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LAMOTRIGINE MILPHARM 200 MG TABLETS

Active substance(s): LAMOTRIGINE

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Lamotrigine Milpharm
25 mg tablets
Lamotrigine Milpharm
50 mg tablets
Lamotrigine Milpharm
100 mg tablets
Lamotrigine Milpharm
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 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 Milpharm is and what
it is used for
2. What you need to know before you take
Lamotrigine Milpharm
3. How to take Lamotrigine Milpharm
4. Possible side effects
5. How to store Lamotrigine Milpharm
6. Contents of the pack and other
information
1. What Lamotrigine Milpharm is and
what it is used for
Half Fold : 340 mm

Lamotrigine Milpharm belongs to a group of
medicines called anti-epileptics. It is used to
treat two conditions – epilepsy and bipolar
disorder.
Lamotrigine Milpharm treats epilepsy by
blocking the signals in the brain that trigger
epileptic seizures (fits).
• For adults and children aged 13 years
and over, Lamotrigine Milpharm can be
used on its own or with other medicines,
to treat epilepsy. Lamotrigine Milpharm
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 Milpharm 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 Milpharm 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 Milpharm 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 Milpharm works in the brain to
have this effect.
2. What you need to know before you
take Lamotrigine Milpharm
DO NOT take Lamotrigine Milpharm
Lamotrigine 25/50/200 mg tablets
• if you are allergic to lamotrigine or any
of the other ingredients of this medicine
(listed in section 6).
Lamotrigine 100 mg tablets
• if you are allergic to lamotrigine, sunset
yellow aluminium lake 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 Milpharm
Warnings and
precautions
Talk to your doctor
or pharmacist before
taking Lamotrigine
• 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: Rare side
effects)
• if you are already taking medicine
that contains lamotrigine.
If any of these applies to you:
 Tell your doctor, who may decide to
lower the dose, or that Lamotrigine
Milpharm is not suitable for you.
Important information about potentially
serious reactions
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 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.
 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:
• 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’re taking Lamotrigine:
 See a doctor as soon as possible or
go to the nearest hospital for help.
You may find it helpful to tell a family
member, caregiver or close friend that
you can become depressed or have
significant changes in mood, and ask
them to read this leaflet. You might ask
them to tell you if they are worried about
your depression or other changes in
your behaviour.
A small number of people being treated with
anti-epileptics such as Lamotrigine Milpharm
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 Milpharm for
epilepsy
The seizures in some types of epilepsy
may occasionally become worse or happen
more often while you’re taking Lamotrigine
Milpharm. 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
Milpharm:
 See a doctor as soon as possible.
Lamotrigine Milpharm 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.
Black

Other medicines and Lamotrigine
Milpharm
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 need 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. 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
Milpharm or make it more likely that people
will have side effects. These include:
• valproate, used to treat epilepsy and
mental health problems
• carbamazepine, used to treat epilepsy
and mental health problems
• phenytoin, primidone or
phenobarbitone, used to treat epilepsy
• 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
Milpharm 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 Milpharm. 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 Milpharm 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 Milpharm 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.
• Pregnancy may alter the effectiveness
of Lamotrigine, so you may need blood
tests and your dose of Lamotrigine may
be adjusted.
• There may be a small increased risk of
birth defects, including a cleft lip or cleft
palate, if Lamotrigine is taken during the
first 3 months of pregnancy.
• Your doctor may advise you to take extra
folic acid if you’re planning to become
pregnant and while you’re pregnant.
 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 Milpharm 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 Milpharm, and will check
your baby from time to time if you decide
to breast-feed.
Driving and using machines
Lamotrigine Milpharm can cause dizziness
and double vision.
 Don’t drive or operate machines
unless you are sure you’re not
affected.
If you have epilepsy, talk to your doctor
about driving and using machines.
Lamotrigine Milpharm tablets contains
lactose
Lamotrigine Milpharm tablets contain small
amounts of a sugar called lactose. If you
have an intolerance to lactose or any other
sugars:
 Tell your doctor, and don’t take
Lamotrigine Milpharm.
Lamotrigine Milpharm 100 mg tablets
contain sunset yellow aluminium lake, which
may cause allergic reactions.
3. How to take Lamotrigine Milpharm
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you’re not sure.
How much Lamotrigine Milpharm to take
It may take a while to find the best dose of
Lamotrigine Milpharm for you. The dose you
take will depend on:
• your age
• whether you are taking Lamotrigine
Milpharm 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 Milpharm
than your doctor tells you to.
The recommended effective dose of
Lamotrigine Milpharm for adults and
children aged 13 years or over is between
100 mg and 400 mg each day.
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 is not recommended for
children aged under 2 years.
How to take your dose of Lamotrigine
Milpharm
Take your dose of Lamotrigine Milpharm
once or twice a day, as your doctor advises.
It can be taken with or without food.
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.
• Swallow your tablets whole. If you need
to halve your tablets ( to take half the
dose for the 25 and 100mg strengths or
for ease of swallowing for the 25, 100
and 200mg strengths), then swallow
tablet halves whole. Remember not
to chew or crush them.See diagrams
below.
• Always take the full dose that your
doctor has prescribed. Never take only
part of a tablet.
How to halve the tablets (25 mg, 100 mg
& 200 mg only)
fig. A

fig. B

fig. C

Use a tablet cutter to halve tablets.
Alternatively, keeping the score-line
side facing upwards, hold both the
upper and lower sides of the tablet, on
either side of the score-line, using the
thumb and index finger of both hands

P15XXXXX

Package leaflet: Information for the user






If you take more Lamotrigine Milpharm
than you should
 Contact a doctor or nearest hospital
emergency department immediately.
If possible, show them the Lamotrigine
Milpharm packet.



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 Milpharm 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 a single dose of
Lamotrigine Milpharm
Don’t take extra tablets to make up for
a missed dose. Just take your next dose at
the usual time.
In case you forget to take multiple doses
of Lamotrigine
 Ask your doctor for advice on how to
start taking it again. It’s important that
you do this.

Half Fold : 340 mm

Don’t stop taking Lamotrigine Milpharm
without advice
Lamotrigine Milpharm must be taken for as
long as your doctor recommends. Don’t stop
unless your doctor advises you to.
If you are taking Lamotrigine Milpharm
for epilepsy
To stop taking Lamotrigine Milpharm, it
is important that the dose is reduced
gradually, over about 2 weeks. If you
suddenly stop taking Lamotrigine Milpharm,
your epilepsy may come back or get worse.
If you are taking Lamotrigine Milpharm
for bipolar disorder
Lamotrigine Milpharm may take some time
to work, so you are unlikely to feel better
straight away. If you stop taking Lamotrigine
Milpharm, 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 Milpharm.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Potentially life-threatening reactions: get
a doctor’s help straight away
A small number of people taking
Lamotrigine Milpharm 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 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 (Drug Reaction with
Eosinophilia and Systemic Symptoms
which is also known as
DRESS hypersensitivity
syndrome)
• 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
the 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.
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. 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 Lamotrigine Milpharm.
In case you have developed StevensJohnson syndrome or toxic epidermal
necrolysis your doctor will tell you that
you must never use lamotrigine again.
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
• feeling sleepy or drowsy
• feeling dizzy
• shaking or tremors
• difficulty in sleeping (insomnia)
• feeling agitated
• diarrhoea
• dry mouth
• feeling sick (nausea) or being sick
(vomiting)
• feeling tired
• 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 vision or blurred vision
• unusual hair loss or thinning (alopecia).
Rare (may affect up to 1 in 1,000 people):
• a life-threatening skin reaction (StevensJohnson 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).
Very rare( may affect up to 1 in 10,000
people):
• a life-threatening skin reaction (toxic
epidermal necrolysis): (see also the
information at the beginning of Section
4).
• Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS): (see
also the information at the beginning of
Section 4)










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).

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




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.
Nightmares.

Reporting of 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 Milpharm
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 blister/label
of the bottle and the carton after the EXP.
The expiry date refers to the last day of that
month.
This medicinal product 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 Milpharm contains
- The active substance is lamotrigine.
Each tablet contains 25 mg lamotrigine.
Each tablet contains 50 mg lamotrigine.
Each tablet contains 100 mg lamotrigine.
Each tablet contains 200 mg lamotrigine.
- The other ingredients are Cellulose
microcrystalline, lactose monohydrate,
indigo carmine aluminium lake (E132)
(For 200 mg only), sunset yellow
aluminium lake (E110) (For 100 mg
only), sodium starch glycolate (Type A),
magnesium stearate, povidone (K30).
What Lamotrigine Milpharm looks like
and contents of the pack
Tablet.
Lamotrigine Milpharm 25 mg tablets are
white to off white coloured, shield shaped
uncoated tablets debossed with ‘D’ and
‘93’on one side and scoreline on the other
side.
The tablet can be divided into equal doses.
Lamotrigine Milpharm 50 mg tablets are
white to off white coloured, rounded square
uncoated tablets debossed with ‘D’ on
multifaceted side and ‘97’ on the flat side.
Lamotrigine Milpharm 100 mg tablets are
peach coloured, mottled, shield shaped
uncoated tablets debossed with ‘D’ and
‘94’on one side and scoreline on the other
side.
The tablet can be divided into equal doses.
Lamotrigine Milpharm 200 mg tablets are
blue coloured, mottled, shield shaped
uncoated tablets debossed with ‘D’ and
‘96’on one side and scoreline on the other
side.
The score line is only to facilitate
breaking for ease of swallowing
and not to divide into equal
doses.
Lamotrigine Milpharm tablets are available in:
- Clear PVC/Aluminium foil blisters
Pack sizes: 1, 7, 10, 14, 20, 21, 28, 30,
40, 42, 46, 50, 56, 60, 90, 98, 100, 200,
250, 500 tablets.
- HDPE bottles with polypropylene cap
and cotton coil
Pack sizes: 60, 90, 100, 250, 500, 1000
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Czech Republic Lamotrigin Aurovitas
Denmark
Lamotrigin “Aurobindo”
Germany
Lamotrigin Aurobindo
25 mg/ 50 mg/ 100 mg/
200 mg Tabletten
Greece
ISLETON 25 mg/ 50 mg/
100 mg/ 200 mg δισκία
Ireland
Lamotrigine Aurobindo
25 mg/ 50 mg/ 100 mg/
200 mg tablets
Poland
Verpin
Portugal
Lamotrigina Aurobindo
Sweden
Lamotrigin Aurobindo
25 mg/ 50 mg/ 100 mg/
200 mg tabletter
United Kingdom Lamotrigine Milpharm
25 mg/ 50 mg/ 100 mg/
200 mg tablets
This leaflet was revised in 12/2017.

P15XXXXX

[fig. A] and halve the tablet by pressing
down and away from the score-line so that
the tablet opens at the score-line side [fig.
B]. Do not hold on to the shoulder (end) of
the tablet, on either side of the score-line
[fig. C], when halving since this may cause
the tablet to crumble.

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