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LAMOTRIGINE DR REDDYS 25MG TABLETS

Active substance(s): LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lamotrigine Dr. Reddy’s 25mg, 50mg, 100mg & 200mg
Tablets

cause serious health problems. If your seizures happen more
often, or if you have a severe seizure while you’re taking
Lamotrigine, see a doctor as soon as possible.

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 symptoms 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.

Other medicines and Lamotrigine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines including herbal
medicines or other medicines bought without a prescription.
If you are taking certain medicines, your doctor may
need to check the dose of Lamotrigine. These include:
• oxcarbazepine, felbamate, gabapentin, levetiracetam,
pregabalin, topiramate or zonisamide to treat for epilepsy
• lithium, olanzapine or aripiprazole used to treat mental health
problems
• bupropion used to treat mental health problems or to stop
smoking.

What is in this leaflet
1. What Lamotrigine Tablets are and what
they are used for
2. What you need to know before you take Lamotrigine
Tablets
3. How to take Lamotrigine Tablets
4. Possible side effects
5. How to store Lamotrigine Tablets
6. Contents of the pack and other information
1. What Lamotrigine Tablets are and what they are used
for
Lamotrigine tablets belong to a group of medicines called antiepileptics. They are used to treat two conditions – epilepsy and
bipolar disorder.
Lamotrigine tablets treat epilepsy by blocking the signals in the
brain that trigger epileptic seizures (fits).
• For adults and children aged 13 years and over
Lamotrigine tablets can be used on their own or with other
medicines to treat epilepsy. Lamotrigine tablets 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 tablets can be used with other medicines, to treat
the same conditions as above. They can be used on their
own to treat a type of epilepsy called typical absence
seizures.
Lamotrigine tablets also treat 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
Tablets can be used alone or with other medicines to prevent
the periods of depression that occur in bipolar disorder. It is not
yet known how Lamotrigine tablets work in the brain to have this
effect.

Tell your doctor if you are taking any of these.
Some medicines interact with Lamotrigine tablets or make it
more likely that you’ll have side effects. These include:
• valproate (for epilepsy and mental health problems)
• carbamazepine used to treat epilepsy and mental health
problems
• phenytoin, primidone or phenobarbitone (for epilepsy)
• risperidone, used to treat mental health problems
• rifampicin (an antibiotic)
• a combination of lopinavir and ritonavir or atazanavir and
ritonavir (to treat Human Immunodeficiency Virus infection)
• hormonal contraceptives, such as the Pill (see below).
Tell your doctor if you are taking, or if you start or stop taking
any of these.
Hormonal contraceptives (such as the Pill) can affect the
way Lamotrigine tablets work.
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 tablets. If you plan to
start using a hormonal contraceptive, talk to your doctor, who
will discuss suitable methods of contraception with you.
Lamotrigine tablets 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 tablets are
affecting the way your contraceptive is working.

Pregnancy and breast-feeding
If you’re pregnant, think you may be pregnant, or are
planning to have a baby ask your doctor or pharmacist for
advice before taking this medicine.
2. What you need to know before you take Lamotrigine
• You should not stop treatment without discussing this
Tablets
with your doctor. This is particularly important if you have
Do not take Lamotrigine
epilepsy.
• if you are allergic (hypersensitive) to lamotrigine or any of the
• Pregnancy may alter the effectiveness of Lamotrigine, so
other ingredients (see Section 6).
you may need blood tests and your dose of Lamotrigine may
If this applies to you tell your doctor and don’t take
be adjusted.
Lamotrigine.
• There may be a small increased risk of birth defects including
a cleft lip or cleft palate if Lamotrigine is taken during the first
Take special care with Lamotrigine.
3 months of pregnancy.
Talk to your doctor before you take Lamotrigine:
• Your doctor may advise you to take extra folic acid if you’re
• if you have kidney or liver problems
planning to become pregnant and while you’re pregnant.
• if you have ever developed a rash when you’ve taken
If you are breast-feeding or planning to breast-feed ask
lamotrigine or other medicines for epilepsy
• if you are already taking a medicine that contains lamotrigine. your doctor or pharmacist for advice before taking this
medicine. Lamotrigine passes into breast milk and may affect
If any of these applies to you, tell your doctor, who may
decide to lower your dose or that Lamotrigine is not suitable for your baby. Your doctor will discuss the risks and benefits of
breast-feeding while you’re taking Lamotrigine tablets, and will
you.
check your baby from time to time if you decide to breast-feed.
Important information about potentially life-threatening
Driving and using machines
reactions
Lamotrigine tablets can cause dizziness and double vision. Do
A small number of people taking Lamotrigine get an allergic
not drive or operate machines unless you are sure you are
reaction or potentially life-threatening skin reaction, which may
not affected.
develop into more serious problems if they are not treated.
These can include Stevens-Johnson Syndrome (SJS), toxic
3. How to take Lamotrigine Tablets
epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia
Always take this medicine exactly as your doctor or
and Systemic Symptoms (DRESS). You need to know the
pharmacist has told you. Check with your doctor or
symptoms to look out for while you are taking Lamotrigine.
pharmacist if you are not sure.
Read the description of these symptoms in Section 4 of
How much Lamotrigine to take
this leaflet under ‘Potentially life-threatening reactions: get a
It may take a while to find the best dose of Lamotrigine
doctor’s help straight away’.
tablets for you. The dose you take will depend on:
Thoughts of harming yourself or suicide
• your age
Anti-epileptic medicines are used to treat several conditions,
• whether you are taking Lamotrigine tablets with other
including epilepsy and bipolar disorder. People with bipolar
medicines
disorder can sometimes have thoughts of harming themselves
• Whether you have problems with your kidneys or liver.
or committing suicide. If you have bipolar disorder, you may be
Your doctor will start you on a low dose, and gradually
more likely to think like this:
increase the dose over a few weeks until you reach a dose
• when you first start treatment
that works for you (called the effective dose). Never take
• if you have previously had thoughts about harming yourself or
more Lamotrigine tablets than your doctor tells you to.
about suicide
• if you are under 25 years old
For adults and children aged over 13 years:
If you have distressing thoughts or experiences, or if you notice The usual effective dose of Lamotrigine tablets is between
that you feel worse or develop new symptoms while you’re
100 mg and 400 mg each day.
taking Lamotrigine:
For children aged 2 to 12 years: The effective dose
See a doctor as soon as possible or go to the nearest
depends on their body weight - usually, it’s between 1mg
hospital for help.
and 15mg for each kilogram of the child’s weight, up to a
You may find it helpful to tell a family member, caregiver or
maximum maintenance dose of 200 mg daily.
close friend that you can become depressed or have
Lamotrigine is not recommended for children aged under
significant changes in mood, and ask them to read this
2 years.
leaflet. You might ask them to tell you if they are worried
about your depression or other changes in your behaviour. How to take your dose of Lamotrigine tablets
A small number of people being treated with anti-epileptics such Take your dose of Lamotrigine tablets once or twice a day,
as your doctor advises. You can take it with or without food.
as Lamotrigine have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately Your doctor may also advise you to start or stop taking other
medicines, depending on what condition you’re being treated for
contact your doctor.
and the way you respond to treatment.
If you’re taking Lamotrigine for epilepsy
• Swallow your tablets whole. Don't break, chew or crush
The seizures in some types of epilepsy may occasionally
them.
become worse or happen more often while taking Lamotrigine.
Some patients may experience severe seizures, which may

Always take the full dose that your doctor has prescribed.
Never take only part of a tablet.
If you take more Lamotrigine tablets than you should
If anyone takes too many Lamotrigine tablets, contact a doctor
or pharmacist immediately. If possible, show them the
Lamotrigine packet.
If you take too many Lamotrigine tablets you may be more
likely to have serious side effects which may be fatal.
Someone who has taken too many Lamotrigine tablets 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 tablets:
Don’t take extra tablets or a double dose to make up for a
forgotten dose.
If you have missed taking a dose of Lamotrigine tablets:
Ask your doctor for advice on how to start taking it again.
It’s important that you do this.
Don’t stop taking Lamotrigine tablets without advice
Take Lamotrigine tablets for as long as your doctor
recommends. Don’t stop unless your doctor advises you to.
If you’re taking Lamotrigine for epilepsy
To stop taking Lamotrigine tablets, it is important that your
dose is reduced gradually, over about 2 weeks. If you
suddenly stop taking Lamotrigine tablets, your epilepsy may
come back or get worse.
If you’re taking Lamotrigine for bipolar disorder
Lamotrigine may take some time to work, so you are unlikely to
feel better straight away. If you stop taking Lamotrigine, 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.
4. Possible side effects
Like all medicines, Lamotrigine tablets can cause side effects,
but not everyone gets them.
Allergic reaction or potentially serious skin reaction, get
a doctor’s help straight away.
A small number of people taking Lamotrigine tablets have 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
(Drug Reaction with Eosinophilia and Systemic Symptoms
which is also known as DRESS hypersensitivity syndrome)
• ulcers in the mouth, throat, nose or genitals
• sore mouth or red swollen eyes (conjunctivitis)
• high temperature (fever), flu-like symptoms or
drowsiness
• swelling of the face, swollen glands in your neck, armpit, groin
• unexpected bleeding or bruising, or your fingers turning blue
• 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 (eosinophilia)
• 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. However, 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, see a doctor at once. Your
doctor may carry out tests on your liver, kidneys or blood, and
may tell you to stop taking Lamotrigine tablets. In case you have
developed Stevens-Johnson syndrome or toxic epidermal
necrolysis your doctor will tell you that you must never use
lamotrigine again.
Very common side effects (may affect more than 1 in 10
people)
• headache
• skin rash.
Common side effects (may affect up to 1 in 10 people)
• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• shaking or tremors
• difficulty in sleeping
• feeling agitated
• diarrhoea
• dry mouth
• feeling sick (nausea) or being sick (vomiting)
• feeling tired
• pain in your back or joints, or elsewhere.
Uncommon side effects (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 side effects (may affect up to 1 in 1,000 people)
• a life-threatening skin reaction (Stevens-Johnson 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 movement (nystagmus)
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
Very rare side effects (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 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 (as shown in blood tests) or liver
failure
• 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
cells (pancytopenia) and a disorder of the bone marrow
called aplastic anaemia
• hallucinations ('seeing' or 'hearing' things that aren't 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
• worsening of the symptoms in people who already have
Parkinson's disease
• lupus-like reaction (symptoms may include: back or joint
pain which sometimes may be accompanied by fever
and/or general ill health).
Frequency not known
• 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 anti-epileptic medications, have a history of
osteoporosis or take steroids
• 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 Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C and keep in the original packaging.
Protect from light.
Do not use this medicine after the expiry date which is stated on
the blisters, carton or bottle after EXP. The expiry date refers to
the last day of that month.
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 Tablets contain
The active ingredient (which makes the tablets work) is
lamotrigine. Each tablet contains either 25mg, 50mg, 100mg or
200mg of lamotrigine. The other ingredients are: mannitol
(E421), powdered cellulose (E460), l-hydroxypropyl cellulose
(E463), hydroxypropyl cellulose (E463), iron oxide yellow
(E172), magnesium stearate (E470b) and talc (E553b).
What Lamotrigine Tablets look like and contents of the pack
Lamotrigine Tablets are yellow, round, flat, bevelled edged
tablets with LMT marked on one side and with a score line
and the tablet strength marked on the other side.
The 25mg tablets are available in pack sizes of 21 or 56.
The 50mg tablets are available in pack sizes of 42 or 56.
The 100mg and 200mg tablets are available in pack sizes of
56.
Manufacturer and marketing authorisation holder:
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley,
East Yorkshire,
HU17 0LD
This leaflet was revised in 06/2016
Lamotrigine Dr. Reddy’s 25mg Tablets: PL 08553/0221
Lamotrigine Dr. Reddy’s 50mg Tablets: PL 08553/0222
Lamotrigine Dr. Reddy’s 100mg Tablets: PL 08553/0223
Lamotrigine Dr. Reddy’s 200mg Tablets: PL 08553/0224

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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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