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PATIENT INFORMATION LEAFLET LAMOTRIGINE FANNIN 25 mg, 50 mg, 100 mg and 200 mg TABLETS

(lamotrigine)

The name of this medicine is Lamotrigine Fannin 25 mg, 50 mg, 100 mg and 200 mg Tablets, which will be referred to as Lamotrigine Fannin Tablets throughout this leaflet.

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, askyour doctororyour pharmacist

•    This medicine has been prescribed for you. Do not pass it onto others, it may harmthem, even if their symptoms are the same asyours

•    If any of the side effects gets serious, orifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

1. WHAT LAMOTRIGINE FANNIN TABLETS ARE AND WHAT THEY ARE USED FOR

The active ingredient in this product is lamotrigine, which belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder.

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

•    For adults and children aged13years and over, Lamotrigine Fannin Tabletscan be used ontheirown or with other medicines, to treat epilepsy. Lamotrigine Fannin Tabletscan also be used with other medicines to treat seizures that occur with a condition called Lennox-Gastaut syndrome.

•    For children aged between 2 and 12 years, Lamotrigine Fannin 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 Fannin 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 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.

2. BEFORE YOU TAKE LAMOTRIGINE FANNIN TABLETS

Do not take Lamotrigine Fannin Tablets if you:

•    are allergic (hypersensitive) to lamotrigine, or any ofthe other ingredients in Lamotrigine Fannin Tablets (these are listed in section 6, Further Information)

Ifthis applies to you:

Tell your doctor, and don’t take Lamotrigine Fannin Tablets.

Take special care with Lamotrigine Fannin Tablets

Your doctor needs to know before you take Lamotrigine Fannin Tablets if you:

•    have problems with your kidneys

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

•    have ever developed meningitis after taking lamotrigine (see section 4)

•    are already taking medicine that contains lamotrigine

Ifany of these applies to you:

Tell your doctor, who may decide to loweryourdose or that Lamotrigine Fannin Tablets are not suitable for you.

Important information about potentially life-threatening reactions

A small numberof people taking lamotrigine get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You needto knowthe symptoms to look out for while you are taking lamotrigine.

•    Readthe description of these symptoms in Section 4 of this leaflet under"Potentially serious reactions: get a doctors 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. Ifyou have bipolar disorder, you may be more likely to think like this:

•    when you first start treatment

•    ifyou have previously has thoughts about harming yourself or about suicide

•    ifyou are under 25 years old

Ifyou have distressing thoughts or experiences, or ifyou notice that you feel worse or develop new symptoms while you¹ re taking Lamotrigine Fannin Tablets:

See a doctor as soon as possible or go to the nearest hospital for help.

A small numberofpeople being treated with anti-epileptics such as Lamotrigine Fannin Tablets have also had thoughts ofharming or killing themselves. If at anytimeyou havethese thoughts, immediately contact your doctor.

If you're taking Lamotrigine Fannin Tablets for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you¹ re taking Lamotrigine Fannin Tablets. Some patients may experience severe seizures, which maycause serious health problems. Ifyour seizures happen more often, or ifyou experience a severe seizure while you’re taking Lamotrigine Fannin Tablets:

See a doctor as soon as possible.

Lamotrigine Fannin Tablets should not be given to people under 18 years to treat bipolar disorder. Medicines used to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under18years.

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.

Ifyou are taking certain medicines, yourdoctormay needtocheck the dose of Lamotrigine Fannin Tablets. These 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 ifyou are taking any of these.

Some medicines interact with Lamotrigine Fannin 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

•    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 ifyou are taking any of these.

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

Yourdoctor may recommendthat you use a particular type ofhormonal contraceptive, or another method of contraception, such ascondoms, acap or coil. Ifyou are using a hormonal contraceptive like the Pill, yourdoctormaytake samples of your blood to check the level oflamotrigine. Ifyou plan to start using a hormonal contraceptive:

Talk to your doctor, who will discuss suitable methods ofcontraceptionwithyou Lamotrigine Fannin Tablets can also affect the way hormonal contraceptives work, although it’s unlikely to make them less effective.

Ifyou 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

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

It is important that you do this becausethere may be an increased risk of birth defects in babieswhose motherstook lamotrigine during pregnancy. These defects include cleft lip or cleft palate. Yourdoctor may adviseyoutotake extra folic acid if you’re planning to become pregnant andwhileyou’re pregnant.

Pregnancy may also alter the effectiveness of Lamotrigine Fannin Tablets, soyour doctormaytake samples ofyour blood to check the level of lamotrigine, and may ad|ust your dose. Talk to your doctor if you're breast-feeding or planning to breast-feed. The active ingredient oflamotrigine 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 Fannin Tablets, and will checkyour babyfrom time to time ifyou decide to breast-feed.

Driving and using machines

Lamotrigine Fannin 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.

Important information about some of the ingredients of Lamotrigine Fannin Tablets

Lamotrigine Fannin Tablets contain small amounts of a sugar called lactose. Ifyou have an intolerance to lactose orany othersugars:

Tell your doctor, and don’t take Lamotrigine Fannin Tablets.

3. HOW TO TAKE LAMOTRIGINE FANNIN TABLETS

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

How much lamotrigine fannin to take

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

•    your age

•    whether you are taking Lamotrigine Fannin Tablets with any other medicine

•    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).    q

Never take more Lamotrigine Fannin Tablets than your doctor tells you to.

The usual effective dose of Lamotrigine Fannin Tablets for adults and children aged over12years is between100 mg and 400 mg each day.

Lamotrigine is not recommendedforchildren aged under2years.

For children aged 2 to 12 years, the effective dose depends on their body weight - usually, it’s between 1 mg and15mgfor each kilogram ofthe child’s weight, up to a maximum of400mg daily.    AXP050FMC

How to take your dose of Lamotrigine Fannin Tablets

Takeyour dose of Lamotrigine Fannin Tablets once ortwice a day, asyourdoctoradvises. Youcantake it with or without food.

Your doctor may also advise you to start or stop taking other medicines, depending on what condition you¹ re being treated for and the way you respond to treatment.

•    Swallow your tablets whole. Don’t break, cheworcrushthem.

•    Always take the full dose that your doctorhas prescribed. Nevertake only part of a tablet.

If you take more Lamotrigine Fannin Tablets than you should

If anyone takes too much lamotrigine:

Contact a doctor or pharmacist immediately. Ifpossible, showthemthe Lamotrigine Fannin Tablets packet.

Someonewho hastakentoo much lamotrigine may have any of these symptoms,

•    rapid, uncontrollable eye movements (nystagmus)

•    clumsiness and lack of co-ordination, affecting their balance (ataxia)

•    loss ofconsciousness orcoma

If you forget to take Lamotrigine Fannin 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 Fannin Tablets:

Ask your doctor for advice on how to start taking it again. It’s important you do this.

Don't stop taking Lamotrigine Fannin Tablets without advice

Take Lamotrigine Fannin Tablets for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you are taking Lamotrigine Fannin Tablets for epilepsy

To stop taking Lamotrigine Fannin Tablets, it is important that your dose is reduced gradually over about2weeks. If you suddenly stop taking Lamotrigine Fannin Tablets, your epilepsy may come back or get worse.

If you are taking Lamotrigine Fannin Tablets for bipolar disorder

Lamotrigine Fannin Tablets maytake some time towork, soyou are unlikely to feel better straight away. If you stop taking Lamotrigine Fannin Tablets, your dose will not need to be reduced gradually. Butyou should still talk to your doctor first, ifyouwantto stop taking Lamotrigine Fannin Tablets.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lamotrigine Fannin Tablets can cause side effects, but not everybody gets them.

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

A small number of people taking Lamotrigine Fannin Tablets 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 fewmonths oftreatment with Lamotrigine Fannin Tablets, especially if you start ontoo high a dose or if your dose is increased too quickly, or ifyou're taking Lamotrigine Fannin Tablets with another medicine called valproate. Some ofthe 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 severe 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 your fingers turning blue

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

In many cases, these symptomswill 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, ifthey are not treated. Ifyou notice any of these symptoms: Contact a doctor immediately. Your doctor may decide to carry out tests onyour liver, kidneys or blood, and may tell you to stop taking Lamotrigine Fannin Tablets.

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:

•    feeling dizzy

•    feeling sleepy ordrowsy

•    feeling sick (nausea) or being sick (vomiting)

•    aggression, agitation or irritability

•    shaking ortremors

•    difficulty in sleeping

•    diarrhoea

•    dry mouth

•    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 Rare side effects

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

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

•    rapid, uncontrollable eye movements (nystagmus)

•    a group ofsymptoms together including, fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may becaused by an inflammation ofthe membranes that coverthe brain and spinal cord (meningitis). These symptoms usually disappear oncetreatment is stopped however if the symptomscontinue orgetworsecontact your doctor.

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

Very rare side effects

These may affect up to 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 |erking, shaking or stiffness

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

•    in people who already have epilepsy, seizures happening more often

•    changes in liver function, which will show up in blood tests, or liver failure

•    changeswhich 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 ofcell (pancytopenia), and a disorder ofthe bone marrowcalled aplastic anaemia

•    a serious disorder of blood clotting, whichcancause 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)

•    lupus-like reaction: a group of symptoms together including, joint pain, muscle pain, fatigue, chest pain, pain when breathing and increased antibodies in the blood that attack the body’s own cells (to be determined by a blood test). These symptoms may be caused by drug-induced lupus, an autoimmune condition from taking this medication.

•    in people who already have Parkinson’s disease, worsening of symptoms

Other side effects

There have been reports ofbone disorders including osteopenia and osteoporosis (thinning ofthe bone) andfractures. Checkwithyour doctor or pharmacist ifyou are on long-term anti-epileptic medication, have a history of osteoporosis, or take steroids.

Reporting of side effects:

Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Youcan also report side effects directly via the Yellow Card Scheme at www.mhra.aov.uk/vellowcard. By reporting side affectsyoucan help provide more information onthe safety of this medicine.

5. HOW TO STORE LAMOTRIGINE FANNIN TABLETS

Keep Lamotrigine Fannin Tablets out of the sight and reach of children.

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

Lamotrigine dose not require any special storage conditions.

Ifyou have any unwanted Lamotrigine Fannin Tablets, don’t dispose ofthem inyourwastewaster or household rubbish. Takethem backtoyour pharmacist, who will dispose ofthem in a way that won’t harm the environment.

6. FURTHER INFORMATION

What Lamotrigine Fannin Tablets contain

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

The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, maize starch, magnesium stearate and iron oxide yellow (E172). What Lamotrigine Fannin Tablets look like and contents of the pack

Lamotrigine Fannin25mg, 50 mg and 100 mg areyellow, round tablets with ‘25’ or‘50’ or ‘100’ on one side and a score-line onthe other.

Lamotrigine Fannin 200 mg Tablets are yellow, capsule-shaped tablets with ‘200’ on one side and a score-line on the other.

Your medicine is available in packs of 21, 28, 42, 56, or 100 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN86GT, UK.

Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN86GT, UK.

This leaflet was last approved in April 2014.