decide to lower your dose or that Lamotrigine
Mylan is not suitable for you:
• if you have problems with your kidneys
• if you have ever developed a rash when you have
taken 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)
• if you are already taking medicine that
contains lamotrigine.

Important information about potentially lifethreatening reactions

A small number of people taking Lamotrigine Mylan
get an allergic reaction or potentially life-threatening
skin reaction, which may develop into more serious
problems if they are not treated. These can include
Stevens–Johnson syndrome (SJS), toxic epidermal
necrolysis (TEN) and drug reaction with eosinophilia
and systemic symptoms (DRESS). You need to know
the symptoms to look out for while you are taking
Lamotrigine Mylan.
Read the description of these symptoms at the start of
section 4 of this leaflet under ‘If you experience any of
the following potentially life-threatening reactions, get
a doctor’s help straight away’.
The highest risk for occurrence of serious skin reactions
is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or
toxic epidermal necrolysis with the use of lamotrigine,
you must not be re-started on lamotrigine at any time.
If you develop a rash or these skin symptoms, seek
immediate advice from a doctor and tell him that you
are taking this medicine.

Thoughts of harming yourself or suicide

Anti-epileptic medicines are used to treat several
conditions, including epilepsy and bipolar disorder.
People with bipolar disorder can sometimes have
thoughts of harming themselves or committing suicide.
If you have bipolar disorder, you may be more likely to
think like this:
• when you first start treatment
• if you have previously had thoughts about harming
yourself or about suicide
• if you are under 25 years old.
If you have distressing thoughts or experiences, or if you
notice that you feel worse or develop new symptoms
while you are taking Lamotrigine Mylan, see a doctor as
soon as possible or go to the nearest hospital for help.
A small number of people being treated with antiepileptics such as Lamotrigine Mylan have had thoughts
of harming or killing themselves. If at any time you have
these thoughts, immediately contact your doctor.

If you are taking Lamotrigine Mylan for epilepsy

The seizures in some types of epilepsy may occasionally
become worse or happen more often while you

are taking Lamotrigine Mylan. 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 are taking
Lamotrigine Mylan, see a doctor as soon as possible.
Lamotrigine Mylan 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 Mylan

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including 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
Lamotrigine Mylan:
• 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
Some medicines interact with Lamotrigine Mylan or
make it more likely that you 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).
• varenicline, used to stop smoking
• metformin used to treat diabetes
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 Mylan 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 a 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 Mylan. If you are using or plan to start using
a hormonal contraceptive, talk to your doctor, who will
discuss suitable methods of contraception with you.
Lamotrigine Mylan can also affect the way hormonal
contraceptives work, although it is 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 Mylan is affecting the way
your contraceptive is working.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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. There may be an increased risk of birth
defects in babies whose mothers took lamotrigine
during pregnancy. These defects include cleft lip or cleft
palate. Your doctor may advise you to take extra folic
acid if you are planning to become pregnant and while
you are pregnant.
Pregnancy may also alter the effectiveness of
Lamotrigine Mylan, so your doctor may take samples of
your blood to check the level of Lamotrigine Mylan, and
may adjust your dose.

Breast-feeding

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
Mylan passes into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of breast
feeding while you are taking Lamotrigine Mylan, and
will check your baby from time to time if you decide to
breast-feed.

Driving and using machines

Lamotrigine Mylan can cause dizziness and double vision.
Do not drive or use machines unless you are sure you
are not affected.
If you have epilepsy, talk to your doctor about driving
and using machines.
Lamotrigine Mylan contains sulphite ammonium
caramel (E150d). This may rarely cause severe allergic
reactions, including swelling of the lips, face or tongue
and swallowing or breathing problems.

3. How to take Lamotrigine Mylan
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 Lamotrigine Mylan to take

It may take a while to find the best dose of Lamotrigine
Mylan for you. The dose you take will depend on:
• your age
• whether you are taking Lamotrigine Mylan with
other medicines
• whether you have problems with your kidneys or liver.
Your doctor will start you on a low dose, 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 Mylan than your doctor
tells you to.
The recommended dose of Lamotrigine Mylan for
adults and adolescents aged 13 years or over is between
100 mg and 400 mg each day.

Use in children:

For children aged 2 to 12 years, the recommended dose
depends on their body weight. The recommended dose
is between 1 mg and 15 mg for each kilogram of the
50062292

Description Lamotrigine 25 mg,100 mg 56
Component Type Leaflet
Affiliate Item Code 1021721
Superceded Affiliate Item Code 730796
TrackWise PR No. 1021721
MA No. 04569/
1208 & 1210
Packing Site/Printer N/A
Supplier Code 50062292

Pharma Code 5021
SAP No. N/A
Vendor Job No. 294450
Trackwise Proof No. 2
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 16 Dec 2016
No. of colours
Colours

1

Time: 09:31
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

child's weight, up to a maximum maintenance dose of
200 mg daily.
Lamotrigine Mylan is not recommended for use in
children below 2 years of age.

How to take your dose of Lamotrigine Mylan

Take your dose of Lamotrigine Mylan once or twice
a day, as your doctor advises. You can take it 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 are
being treated for and the way you respond to treatment.
You can take the dispersible tablets by swallowing
them whole with a little water, by chewing them, or by
dissolving them in water:

If you chew the tablet

You may need to drink a little water at the same time
to help the tablet dissolve in your mouth. Then drink
some more water to make sure you have swallowed all
the medicine.

To make a liquid medicine

Put the tablet in a glass with at least enough water to
cover the whole tablet. Either stir to dissolve, or wait for
about a minute, until the tablet is fully dissolved.
Drink all the liquid. Add a little more water to the
glass and drink that, to make sure you have taken all
the medicine.

If you take more Lamotrigine Mylan than
you should

Contact a doctor or nearest hospital emergency
department immediately. If possible, show them the
Lamotrigine Mylan packet.
If you take too much Lamotrigine Mylan you may be
more likely to have serious side effects which may be
fatal. Someone who has taken too much Lamotrigine
Mylan may have any of these symptoms:
• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of co-ordination, affecting their
balance (ataxia)
• heart rhythm changes (detected usually on ECG)
• loss of consciousness, fits (convulsions) or coma.
If you forget to take Lamotrigine Mylan - Do not
take extra tablets or a double dose to make up for a
forgotten dose. Just take your next dose at the usual
time. Ask your doctor for advice on how to start taking it
again. It is important that you do this.

If you stop taking Lamotrigine Mylan

Do not stop taking Lamotrigine Mylan without advice
- Take Lamotrigine Mylan for as long as your doctor
recommends. Do not stop unless your doctor advises
you to.
If you are taking Lamotrigine Mylan for epilepsy, it
is important that your dose is reduced gradually, over
about 2 weeks. If you suddenly stop taking Lamotrigine
Mylan, your epilepsy may come back or get worse.
If you are taking Lamotrigine Mylan for bipolar
disorder – Lamotrigine Mylan may take some time to
work, so you are unlikely to feel better straight away.
If you stop taking Lamotrigine Mylan 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 Mylan.
If you have further questions on the use of this
medicine, ask your doctor or pharmacist.

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

Potentially life-threatening reactions: get a doctor’s
help straight away
A small number of people taking Lamotrigine Mylan
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,
especially if the starting dose is too high or if the dose
is increased too quickly, or if Lamotrigine Mylan 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 lifethreatening skin reactions including widespread rash
with blisters and peeling skin, particularly occurring
around the mouth, nose, eyes and genitals (StevensJohnson syndrome), extensive peeling of the skin
(more than 30% of the body surface - toxic epidermal
necrolysis) or extended rashes with liver, blood and
other body organs involvement (DRESS)
• 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 your fingers
turning blue
• A sore throat, or more infections (such as colds)
than usual
• Increased levels of liver enzymes seen in blood tests
• An increase in a type of white blood cells (eosinophils)
• Enlarged lymph nodes
• Involvement of the organs of the body including liver
and kidneys
• 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.
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. 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
Mylan. In case you have developed Stevens-Johnson
syndrome or toxic epidermal necrolysis your doctor will
tell you that you must never use lamotrigine again.

Other side effects include:
Very common (may affect more than 1 in 10 people):
• Headache
• Skin rash.
Common (may affect up to 1 in 10 people):
• Agitation, aggression or irritability
• Shaking or tremors
• Feeling dizzy
• Feeling sleepy, drowsy or tired
• Difficulty in sleeping
• Feeling sick (nausea) or being sick (vomiting)
• Diarrhoea
• Dry mouth
• Pain in your back or joints, or elsewhere.
Uncommon (may affect up to 1 in 100 people):
• Clumsiness and lack of co-ordination (ataxia)
• Double or blurred vision
• Hair loss
Rare (may affect up to 1 in 1,000 people):
• Rapid, uncontrollable eye movements (nystagmus)
• Itchy eyes, with discharge and crusty eyelids
(conjunctivitis)
Very rare (may affect up to 1 in 10,000 people):
• 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
• Changes in liver function, which will show up in blood
tests, or liver failure
• 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 cells (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)
• 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).
• DRESS (see ‘Potentially life threatening reactions’ above).
Not known (cannot be estimated from the available data):
• 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.
• Swollen glands in the neck, armpit or groin
(lymphadenopathy)
• Nightmares

Reporting of 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. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Lamotrigine Mylan
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date, which is
stated on the carton and the blister after 'EXP'.
The expiry date refers to the last day of that month.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other information
What Lamotrigine Mylan contains

The active substance is lamotrigine.
Lamotrigine Mylan 25 mg Dispersible tablets: each
tablet contains 25 mg lamotrigine.
Lamotrigine Mylan 100 mg Dispersible tablets: each
tablet contains 100 mg lamotrigine.
The other ingredients are magnesium stearate
(E572), microcrystalline cellulose (E460), sodium
starch glycolate, povidone, colloidal silica anhydrous
(E551), saccharin sodium (E421), mannitol (E421) and
blackcurrant flavouring containing glyceryl triacetate
(E1518) and sulfite ammonia caramel (E150d) (see
section 2 “Lamotrigine Mylan contains sulphite
ammonium caramel (E150d)”.

What Lamotrigine Mylan looks like and contents
of the pack -

Lamotrigine Mylan 25 mg Dispersible tablets - White
to off white, round tablets marked with 'LY' over '25' on
one side and plain on the other side.
Lamotrigine Mylan 100 mg Dispersible tablets – White
to off white, round tablets marked with 'LY' over '100' on
one side and plain on the other side.
The tablets are available in blisters of 14, 21, 28, 30, 46,
56, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertforshire, EN6 1TL,
United Kingdom.

Manufacturers

Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, Mylan utca 1,
Komarom 2900, Hungary.
This leaflet was last revised in 12/2016

1021721
50062292

Description Lamotrigine 25 mg,100 mg 56
Component Type Leaflet
Affiliate Item Code 1021721
Superceded Affiliate Item Code 730796
TrackWise PR No. 1021721
MA No. 04569/
1208 & 1210
Packing Site/Printer N/A
Supplier Code 50062292

Pharma Code 5021
SAP No. N/A
Vendor Job No. 294450
Trackwise Proof No. 2
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 16 Dec 2016
No. of colours
Colours

1

Time: 09:31
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

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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