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LAMOTRIGINE MYLAN 100 MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE

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• 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.

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).
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.

Warnings and precautions:

Pregnancy and breast-feeding

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
Lennox-Gastaut 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:

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
life-threatening reactions

111211122121

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

111211122121

Package leaflet: Information for the patient

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.

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 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.
50060394

Description Lamotrigine 25 mg,100 mg 56
Component Type Leaflet
Affiliate Item Code 730796
Superceded Affiliate Item Code 517622
TrackWise PR No. 730796
MA No. 04569/1208 & 1210
Packing Site/Printer N/A
Supplier Code 50060394

Pharma Code 4377
SAP No. N/A
Vendor Job No. 265268
Trackwise Proof No. 2
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 16 Oct 2015
No. of colours
Colours

Time: 09:58
Page Count

1

1/2

Black

Non-Print
Colours
Equate CMYK
with
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Dimensions 170 x 480 mm

Body Text Size 9pt
Min Text Size used 9pt

Sign-offs

v1/May 2015

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 life-threatening skin reactions including
widespread rash with blisters and peeling skin,
particularly occurring around the mouth, nose,
eyes and genitals (Stevens-Johnson syndrome),
extensive peeling of the skin (more than 30% of
the body surface - toxic epidermal necrolysis) 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
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).

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, Herts. EN6 1TL.

Manufacturers

Generics [UK] Ltd, Potters Bar, Herts. EN6 1TL.
OR
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
OR
Mylan Hungary Kft, Mylan utca 1,
Komarom 2900,Hungary.
This leaflet was last revised in 10/2015

730796
50060394

Description Lamotrigine 25 mg,100 mg 56
Component Type Leaflet
Affiliate Item Code 730796
Superceded Affiliate Item Code 517622
TrackWise PR No. 730796
MA No. 04569/1208 & 1210
Packing Site/Printer N/A
Supplier Code 50060394

Pharma Code 4377
SAP No. N/A
Vendor Job No. 265268
Trackwise Proof No. 2
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 16 Oct 2015
No. of colours
Colours

Time: 09:58
Page Count

1

2/2

Black

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

Body Text Size 9pt
Min Text Size used 9pt

Sign-offs

v1/May 2015

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.

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