Lamictal Chewable tablets

Lamictal Chewable tablets is a brand of medicine containing the active ingredient lamotrigine.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

LAMICTAL®
dispersible/chewable tablets

lamotrigine


Consumer Medicine Information

There are reports of severe, potentially life-threatening rashes associated with Lamictal treatment, particularly in children. Lamictal should be discontinued at the first sign of rash unless the rash is clearly not drug related.

What is in this leaflet

This leaflet answers some common questions about Lamictal tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Lamictal against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

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What Lamictal is used for

Lamictal tablets contain lamotrigine as the active ingredient and belongs to a group of medicines called "anti-epileptic drugs".

Anti-epileptic drugs such as Lamictal are used to treat several conditions, including epilepsy and bipolar disorder.

It is used for the treatment of epilepsy in patients over 2 years of age. In general, it is initially used in addition to other medicines, for the treatment of epilepsy including partial or generalized seizures and Lennox-Gastaut syndrome. It is thought that this medicine works by changing the levels of some chemicals associated with seizures.

Lamictal is also used to help prevent depression in adults over 18 years of age with bipolar disorder.

Ask your doctor if you have any questions about why Lamictal has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor’s prescription.

It is not addictive.

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Before you take it

When you must not take it

Do not take Lamictal if you have ever had an allergic reaction to:

  • lamotrigine
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take this medicine after the expiry date (EXP) printed on the pack has passed.

Do not take it if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are taking any other medicines that contain lamotrigine.

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you have or have had any of the following medical conditions:

  • a history of allergy or rash to other anti-epileptic drugs
  • liver or kidney disease
  • Parkinson's disease
  • if you have ever developed meningitis after taking lamotrigine.

Tell your doctor if you are pregnant or trying to become pregnant. Lamictal may affect your unborn baby if you take it during pregnancy but it is still important that you control your fits while you are pregnant. Your doctor will discuss the risks and benefits of taking it during pregnancy.

It is recommended that women on anti-epileptic drugs, such as Lamictal, receive pre-pregnancy counselling with regard to the possible risk to their unborn child.

Studies have shown a decrease in the levels of folic acid during pregnancy when Lamictal is also used. It is therefore recommended that you take a daily 5 mg folate supplement before becoming pregnant and during the first 12 weeks of your pregnancy.

Tell your doctor if you are breast feeding or planning to breast feed. Lamictal can pass into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking Lamictal if you are breast feeding.

Do not give this medicine to anyone else even if their symptoms seem similar to yours.

Do not take Lamictal to treat any other complaints unless your doctor says to.

Use in children

Epilepsy: Lamictal is not recommended in children under 2 years of age. Children's weight should be checked and the dose reviewed as weight changes with growth occur.

Bipolar: Lamictal is not recommended in children and adolescents under 18 years of age.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with Lamictal. These include:

  • valproate and carbamazepine, used to treat both epilepsy and mental health problems
  • any form of hormonal medicine, e.g. "the pill" or HRT
  • other anti-epileptic drugs, e.g. phenytoin, primidone or phenobarbitone
  • OCT2 substrates such as dofetilide
  • rifampicin, an antibiotic, which is used to treat infections, including tuberculosis
  • medicines used to treat Human Immunodeficiency Virus (HIV) infection
  • risperidone, used to treat mental health problems.

These medicines may be affected by Lamictal or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to avoid while taking Lamictal.

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How to take it

Using Lamictal for the first time

You may notice that you feel dizzy, tired or unsteady in the first few weeks of treatment with Lamictal. During this period you may also notice that you have slight problems with your vision. As your reactions may be slower during this period you should not operate any machinery or drive a car. If any of these effects do not go away or are troublesome you should see your doctor.

Contact your doctor immediately if you develop any skin rash such as spots or 'hives' during Lamictal treatment.

There are reports of severe, potentially life-threatening rashes associated with Lamictal treatment, particularly in children. Lamictal should be discontinued at the first sign of rash unless the rash is clearly not drug related.

If you have any questions about taking Lamictal ask your doctor or pharmacist.

How much to take

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

  • your age and weight
  • whether you are taking Lamictal with other medications
  • whether you have any kidney or liver problems.

Never take more Lamictal than your doctor tells you to.

Do not increase the dose more quickly than you have been told.

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.

Women taking hormonal contraceptives, such as the birth control ‘pill’ may need a higher maintenance dose of Lamictal. Your doctor will usually decrease your dose once you stop taking hormonal contraceptives.

Tell your doctor if there are any changes in your menstrual pattern such as breakthrough bleeding whilst on the ‘pill’. Your doctor may need to adjust the dose of Lamictal as the ‘pill’ may not work as effectively for contraception whilst taking it.

How to take it

Lamictal tablets may be swallowed whole, chewed or dispersed in a small volume of water (at least enough to cover the whole tablet).

It can be taken with or without food.

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

How long to take it

For epilepsy patients, do not stop taking Lamictal or change the dose without first checking with your doctor. Your doctor will advise you if you need to stop taking Lamictal tablets and how to do this gradually over a period of two weeks.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too many Lamictal tablets. Do this even if there are no signs of discomfort or poisoning.

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

Symptoms of Lamictal overdose can include rapid, uncontrollable eye movements, clumsiness and lack of coordination affecting your balance, impaired or loss of consciousness, fits or coma.

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While you are taking it

Things you must do

Take Lamictal exactly as your doctor has prescribed.

Contact your doctor immediately if you develop any skin rash such as spots or 'hives' during Lamictal treatment.

There are reports of severe, potentially life-threatening rashes associated with Lamictal treatment, particularly in children. Lamictal should be discontinued at the first sign of rash unless the rash is clearly not drug related.

Tell any other doctor, dentist or pharmacist who is treating you that you are taking Lamictal, especially if you are about to be started on any new medicines.

If you require a laboratory test, tell your doctor or hospital that you are taking this medicine. Lamictal may interfere with some laboratory tests to detect other drugs.

Talk to your doctor as soon as possible if you are pregnant or if you are planning to become pregnant. Your doctor will discuss the risks and benefits of taking Lamictal during pregnancy.

Talk to your doctor if you are breast feeding or planning to breast feed. Lamictal can pass into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast feeding while you are taking it.

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Things you must not do

For epilepsy patients, do not stop taking Lamictal or change the dose without first checking with your doctor.

If you stop taking Lamictal suddenly, your epilepsy may come back or become worse. This is known as "rebound seizures". Your doctor will advise you if you need to stop taking Lamictal and how to do this gradually over about 2 weeks.

Do not take a double dose to make up for any that you may have missed.

Things to be careful of

Be careful driving or operating machinery until you know how Lamictal affect you. Make sure you know how you react to Lamictal before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.
Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling dizzy or sleepy.

Tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital if you or someone you know has any suicidal thoughts or other mental/mood changes. All mentions of suicide or violence must be taken seriously. Families and caregivers of children and adolescents who are taking Lamictal should be especially watchful for any changing behaviour. Anti-epileptic medicines such as Lamictal may increase the risk of suicidal behaviour (including suicidal thoughts and suicide attempts).

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Side effects

Tell your doctor as soon as possible if you do not feel well while you are taking Lamictal. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

The most commonly reported side effects of Lamictal are:

  • dizziness
  • movement problems such as tics, unsteadiness and jerkiness
  • tremors
  • skin rash
  • headache
  • nausea
  • vomiting
  • feeling drowsy or tired
  • blurred or double vision
  • rapid, uncontrollable eye movements
  • trouble sleeping
  • feeling sleepy
  • irritability, aggression or agitation
  • hallucinations, confusion
  • increased activity in children
  • joint, back or stomach pain
  • respiratory or lung problems
  • depression
  • loss of memory
  • liver problems
  • diarrhoea
  • dry mouth.

In general these side effects usually happen during the first few weeks of treatment with Lamictal.

Tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital if you or someone you know has any suicidal thoughts or other mental/mood changes whilst taking Lamictal tablets. All mentions of suicide or violence must be taken seriously. Families and caregivers of children and adolescents who are taking Lamictal should be especially watchful for any changing behaviour. Anti-epileptic medicines such as Lamictal may increase the risk of suicidal behaviour (including suicidal thoughts and suicide attempts).

Potentially serious skin reaction

A small number of people taking Lamictal get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. Severe allergic reactions are rare.

These symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if the dose is too high or if the dose is increased too quickly, or if Lamictal is taken with a medicine called valproate. Serious skin reactions are more common in children. Symptoms of these serious allergic reactions include:

  • any skin reaction, e.g. rash or 'hives'
  • wheezing, difficulty in breathing
  • swelling of the face, lips or tongue
  • sore mouth or sore eyes
  • fever
  • swollen glands.

Tell your doctor immediately if you notice any of the above symptoms.

Liver and blood problems

Tell your doctor if you notice any of these symptoms:

  • drowsiness
  • itching
  • abdominal pain or tenderness
  • feeling very tired
  • easy bruising or unusual bleeding
  • a sore throat, or more infections such as a cold, than usual
  • yellow skin (jaundice).

Your doctor may decide to carry out tests on your liver, kidneys or blood and may tell you to stop taking Lamictal if you experience these rare symptoms.

If you are taking Lamictal for epilepsy, tell your doctor as soon as possible if your seizures get worse or if you have a new type of seizure. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Tell your doctor if you notice anything else that is making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet. Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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After taking it

Storage

Keep Lamictal tablets in a cool dry place, protected from light, where the temperature stays below 30°C.

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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Product description

What it looks like

Lamictal dispersible/chewable tablets come in 6 different strengths.

  • 2 mg: white to off-white round tablets, with an odour of blackcurrant. Marked "LTG 2" on one side and engraved with two overlapping super-ellipses on the other. Available in bottles of 30 tablets.
  • 5 mg: white to off-white, elongated, biconvex, unscored tablets with an odour of blackcurrant. Marked "GSCL2" on one side and "5" on the other. The tablets may be slightly mottled. Available in bottles of 56 tablets.
  • 25 mg/50 mg/100 mg or 200 mg: white to off-white, multi-faceted, superelliptical (rounded square), unscored tablets with an odour of blackcurrant. The tablets may be slightly mottled.
    - The 25 mg tablet is marked "GSCL5" on one side and "25" on the other.
    - The 50 mg tablet is marked "GSCX7" on one side and "50" on the other.
    - The 100 mg tablet is marked "GSCL7" on one side and "100" on the other.
    - The 200 mg tablet is marked "GSEC5" on one side and "200" on the other.
    Available in blister packs of 56 tablets.

Ingredients

Active ingredient:
Each Lamictal tablet contains either 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg of lamotrigine.

Inactive ingredients:

  • calcium carbonate
  • hydroxypropylcellulose
  • aluminium magnesium silicate
  • sodium starch glycollate
  • povidone
  • saccharin sodium
  • magnesium stearate
  • blackcurrant flavour.

Lamictal tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

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CMI provided by MIMS Australia, November 2014  

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