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LAMOTRIGINE CONSILIENT 200MG TABLETS

Active substance(s): LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamotrigine Consilient
25 mg, 50 mg, 100 mg and 200 mg Tablets
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• 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 you have any further questions, ask your doctor or pharmacist. If any of
the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lamotrigine Consilient tablets are and what they are used for
2. Before you take Lamotrigine Consilient tablets
3. How to take Lamotrigine Consilient tablets
4. Possible side effects
5. How to store Lamotrigine Consilient tablets
6. Further information
1. What Lamotrigine Consilient tablets are and what they are
used for
Lamotrigine tablets belong to a group of medicines called anti-epileptics. 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.
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 on their own 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.
2. Before you take Lamotrigine Consilient tablets
Do not take Lamotrigine :
• if you are allergic (hypersensitive) to lamotrigine or any of the other
ingredients of Lamotrigine tablets (listed in Section 6).
If this applies to you, tell your doctor and do not take Lamotrigine tablets.
Take special care with Lamotrigine
Your doctor needs to know before you take Lamotrigine tablets:
• if you have problems with your kidneys
• if you have ever developed a rash when you have taken lamotrigine or
other medicines for epilepsy
• if you are already taking medicine that contains lamotrigine.
If any of these apply to you, tell your doctor, who may decide to lower your dose or
that Lamotrigine tablets, are not suitable for you.
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 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.
Lamotrigine tablets 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, if
you have 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, 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
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
• olanzapine, used to treat mental health problems
• 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, 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. 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 is 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
Talk to your doctor if you are pregnant, if you might be pregnant, or if you
are planning to become pregnant.
You should not stop treatment for your epilepsy while you are pregnant. However,
there is an increased risk of birth defects in babies whose mothers took Lamotrigine
tablets 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 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 are breast feeding or planning to breast feed.
Lamotrigine passes into breast milk and may affect your baby. Your doctor will
discuss the risks and benefits of breast feeding while you are 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, do not drive or
operate machines if you are 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
intolerance to lactose or any other sugars, tell your doctor and do not take
Lamotrigine tablets.
3. How to take Lamotrigine Consilient tablets
Always use Lamotrigine tablets exactly as your doctor has told you to.
Check with your doctor or pharmacist if you are not sure.
How much Lamotrigine to take
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 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 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.
For children aged 2 to 12 years, the effective dose depends on their body weight usually, it is 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 are 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 many Lamotrigine tablets, contact a doctor or pharmacist
immediately. If possible, show them the Lamotrigine tablets packet.
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)
• loss of consciousness or coma.
If you forget to take Lamotrigine tablets
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 tablets, ask your doctor for
advice on how to start taking it again. It is important that you do this.
Do not stop taking Lamotrigine tablets without advice
Take Lamotrigine tablets for as long as your doctor recommends. Do not 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. 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 everyone gets
them.
If any of the following happen, tell your doctor immediately:
• skin rashes or redness
• 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.
These maybe symptoms of an allergic reaction or potentially serious skin
reaction. 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.
In many cases, these symptoms will be signs of less serious side effects. However,
you must be aware that they are potentially serious and may develop into more
serious problems, such as organ failure or a very severe skin condition, if they are
not treated. So, if you notice any of these symptoms see 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 tablets.
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, if your dose is
increased too quickly, or if you are taking Lamotrigine tablets with another medicine
called valproate. Children are more likely to be affected than adults.
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.
Immediately contact your doctor or go to the casualty department at your
nearest hospital if:
• you have thoughts of harming or killing yourself
If you are taking Lamotrigine tablets for epilepsy
The seizures in some types of epilepsy may occasionally become worse or
happen more often while you are 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 are taking Lamotrigine tablets, contact a doctor as soon
as possible.

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, with severe blisters, and bleeding from the lips, eyes, mouth,
nose and genital area (Stevens-Johnson syndrome).
Very rare side effects
These may affect up to 1 in 10,000 people:
• hallucinations (‘seeing’ or ‘hearing’ things that are not 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, starting with a painful red area, developing into large
blisters then peeling of layers of skin (toxic epidermal necrolysis)
• 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 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.
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 Consilient tablets
Keep 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.
Do not store above 30°C.
If you have any unwanted Lamotrigine tablets, do not dispose of them in your waste
water or your household rubbish. Take them back to your pharmacist, who will
dispose of them in a way that will not harm the environment.
6. Further information
What Lamotrigine tablets contain
• Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of the active ingredient
lamotrigine.
• The other ingredients are magnesium carbonate, microcrystalline cellulose,
povidone, lactose monohydrate, yellow iron oxide (E172) and magnesium
stearate.
What Lamotrigine tablets look like and the contents of the pack
• Lamotrigine tablets are pale yellow, round, flat faced, uncoated tablets marked
with either “25”, “50”, “100” or “200” on one side (depending on the strength).
• Lamotrigine tablets are supplied in blister packs of 10, 14, 20, 28, 30, 42, 50,
56, 98 and 100 tablets.
Marketing Authorisation Holder
Consilient Health Ltd,
5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland.
Manufacturer
McGregor Cory Limited,
Middleton Close, Banbury, Oxon, OX16 4RS
This leaflet was last revised: December 2013

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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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