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LAMOTRIGINE MYLAN 100MG TABLETS

Active substance(s): LAMOTRIGINE

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Package leaflet: Information for the user

Lamotrigine Mylan 25 mg Tablets
Lamotrigine Mylan 50 mg Tablets
Lamotrigine Mylan 100 mg Tablets
Lamotrigine Mylan 200 mg Tablets
(lamotrigine)

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

Lamotrigine Mylan treats epilepsy

People with epilepsy are prone to having periods
of uncontrolled electrical signals in the brain.
These periods of uncontrolled electrical activity
may lead to seizures.
Lamotrigine 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.

A small number of people being treated with
anti‑epileptics such as lamotrigine 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. 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 see a doctor as
soon as possible.

Children and adolescents under 18 years

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.
Some medicines interact with lamotrigine 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 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.

2. What you need to know before you
take Lamotrigine Mylan

Lamotrigine Mylan 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 is affecting the way your
contraceptive is working.

Do not take Lamotrigine Mylan:

Pregnancy and breast-feeding

• i f you are allergic to lamotrigine or to 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 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 kidney problems
• if you have ever developed a rash after taking
lamotrigine or other medicines for bipolar
disorder or epilepsy
• if you 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.

During treatment
Important information about potentially lifethreatening reactions:

A small number of people taking Lamotrigine
Mylan get an allergic reaction or potentially lifethreatening 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 lifethreatening reactions, get a doctor’s help straight
away or go to the nearest hospital emergency
department’. Your doctor may tell you to stop
taking Lamotrigine.
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, see a
doctor as soon as possible or go to the nearest
hospital for help.

Pregnancy

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.
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, so your doctor may take samples of
your blood to check the level of lamotrigine, and
may adjust your dose.

Breast-feeding

If you are breast-feeding or planning to breastfeed ask your doctor or pharmacist for advice
before taking this medicine. The active ingredient
of lamotrigine 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 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 lactose

If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine.

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 over 13 years 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
704217
50060137

Lamotrigine 200 mg,25 mg,50 mg,100 mg 200,90,60,

Description 28,30,56,21,46,14,42,100
Component Type Leaflet
Affiliate Item Code 704217
Superceded Affiliate Item Code 517252
TrackWise PR No. 704217
MA No. 04569/0616-0619
Packing Site/Printer N/A
Supplier Code 50060137

Pharma Code 4217
SAP No. N/A
Vendor Job No. 262448
Trackwise Proof No. 2
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 16 Sep 2015
No. of colours
Colours

1

Time: 11:38
Page Count

1/2

Black

Non-Print
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Equate CMYK
with
Main Font Myriad Pro
Dimensions

170 x 600 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

for each kilogram of the child’s weight, up to a
maximum maintenance dose of 200 mg daily.
Your doctor may increase the dose of Lamotrigine
Mylan if given in combination with certain
other medicines.
Where a child’s dose cannot be achieved using
these tablets, other forms of this medicine may be
available. Speak to your doctor or pharmacist.
Lamotrigine Mylan is not recommended for
children aged under 2 years.

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.
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.
• swallow your tablets whole with water. Don’t
break, chew or crush them.
• always take the full dose that your doctor has
prescribed. Never take only part of a tablet.
If you take more Lamotrigine Mylan than
you should
Contact a doctor or nearest hospital emergency
department immediately. If possible, show them
the carton or bottle your medicine came in.
If you take too much lamotrigine you may be
more likely to have serious side effects which
may be fatal. Someone who has taken too much
lamotrigine 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.
If you have missed taking a dose of Lamotrigine
Mylan, 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.
Lamotrigine Mylan must be taken 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
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.
If you experience any of the following
potentially life-threatening reactions, get a
doctor’s help straight away or go to the nearest
hospital emergency department.
A small number of people taking lamotrigine 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 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, such as in
Drug Reaction with Eosinophilia and Systemic
Symptoms (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 cell
(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 as soon as possible. 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 StevensJohnson syndrome or toxic epidermal necrolysis
your doctor will tell you that you must never use
lamotrigine again.
Very rare (may affect up to 1 in 10,000 people)
• reduced numbers of different blood cells, which
may cause pale skin, feeling tired and breathless
and having dark urine (reduced number of red

Lamotrigine 200 mg,25 mg,50 mg,100 mg 200,90,60,

Description 28,30,56,21,46,14,42,100
Component Type Leaflet
Affiliate Item Code 704217
Superceded Affiliate Item Code 517252
TrackWise PR No. 704217
MA No. 04569/0616-0619
Packing Site/Printer N/A
Supplier Code 50060137

Pharma Code 4217
SAP No. N/A
Vendor Job No. 262448
Trackwise Proof No. 2
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

blood cells), frequent infections with fever, chills,
sore throat or mouth ulcers (reduced number of
white blood cells), bleeding or bruising for longer
than normal or unexpectedly (reduced number
of platelets). These changes may happen all at
once (pancytopenia) or as 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)
• lupus-like reaction (symptoms may include:
back or joint pain which sometimes may be
accompanied by fever and/or general ill health)
• yellowing of the whites of the eyes or skin,
abdominal pain, dark urine, pale bowel
movements and itching, which may be signs of
liver failure.

Other posisble side effects
Very common (may affect more than 1 in
10 people):
• headache
• skin rash.
Common (may affect up to 1 in 10 people):
• aggression or irritability
• shaking or tremors
• feeling dizzy
• feeling sleepy, drowsy or tired
• difficulty in sleeping (insomnia)
• feeling agitated
• 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
• in people who already have Parkinson’s disease,
worsening of the symptoms.
Not known (frequency 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 longterm antiepileptic medication, have a history of
osteoporosis, or take steroids.
• nightmares .

Reporting side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. 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. Content of the pack and other
information
What Lamotrigine Mylan contain

The active substance is lamotrigine.
Lamotrigine Mylan 25 mg tablets
Each tablet contains 25 mg lamotrigine.
Lamotrigine Mylan 50 mg tablets
Each tablet contains 50 mg lamotrigine.
Lamotrigine Mylan 100 mg tablets
Each tablet contains 100 mg lamotrigine.
Lamotrigine Mylan 200 mg tablets
Each tablet contains 200 mg lamotrigine.
The other ingredients are lactose anhydrous (see
section 2, “Lamotrigine Mylan contains lactose”),,
magnesium stearate (E572), microcrystalline
cellulose (E460), sodium starch glycolate,
povidone and iron oxide yellow (E172).

What Lamotrigine Mylan look like and
contents of the pack

Lamotrigine Mylan are yellow round tablets.
The 25 mg tablets are marked with “LG” over “25”
on one side and “G” on the other side.
The 50 mg tablets are marked with “LG” over “50”
on one side and “G” on the other side.
The 100 mg tablets are marked with “LG” over
“100” on one side and “G” on the other side.
The 200 mg tablets are marked with “LG” over
“200” on one side and “G” on the other side.
The tablets are available in bottles and blisters in
pack sizes of: 14, 21, 28, 30, 42 (25 mg only), 46,
56, 60, 90, 100 and 200 (25 mg, 50 mg and 100 mg
only) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Herts EN6 1TL, United Kingdom

Manufacturer

Generics [UK] Ltd, Station Close, 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: 09/2015
704217
50060137

Date: 16 Sep 2015
No. of colours
Colours

1

Time: 11:38
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions

170 x 600 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

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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