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LAMOTRIGINE TEVA 25MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 of the side effects talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

IN THIS LEAFLET:
1.
2.
3.
4.
5.
6.

What Lamotrigine is and what it is used for
What you need to know before you take Lamotrigine
How to take Lamotrigine
Possible side effects
How to store Lamotrigine
Contents of the pack and other 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 epilepsy.
Lamotrigine treats epilepsy by blocking the signals in the brain that
trigger epileptic seizures (fits).
Pharma code 484

• 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.

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LAMOTRIGINE

Important information about potentially life-threatening reactions
A small number of people taking Lamotrigine have experienced 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 life-threatening reactions: get a doctor’s help
straight away’.
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
Warnings and precautions
Talk to your doctor before taking Lamotrigine if you:
• have problems with your kidneys
• have ever developed a rash when you’ve taken lamotrigine or
other medicines for epilepsy
• 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.

tests on your liver, kidneys or blood, and may tell you to stop taking
Lamotrigine.
Thoughts of harming yourself or suicide
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 had thoughts of harming or killing themselves. If
at any time you have these thoughts, immediately contact your
doctor.
Risk of increased or severe seizures
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.
Other medicines and Lamotrigine

Top of page cut-off to middle of registration mark: 44 mm.

LAMOTRIGINE TEVA 5 mg, 25 mg
AND 100 mg 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.
Tell your doctor or pharmacist if you’re taking, have recently taken
or might take any of the following:• 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
If you start or stop taking certain medicines whilst you are taking
Lamotrigine, your doctor may need to check your dose of
Lamotrigine. These include:
• atazanavir in combination with ritonavir
• lopinavir in combination with ritonavir
Tell your doctor if you start or stop taking any of these.
Some medicines interact with Lamotrigine 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 phenobarbital, 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 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 plan to start using
a hormonal contraceptive, 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, breast-feeding and fertility
Watch out for important symptoms
• If you are pregnant, think you may be pregnant or are planning
If you develop a rash or these skin symptoms, stop taking
to have a baby, ask your doctor or pharmacist for advice before
Lamotrigine, seek urgent advice from a doctor and tell him that you
taking this medicine.
are taking this medicine:
You should not stop treatment for your epilepsy while you’re
pregnant. However, there is an increased risk of birth defects in
• Potentially life-threatening skin rashes (Stevens-Johnson
babies whose mothers took Lamotrigine during pregnancy.
syndrome, toxic epidermal necrolysis or DRESS) have been
These defects include cleft lip or cleft palate. Your doctor may
reported with the use of Lamotrigine, appearing initially as
advise you to take extra folic acid if you’re planning to become
reddish target-like spots or circular patches often with central
pregnant and while you’re pregnant.
blisters on the trunk. For more information on these reactions,
Pregnancy may also alter the effectiveness of Lamotrigine, so
• please read section 4 (Possible side effects).
your doctor may take samples of your blood to check the level of
• Additional signs to look for include ulcers in the mouth, throat,
Lamotrigine, and may adjust your dose.
nose, genitals and conjunctivitis (red and swollen eyes).
• Talk to your doctor if you’re breast feeding or planning to breast
• These potentially life-threatening skin rashes are often
feed. The active ingredient of Lamotrigine passes into breast
accompanied by flu-like symptoms and a rash on the face then
milk and may affect your baby. Your doctor will discuss the risks
an extended rash with a high temperature, increased levels of
and benefits of breast feeding while you’re taking Lamotrigine,
liver enzymes seen in blood tests and an increase in a type of
and will check your baby from time to time if you decide to
white blood cell (eosinophilia) and enlarged lymph nodes. The
breast feed.
rash may progress to widespread blistering or peeling of the
skin.
Driving and using machines
• The highest risk for occurrence of serious skin reactions is
• Lamotrigine can cause dizziness and double vision. Don’t drive
within the first weeks of treatment.
or operate machines unless you are sure you’re not affected.
• If you have developed Stevens-Johnson syndrome or toxic
• If you have epilepsy, talk to your doctor about driving and using
epidermal necrolysis or a drug reaction with eosinophilia and
machines.
systemic symptoms (DRESS) with the use of Lamotrigine, you
must not be re-started on Lamotrigine at any time.
HOW TO TAKE LAMOTRIGINE
• a high temperature (fever)
• drowsiness
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
These symptoms are more likely to happen during the first few
months of treatment with Lamotrigine, especially if you start on too How much Lamotrigine to take
high a dose or if your dose is increased too quickly, or if you’re
It may take a while to find the best dose of Lamotrigine for you. The
taking Lamotrigine with another medicine called valproate. Children dose you take will depend on:
are more likely to be affected than adults.
• your age
• whether you are taking Lamotrigine with other medicines
The symptoms listed above can develop into more serious
• whether you have problems with your kidneys or liver.
problems, such as organ failure or a very severe skin condition, if
they are not treated. If you notice any of these symptoms, see a
doctor as soon as possible. Your doctor may decide to carry out

3

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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 than your
doctor tells you to.







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.

The recommended effective dose of Lamotrigine for adults and
children aged over 12 years is between 100 mg and 400 mg each day. Common side effects
These may affect up to 1 in 10 people:
For children aged 2 to 12 years, the effective dose depends on their
• aggression or irritability
body weight – usually, it’s between 1 mg and 15 mg for each
• rapid, uncontrollable eye movements (nystagmus)
kilogram of the child’s weight, up to a maximum of 400 mg daily.
• shaking or tremors
Lamotrigine is not recommended for children aged under 2 years.
• difficulty in sleeping
• diarrhoea
How to take your dose of Lamotrigine Dispersible Tablets
• feeling tired
Take your dose of Lamotrigine once or twice a day, as your doctor
advises. You can take it with or without food.
Rare side effects
Your doctor may also advise you to start or stop taking other
These may affect up to 1 in 1,000 people:
medicines, depending on what condition you’re being treated for
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
and the way you respond to treatment.
Very rare side effects
• You can take Lamotrigine dispersible tablets by swallowing them
These may affect up to 1 in 10,000 people:
whole with a little water, by chewing them, or by dissolving them
• hallucinations (‘seeing’ or ‘hearing’ things that aren’t really
in water.
there)
• Always take the full dose that your doctor has prescribed.
• confusion or agitation
Never take only part of a tablet.
• feeling ‘wobbly’ or unsteady when you move about
If you chew the tablet:
• uncontrollable body movements (tics), uncontrollable muscle
You may need to drink a little water at the same time to help the
spasms affecting the eyes, head and torso (choreoathetosis), or
tablet dissolve in your mouth. Then drink some more water to make
other unusual body movements such as jerking, shaking or
sure you have swallowed all the medicine.
stiffness
• in people who already have epilepsy, seizures happening more
To make a liquid medicine:
often
Put the tablet in a glass with at least enough water to cover the
• changes in liver function, which will show up in blood tests, or
whole tablet.
liver failure
Either stir to dissolve, or wait for about a minute, until the tablet is
• changes which may show up in blood tests — including reduced
fully dissolved.
numbers of red blood cells (anaemia), reduced numbers of white
Drink all the liquid.
blood cells (leucopoenia, neutropenia, agranulocytosis),
Add a little more water to the glass and drink that, to make sure
reduced numbers of platelets (thrombocytopenia), reduced
you’ve taken all the medicine.
numbers of all these types of cell (pancytopenia), and a disorder
If you take more Lamotrigine than you should
of the bone marrow called aplastic anaemia
If anyone takes too much Lamotrigine, contact a doctor or
• in people who already have Parkinson’s disease, worsening of
pharmacist immediately. If possible, show them the Lamotrigine
the symptoms.
packet.
Frequency not known
Someone who has taken too much Lamotrigine may have any of
The frequency of these side effects cannot be estimated from the
these symptoms:
currently available data:
• rapid, uncontrollable eye movements (nystagmus)
• There have been reports of bone disorders including osteopenia
• clumsiness and lack of co-ordination, affecting their balance
and osteoporosis (thinning of the bone) and fractures. Check
(ataxia)
with your doctor or pharmacist if you are on long-term
• loss of consciousness or coma.
antiepileptic medication, have a history of osteoporosis, or take
If you forget to take Lamotrigine
steroids.
Don’t take extra tablets or a double dose to make up for a forgotten • swollen glands (lymphadenopathy)
dose. If you have missed taking a dose of this medicine, ask your
• aseptic meningitis
doctor for advice on how to start taking it again. It’s important that • DRESS
you do this.
Reporting of side effects:
Don’t stop taking Lamotrigine without advice
If you get any side effects, talk to your doctor or pharmacist . This
Take Lamotrigine for as long as your doctor recommends. Don’t
includes any possible side effects not listed in this leaflet. You can
stop unless your doctor advises you to.
also report side effects directly via the Yellow Card Scheme at:
To stop taking Lamotrigine, it is important that your dose is reduced www.mhra.gov.uk/yellowcard.
gradually, over about 2 weeks. If you suddenly stop taking
By reporting side effects you can help provide more information on
Lamotrigine, your epilepsy may come back or get worse.
the safety of this medicine

4

POSSIBLE SIDE EFFECTS

5

Like all medicines, this medicine can cause side effects, but not
everyone gets them.
Allergic reaction or potentially serious skin reaction: 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, and even life-threatening, problems if they are
not treated. 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 (DRESS).
• Ulcers in the mouth,throat, nose or genitals
• a sore mouth or 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 your 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.
Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) , or extended rashes with
liver, blood and other body organs involvement (DRESS) have been
reported (see section 2).
These are very serious but rare or very rare side effects. You may
need urgent medical attention or hospitalisation. In many cases,
your symptoms will be signs of less serious side effects. But you
must be aware that they are potentially serious – 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.
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.
Very common side effects
These may affect more than 1 in 10 people:
• headache
• feeling dizzy

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HOW TO STORE LAMOTRIGINE

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original blister pack to protect
from moisture.
Do not use this medicine after the expiry date which is stated on the
outer packaging. The expiry date refers to the last day of that
month.
Do not throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Lamotrigine Teva Dispersible Tablets contain:
• The active ingredient is lamotrigine.
• Other ingredients are mannitol, microcrystalline cellulose,
sodium starch glycolate, pregelatinised starch, croscarmellose
sodium, colloidal anhydrous silica, sodium stearyl fumarate,
saccharin sodium and artificial cherry flavour.
What Lamotrigine Teva Dispersible Tablets look like and contents
of the pack:
• The 5 mg tablets are white to off white, round tablets, number
“93” on one side and “688” on the other.
• The 25 mg tablets are white to off white, oval tablets, number
“93” on one side and “132” on the other.
• The 100 mg tablets are white to off white, round tablets, number
“100” on one side and “DLT” on the other.
• 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 30, 50, 56, 60 and
90.
• The 100 mg tablets are available in pack sizes of 28 30, 50, 56, 100
and 200.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: July 2015
PL 00289/0505-0506, PL00289/0508

84117-ZB
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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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