LAMOTRIGINE CIPLA 100 MG TABLETS

Active substance: LAMOTRIGINE

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PATIENT INFORMATION LEAFLET
LAMOTRIGINE CIPLA
25 mg, 50 mg, 100 mg and 200 mg TABLETS
(lamotrigine)
The name of this medicine is Lamotrigine Cipla 25 mg, 50 mg, 100 mg and 200 mg Tablets,
which will be referred to as Lamotrigine Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or your pharmacist
• This medicine has been prescribed for you. Do not pass it on to others; it may harm them,
even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in the
leaflet, please tell your doctor or pharmacist
In this leaflet
1. What Lamotrigine Tablets are and what they are used for
2. Before you take Lamotrigine Tablets
3. How to take Lamotrigine Tablets
4. Possible side effects
5. How to store Lamotrigine Tablets
6. Further Information
1. WHAT LAMOTRIGINE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in this product is lamotrigine, which belongs to a group of medicines
called anti-epileptics. It is 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 those conditions. It can be used on its 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 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 works in the brain to have this effect.

2. BEFORE YOU TAKE LAMOTRIGINE TABLETS
Do not take Lamotrigine Tablets if you:
• are allergic (hypersensitive) to lamotrigine, or any of the other ingredients in Lamotrigine
Tablets (these are listed in section 6, Further Information)
If this applies to you:
Tell your doctor,and don’t take Lamotrigine Tablets.
Take special care with Lamotrigine Tablets
Your doctor needs to know before you take Lamotrigine Tablets if you:
• have problems with your kidneys
• have ever developed a rash when you’ve taken lamotrigine or other medicines for epilepsy
or bipolar disorder
• are already taking medicine that contains lamotrigine
• Lamotrigine can occasionally cause some serious allergic reactions or potentially lifethreatening skin reaction (incl. DRESS). For more information on these, please read section 4
(Possible side effects).
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash
with a high temperature, increased levels of liver enzymes seen in blood tests and an increase
in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
If any of these applies to you:
Tell your doctor,who may decide to lower your dose or that Lamotrigine Tablets are not
suitable for you.
Watch out for important symptoms
A small number of people taking lamotrigine get an allergic reaction or potentially serious
skin reaction, which may develop into more serious problems if they are not treated. You
need to know the symptoms to look out for while you are taking Lamotrigine Tablets.
• Read the description of these symptoms in Section 4 of this leaflet under “Potentially
serious 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 Tablets:
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 Tablets 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 Tablets for epilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often
while you’re taking Lamotrigine Tablets. 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 Tablets:
See a doctor as soon as possible.

Lamotrigine Tablets should not be given to people 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.
Taking other medicines
Tell your doctor or pharmacist if you’re taking any other medicines, if you’ve taken any
recently, or if you start taking new ones – these include herbal medicines or other
medicines you bought without a prescription.
If you are taking certain medicines, your doctor may need to check the dose of Lamotrigine
Tablets. These 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 Tablets or make it more likely that you’ll 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
• a combination of lopinavir and ritonavir or atazanavir and ritonavir, used to treat
Human Immunodeficinecy Virus (HIV) infection
• hormonal contraceptives, such as the Pill (see below).
Tell your doctor if you are 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. 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 is affecting the way your
contraceptive is working.
Pregnancy and breast-feeding
Talk to your doctor if you’re pregnant, if you might be pregnant, or if you’re planning
to become pregnant.
It is important that you do this because 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’re planning to become

pregnant and while you’re pregnant.
Pregnancy may also alter the effectiveness of Lamotrigine Tablets, so your doctor may take
samples of your blood to check the level of lamotrigine, and may adjust your dose.
Talk to your doctor if you’re breast-feeding or planning to breast-feed. 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 Tablets, and
will check your baby from time to time if you decide to breast-feed.
Driving and using machines
Lamotrigine Tablets 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.
Important information about some of the ingredients of Lamotrigine Tablets
Lamotrigine 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 Tablets.
3. HOW TO TAKE LAMOTRIGINE TABLETS
Always use Lamotrigine Tablets exactly as your doctor has told you to. Check with your
doctor or pharmacist if you’re not sure.
How much lamotrigine to take
For doses not realisable / practicable with these strengths of tablet, other strengths of this
medicinal product are available.
It may take a while to find the best dose of Lamotrigine Tablets for you. The dose you take
will depend on:
• your age
• whether you are taking Lamotrigine Tablets with any other medicine
• 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 Tablets than your doctor tells you to.
The usual effective dose of Lamotrigine Tablets for adults and children aged over 12 years is
between 100 mg and 400 mg each day.
Lamotrigine is not recommended for children aged under 2 years.
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.
How to take your dose of Lamotrigine Tablets
Take your dose of Lamotrigine Tablets 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’re being treated for and the way you respond to treatment.
• Swallow your tablets whole. 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 Tablets than you should
If anyone takes too much lamotrigine :
Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine
Tablets packet.
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)
• loss of consciousness 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 are taking Lamotrigine Tablets 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 are taking Lamotrigine Tablets for bipolar disorder
Lamotrigine Tablets may take some time to work, so you are unlikely to feel better straight
away. If you stop taking Lamotrigine Tablets, 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 Tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lamotrigine Tablets can cause side effects, but not everybody gets them.
Allergic reaction or potentially serious skin reaction: get a doctor’s help straight away.
A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially
serious skin reaction, which may develop into more serious and even life-threatening
problems if they are not treated.
These symptoms are more likely to happen during the first few months of treatment with
Lamotrigine Tablets, especially if you start on too high a dose or if your dose is increased too
quickly, or if you’re taking Lamotrigine Tablets 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) or DRESS
• 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 your 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 Tablets.
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 people:
• 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)
• a rare skin condition, (Stevens-Johnson syndrome: see also the information at the beginning
of Section 4).
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
• a severe skin reaction (toxic epidermal necrolysis : see also the information at the beginning
of Section 4).
• 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 (leucopoenia, 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
• 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 symptoms
• 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)
Other side effects
Other side effects have occurred in a small number of people but their exact frequency is
unknown:
• DRESS
• 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 but if the symptoms continue or get worse contact your
doctor.
If you get side effects
If any of the side effects becomes severe or troublesome, or if you notice any side effects
not listed in this leaflet please tell your doctor or pharmacist.

5. HOW TO STORE LAMOTRIGINE TABLETS
Keep Lamotrigine Tablets out of the reach and sight of children.
Do not use Lamotrigine Tablets after the expiry date shown on the blisters, carton or bottle.
The expiry date refers to the last day of that month.
Lamotrigine does not require any special storage conditions.
If you have any unwanted Lamotrigine Tablets, don’t dispose of them in your wastewater or
household rubbish. Take them back to your pharmacist, who will dispose of them in a way
that won’t harm the environment.
6. FURTHER INFORMATION
What Lamotrigine Tablets contain
The active ingredient is lamotrigine. Each tablet contains 25, 50, 100 or 200 mg of
lamotrigine.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch
glycolate, maize starch, magnesium stearate and iron oxide yellow (E172).
What Lamotrigine Tablets look like and contents of the pack
Lamotrigine 25 mg, 50mg and 100mg Tablets are yellow, round tablets with '25' or '50' or
'100' on one side and a score-line on the other.
Lamotrigine 200 mg Tablets are yellow, capsule-shaped tablets with ‘200’ on one side and a

score-line on the other.
Your medicine is available in packs of 21, 28, 42, 56, or 100 tablets (not all pack sizes may
be marketed).
Marketing Authorisation Holder:
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
Manufacturer responsible for batch release: Fannin (UK) Limited, 57 High Street,
Odiham, Hants, RG29 1LF, UK
This leaflet was last revised in May 2014.

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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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