PACKAGE LEAFLET: INFORMATION FOR THE USER Lamotrigine Dr. Reddy's 25mg, 50mg, 100mg & 200mg Tablets

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 only. 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.

What is in this leaflet!

1.    What Lamotrigine Tablets are and what they are used for

2.    What you need to know before you take Lamotrigine Tablets

3.    How to take Lamotrigine Tablets

4.    Possible side effects

5.    How to store Lamotrigine Tablets

6.    Contents of the pack and other information

1. What Lamotrigine Tablets are and what they are used for

Lamotrigine tablets belong to a group of medicines called antiepileptics. 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 as above. 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 alone 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. What you need to know before you take Lamotrigine Tablets

Do not take Lamotrigine

•    if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients (see Section 6).

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

Take special care with Lamotrigine.

Talk to your doctor before you take Lamotrigine:

•    if you have kidney or liver problems

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

•    if you are already taking a 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.

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 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'.

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:

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

You may find it helpful to tell a family member, caregiver or close friend that you can become depressed or have significant changes in mood, and ask them to read this leaflet. You might ask them to tell you if they are worried about your depression or other changes in your behaviour.

A small number of people being treated with anti-epileptics such as Lamotrigine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

If you're taking Lamotrigine for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while taking Lamotrigine. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often, or if you have 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.

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

•    oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide to treat for 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 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 (for epilepsy and mental health problems)

•    carbamazepine used to treat epilepsy and mental health problems

•    phenytoin, primidone or phenobarbitone (for epilepsy)

•    risperidone, used to treat mental health problems

•    rifampicin (an antibiotic)

•    a combination of lopinavir and ritonavir or atazanavir and ritonavir (to treat Human Immunodeficiency Virus 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 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 are affecting the way your contraceptive is working.

Pregnancy and breast-feeding If you're pregnant, think you may be pregnant, or are 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.

•    Pregnancy may alter the effectiveness of Lamotrigine, so you may need blood tests and your dose of Lamotrigine may be adjusted.

•    There may be a small increased risk of birth defects including a cleft lip or cleft palate if Lamotrigine is taken during the first 3 months of pregnancy.

•    Your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.

If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. 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. Do not drive or operate machines unless you are sure you are not affected.

Always take this medicine exactly as your doctor or pharmacist 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 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.

For adults and children aged over 13 years:

The usual effective dose of Lamotrigine tablets 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 1mg and 15mg for each kilogram of the child's weight, up to a maximum maintenance dose of 200 mg daily.

Lamotrigine is not recommended for children aged under 2 years.

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

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

If you take too many Lamotrigine tablets you may be more likely to have serious side effects which may be fatal.

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)

•    heart rhythm changes (detected usually on ECG)

•    loss of consciousness, fits (convulsions) 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're taking Lamotrigine 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're taking Lamotrigine for bipolar disorder

Lamotrigine may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine, 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.

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

•    ulcers in the mouth, throat, nose or genitals

•    sore mouth or red swollen eyes (conjunctivitis)

•    high temperature (fever), flu-like symptoms or drowsiness

•    swelling of the face, swollen glands in your neck, armpit, groin

•    unexpected bleeding or bruising, or your fingers turning blue

•    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 (eosinophilia)

•    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. However, 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, see a doctor at once. Your doctor may 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 never use lamotrigine again.

Very common side effects (may affect more than 1 in 10 people)

•    headache

•    skin rash.

Common side effects (may affect up to 1 in 10 people)

•    aggression or irritability

•    feeling sleepy or drowsy

•    feeling dizzy

•    shaking or tremors

•    difficulty in sleeping

•    feeling agitated

•    diarrhoea

•    dry mouth

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

•    feeling tired

•    pain in your back or joints, or elsewhere.

Uncommon side effects (may affect up to 1 in 100 people)

•    clumsiness and lack of co-ordination (ataxia)

•    double vision or blurred vision

•    unusual hair loss or thinning (alopecia)

Rare side effects (may affect up to 1 in 1,000 people)

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

•    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 movement (nystagmus)

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

Very rare side effects (may affect up to 1 in 10,000 people)

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

•    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): see also the information at the beginning of section 4

•    a high temperature (fever): see also the information at the beginning of section 4

•    swelling around face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of section 4

•    changes in liver function (as shown in blood tests) or liver failure

•    a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of Section 4

•    changes which may show up in 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 cells (pancytopenia) and a disorder of the bone marrow called aplastic anaemia

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

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

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

Frequency not known

•    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 medications, have a history of osteoporosis or take steroids

•    nightmares.

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 effects you can help provide more information

on the safety of this medicine.

5. How to store Lamotrigine Tablets

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

Do not store above 25°C and keep in the original packaging. Protect from light.

Do not use this medicine after the expiry date which is stated on the blisters, carton or bottle after EXP. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Lamotrigine Tablets contain

The active ingredient (which makes the tablets work) is lamotrigine. Each tablet contains either 25mg, 50mg, 100mg or 200mg of lamotrigine. The other ingredients are: mannitol (E421), powdered cellulose (E460), l-hydroxypropyl cellulose (E463), hydroxypropyl cellulose (E463), iron oxide yellow (E172), magnesium stearate (E470b) and talc (E553b).

What Lamotrigine Tablets look like and contents of the pack

Lamotrigine Tablets are yellow, round, flat, bevelled edged tablets with LMT marked on one side and with a score line and the tablet strength marked on the other side.

The 25mg tablets are available in pack sizes of 21 or 56.

The 50mg tablets are available in pack sizes of 42 or 56.

The 100mg and 200mg tablets are available in pack sizes of 56.

Manufacturer and marketing authorisation holder:

Dr. Reddy's Laboratories (UK) Ltd.,

6 Riverview Road, Beverley,

East Yorkshire,

HU170LD

This leaflet was revised in 06/2016

Lamoirigine Dr. Reddy¹ s 25mg Tablets: PL 08553/0221 Lamotrigine Dr. Reddy¹ s 50mg Tablets: PL 08553/0222 Lamotrigine Dr. Reddy's 100mg Tablets: PL 08553/0223

Lamotrigine Dr. Reddy's 200mg Tablets: PL 08553/0224