PHARMACODE AREA

Package leaflet: Information for the user Lamotrigine Cipla 25mg, 50mg, 100mg and 200 mg 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. Do not pass it on to others.It may harm them, even if their symptoms 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.

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

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 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 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.

Do not take Lamotrigine Tablets if you:

•    are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor or pharmacist before taking Lamotrigine Tablets if you:

•    have any kidney problems

•    have ever developed a rash after taking lamotrigine or other medicines for epilepsy or bipolar disorder

•    are already taking medicine that contains lamotrigine

•    have ever developed meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Not known side effects)

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

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.

If any of these applies to you:

Tell your doctor, who may decide to lower your dose or that Lamotrigine Tablets are 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. These can include Stevens-Johnson syndromes (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 Tablets.

•    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 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.

Children and adolescents

Lamotrigine Tablets should not be given to people 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 Tablets

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.

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

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

•    lithium, aripiprazole 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 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

•    risperidone, used to treat mental health problems

•    rifampicin, which is an antibiotic

•    Medication 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 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 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 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 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 Tablets, so you may need blood tests and your dose of lamotrigine may be adjust .

If you are pregnant, think you may be pregnant or 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 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.

Important information about some of the ingredients of Lamotrigine Tablets

Lamotrigine Tablets contain small amounts of a sugar called lactose. If you have an intolerance to lactose or any other sugars:

Tell your doctor and don't take Lamotrigine Tablets.

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you're 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 any other medicine

•    whether you have problems with your kidneys or liver.

Your doctor will prescribed 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 Tablets than your doctor tells you to.

The usual effective dose of Lamotrigine Tablets for adults and children aged 13 years or over is between 100 mg and 400 mg each day.

Lamotrigine is not recommended for children aged under 2 years.

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 200 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'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 Tablets than you should

Contact a doctor or nearest hospital emergency department immediately. If possible, show them the Lamotrigine Tablets packet.

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If you take too much Lamotrigine Tablets you may be more likely to have serious side effects which may be fatal. 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)

•    heart rhythm changes (detected usually on ECG)

•    loss of consciousness, fits (convulsion) or coma

If you forget to take Lamotrigine Tablets

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

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

If you stop taking Lamotrigine Tablets

Lamotrigine Tablets must be taken 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

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

A small number of people taking Lamotrigine 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 few months of treatment with

Lamotrigine Tablets, especially if the starting dose is too high or if the dose is increased too quickly or if Lamotrigine Tablets 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 epidermalnecrolysis) or extended rashes with liver, blood and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as hypersensitivity syndrome)

•    ulcers in 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.

•    increased levels of liver enzymes seen in blood tests

•    an increase in a type of white blood cell (eosinophils)

•    enlarged lymph nodes

•    involvement of the organs of the body including liver and kidneys.

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 of these 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 Tablets. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must near use lamotrigine again.

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:

•    aggression or irritability

•    feeling sleepy or drowsy

•    feeling dizzy

•    shaking or tremors

•    difficulty in sleeping ( nsomn a)

•    feeling agitated

•    diarrhoea

•    dry mouth

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

•    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)

•    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).

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

•    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

•    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

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

•    lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).

Not known (frequency cannot be estimated from the available data)

•    Nightmares.

•    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 anti-epileptic 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.

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 blisters, carton or bottle. The expiry date refers to the last day of that month.

Store in the original package.

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

What Lamotrigine Tablets contain

The active substance is lamotrigine. Each tablet contains 25mg, 50mg, 100mg 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 Tablets look like and contents of the pack

Lamotrigine 25 mg, 50mg and 100mg Tablets are yellow, round tablets with '25' or '50' or '100' on one side and a score-line on the other.

Lamotrigine 200 mg Tablets are yellow, capsule-shaped tablets with '200' on one side and plain on the other.

Lamotrigine Tablets are available in packs of 21, 28, 42, 56, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.

Manufacturer:

Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in Month of variation approval.

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