LAMOTRIGINE TEVA 200MG DISPERSIBLE TABLETS

Active substance: LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lamotrigine Teva 2, 5, 25, 50, 100 and 200 mg Tablets

Read all of this leaflet carefully before you start using this medicine.
• 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. 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 this leaflet, please tell
your doctor or pharmacist.

IN THIS LEAFLET:
1. What Lamotrigine is and what it is used for
2. Before you take Lamotrigine
3. How to take Lamotrigine
4. Possible side effects
5. How to store Lamotrigine
6. Further information

1.

What Lamotrigine is and what it is used for

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat two conditions epilepsy
and bipolar disorder.
Lamotrigine treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits).
• For adults and children aged 13 years and over, Lamotrigine can be used on its own or with other
medicines, to treat epilepsy. Lamotrigine 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 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 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 dispair). 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

Do not take Lamotrigine:
• if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamotrigine
(listed in Section 6).
If this applies to you:
Tell your doctor, and don’t take Lamotrigine.

Take special care with lamotrigine:
Your doctor needs to know before you take 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: Other 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 your dose or that Lamotrigine, is not suitable for you.
Important information about potentially serious reactions
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.
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:
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 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 for epilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re
taking Lamotrigine. 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:
See a doctor as soon as possible.
Lamotrigine 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’re taking any other medicines, have taken any recently, or if you
start taking new ones — these include herbal medicines or other medicines you bought without a
prescription.

Your doctor needs 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 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, or if you start or stop taking, any of these.
Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine 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. 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 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’s 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, 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, and will check your baby from time to
time if you decide to breast feed.
Driving and using machines:
Lamotrigine 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.

3.

How to take Lamotrigine

Always take Lamotrigine exactly as your doctor has told you. 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 for you. The dose you take will depend on:
• your age
• whether you are taking Lamotrigine 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 than your doctor
tells you to.
The usual effective dose of Lamotrigine 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
Take your dose of Lamotrigine once or twice a day, as your doctor advises. It can be taken it with or without
food.
Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
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.
Lamotrigine dispersible/chewable tablets can be swallowed whole with a little water, chewed, or mixed with
water to make a liquid medicine.
If you chew the tablet:
You may need to drink a little water at the same time to help the tablet dissolve in your mouth. Then drink
some more water to make sure you have swallowed all the medicine.
To make a liquid medicine:
Put the tablet in a glass with at least enough water to cover the whole tablet.
Either stir to dissolve, or wait until the tablet is fully dissolved.
Drink all the liquid.
Add a little more water to the glass and drink that, to make sure no medicine is left in the glass.
If you take more Lamotrigine than you should
Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine 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
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:
Ask your doctor for advice on how to start taking it again. It’s important that you do this.
Don’t stop taking Lamotrigine without advice
Lamotrigine must be taken for as long as your doctor recommends. Don’t stop unless your doctor advises
you to.
If you are taking Lamotrigine for epilepsy
To stop taking Lamotrigine, it is important that your dose is reduced gradually, over about 2 weeks. If
you suddenly stop taking Lamotrigine, your epilepsy may come back or get worse.
If you are 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 can cause side effects, but not everyone gets them.
Potentially serious reactions: get a doctor’s help straight away
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.
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 severe skin reactions including widespread rash with
blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (StevensJohnson 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 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.
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 severe skin reaction (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, 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.
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.
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). These symptoms usually disappear once treatment is stopped however 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

Keep Lamotrigine out of the sight and reach of children.
Do not use Lamotrigine after the expiry date which is stated on the blisters, carton or bottle. The expiry date
refers to the last day of that month.
Do not store above 30oC. Store in the original blister pack to protect from moisture.
If you have any unwanted Lamotrigine tablets, don’t 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 won’t harm the
environment.

6. Further information
What Lamotrigine Teva Tablets contains:
• The active ingredient is lamotrigine 2, 5, 25, 50, 100 or 200 mg
• The other ingredients are mannitol (E421), cellulose microcrystalline, sodium starch glycolate (Type A),
maize starch pregelatinised, croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate,
saccharin sodium, artificial cherry flavour (constituents including modified food starch (E1450).
What Lamotrigine Teva Tablets looks like and contents of the pack:
• Lamotrigine 2 mg Dispersible Tablets are white to off-white round tablets debossed with the number “2”
on one side and “DLT” on the other
• Lamotrigine 5 mg Dispersible Tablets are white to off white, round tablets, debossed with the number
“93” on one side and “688” on the other
• Lamotrigine 25 mg Dispersible Tablets are white to off white, oval shaped tablets, debossed with the
number “93” on one side and “132” on the other
• Lamotrigine 50 mg Dispersible Tablets are white to off white, round tablets, debossed with the number
“50” on one side and “DLT” on the other
• Lamotrigine 100 mg Dispersible Tablets are white to off white, round tablets, debossed with the number
“100” on one side and “DLT” on the other
• Lamotrigine 200 mg Dispersible Tablets are white to off white, round tablets, debossed with the number
“200” on one side and “DLT” on the other
• The 2 mg tablets are available in pack sizes of 28 and 30
• The 5 mg tablets are available in pack sizes of 28, 30, 50, 56, 60 and 90
• The 25 mg tablets are available in pack sizes of 21, 28, 30, 42, 50, 56, 60 and 90
• The 50 mg tablets are available in pack sizes of 28, 30, 42, 50, 56, 60, 90, 100 and 200
• The 100 and 200 mg tablets are available in pack sizes of 28, 30, 50, 56, 60, 90, 100 and 200
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited,
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex,BN22 9AG.

This leaflet was last revised in 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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