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Document: leaflet MAH BRAND_PL 00003-0273 change

• leaflet MAH BRAND_PL 00003-0273
• leaflet MAH BRAND_PLPI 08747-0307

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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

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.

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: 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 Lamictal is not suitable for you.

Important information about potentially life-threatening reactions

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.

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 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 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 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 with 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

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.

•    Pregnancy may alter the effectiveness of Lamictal, so you may need blood tests and your dose of Lamictal may be adjusted.

•    There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if Lamictal is taken during the first 3 months of pregnancy.

•    Your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.

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.

Important information about some of the ingredients of Lamictal

Lamictal tablets contain small amounts of a sugar called lactose. If you have an intolerance to lactose or any other sugars:

Tell your doctor and don't take Lamictal.

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5 How to store Lamictal

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: l» 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 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.

Lamictal is not recommended for children aged under 2 years.

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.

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.

•    Swallow your tablets whole. Don't break, chew or crush them.

•    Always take the full dose that your doctor has prescribed. Never take only part of a tablet.

If you take more Lamictal than you should

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

If you take too much Lamictal you may be more likely to have serious side effects which may be fatal.

Someone who has taken too much Lamictal 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 Lamictal

Don't take extra tablets to make up for a missed dose. Just take your next dose at the usual time.

In case you forget to take multiple doses of Lamictal Ask your doctor for advice on how to start taking it again. It's important that you do this.

Don't stop taking Lamictal without advice

Lamictal must be taken for as long as your doctor recommends. Don't stop unless your doctor advises you to.

If you're taking Lamictal for epilepsy

To stop taking Lamictal, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamictal, your epilepsy may come back or get worse.

If you're taking Lamictal for bipolar disorder

Lamictal may take some time to work, so you are unlikely to feel better straight away.

If you stop 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.

4 Possible side effects

Like all medicines, this medicine can cause side effects, but not everyone gets them.

Potentially life-threatening reactions: get a doctor's help straight away

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 symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if the starting dose is too high or if the dose is increased too quickly or if Lamictal 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 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 Lamictal. 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

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

•    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

These 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

These may affect up to 1 in 1,000 people:

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

•    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)

•    itchy eyes, with discharge and crusty eyelids (conjunctivitis).

Very rare side effects

These may affect up to 1 in 10,000 people:

•    a life-threatening skin reaction (toxic epidermal necrolysis): see also the information at the beginning of Section 4

•    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): (see also the information at the beginning of Section 4)

•    a high temperature (fever): (see also the information at the beginning of Section 4)

•    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 anti-epileptic medication, have a history of osteoporosis or take steroids

•    Nightmares.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the blisters or carton. 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 household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6 Contents of the pack and other information

What Lamictal tablets contain

The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (Type A), iron oxide yellow (E172) and magnesium stearate.

What Lamictal tablets look like and contents of the pack

Lamictal tablets (all strengths) are square with rounded corners and pale, yellowish brown in colour. Not all listed pack sizes may be marketed. Lamictal 25 mg tablets are marked 'GSEC7' on one side and '25' on the other. Each pack contains blisters of 14, 21, 28, 30, 42, 50, 56 or 100 tablets. Lamictal 50 mg tablets are marked 'GSEE1' on one side and '50' on the other. Each pack contains blisters of 14, 28, 30, 42, 56, 90, 98 or 100 tablets.

Lamictal 100 mg tablets are marked 'GSEE5' on one side and '100' on the other. Each pack contains blisters of 28, 30, 42, 50, 56, 60, 90, 98 or 100 tablets. Lamictal 200 mg tablets are marked 'GSEE7' on one side and '200' on the other. Each pack contains blisters of 28, 30, 42, 56 or 100 tablets.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder:

The Wellcome Foundation Ltd., Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufacturer: GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189, 60-322 Poznan, Poland This leaflet was last revised in March 2016 Lamictal is a registered trade mark of the GSK group of companies

© 2016 GSK group of companies. All rights reserved

GlaxoSmithKline

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