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LAMOTRIGINE TEVA 50 MG TABLETS

Active substance(s): LAMOTRIGINE / LAMOTRIGINE / LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Lamotrigine Teva 25, 50, 100 and 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 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.

WHAT IS IN THIS LEAFLET:
1. What Lamotrigine Teva is and what it is used for
2. What you need to know before you take Lamotrigine Teva
3. How to take Lamotrigine Teva
4. Possible side effects
5. How to store Lamotrigine Teva
6. Contents of the pack and other information
1.

What Lamotrigine Teva 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 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.

What you need to know before you take Lamotrigine Teva

Do not take Lamotrigine Teva:

if you are allergic to lamotrigine 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

Warnings and precautions
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Talk to your doctor or pharmacist before taking 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: Rare 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 the dose or that Lamotrigine is not suitable for you
Important information about potentially life-threatening reactions
A small number of people taking Lamotrigine get an allergic reaction or potentially life threatening skin
reaction, which may develop into more serious problems if they are not treated. These can include Stevens–
Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS). 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 lifethreatening 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.

You may find it helpful to tell a family member, caregiver or close friend that you can
become depressed or have significant changes in mood, and ask them to read this leaflet. You
might ask them to tell you if they are worried about your depression or other changes in your
behaviour.
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.
Children and adolescents

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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.
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.
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 , olanzapine or aripiprazole, 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 any of these, or if you start or stop taking any.
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 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
Pregnancy
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.
• Pregnancy may alter the effectiveness of Lamotrigine, so you may need blood tests and your dose of
Lamotrigine may be adjusted.
• There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if
Lamotrigine is taken during the first 3 months of pregnancy.
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• Your doctor may advise you to take extra folic acid if you’re planning to become pregnant and while
you’re pregnant.

Breast-feeding


If you are breastfeeding or planning to breastfeed ask your doctor or pharmacist for advice
before taking this medicine. The active ingredient of Lamotrigine passes into breast milk and may
affect your baby. Your doctor will discuss the risks and benefits of breastfeeding 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 use machines unless you are sure you’re not affected.
If you have epilepsy, talk to your doctor about driving and using machines.
Lamotrigine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product..
Lamotrigine 100 mg tablet contains Yellow orange S (E110)
Lamotrigine 100 mg tablet contains colouring agent Yellow orange S (E110) which may cause allergic
reactions.

3.

How to take Lamotrigine Teva

Always use this medicine exactly as your doctor or pharmacist 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 maintenance dose of 200 mg
daily.

Lamotrigine is not recommended for children aged under 2 years.

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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 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. The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
• Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
.
If you take more Lamotrigine than you should

Contact a doctor or nearest hospital emergency department immediately. If possible, show
them the Lamotrigine packet.
If you take too much Lamotrigine you may be more likely to have serious side effects which may be
fatal.
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)
• heart rhythm changes (detected usually on ECG)
• loss of consciousness , fits (convulsions) or coma.
If you forget to take a single dose of Lamotrigine
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

In case you forget to take multiple doses 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 the 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Potentially life-threatening reactions: get a doctor’s help straight away

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A small number of people taking lamotrigine get 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 is 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
a sore mouth or red or swollen eyes (conjunctivitis)
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
increased levels of liver enzymes seen in blood tests
an increase in a type of white blood cell (eosinophils)
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 but 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:
 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. 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 (insomnia)
• feeling agitated
• diarrhoea
• dry mouth
• feeling sick (nausea) or being sick (vomiting)
• feeling tired
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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 movements (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 the 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, which will show up in blood tests, or liver failure: see also the
information at the beginning of Section 4
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, 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
hallucinations (‘seeing’ or ‘hearing’ things that aren’t really 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
in people who already have Parkinson’s disease, worsening of the symptoms
lupus-like reaction (symptoms may include: back or joint pain which sometimes may be
accompanied by fever and/or general ill health).

Other side effects
Other side effects have occurred in a small number of people but their exact frequency is unknown:
• 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.
• Nightmares.
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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 Teva
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 blisters or carton after EXP. The
expiry date refers to the last day of that month.
Lamotrigine 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 Teva Tablets contains:
• The active substance is lamotrigine . Each tablet contains 25, 50, 100 or 200 mg lamotrigine.
• The other ingredients are lactose monohydrate, cellulose microcrystalline, starch pregelatinised,
povidone K-30, silica colloidal anhydrous, sodium starch glycolate (Type A) and magnesium stearate. In
addition, the 100 mg tablets contain Yellow orange S (E110) and the 200 mg tablets contain indigo
carmine (E132).
What Lamotrigine Teva Tablets looks like and contents of the pack:
• Lamotrigine 25 mg Tablets are white to off white, diamond-shaped tablets, debossed with the number
“93” on one side and scored between the two numbers, debossed “39” on the other side of the tablet.
The tablets can be divided into equal halves.
• Lamotrigine 50 mg Tablets are white to off white, round-shaped tablets, debossed with the number “50”
on one side and debossed “LT” on the other side of the tablet
• Lamotrigine 100 mg Tablets are peach, diamond-shaped tablets, debossed with the number “93” on one
side and scored between the two numbers, debossed “463” on the other side of the tablet
• 200 mg: Lamotrigine 200 mg Tablets are blue, diamond-shaped tablets, debossed with the number “93”
on one side and scored between the two numbers, debossed “7248” on the other side of the tablet. The
tablets can be divided into equal halves.
• Lamotrigine 25 are available in pack sizes of 14, 21, 30, 42,50, 56, 60, 90 or 100 tablets. Calendar
packs: 21, 42 tablets
• Lamotrigine 50 mg Tablets are available in pack sizes of: 14, 21, 30, 42, 50, 56, 60, 90, 100 or 200
tablets.Calendar packs: 21, 42 tablets
• Lamotrigine 100 and 200 mg tablets are available in pack sizes of 21, 30, 42,50, 56, 60, 90 ,100 or 200
tablets. Calendar packs; 21, 42 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised in December 2016
PL 00289/0500 - 0503

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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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