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LAMOTRIGINE TEVA 200MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE / LAMOTRIGINE / LAMOTRIGINE

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Package leaflet: Information for the patient
Lamotrigine Teva 2, 5, 25, 50, 100 and 200 mg dispersible Tablets

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 dispersible tablets is and what it is used for
2. What you need to know before you take Lamotrigine dispersible tablets
3. How to take Lamotrigine dispersible tablets
4. Possible side effects
5. How to store Lamotrigine dispersible tablets
6. Contents of the pack and other information

1.

What Lamotrigine dispersible tablets is and what it is used for

Lamotrigine dispersible tablets belongs to a group of medicines called anti-epileptics. It is used to treat two
conditions epilepsy and bipolar disorder.
Lamotrigine dispersible tablets treats epilepsy by blocking the signals in the brain that trigger epileptic
seizures (fits).
 For adults and children aged 13 years and over, Lamotrigine dispersible tablets 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 dispersible 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 dispersible tablets 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 dispersible tablets 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 dispersible tablets work in the brain to have this effect.
2.

What you need to know before you take Lamotrigine dispersible tablets

Do not take Lamotrigine dispersible tablets:
 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 dispersible tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lamotrigine dispersible tablets
 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 dispersible tablets, is not
suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking Lamotrigine dispersible tablets get an allergic reaction or potentially lifethreatening 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 dispersible tablets.

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 dispersible tablets:

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 dispersible 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 dispersible tablets for epilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re
taking Lamotrigine dispersible 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 dispersible tablets:

See a doctor as soon as possible.
Children and adolescents
Lamotrigine dispersible 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.

Other medicines and Lamotrigine dispersible tablets
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 dispersible tablets. These medicines include:
 oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide,
used to treat epilepsy
 lithium , olanzapineor 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 dispersible tablets 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 dispersible 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 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 dispersible 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 dispersible tablets 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 dispersible tablets, so you may need
blood tests and your dose of Lamotrigine dispersible tablets may be adjusted.
There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if
Lamotrigine dispersible tablets is taken during the first 3 months pregnancy.
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 breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice
before taking this medicine. The active ingredient of Lamotrigine dispersible tablets 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 dispersible tablets, and will check your baby from time to time if you
decide to breast feed.

Driving and using machines:
Lamotrigine dispersible tablets 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.
3.

How to take Lamotrigine dispersible tablets

Always take 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 dispersible tablets to take
It may take a while to find the best dose of Lamotrigine dispersible tablets for you. The dose you take will
depend on:
 your age
 whether you are taking Lamotrigine dispersible tablets 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 dispersible
tablets than your doctor tells you to.
The usual effective dose of Lamotrigine dispersible tablets 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 dispersible tablets is not recommended for children aged under 2 years.
How to take your dose of Lamotrigine dispersible tablets
Take your dose of Lamotrigine dispersible tablets 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 tablets can be swallowed whole with a little water, chewed, or mixed with water to
make a liquid medicine.
To 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 all the medicine has been swallowed.

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 dispersible tablets than you should

Contact a doctor or nearest hospital emergency department immediately. If possible, show them
the Lamotrigine dispersible tablets packet.

If you take too much Lamotrigine dispersible tablets you may be more likely to have serious
side effects which may be fatal.
Someone who has taken too much Lamotrigine dispersible 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 a single dose of Lamotrigine dispersible tablets
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 dispersible 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 dispersible tablets without advice
Lamotrigine dispersible tablets must be taken for as long as your doctor recommends. Don’t stop unless
your doctor advises you to.
If you are taking Lamotrigine dispersible tablets for epilepsy
To stop taking Lamotrigine dispersible tablets, it is important that the dose is reduced gradually, over
about 2 weeks. If you suddenly stop taking Lamotrigine dispersible tablets, your epilepsy may come back or
get worse.
If you are taking Lamotrigine dispersible tablets for bipolar disorder
Lamotrigine dispersible tablets may take some time to work, so you are unlikely to feel better straight away.
If you stop taking Lamotrigine dispersible 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 dispersible tablets.
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 everyone gets them.

Potentially life-threatening reactions: get a doctor’s help straight away
A small number of people taking Lamotrigine dispersible tablets get an allergic reaction or potentially lifethreatening 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
dispersible tablets, especially if the starting dose is too high or if the dose is increased too quickly, or if
Lamotrigine dispersible tablets 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 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 dispersible 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 (insomnia)
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 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)

Very rare side effects: may affect up to 1 in 10,000 people:
 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, 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
 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
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 dispersible tablets

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.
Do not store above 30oC. Store in the original blister pack to protect from moisture.
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 dispersible tablets contain:
 The active substance is lamotrigine Each tablet contains 2, 5, 25, 50, 100 or 200 mg lamotrigine
 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 dispersible tablets look 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 09/ 2016.

Expand Transcript

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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