PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamotrigine Consilient 25 mg, 50 mg, 100 mg and 200 mg tablets

Read this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    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 you have any further questions, ask your doctor or pharmacist. If any of the side effects get 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 Consilient tablets are and what they are used for

2.    Before you take Lamotrigine Consilient tablets

3.    How to take Lamotrigine Consilient tablets

4.    Possible side effects

5.    How to store Lamotrigine Consilient tablets

6.    Further information

Lamotrigine tablets belong to a group of medicines called anti-epileptics. They are used to treat two conditions - epilepsy and bipolar disorder.

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

For adults and children aged 13 years and over

Lamotrigine tablets can be used on their own or with other medicines, to treat epilepsy. Lamotrigine tablets 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 tablets can be used with other medicines, to treat the same conditions. They can be used on their own to treat a type of epilepsy called typical absence seizures.

Lamotrigine tablets also treat 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 tablets can be used on their own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamotrigine tablets work in the brain to have this effect.

2. BEFORE YOU Take LAMOTRIGINE CONSILIENT TABLETS Do not take Lamotrigine :

•    if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamotrigine tablets (listed in Section 6).

If this applies to you, tell your doctor and do not take Lamotrigine tablets.

Take special care with Lamotrigine

Your doctor needs to know before you take Lamotrigine tablets:

•    if you have problems with your kidneys

•    if you have ever developed a rash when you have taken lamotrigine or other medicines for epilepsy

•    if you are already taking medicine that contains lamotrigine.

If any of these apply to you, tell your doctor, who may decide to lower your dose or that Lamotrigine 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 are taking Lamotrigine tablets, 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 tablets have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Lamotrigine tablets 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 are taking any other medicines, if you have taken any recently, or if you start taking new ones - these include herbal medicines or other medicines you bought without a prescription.

If you are taking certain medicines, your doctor may need to check the dose of Lamotrigine tablets. These include:

•    oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy

•    lithium, 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 tablets or make it more likely that you 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

•    olanzapine, used to treat mental health problems

•    risperidone, used to treat mental health problems

•    rifampicin, which is an antibiotic

•    a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection

•    hormonal contraceptives, such as the Pill (see below).

Tell your doctor if you are taking, or if you start or stop taking, any of these.

Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine tablets work

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. If you plan to start using a hormonal contraceptive talk to your doctor, who will discuss suitable methods of contraception with you.

Lamotrigine tablets can also affect the way hormonal contraceptives work, although it is 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 tablets are affecting the way your contraceptive is working.

Pregnancy and breast feeding

Talk to your doctor if you are pregnant, if you might be pregnant, or if you are planning to become pregnant.

You should not stop treatment for your epilepsy while you are pregnant. However, there is an increased risk of birth defects in babies whose mothers took Lamotrigine tablets during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you to take extra folic acid if you are planning to become pregnant and while you are pregnant.

Pregnancy may also alter the effectiveness of Lamotrigine tablets, so your doctor may take samples of your blood to check the level of Lamotrigine, and may adjust your dose.

Talk to your doctor if you are breast feeding or planning to breast feed.

Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast feeding while you are taking Lamotrigine tablets, and will check your baby from time to time if you decide to breast feed.

Driving and using machines

Lamotrigine tablets can cause dizziness and double vision, do not drive or operate machines if you are affected.

If you have epilepsy, talk to your doctor about driving and using machines.

Important information about some of the ingredients of Lamotrigine tablets

Lamotrigine tablets contain small amounts of a sugar called lactose. If you have intolerance to lactose or any other sugars, tell your doctor and do not take Lamotrigine tablets.

3. HOW TO TAKE LAMOTRIGINE CONSILIENT TABLETS

Always use Lamotrigine tablets exactly as your doctor has told you to.

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 tablets for you. The dose you take will depend on:

•    your age

•    whether you are taking Lamotrigine tablets with other medicines

•    whether you have problems with your kidneys or liver.

Your doctor will start you on a low dose, 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 tablets than your doctor tells you to.

The usual effective dose of Lamotrigine tablets for adults and children aged over 12 years 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 is between 1 mg and 15 mg for each kilogram of the child's weight, up to a maximum of 400 mg daily.

How to take your dose of Lamotrigine tablets

Take your dose of Lamotrigine tablets once or twice a day, as your doctor advises.

You can take it with or without food.

Your doctor may also advise you to start or stop taking other medicines, depending on what condition you are 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 tablets than you should

If anyone takes too many Lamotrigine tablets, contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine tablets packet.

Someone who has taken too many Lamotrigine tablets 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 tablets

Do not take extra tablets or a double dose to make up for a forgotten dose.

If you have missed taking a dose of Lamotrigine tablets, ask your doctor for advice on how to start taking it again. It is important that you do this.

Do not stop taking Lamotrigine tablets without advice

Take Lamotrigine tablets for as long as your doctor recommends. Do not stop unless your doctor advises you to.

If you are taking Lamotrigine tablets for epilepsy

To stop taking Lamotrigine tablets, it is important that your dose is reduced

gradually, over about 2 weeks.

If you suddenly stop taking Lamotrigine tablets, your epilepsy may come back or get worse.

If you are taking Lamotrigine tablets for bipolar disorder

Lamotrigine tablets may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine tablets, your dose will not need to be reduced gradually. You should still talk to your doctor first, if you want to stop taking Lamotrigine tablets.

4. possible side effects

Like all medicines, Lamotrigine tablets can cause side effects, but not everyone gets them.

If any of the following happen, tell your doctor immediately:

•    skin rashes or redness

•    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 your fingers turning blue

•    a sore throat, or more infections (such as colds) than usual.

These maybe symptoms of an allergic reaction or potentially serious skin reaction. A small number of people taking Lamotrigine tablets get an allergic reaction or potentially serious skin reaction, which may develop into more serious, and even life-threatening, problems if they are not treated.

In many cases, these symptoms will be signs of less serious side effects. However, you must be aware that they are potentially serious and may develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated. So, if you notice any of these symptoms see a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine tablets.

These symptoms are more likely to happen during the first few months of treatment with Lamotrigine tablets, especially if you start on too high a dose, if your dose is increased too quickly, or if you are taking Lamotrigine tablets with another medicine called valproate. Children are more likely to be affected than adults.

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.

Immediately contact your doctor or go to the casualty department at your nearest hospital if:

•    you have thoughts of harming or killing yourself

If you are taking Lamotrigine tablets for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you are taking Lamotrigine tablets. 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 are taking Lamotrigine tablets, contact a doctor as soon as possible.

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

•    dry mouth

•    feeling tired

•    pain in your back or joints, or elsewhere.

Rare side effects

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

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

•    a rare skin condition, with severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area (Stevens-Johnson syndrome).

Very rare side effects

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

•    hallucinations ('seeing'or 'hearing' things that are not 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

•    a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis)

•    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 (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

•    a 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.

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 consilient tablets

Keep out of the reach and sight of children.

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

Do not store above 30°C.

If you have any unwanted Lamotrigine tablets, do not dispose of them in your waste water or your household rubbish. Take them back to your pharmacist, who will dispose of them in a way that will not harm the environment.

6. further information

What Lamotrigine tablets contain

•    Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of the active ingredient lamotrigine.

•    The other ingredients are magnesium carbonate, microcrystalline cellulose, povidone, lactose monohydrate, yellow iron oxide (E172) and magnesium stearate.

What Lamotrigine tablets look like and the contents of the pack

•    Lamotrigine tablets are pale yellow, round, flat faced, uncoated tablets marked with either "25" "50", "100" or "200" on one side (depending on the strength).

•    Lamotrigine tablets are supplied in blister packs of 10, 14, 20, 28, 30, 42, 50, 56, 98 and 100 tablets.

Marketing Authorisation Holder

Consilient Health Ltd,

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland.

Manufacturer

McGregor Cory Limited,

Middleton Close, Banbury, Oxon, OX16 4RS

This leaflet was last revised: December 2013