PACKAGE LEAFLET: INFORMATION FOR THE PATIENT    saraoooLrooo

Lamotrigine 25, 50,100 and 200 mg Dispersible Tablets

Lamotrigine

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.    Possible side effects

5.    How to store Lamotrigine

6.    Contents of the pack and other information

ASANDOZ

What Lamotrigine is and what it is used for

Lamotrigine belongs to the 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 despair). For adults aged 18 years and over, Lamotrigine 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 works in the brain to have this effect.

What you need to know before you take Lamotrigine

Do not take Lamotrigine:

•    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 Lamotrigine.

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).

•    if you are already taking medicine that contains lamotrigine.

If any of these apply 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 serious problems if they are not treated. You need to know the symptoms 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 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:

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 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 severe seizure while you’re taking Lamotrigine: See a doctor as soon as possible.

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 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 Lamotrigine. 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.

Tell your doctor if you are taking any of these.

Some medicines interact with Lamotrigine 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 Lamotrigine 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 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

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 you may need blood tests and your dose of Lamotrigine 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 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, and will check your baby from time to time if you 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.

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How to take Lamotrigine

Always take this medicine exactly as your doctor 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 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 than your doctor tells you to.

The usual effective dose of Lamotrigine for adults and children aged 13 years or over is between 1oo mg and 4oo mg each day.

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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.

Lamotrigine is not recommended for children aged under 2 years.

How to take your dose of Lamotrigine

Take your dose of Lamotrigine 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.

Lamotrigine dispersible tablets can either be swallowed whole with a little water, or mixed with water to make a liquid 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 no medicine is left in the glass.

If you take more Lamotrigine than you should Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine packet.

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)

•    loss of consciousness or coma.

If you forget to take Lamotrigine

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

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’re taking Lamotrigine for epilepsy

To stop taking Lamotrigine, 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’re 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.

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Possible side effects

Rare side effects (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 (may affect upto 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 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 numbersof red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers ofplatelets (thrombocytopenia), reduced numbers ofall 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 reation (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 antiepileptic medication, have a history of osteoporosis, or take steroids.

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 viathe Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

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

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

•    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.

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 ofthese 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 Lamotrigine.

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 (may affect more than 1in10 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

•    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

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How to store Lamotrigine

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

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

This medicinal product 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 measures will help protect the environment.

Contents of the pack and other information

What Lamotrigine 25/50/100/200 contains The active substance is: lamotrigine. Lamotrigine 25, 50,100 and 200 contains 25, 50, 100 and 200 mg of lamotrigine, respectively, per dispersible tablet.

The other ingredients are: microcrystalline cellulose (E460), povidone (E1201), sodium starch glycolate, hydroxypropylcellulose (E463), sodium saccharine (E954), blackberry flavouring (one ingredient is maltodextrin), magnesium stearate (E470b), anhydrous colloidal silicon dioxide (E551).

What Lamotrigine dispersible tablets look like and contents of the pack

Lamotrigine dispersible tablets are white to off-white, round and flat with grooved edges.

Packaging

Contents of the packs:

PVC/PE/PVDC/Al blister: 14, 20, 28, 30, 50, 56, 60, 90, 100,

200 tablets

PVC/PE/PVDC/Al perforated unit dose blister: 100 x 1 tablets PP container with LDPE lid: 90, 100, 200 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria or Salutas Pharma GmbH, Dieselstrasse 5, D-70839, Gerlingen, Germany or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or Lek Pharmaceuticalsd.d., Verovskova 57, Sl-1526 Ljubljana, Slovenia.

This leafletwas last revised in 10/2013.

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