Lamotrigine Actavis 5mg, 25mg and 100mg dispersible tablets

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets 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 tablets is and what it is used for

2| Before you take Lamotrigine tablets

3| How to take Lamotrigine tablets

3 Possible side effects

3 How to store Lamotrigine tablets

_6 Further information 3 What Lamotrigine tablets is and what it is used for

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

Lamotrigine tablets treats 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 its 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 those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.

Lamotrigine tablets 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 tablets 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 tablets works in the brain to have this effect.

3 Before you take Lamotrigine tablets:

Do not take Lamotrigine tablets 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 don't take Lamotrigine tablets

If you develop a rash or the following skin symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine:

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Lamotrigine tablets appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.

•    If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Lamotrigine tablets you must not be re-started on Lamotrigine tablets at any time.

Take special care with Lamotrigine tablets

Your doctor needs to know before you take Lamotrigine tablets if you:

•    have problems with your kidneys

•    suffer from liver problems, as your doctor may need to decrease your dose

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

•    are already taking medicine that contains lamotrigine

•    have Parkinsons disease.

If any of these applies to you: Tell your doctor, who may decide to lower your dose or that Lamotrigine tablets, is not suitable for you.

Watch out for important symptoms

If you develop any of these symptoms after you start taking Lamotrigine tablets, get a doctor's help straight away:

•    an unusual skin reaction, such as redness or rashes

•    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 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 or if your dose is increased too quickly, or if you're taking Lamotrigine tablets with another medicine called valproate. Children are more likely to be affected than adults.

Lamotrigine can occasionally cause some serious allergic reactions or potentially life-threatening skin reactions (incl. DRESS). For more information on these reactions, please read section 4 (Possible side effects).

DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated.

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

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 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.

If you're taking Lamotrigine tablets for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you're 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're taking Lamotrigine tablets: See a doctor as soon as possible.

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're taking any other medicines, if you've 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'll 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, atazanavir 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 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 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 tablets. 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'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 tablets is affecting the way your contraceptive is working.

Pregnancy and breast feeding

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

You should not stop treatment for your epilepsy while you're 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're planning to become pregnant and while you're 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 tablets, and may adjust your dose.

Talk to your doctor if you're breast feeding or planning to breast feed. The

active ingredient of Lamotrigine tablets 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 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.

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.

^| How to take Lamotrigine tablets

Always use Lamotrigine tablets exactly as your doctor has told you to. Check with your doctor or pharmacist if you're not sure.

How much Lamotrigine tablets to take

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

•yourage

•    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 100mg and 400mg each day.

For children aged 2 to 12 years, the effective dose depends on their body weight - usually, it's between 1mg and 15mg for each kilogram of the child's weight, up to a maximum of 400mg 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.

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

You can take Lamotrigine tablets dispersible/chewable tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water:

If you chew the tablet:

You may need to drink a little water at the same time to help the tablet dissolve in your mouth. Then drink some more water to make sure you have swallowed all the 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 you've taken all the medicine.

If you take more Lamotrigine tablets than you should

If anyone takes too much Lamotrigine tablets: Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine tablets packet.

Someone who has taken too much 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:

Don't 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's important that you do this.

Don't stop taking Lamotrigine tablets without advice

Take Lamotrigine tablets for as long as your doctor recommends. Don't 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. But you should still talk to your doctor first, if you want to stop taking Lamotrigine tablets.

Possible side effects

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

Allergic reaction or potentially serious skin reaction: get a doctor's help straight away

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. Symptoms of these reactions include:

•    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.

•    DRESS

In many cases, these symptoms will be signs of less serious side effects.

But you must be aware that they are potentially serious - 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 Continued top of next column AAAH7370

Very common side effects: (affects 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: (affects less than 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: (affects less than 1 in 1,000 people):

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

Very rare side effects: (affects less than 1 in 10,000 people):

•    hallucinations ('seeing' or 'hearing' things that aren't 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

•    rashes, erythema multiforme (circular, irregular red patches), lumps in the armpits or groin area. Potentially life-threatening skin rashes (Stevens-Johnson syndrome - severe skin rash with flushing, fever, blisters or ulcers and toxic epidermal necrolysis - severe rash involving reddening, peeling and swelling of the skin that resembles severe burns) have been reported very rarely (see section 2).

•    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. Other (frequency not known)

•    aseptic meningitis (symptom include sensitivity to light, rash, muscle pain, fever and stiff neck).

•    hair loss

•    DRESS

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, pharmacist or nurse. 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.

^| How to store Lamotrigine tablets

Keep out of the sight and reach of children.

Do not use 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. Store in the original packaging.

If you have any unwanted tablets, don't 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 won't harm the environment.

^| Further information

What Lamotrigine tablets contain

The active substance (the ingredient that makes the medicine work) is lamotrigine. Each tablet contains either 5mg, 25mg or 100mg of the active substance.

The other ingredients are magnesium carbonate, microcrystalline cellulose, povidone, hydroxypropyl cellulose, sodium saccharin, crospovidone, guar gum, blackcurrant flavour and magnesium stearate.

What Lamotrigine tablets looks like and contents of the pack

Lamotrigine tablets are white to almost white, round, flat, uncoated tablets. Available pack sizes are 28 or 56 tablets.

Marketing Authorisation Holder

Actavis, Barnstaple, EX32 8NS, UK

Manufacturer

Actavis ehf., Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland This leaflet was last revised in March 2015

If you would like a leaflet with larger ^% text, please contact 01271 311257.

vactavis

Actavis, Barnstaple, EX32 8NS, UK