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Lamotrigine Teva 100mg Tablets

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PAGE 1: FRONT FACE (INSIDE OF REEL)

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LAMOTRIGINE TEVA 25 mg, 50 mg, 100 mg AND 200 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

•    Keepthis leaflet. You may need to read itagain.

•    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. Itmay harm them,even iftheir signs of illness are the same as yours.

•    If you get any ofthe side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

INTHIS 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

WHAT LAMOTRIGINE IS AND WHAT IT IS USED FOR

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat epilepsy.

Lamotrigine treats epilepsy by blocking the signals in the brain

that trigger epileptic seizures (fits).

•    For adults and children aged 13years 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 12years, 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.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMOTRIGINE

Important information about potentially life-threatening reactions

A small number of people taking Lamotrigine have experienced an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms(DRESS). 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'.

DO NOT take Lamotrigine:

•    if you are allergic (hypersensitive) to lamotrigine or any ofthe other ingredients of lamotrigine (listed in section 6).

If this applies to you, tell your doctor, and don't take Lamotrigine.

Take special care with Lamotrigine Warnings and precautions

Talk to your doctor before taking before you take Lamotrigine if you:

•    have problems with your kidneys

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

•    are already taking medicine that contains lamotrigine.

If any of these applies to you, tell your doctor, who may decide to lower your dose, or that Lamotrigine is not suitable for you. Watch out for important symptoms If you develop a rash or these skin symptoms, stop taking Lamotrigine, seek urgent advice from a doctor and tell him that you are taking this medicine:

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS) have been reported with the use of Lamotrigine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. For more information on these reactions, please read section 4 (Possible side effects).

•    Additional signsto lookfor 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 symptomsand 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 rash may progress to widespread blistering or peeling of the skin.

•    The highest risk for occurrence ofserious skin reactions is within the first weeks of treatment

•    If you have developed Stevens-Johnson syndrome/toxic epidermal necrolysis or a drug reaction with eosinophilia and systemic symptoms(DRESS) with the use of Lamotrigine,you must not be re-started on Lamotrigine at anytime

•    a high temperature (fever)

•    drowsiness.

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

The symptomslisted above can develop intomore 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 outtests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine.

Thoughts of harming yourself or suicide

If you have distressing thoughts or experiences, or if you notice thatyou 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 had thoughts ofharming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Risk of increased or severe seizures

The seizures in sometypes ofepilepsymay 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.

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.

•    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.

If you start or stop taking certain medicines whilst you are taking Lamotrigine, your doctor may need to check your dose of Lamotrigine. These include:

•    atazanavir in combination with ritonavir

•    lopinavir in combination with ritonavir.

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

Some medicines interact with Lamotrigine 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 phenobarbital, used to treat epilepsy

•    olanzapine, used to treat mental health problems

•    risperidone, used to treat mental health problems

•    ritampicin, 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 works

•    Your doctor may recommend thatyou use a particulartype 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 maytake 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 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 isworking.

Pregnancy, breast-feeding and fertility

•    If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacistfor advice before taking this medicine.

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 during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you totake extra folic acid if you're planning to become pregnant and while you're pregnant.

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

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

Important information about some of the ingredients of Lamotrigine

Lamotrigine tablets contain small amounts of a sugar called

lactose. If you have intolerance to lactose or any other sugars, tell your doctor, and don't take Lamotrigine.

Lamotrigine 100 mg and 200mgtablets also contain E110 (sunset yellow FCF), which may cause allergic reactions.

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a 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 problemswith your kidneys or liver.

Your doctor will start you on a low dose, and gradually increase the dose over a fewweeks until you reach a dose thatworksfor you (called the effective dose). Never take more Lamotrigine than your doctor tells you to.

The recommended effective dose of Lamotrigine 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's between 1 mg and 15 mg for each kilogram of the child's weight, up to a maximum of 400 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. You can take it with or withoutfood.

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.

   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

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

Someone who hastaken 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 or a double dose to make up for a forgotten dose. If you have missed taking a dose of this medicine 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

Take Lamotrigine for as long as your doctor recommends. Don't

stop unless your doctor advises you to.

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

^4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 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 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 ofthe skin (more than 30% ofthe body surface-toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement(DRESS)

   a sore mouth or eyes (conjunctivitis)

   a high temperature (fever), flu-like symptomsor 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

•    increased levels of liver enzymes seen in blood tests

•    an increase in a type ofwhite blood cell (eosinophils)

•    enlarged lymph nodes

•    involvement ofthe organs ofthe body including liver and kidneys. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or extended rashes with liver, blood and other body organs involvement(DRESS) have been reported (see section 2).

These are very serious butrare or very rare side effects. You may need urgent medical attention or hospitalisation. In many cases, your 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 outtests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine.

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

•    feeling tired.

Rare side effects

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

•    itchy eyes,with discharge and crusty eyelids (conjunctivitis) 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 bodymovements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual bodymovements such as jerking, shaking or stiffness

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

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

•    changes which may showupin blood tests— including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, 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

•    in people who already have Parkinson's disease, worsening of the symptoms.

Frequency not known

The freguency ofthese side effects cannot be estimated from the currently available data:

•    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.

•    swollen glands (lymphadenopathy)

•    aseptic meningitis

•    DRESS.

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 effectsyou can help provide more information on the safety of this medicine.

HOW TO STORE LAMOTRIGINE

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

Do not store above 30oC. Store in the original blister packto protect from moisture.

Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

^6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Lamotrigine Teva Tablets contain:

•    The active ingredient is lamotrigine

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

What Lamotrigine Teva Tablets look like and contents of the pack:

•    Lamotrigine 25 mg tablets are white to offwhite, diamond shaped tablets, debossed with the number "93" on one side and scored between the two numbers, debossed "39" on the other side.

•    Lamotrigine 50 mg Tablets are white to offwhite, round shaped tablet, debossed with the number "50" on one side and debossed "LT" on the other side.

•    Lamotrigine 100mg 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.

•    Lamotrigine 200mg 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.

•    Lamotrigine packsare blister packsoftransparentorwhite opague PVC/PVDC-aluminium lidded with aluminium foil for 21,21 calendar, 30,42,42 calendar, 56, 60, 90, or 100 tablets.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised: 07/2014 PL00289/0496-0499

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