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LAMOTRIGINE AMNEAL 100 MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Lamotrigine Amneal 100 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 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 Amneal is and what it is used for
2. Before you take Lamotrigine Amneal
3. How to take Lamotrigine Amneal
4. Possible side effects
5. How to store Lamotrigine Amneal dispersible tablets
6. Further information
1. WHAT LAMOTRIGINE AMNEAL 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 Amneal treats epilepsy by blocking the signals in the brain that trigger epileptic
seizures (fits).
• For adults and children aged 13 years and over, Lamotrigine Amneal can be used on its own
or with other medicines, to treat epilepsy. Lamotrigine Amneal 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 Amneal 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 Amneal 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 Amneal 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 Amneal works in the brain to have this effect.

2. BEFORE YOU TAKE LAMOTRIGINE AMNEAL
DO NOT take Lamotrigine Amneal dispersible tablets
• if you are allergic (hypersensitive) to Lamotrigine Amneal or any of the other ingredients of
Lamotrigine Amneal dispersible tablets (listed in section 6).
If this applies to you:
ÆÆ Tell your doctor, and don’t take Lamotrigine Amneal dispersible tablets.
Take special care with Lamotrigine Amneal
Important information about potentially serious reactions:
A small number of people taking Lamotrigine Amneal 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 Amneal 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 target-like 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 necrolysis 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.
ÆÆ See also section 4 of this leaflet under ‘Potentially serious reactions: get a doctor’s help
straight away’.
Your doctor needs to know before you take Lamotrigine Amneal:
• 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 are already taking medicine that contains lamotrigine.
If any of these applies to you:
ÆÆ Tell your doctor, who may decide to lower the dose, or that Lamotrigine Amneal dispersible
tablets are not suitable for you.
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 Amneal:
ÆÆ 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 any time you have these thoughts, immediately contact your doctor.
If you’re taking Lamotrigine Amneal for epilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often while
you’re taking Lamotrigine Amneal. 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 Amneal:
ÆÆ See a doctor as soon as possible.
Lamotrigine Amneal 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 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 Amneal. 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
ÆÆ Tell your doctor if you are taking any of these.
Some medicines interact with Lamotrigine Amneal 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).
ÆÆ 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 Amneal 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 Amneal. If
you are using a hormonal contraceptive, or if you plan to start using one:
ÆÆ Talk to your doctor, who will discuss suitable methods of contraception with you.
Lamotrigine Amneal 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:
ÆÆ Tell your doctor. These may be signs that Lamotrigine Amneal is affecting the way your
contraceptive is working.
Pregnancy and breast-feeding
There may be an increased risk of birth defects in babies whose mothers took Lamotrigine Amneal
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 Amneal, so you may need blood tests and
your dose of Lamotrigine Amneal may be adjusted.
ÆÆ 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 without discussing this with your
doctor. This is particularly important if you have epilepsy.
ÆÆ Talk to your doctor if you’re breast feeding or planning to breast-feed. The active
ingredient 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 Amneal, and will check
your baby from time to time if you decide to breast-feed.

Driving and using machines
Lamotrigine Amneal can cause dizziness and double vision.
ÆÆ 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 AMNEAL
Always take Lamotrigine Amneal exactly as your doctor has told you to. Check with your
doctor or pharmacist if you’re not sure.
How much Lamotrigine Amneal to take
It may take a while to find the best dose of Lamotrigine Amneal for you. The dose you take will depend
on:
• your age
• whether you are taking Lamotrigine Amneal 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
Amneal than your doctor tells you to.
The usual effective dose of Lamotrigine Amneal 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 Amneal is not recommended for children aged under 2 years.

• dry mouth
• feeling tired
• pain in your back or joints, or elsewhere.

How to take your dose of Lamotrigine Amneal
Take your dose of Lamotrigine Amneal once or twice a day, as your doctor advises. It can be taken
with or without food.

Rare side effects
These may affect up to 1 in 1,000 people:
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
• Potentially life-threatening skin rashes (Stevens–Johnson syndrome) have been reported (see
section 2 and at the beginning of section 4).

• 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 Amneal dispersible tablets can either 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 the 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 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 no medicine is left in the glass.
If you take more Lamotrigine Amneal than you should
ÆÆ Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine
Amneal packet.
Someone who has taken too much Lamotrigine Amneal 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 Amneal
Don’t take extra tablets or a double dose to make up for a forgotten dose.
ÆÆ Ask your doctor for advice on how to start taking it again. It’s important that you do this.
Don’t stop taking Lamotrigine Amneal without advice
Lamotrigine Amneal must be taken for as long as your doctor recommends. Don’t stop unless your
doctor advises you to.
If you are taking Lamotrigine Amneal for epilepsy
To stop taking Lamotrigine Amneal, 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 Amneal for bipolar disorder
Lamotrigine Amneal may take some time to work, so you are unlikely to feel better straight away. If
you stop taking Lamotrigine Amneal, 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 Amneal.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lamotrigine Amneal 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 Amneal 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
Amneal, especially if the starting dose is too high or if the dose increased too quickly, or if Lamotrigine
Amneal 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 (Stevens-Johnson 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 the 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:
ÆÆ 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 Amneal.

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

Very rare side effects
These may affect up to 1 in 10,000 people:
• Potentially life-threatening skin rashes (toxic epidermal necrolysis) have been reported (see
section 2 and at the beginning of section 4).
• 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
• 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 (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
• 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.
Possible risk of bone disorders
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).
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 AMNEAL DISPERSIBLE TABLETS

Keep out of the reach and sight of children.
Do not use Lamotrigine Amneal dispersible tablets after the expiry date, which is stated on the carton
after the EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION

What Lamotrigine Amneal dispersible tablets contain
–– The active substance is lamotrigine. Each dispersible tablet contains 100 mg lamotrigine.
–– The other ingredients are cellulose microcrystalline, magnesium carbonate heavy, polacrilin
potassium, sucralose, povidone (K-30), magnesium stearate, black currant flavor (maltodextrin,
artificial flavors, triacetin, acetic acid & caramel color).
What Lamotrigine Amneal dispersible tablets looks like and contents of the pack
Dispersible tablet.
Lamotrigine Amneal 100 mg dispersible tablets
White to off-white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side
and ‘78’ on flat side.
Lamotrigine Amneal dispersible tablets are available in:
–– PVC/Aclar/Al blister:
Pack sizes: 7, 10, 14, 20, 21, 28, 30, 40, 42, 50, 56, 60, 90, 98, 100, 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 07/2014.

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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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