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Lamotrigine Teva 200mg Dispersible Tablets

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Package leaflet: Information for the user

Lamotrigine Teva 2, 5, 25, 50, 100 and 200 mg dispersibleTablets

Read all of this leaflet carefully before you start using 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 signs of illness 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 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

1.    What Lamotrigine is and what it is used for

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

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

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

Lamotrigine 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 dispair). 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.    What you need to know before you take Lamotrigine Do not take Lamotrigine:

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

If this applies to you:

Tell your doctor, and don’t take Lamotrigine.

Warnings and precautions

Talk to your doctor or pharmacist before taking lamotrigine

•    if you have any kidney problems

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

•    if you have ever developed meningitis after taking lamotrigine (read the description of these symptoms in Section 4 of this leaflet: Very rare side effects)

   if you 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. 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.

A small number of people being treated with anti-epileptics such as Lamotrigine 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 for epilepsy

The seizures in some types of epilepsy may 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.

Children and adolescents

Lamotrigine 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.

Other medicines and Lamotrigine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems.

This is to make sure you take the correct dose of Lamotrigine. These medicines include:

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

•    lithium 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 or make it more likely that people 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

•    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 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 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 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 Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It’s important that you do this because 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, so your doctor may take samples of your blood to check the level of Lamotrigine, and may adjust your dose.

Breast-feeding

*    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.

3. How to take Lamotrigine

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 for you. The dose you take will depend on:

•    your age

•    whether you are taking Lamotrigine with other medicines

•    whether you have any kidney or liver problems .

Your doctor will prescribe 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 than your doctor tells you to.

Use in children and adolescents

The usual effective dose of Lamotrigine for adults and children aged 13 years or over 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. It can be taken it with or without food.

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

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.

Lamotrigine dispersible/chewable tablets can be swallowed whole with a little water, chewed, or mixed with water to make a liquid medicine.

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 until the tablet is fully dissolved.

Drink all the liquid.

Add a little more water to the glass and drink that, to make sure no medicine is left in the glass.

If you take more Lamotrigine than you should

Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine packet.

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)

   loss of consciousness or coma.

If you forget to take Lamotrigine

Don’t take a double dose to make up for a forgotten dose.

If you have missed taking a dose of Lamotrigine:

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

Lamotrigine must be taken for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you are taking Lamotrigine for epilepsy

To stop taking Lamotrigine, it is important that your dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine, your epilepsy may come back or get worse.

If you are 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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you get any of the following side effects, stop taking this medicine and seek urgent medical advice immediately.

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

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 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 (DRESS)

   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 the 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.

But you must be aware that they

such as organ failure, if they are not

out tests on your liver, kidneys or


In many cases, these symptoms will be signs of less serious side effects. are potentially serious and can develop into more serious problems, treated. If you notice any of these symptoms:

Contact a doctor immediately. Your doctor may decide to carry blood, and may tell you to stop taking Lamotrigine.

Very Common side effects (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 (may affect up to 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 (may affect up to 1 in 1,000 people):

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

   a severe skin reaction (Stevens-Johnson syndrome: see also the information at the beginning of section

4).

Very rare side effects (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 jerking, shaking or stiffness

•    a severe 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)

•    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, agranulo-cytosis), 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 serious 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 side effects

Other side effects have occurred in a small number of people but their exact frequency is unknown:

•    A group of symptoms together including: fever, nausea, vomit

•    ing, 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.

• 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.

5.    How to store Lamotrigine

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 after the abbreviation EXP.

The expiry date refers to the last day of that month.

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

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 Teva Tablets contains:

•    The active ingredient is lamotrigine 2, 5, 25, 50, 100 or 200 mg

•    The other ingredients are mannitol (E421), cellulose microcrystalline, sodium starch glycolate (Type A), maize starch pregelatinised, croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate, saccharin sodium, artificial cherry flavour (constituents including modified food starch (E1450).

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

•    Lamotrigine 2 mg Dispersible Tablets are white to off-white round tablets debossed with the number “2” on one side and “DLT” on the other

•    Lamotrigine 5 mg Dispersible Tablets are white to off white, round tablets, debossed with the number “93” on one side and “688” on the other

•    Lamotrigine 25 mg Dispersible Tablets are white to off white, oval shaped tablets, debossed with the number “93” on one side and “132” on the other

•    Lamotrigine 50 mg Dispersible Tablets are white to off white, round tablets, debossed with the number “50” on one side and “DLT” on the other

•    Lamotrigine 100 mg Dispersible Tablets are white to off white, round tablets, debossed with the number “100” on one side and “DLT” on the other

•    Lamotrigine 200 mg Dispersible Tablets are white to off white, round tablets, debossed with the number “200” on one side and “DLT” on the other

•    The 2 mg tablets are available in pack sizes of 28 and 30

•    The 5 mg tablets are available in pack sizes of 28, 30, 50, 56, 60 and 90

•    The 25 mg tablets are available in pack sizes of 21, 28, 30, 42, 50, 56, 60 and 90

•    The 50 mg tablets are available in pack sizes of 28, 30, 42, 50, 56, 60, 90, 100 and 200

•    The 100 and 200 mg tablets are available in pack sizes of 28, 30, 50, 56, 60, 90, 100 and 200 Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,BN22 9AG.

This leaflet was last revised in 05/ 2014.