LAMOTRIGINE MILPHARM 25 MG TABLETS

Active substance: 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
Lamotrigine Milpharm belongs to a group of medicines called antiepileptics. 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
Your doctor needs to know before you take Lamotrigine
Milpharm:

if you have any kidney problems

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

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

Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported with
the use of Lamotrigine Milpharm, appearing initially as reddish
target-like spots or circular patches often with central blisters
on the trunk.

Additional signs to look for include ulcers in the mouth, throat,
nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often
accompanied by flu-like symptoms. The rash may progress to
widespread blistering or peeling of the skin.

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 Milpharm, you
must not be re-started on Lamotrigine Milpharm at any time.
 Read the description of these symptoms in section 4 of
this leaflet under ‘Potentially serious reactions: get a doctor’s help
straight away’.

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’re taking
Lamotrigine:
 See a doctor as soon as possible or go to the nearest
hospital for help.
A small number of people being treated with anti-epileptics such as
Lamotrigine Milpharm have also had thoughts of harming or killing
themselves. If 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.
Other medicines and Lamotrigine Milpharm
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines — these include 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 or olanzapine, 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

phenytoin, primidone or phenobarbitone, used to treat
epilepsy

risperidone, used to treat mental health problems

rifampicin, which is an antibiotic

a combination of lopinavir and ritonavir, used to treat Human
Immunodeficiency Virus (HIV) infection

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
There may be an increased risk of birth defects in babies whose
mothers took Lamotrigine Milpharm during pregnancy. These
defects include cleft lip or cleft palate. Your doctor may advise you
to take extra folic acid if you’re planning to become pregnant and
while you’re pregnant.
Pregnancy may also alter the effectiveness of Lamotrigine
Milpharm, so you may need blood tests and your dose of
Lamotrigine may be adjusted.
 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.
 Talk to your doctor if you’re breast feeding or planning to
breast feed. 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
Lamotrigine Milpharm tablets contain small amounts of a sugar
called lactose. If you have 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.
For doses not realisable/practicable with this strength other
strengths of this medicinal product are available.
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 usual 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 of 400 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.




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LAMOTRIGINE
MILPHARM
TABLETS

Package leaflet: Information for the user



LAMOTRIGINE
MILPHARM
TABLETS

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Swallow your tablets whole. If you need to halve your tablets
( to take half the dose for the 25 and 100 mg strengths or for
ease of swallowing for the 25, 100 and 200 mg 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.

How to halve the tablets (25 mg, 100 mg & 200 mg only)
fig. A

fig. B

fig. C







agranulo-cytosis), reduced numbers of platelets
(thrombocytopenia), reduced numbers of all these types of cell
(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)
swelling around the face (oedema) or swollen glands in the
neck, armpit or groin (lymphadenopathy)
in people who already have Parkinson’s disease, worsening of
the symptoms.

Use a tablet cutter to halve tablets. Alternatively, keeping the scoreline 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 [fig. A] and halve the tablet by pressing down
and away from the score-line so that the tablet opens at the scoreline 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.

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

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).

If you take more Lamotrigine Milpharm than you should
 Contact a doctor or pharmacist immediately. If possible,
show them the Lamotrigine Milpharm packet.

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.

If you forget to take Lamotrigine Milpharm
Don’t take extra tablets or a double dose to make up for a
forgotten dose.
 Ask your doctor for advice on how to start taking it again.
It’s important that you do this.
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 serious reactions: get a doctor’s help straight away
A small number of people taking Lamotrigine Milpharm get an
allergic reaction or potentially serious 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 severe 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)

a sore mouth or eyes

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.
In many cases, these symptoms will be signs of less serious side
effects. But you must be aware that they are potentially serious
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.
Very common side effects
These may affect more than 1 in 10 people:

headache

feeling dizzy

feeling sleepy or drowsy

clumsiness and lack of co-ordination (ataxia)

double vision or blurred vision

feeling sick (nausea) or being sick (vomiting)

skin rash.
Common side effects
These may affect up to 1 in 10 peolple:

aggression or irritability

rapid, uncontrollable eye movements (nystagmus)

shaking or tremors

difficulty in sleeping

diarrhoea

dry mouth

feeling tired

pain in your back or joints, or elsewhere.
Rare side effects
These may affect up to 1 in 1,000 people:

itchy eyes, with discharge and crusty eyelids (conjunctivitis)

Potentially life-threatening skin rashes (Stevens-Johnson
syndrome) have been reported (see section 2).
Very rare side effects
These may affect up to 1 in 10,000 people:

hallucinations (‘seeing’ or ‘hearing’ things that aren’t really
there)

confusion or agitation

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

Potentially life-threatening skin rashes (Toxic epidermal
necrolysis) have been reported (see section 2)

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,

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 Lamotrigine Aurobindo 25 mg/ 50 mg/ 100 mg
tablety
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
Hungary
Lamotrigin Aurobindo 50 mg/ 100 mg tabletta
Ireland
Lamotrigine Aurobindo 25 mg/ 50 mg/ 100 mg/
200 mg tablets
Poland
Lamotrigine Aurobindo
Portugal
Lamotrigina Aurobindo
Slovakia
Lamotrigin Aurobindo 25 mg/ 50 mg/ 100 mg
tablety
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 06/2014.

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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)

loss of consciousness or coma.

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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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