Pharma code Ref. No. 2057

n

II

i    Lamictal”

to    2 mg, 5 mg. 25 mg and 100 mg

■a    lamotrigine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for

Keep this leaflet. You may need to read

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.

What is in this leaflet

1    What Lamictal Is and what It Is used for

2    What you need to know before you take Lamictal

3    How to take Lamictal

4    Possible side effects

5    How to store Lamictal

6    Contents of the pack and other information

1 What Lamictal is and what it is used for

2 What you need to know before you take Lamictal

3 How to take Lamictal

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name    Lamictal 2 mg

chewable/dispersible tablets Lamictal 5 mg

chewable/dispersible tablets Lamictal 25 mg chewable/dispersible tablets Lamictal 100 mg chewable/dispersible tablets Reference number    00003/0375

This is a service provided by the Royal National Institute of Blind People._

Lamictal belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder.

Lamictal treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits)

•    For adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines, to treat epilepsy. Lamictal 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, Lamictal 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.

Lamictal 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, Lamictal 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 Lamictal works in the brain to have this effect.

in

Do not take Lamictal:

•    if you are allergic (hypersensitive) 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 Lamictal.

Take special care with Lamictal

Talk to your doctor or pharmacist before taking Lamictal:

•    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: Other 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 Lamictal is not suitable for you.

Important information about potentially life-threatening

A small number of people taking Lamictal 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 Lamictal.

^ Read the description of these symptoms in Section 4 of this leaflet under 'Potentially life-threatening 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 Lamictal:

^ 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 Lamictal 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 Lamictal for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamictal. 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 Lamictal:

^ See a doctor as soon as possible.

Lamictal 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 Lamictal

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 Lamictal. 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 Lamictal or make it more likely that people will have side effects. These include:

•    valproate, used to treat epilepsy and mental health

•    carbamazepine, used to treat epilepsy and mental health

•    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 Lamictal 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 Lamictal. 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 wi th you.

Lamictal 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 Lamictal 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 Lamictal 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 Lamictal, so you may need blood tests and your dose of Lamictal may be adjusted.

^ If you are pregnant, 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.

^ 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 Lamictal passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while you're taking Lamictal and will check your baby from time to time if you decide to breast-feed.

Driving and using machines

Lamictal 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.

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 Lamictal to take

It may take a while to find the best dose of Lamictal for you. The dose you take will depend on:

•    your age

•    whether you are taking Lamictal 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 Lamictal than your doctor tells you to.

The usual effective dose of Lamictal for adults and children aged 13 years or over is between 100 mg and 400 mg each

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.

Lamictal is not recommended for children aged under

How to take your dose of Lamictal

Take your dose of Lamictal once or twice a day, as your doctor advises. It can be taken 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.

Lamictal chewable/dispersible tablets can either be swallowed whole with a little water, chewed or mixed with water to make a liquid medicine.

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4 Possible side effects

6 Contents of the pack and other information

lo chew the tablet:

some more water to make sure all the medicine has

rmake a liquid medicine:

Put the tablet in a glass with at least enough

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fully dissolved.

• Drink all the liquid.

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If you take more Lamictal than you should

1^ Contact a doctor or nearest hospital emergency department immediately. If possible, show them the Lamictal packet.

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Someone who has taken too much Lamictal may have ^ary ^{of these s}y^mp^toms:

• rapid, uncontrollable eye movements (nystagmus) n, affecting

Don't stop taking Lamictal without advice

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If you're taking Lamictal for epilepsy

To stop taking Lamictal, it is important that the dose

suddenly stop taking Lamictal, your epilepsy may come back or get worse.

If you're taking Lamictal for bipolar disorder

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taking Lamictal, your dose will not need to be reduced gradually but you should still talk to your doctor first, if you want to stop taking Lamictal.

Like all medicines, this medicine can cause side effects, but not everyone gets them. Potentially life-threatening reactions: get a doctor's help t away

•    cfisiitacE ”-""", ^affectin

•    heart rhythm changes (detected usually on ECG)

•    loss of consciousness, fits (convulsions) or coma.

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reaction, which may develop into more serious problems if they are not treated.

These symptoms are more likely to happen during the

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dose is increased too quickly or if Lamictal is taken with another medicine called valproate. Some of the

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life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly

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epidermal necrolysis) or extended rashes with liver,

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which is also known as hypersensitivity syndrome) ulcers in the mouth, throat, nose or genitals

a^chigrt?m^v?e^s)ature (fever), flu-like symptoms or drowsiness

swelling around your face or swollen glands in

your neck, armpit or groin

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•    a sore throat or more infections (such as colds)

•    fnaeasiad levels of liver enzymes seen in blood tests

•    an increase in a type of white blood cell (eosinophils)

•    enlarged lymph nodes

• l^nstf ^{organs of the body including}    T^heaei?e^ayh^eaet^n^pg^t

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

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^ 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 Lamictal. In

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doctor will tell you that you must never use lamotrigine again.

Very common side effects

These may affect more than 1 in 10 people:

•    headache

•    skin rash.

Common side effects

These may affect up to 1 in 10 people: aggression or irritability

_ffe_eee_ll_iin_ngg s_dl_ie_ze_zp_yy or drowsy

shaking or tremors

^fd^eia^er^lirⁿh^goe^aa^gitated dry mouth

feeling sick (nausea) or being sick (vomiting) feeling tired

pain in your back or joints, or elsewhere.

Uncommon side effects

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• double vision or blurred vision.

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a life-threatening skin reaction (Stevens-Johnson syndrome): (see also the information at the beginning of Section 4)

nauseas ^o0Omy;:n^pg^t,^oh^me^sa^,a^te^hes^rtl^lfⁿf^cn^uedkⁿ,^gnd^e;er,

extreme sensitivity to bright light. This may be caused by an inflammation of the membranes

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is stopped however if the symptoms continue or

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and crusty s_e(_yn_ey_lis_dta_sgmus)

Very rare side effects

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necrolysis): (see also the information at the beginning of Section 4)

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a high temperature (fever), (see also

(fever): (see also the beginning of Section 4)

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changes in liver function, which will show up in

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a serious disorder of blood clotting, which can cause unexpected bleeding or bruising

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tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood

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reduced numbers of all these types of cell (pancytopenia) and a disorder of the bone marrow called aplastic anaemia

sessions™' ^or '^hearing' ^{things that}

•    confusion

. feeling 'wobbly' or unsteady when you move about

head and torso (choreoathetosis) or other unusual body movements such as jerking, shaking or

•    h;pp:r^|n^wm^'fr^{ha;e epilepsy}, ^seizures

•    in people who already have Parkinson's disease, worsening of the symptoms.

•    osposntsnas, s= msay r* ^back

accompanied by fever and/or general ill health). 0^hre|^rde^sefeteha;es;c^surred in a sma.....ber of

of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term

^aoⁿst^te^i-o^ep^po^ilr^eo^ps^tiⁱs^co^mrt^ea^dk^ice^as^tt^ioerⁿo^,i^hd^as^{ve a history of} Nightmares.

g of side effects

el-a^Ssffsddfts not 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

5 How to store Lamictal

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this medicine out of the sight and reach of

What Lamictal chewable/    Marketing authorisation holder

dispersible tablets contain    and manufacturer

The active substance is lamotrigine. Each

25^e;g^aOo^lr^el^do0:g^si'"eo^tarbgene^{ontalns 2 mg}, ^{5 mg},

The other ingredients are: calcium carbonate, low

ir: The Wellcome

Foundation Ltd., Stockley Park West, Uxbridge, Middlesex UB11 1BT

s^aGuural5ZkG^laxo,^St^mot₃^hK2ⁱsoz^Pn^harp^aoceud^calsSA,

This leaflet was last revised in January 2015 Lamictal is a registered trade mark of the GSK group of companies

© 2015 GSK group of companies. All rights reserved

starch glycolate (Type A), povidone K30, saccharin sodium, magnesium stearate, blackcurrant flavour.

What Lamictal chewable/ dispersible tablets look like and

ca^n^ae ntew aofe /tlhfe rPrSc tablets (all strengths) are white to off-white and may be slightly mottled. They smell of blackcurrant. Not all listed pack sizes are marketed.

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Do not use this medicine after the expiry date shown on the blisters, carton or bottle. The expiry date refers to the last day of that month.

Lamictal does not require any special storage conditions.

Do not throw away any medicines via wastewater or

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protect the environment.

Lamictal 5 mg chewable/dispersible tablets are elongated with curved sides. They are marked

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with rounded corners. They are marked 'GSCL5' on one side, and '25' on the other. Each pack contains blisters of 10, 14, 21, 28, 30, 42, 50, 56 or 60 tablets.

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'GSCL7' on one side, and '100' on the other. Each pack contains blisters of 10, 14, 28, 30, 42, 50, 56, 60, 90,

98, 100, 196 or 200 tablets.