LAMOTRIGINE DISPERSIBLE 100 MG TABLETS

Active substance: LAMOTRIGINE

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1438 737 629 • email: geoff.corrin@arrowgenerics.com
Lamotrigine 2 mg, 5 mg, 25 mg, 50 mg, 100 mg and 200 mg
Dispersible Tablets
(Lamotrigine)
-

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your 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 Dispersible Tablets are and what they are used for
2. 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. Further information

1. WHAT LAMOTRIGINE DISPERSIBLE TABLETS ARE AND WHAT THEY ARE 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 treat 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 their own or with other medicines, to treat epilepsy. Lamotrigine Dispersible
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 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 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 Dispersible 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 Dispersible Tablets work in the brain to have
this effect.

2. BEFORE YOU TAKE LAMOTRIGINE DISPERSIBLE TABLETS
Do not take Lamotrigine Dispersible Tablets
• If you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of
Lamotrigine Dispersible Tablets (listed in section 6)
If this applies to you:

Tell your doctor, and don’t take Lamotrigine Dispersible Tablets.
Take special care with Lamotrigine Dispersible Tablets
Your doctor needs to know before you take Lamotrigine Dispersible Tablets:
• if you have problems with your kidneys
• if you have ever developed a rash when you’ve 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 Dispersible
Tablets are not suitable for you.
Watch out for important symptoms
If you develop any of these symptoms after you start taking Lamotrigine Dispersible Tablets, get
a doctor’s help straight away:
• an unusual skin reaction, such as redness or rashes (see “Potentially life-threatening
skin rashes” below)
• 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 symptoms are more likely to happen during the first few months of treatment with
Lamotrigine Dispersible Tablets, especially if you start on too high a dose or if your dose is
increased too quickly, or if you’re taking Lamotrigine Dispersible Tablets with another medicine
called valproate. Children are more likely to be affected than adults.
The symptoms listed above can develop into more serious 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 tests on your
liver, kidneys or blood, and may tell you to stop taking Lamotrigine Dispersible Tablets.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of lamotrigine, appearing initially as reddish targetlike spots or circular patches often with central blisters on the trunk.
• Additional signs to look for include ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes).
• These potentially life-threatening skin rashes are often accompanied by flu-like
symptoms. The rash may progress to widespread blistering or peeling of the skin.
• The highest risk for occurrence of serious skin reactions is within the first weeks of
treatment.
• If you have developed Stevens-Johnson syndrome or toxic epidermal necrosis with the
use of lamotrigine, you must not be re-started on lamotrigine at any time.
• If you develop a rash or these skin symptoms, seek immediate advice from a doctor and
tell him that you are taking this medicine.

Thoughts of harming yourself or suicide
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 Dispersible 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 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 are taking Lamotrigine Dispersible Tablets:

See a doctor as soon as possible.
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.
Taking other medicines
Tell your doctor or pharmacist if you’re taking any other medicines, if you’ve 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
Dispersible 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 Dispersible Tablets 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 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 or a combination of atazanavir 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 Dispersible
Tablets 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 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

Talk to your doctor if you’re pregnant, if you might be pregnant, or if you’re planning
to become pregnant.
You should not stop treatment for your epilepsy while you’re pregnant. However, there is 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 Dispersible 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’re breast feeding or planning to breast feed. 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 are 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 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 DISPERSIBLE TABLETS
Always use Lamotrigine Dispersible Tablets exactly as your doctor has told you to. Check
with your doctor or pharmacist if you’re 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 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
Dispersible Tablets than your doctor tells you to.
The usual effective dose of Lamotrigine Dispersible 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 Dispersible Tablets
Take your dose of Lamotrigine Dispersible Tablets once or twice a day, as your doctor advises.
You can take 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.
You can take Lamotrigine Dispersible Tablets by swallowing them whole with a little water, by
chewing them, or by dissolving them in water:
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 for about a minute, until the tablet is fully dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink that, to make sure you’ve taken all the
medicine.
If you take more Lamotrigine Dispersible Tablets than you should
If anyone takes too much Lamotrigine Dispersible Tablets

Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine
Dispersible Tablets packet.
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)
• loss of consciousness or coma.
If you forget to take Lamotrigine Dispersible Tablets
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 Dispersible Tablets

Ask your doctor for advice on how to start taking it again. It is important that you do
this.
Don’t stop taking Lamotrigine Dispersible Tablets without advice
Take Lamotrigine Dispersible Tablets 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 your 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Lamotrigine Dispersible Tablets can have side effects, but not everybody gets
them.
Allergic reaction or potentially serious skin reaction: get a doctor’s help straight away
A small number of people taking Lamotrigine Dispersible 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. Symptoms of these reactions include:
• 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.
In many cases, these 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 Dispersible Tablets.
Very common side effects: affects more than 1 user in 10:
• 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: affects 1 to 10 users in 100:
• 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: affects 1 to 10 users in 10,000
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
Very rare side effects: affects less than 1 user in 10,000
• 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
potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis): see also section 2 and 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 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.

Other side effects (Not known: frequency cannot be estimated from the available data)
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).
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.
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 DISPERSIBLE TABLETS
Keep Lamotrigine Dispersible Tablets out of the sight and reach of children.
Do not use Lamotrigine Dispersible Tablets after the expiry date (EXP) shown on the blisters or
carton. The expiry date refers to the last day of that month.
Lamotrigine 2 mg and 5 mg Dispersible Tablets should be stored below 25ºC.
Lamotrigine 25 mg, 50 mg, 100 mg and 200 mg Dispersible Tablets do not require any special
storage conditions.
If you have any unwanted Lamotrigine Dispersible 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 Dispersible Tablets contain

• The active substance is lamotrigine
Each dispersible tablet will contain either 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg of
lamotrigine.
• The other ingredients are microcrystalline cellulose, silica colloidal anhydrous, mannitol (E421),
croscarmellose sodium, saccharin sodium, talc, povidone K30, magnesium stearate and
blackcurrant flavour containing maltodextrin, gum arabic (E414), benzyl alcohol, triacetin and
maltol.
What Lamotrigine Dispersible Tablets look like and contents of the pack
Lamotrigine 2 mg Dispersible Tablets: The tablets are round, white to off-white in colour, marked
‘LI’ over ‘2’ on one side and ‘>’ on the other side. They are available in packs of blisters
containing 30 and 50 dispersible tablets.
Lamotrigine 5 mg Dispersible Tablets: The tablets are oval, white to off-white in colour, marked
‘LI’ scoreline ‘5’ on one side and ‘>’ on the other side. They are available in packs of blisters
containing 14, 28, 30, 50, 56, 90 and 100 dispersible tablets.
Lamotrigine 25 mg Dispersible Tablets: The tablets are shield-shaped, white to off-white in colour,
marked ‘>’ over ‘LI25’ on one side and with a scoreline on the other side. They are available in
packs of blisters containing 21, 28, 30, 42, 50, 56, 90 and 100 dispersible tablets.
Lamotrigine 50 mg Dispersible Tablets: The tablets are shield-shaped, white to off-white in colour,
marked ‘>’ over ‘LI50’ on one side and with a scoreline on the other side. They are available in
packs of blisters containing 30, 42, 50, 56, 90, 100 and 200 dispersible tablets.
Lamotrigine 100 mg Dispersible Tablets: The tablets are shield-shaped, white to off-white in
colour, marked ‘>’ over ‘LI100’ on one side and with a scoreline on the other side. They are
available in packs of blisters containing 28, 50, 56, 90, 98, 100 and 200 dispersible tablets.
Lamotrigine 200 mg Dispersible Tablets: The tablets are shield-shaped, white to off-white tablet,
marked ‘>’ over ‘LI200’ on one side and a scoreline on the other side. They are available in packs
of blisters containing 30, 50, 56, 90, 98, 100 and 200 dispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder*:
Arrow Lakemedel AB, Nybrogatan 59, S-11440 Stockholm, Sweden
or
Juta Pharma GmbH, Gutenberstrasse 13, 24941, Flensburg, Germany
or
Arrow Generics Limited, Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom
Manufacturer*:
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ
or
Qualiti (Burnley) Limited, Talbot Street, Briercliffe, Burnley, BB10 2JY, UK
or
Arrow Generics Limited, Unit 4/5 Willborough Cluster, Clonshaugh Industrial Estate, Clonshaugh,
Dublin 17, Republic of Ireland
or
Juta Pharma GmbH, Gutenbergstrasse 13, 24941, Flensburg, Germany
or
Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta
This leaflet was last approved in:
* Note that final leaflet will only specify marketing authorisation holder and manufacturer(s)
responsible for batch release in territory where product is being marketed.

This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium: Lamotrigine Arrow Generics 2/5/25/50/100/200mg Dispers, dispergeerbare tabletten
Czech Republic: Rubimar 25/50/100mg tbl dis
Germany: Lamo-Q 25/50/100/200mg Tabletten zur Herstellung einer Suspension zum
Einnehmen
Ireland: Lamotrigine 2/5/25/50/100/200mg Dispersible Tablets
Italy: Lamotrigina Arrow 5/25/50/100/200mg compresse dispersibili
United Kingdom: Lamotrigine 2/5/25/50/100/200mg Dispersible Tablets

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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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