Package leaflet: Information for the user

Lamotrigine 25, 50, 100 and 200 mg Tablets

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 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 Lamotrigine is and what it is used for

2.    What you need to know before you take Lamotrigine

3.    How to take Lamotrigine

4.    Poss ible side effects

5.    How to store Lamotrigine

6.    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 two conditions epilepsy and bipolar disorder.

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

•    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.

Lamotrigine 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 dispair). For adults aged 18 y ears and ove r, Lamotrigine can be us ed on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not y et known how Lamotrigine works in the brain to have this effect.

2. What you need to know before you take Lamotrigine Do not take Lamotrigine:

• if you are allergic 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 lamotrigine

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Warnings and precautions

Talk to your doctor or pharmacist before taking lamotrigine:

•    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 lamotrigine is not suitable for you Important information about potentially life-threatening reactions

A small number of people taking Lamotrigine get an allergic reaction or potentially life-threatening skin reaction, which may develop into more seriou s problems if they are not treated. These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and sy stemic sy mptoms (DRESS). You need to kn ow the sy mptoms 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 ’.

Thoughts of harming yourself or suicide

Anti-epileptic medicines are use d to trea t se veral c onditions, including epilepsy and bipolar disorder. People with bipolar disorder ca n sometimes hav e th oughts of harm ing them selves 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:

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 a lso had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

If you’re taking Lamotrigine for epilepsy

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 sev ere seizure while you’re taking lamotrigine:

See a doctor as soon as possible.

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Children and adolescents

Lamotrigine 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 lamotrigine

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 y ou are taking other medicines to treat epilepsy or mental health problems. This is to make sure you take the correct dose of Lamotrigine. These medicines include:

•    oxcarbazepine, felbamate , gabapentin, levetiracetam, pr egabalin, 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 inte ract with lamotrigine or make it more like ly 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 lamotrigine works

Your doctor may recommend that y ou use a p articular type of horm onal contraceptive or another method of contraception, such as cond oms, a cap o r a coil. If y ou are using a hormonal contraceptive like the Pill , y our doctor may take samples of y our blood to c heck the level of lamotrigine. 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.

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 and breast-feeding Pregnancy

There may be 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, so y ou may need blood tests and y our dose of lamotrigine may be adjusted.

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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.

Breast-feading

If you are breast-feeding or pl anning to b reast-feed ask your doctor or pharmacist for advice before taking this medicine. The active ingredient of lamotrigine passes into breast milk and m ay affect your baby. Your doctor will discuss the risks and benefits of bre ast-feeding while y ou’re taking lamotrigine, and wil l check y our baby from time to time if y ou decide to breast-feed.

Driving and using machines:

Lamotrigine 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.

Lamotrigine contains lactose

Lamotrigine tablets contain small a mounts of a sugar called lactose. If you have intoleran ce to lactose or any other sugars:

Tell your doctor, and don’t take lamotrigine.

Lamotrigine 100 mg tablet contains Yellow orange S (E110)

Lamotrigine 100 mg tablet contains colouring agent Yellow orange S (E110) w hich may cause allergic reactions.

3. How to take Lamotrigine

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 Lamotrigine to take

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

•    your age

•    whether you are taking Lamotrigine with other medicines

•    whether you have any kidney or liver problems.

Your doctor will prescrib e 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 than your doctor tells you to.

Use in children and adolescents

The usual effective dose of lamotrigine for a dults and chil dren aged 13 years or over is between 100 mg and 400 mg each day.

Lamotrigine is not recommended for children aged under 2 years.

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For children aged 2 to 12 years, the effective dos e depends on their body weight — usu ally, it’s between 1 mg and 15 mg for each kilo gram of the child’s weight, up to a maximum maintenance dose of 200 mg daily.

How to take your dose of Lamotrigine

Take your dose of lamotrigine once or twice a day, as y our doctor advises. It can be taken with or without food.

Your doctor may also advise you to start or st op taking other m edicines, 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 Lamotrigine than you should

Contact a doc tor or nearest hospital eme rgency dep artment imme diately. If possible, show them the lamotrigine packet.

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

Someone who has taken too much lamotrigine 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 Lamotrigine

Do not take a d ouble dose to make up for a forgotten dose . Just take your next dose at the usual time.

If you stop taking Lamotrigine

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

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

If you are taking Lamotrigine for epilepsy

To stop ta king la motrigine, 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 for bipolar disorder

Lamotrigine may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine, 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

A small number of people taking lamotrigine get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated.

These sy mptoms are m ore likely to happen dur ing the first few months of trea tment wi th Lamotrigine, especially is the starting dose is too high or if the dose is increased too quickly, or if Lamotrigine is taken with another medicine ca lled 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 occ urring ar ound the mouth, nose, ey es 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 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 le ss 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 immed iately. Your doctor may decide to carry out tests on your liver, kidneys or blood and may tell y ou to stop taking lamotrigine. In case you have develop ed Stevens-Johnson sy ndrome or toxic e pidermal ne crolysis y our doctor will tell y ou that y ou must never use lamotrigine again.

Very common side effects: may affect more than 1 in 10 people:

•    headache

•    skin rash.

Common side effects: 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

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•    pain in your back or joints, or elsewhere.

Uncommon side effects: may affect up to 1 in 100 people:

•    clumsiness and lack of co-ordination (ataxia)

•    double vision or blurred vision.

Rare side effects: may affect up to 1 in 1,000 people:

•    a life-threa tening ski n reacti on (Ste vens-Johnson sy ndrome: see also the information at the

beginning of Section 4)

•    a group of sy mptoms together includ ing: fever, nause a, vomiting, he adache, stiff neck and

extreme sensitivity to bri ght light. This may be c aused by an inflammation of the membranes that cover the brain and spina l cord (m eningitis). These symptoms usua lly 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: 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

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

•    swelling around the face (oedema) or swollen gland s in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of Section 4

•    changes in liver func tion, which will show up in blood tests, or li ver failure: see also the information at the beginning of Section 4

•    a serious disorder of blood clotting, whic h 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 b lood cells (leucopoenia, 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 bo ne) an d fractures. C heck with your doctor or pharm acist if you are on long-term antiepileptic medication long-term, have a history of osteoporosis, or take steroids.

•    DRESS.

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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.

5.    How to store Lamotrigine

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

Do not usethis medicine after the expiry date which is stated on the blisters, c arton or bottle after EXP. The expiry date refers to the last day of that month.

Lamotrigine 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. These measures will help protect the environment.

6.    Contents of the pack and other information What Lamotrigine contains:

•    The active substance is lamotrigine 25, 50, 100 or 200 mg

•    The other ingredients are lactose monohydrate, cellulose microcrystalline, starch pregelatinised, povidone K-30, silica colloidal anhydrous, sodium starch glycolate (Type A) and magnesium stearate. In addition, the 100 mg tablets contain Yellow orange S (E110) and the 200 mg tablets contain indigo carmine (E132).

What Lamotrigine looks like and contents of the pack:

•    Lamotrigine 25 mg Tablets a re white to off white, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, debossed “39” on the other side of the tablet. The tablets can be divided into equal halves.

•    Lamotrigine 50 mg Tablets are white to off white, round-shaped tablets, debossed with the number “50” on one side and debossed “LT” on the other side of the tablet

•    Lamotrigine 100 mg Tablets are peach, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, debossed “463” on the other side of the tablet

•    200 mg: Lamotrigine 200 mg Tablets are blue, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, debossed “7248” on the other side of the tablet. The tablets can be divided into equal halves.

•    Lamotrigine 25 are available in pack sizes of 14, 21, 30, 42, 56, 60, 90 or 100 tablets.

Calendar packs: 21, 42 tablets

•    Lamotrigine 50 mg Tablets are available in pack sizes of: 14, 21, 30, 42, 56, 60, 90, 100 or 200 tablets.Calendar packs: 21, 42 tabletsLamotrigine 100 and 200 mg tablets are available in pack sizes of 21, 30, 42, 56, 60, 90 100 or 200 tablets. Calendar packs; 21, 42 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in {07/2014}

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