WARNING: 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.

Active ingredient(s): Lamotrigine

Consumer Medicine Information (CMI)

This leaflet provides important information about using LAMICTAL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using LAMICTAL.

Where to find information in this leaflet:

1. Why am I using LAMICTAL?
2. What should I know before I use LAMICTAL?
3. What if I am taking other medicines?
4. How do I use LAMICTAL?
5. What should I know while using LAMICTAL?
6. Are there any side effects?
7. Product details

1. Why am I using LAMICTAL?

LAMICTAL contains the active ingredient lamotrigine. LAMICTAL is an anti-epileptic drug. It is thought to work by changing the levels of some chemicals in the brain that are associated with seizures.

LAMICTAL is 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.

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

It is not addictive.

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any question about why LAMICTAL has been prescribed for you.

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

2. What should I know before I use LAMICTAL?

Warnings

Do not use LAMICTAL if:

• you are allergic to lamotrigine, or any of the ingredients listed at the end of this leaflet.
• always check the ingredients to make sure you can use this medicine.
• if the expiry date (EXP) printed on the pack has passed.
• if the packaging is torn or shows signs of tampering.

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

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

Check with your doctor if you:

• have any other medical conditions including liver or kidney disease, a history of allergy or rash to other antiepileptic drugs, Parkinson’s disease or if you have ever developed meningitis after taking lamotrigine.
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

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 so.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend 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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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 breastfeeding.

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.

3. What if I am taking other medicines?

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

Some medicines may interfere with LAMICTAL and affect how it works. 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 LAMICATAL 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.

Medicines that may reduce the effect of LAMICTAL include:

• Hormonal contraceptives

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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect LAMICTAL.

4. How do I use LAMICTAL?

How much to take / use

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.

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.

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.

If you forget to use LAMICTAL

LAMICTAL should be used regularly at the same time each day. If you miss your dose at the usual time.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much LAMICITAL

If you think that you have used too much LAMICTAL you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should 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.

5. What should I know while using LAMICTAL?

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.

Things you should do

Take LAMICTAL exactly how your doctor has prescribed.

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.

Contact your doctor immediately if you develop any skin rash such as spots or ‘hives’ during LAMICTAL treatment.

There are reports of rare, severe, potentially life-threatening rashes associated with LAMICTAL treatment, particularly in children.

These rashes may be from conditions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Haemophagocytic Lymphohistiocytosis (HLH) which can be fatal if not treated immediately.

LAMICTAL should be discontinued at the first sign of rash unless the rash is clearly not drug related.

Contact your doctor if you experience a rash or sunburn after taking LAMICTAL and having been exposed to sun or artificial light, e.g. solarium.

Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself against the sun, e.g. use of a sunscreen and/or to wear protective clothing.

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).

Talk to your doctor if you are or are planning to become pregnant or breastfeed.

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 should 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how LAMICTAL affects you.

LAMICTAL may cause dizziness in some people.

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.

Looking after your medicine

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

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor as soon as possible if you do not feel well while taking LAMICTAL

Less serious side effects

Serious side effects

Suicidal thoughts or other mental/mood changes

Lamictal may increase the risk of suicidal behavior (including suicidal thoughts and attempts).

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 behavior.

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.

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 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 reactions e.g. rash, hives
• skin rash or sunburn after exposure to sun or artificial light
• wheezing, difficulty breathing
• swelling of face, lips or tongue
• sore mouth or eyes
• fever
• swollen glands.

Potentially serious aspect meningitis

LAMICTAL increases the risk of developing aseptic meningitis, which is a serious inflammation of the protective membrane that covers the brain and spinal cord.

Many of the side effects already listed are symptoms of this condition, as well as light sensitivity, stiff neck, muscle pains and chills.

Tell your doctor if you notice any of these 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 or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What LAMICTAL contains

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

Do not take this medicine if you are allergic to any of these ingredients.

What LAMICTAL looks like

LAMICTAL dispersible/chewable tablets come in 5 different strengths.

LAMICTAL 5 mg:

White to off-white, caplet shaped biconvex tablet embossed with “5” on one side and plain on the other.

Available in bottles of 56 tablets.

(Aust R 51718)

LAMICTAL 25 mg:

White to off-white, multi-faceted, superelliptical (rounded square), unscored tablets. 25 mg tablet is plain on one side and ‘25’ on the other side.

(Aust R 51548)

LAMICTAL 50 mg:

White to off-white, multi-faceted, superelliptical (rounded square), unscored tablets. 50 mg tablet is plain on one side and ‘50’ on the other side.

(Aust R 57190)

LAMICTAL 100 mg:

White to off-white, multi-faceted, superelliptical (rounded square), unscored tablets. 100 mg tablet is plain on the one side and ‘100’ on the other side.

(Aust R 51549)

LAMICTAL 200 mg: white to off-white, multi-faceted, superelliptical (rounded square), unscored tablets. 200 mg tablet is plain on the one side and ‘200’ on the other side.

(Aust R 57262)

The 25 mg, 50 mg, 100 mg or 200 mg strengths are available in blister packs of 56 tablets. The 25 mg tablet is also available in sample packs of 7 tablets.

Who distributes LAMICTAL

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

This leaflet was revised in October 2022.

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