SUMMARY CMI
APX-LAMOTRIGINE
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
1. Why am I using APX-LAMOTRIGINE?
APX-LAMOTRIGINE contains the active ingredient Lamotrigine. APX-LAMOTRIGINE is used to treat epilepsy.
For more information, see Section 1. Why am I using APX-LAMOTRIGINE? in the full CMI.
2. What should I know before I use APX-LAMOTRIGINE?
Do not use if you have had an allergic reaction to APX-LAMOTRIGINE or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use APX-LAMOTRIGINE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with APX-LAMOTRIGINE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use APX-LAMOTRIGINE?
APX-LAMOTRIGINE may be swallowed whole, chewed or dispersed in a small volume of water (at least enough to cover the whole tablet).
More instructions can be found in Section 4. How do I use APX-LAMOTRIGINE? in the full CMI.
5. What should I know while using APX-LAMOTRIGINE?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using APX-LAMOTRIGINE? in the full CMI.
6. Are there any side effects?
Common side effects include dizziness, movement problems, 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, diarrhea, dry mouth. Serious side effects include serious skin and allergic reactions, liver and blood problems.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
WARNING: There are reports of severe, potentially life-threatening rashes associated with Lamotrigine treatment, particularly in children. APX-LAMOTRIGINE should be discontinued at the first sign of rash unless the rash is clearly not drug related.
FULL CMI
APX-LAMOTRIGINE
Active ingredient: Lamotrigine
Consumer Medicine Information (CMI)
This leaflet provides important information about using APX-LAMOTRIGINE. 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 APX-LAMOTRIGINE.
Where to find information in this leaflet:
1. Why am I using APX-LAMOTRIGINE?
2. What should I know before I use APX-LAMOTRIGINE?
3. What if I am taking other medicines?
4. How do I use APX-LAMOTRIGINE?
5. What should I know while using APX-LAMOTRIGINE?
6. Are there any side effects?
7. Product details
1. Why am I using APX-LAMOTRIGINE?
APX-LAMOTRIGINE contains the Lamotrigine as the active ingredient and belongs to a group of medicines called "anti-epileptic drugs".
Anti-epileptic drugs such as APX-LAMOTRIGINE are used to treat epilepsy.
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.
Ask your doctor if you have any questions about why APX-LAMOTRIGINE has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor's prescription.
There is no evidence that it is addictive.
2. What should I know before I use APX-LAMOTRIGINE?
Warnings
Do not use APX-LAMOTRIGINE 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 APX-LAMOTRIGINE.
Do not take APX-LAMOTRIGINE if the expiry date (Exp.) printed on the pack has passed.
Do not take it if the packaging shows signs of tampering or the tablets do not look quite right.
Check with your doctor if you:
- 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
- take any medicines for any other condition
- if you are taking any other medicines that contain lamotrigine
- Are allergic to any other medicines or any foods, dyes or preservatives
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Tell your doctor immediately if you become pregnant or if you are planning to become pregnant.
Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.
APX-LAMOTRIGINE 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 APX-LAMOTRIGINE, receive pre-pregnancy counselling regarding the possible risk to their unborn child.
Studies have shown a decrease in the levels of folic acid during pregnancy when APX-LAMOTRIGINE 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.
APX-LAMOTRIGINE can pass into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking this medicine if you are breast feeding.
Use in Children
APX-LAMOTRIGINE 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.
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 APX-LAMOTRIGINE. 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 APX-LAMOTRIGINE 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APX-LAMOTRIGINE.
4. How do I use APX-LAMOTRIGINE?
Taking APX-LAMOTRIGINE for the first time
You may notice that you feel dizzy, tired or unsteady in the first few weeks of treatment with APX-LAMOTRIGINE tablets. 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 appliances, and you should not drive a car. If any of these effects do not go away or are troublesome you should see your doctor.
Ask your doctor or pharmacist if you have any questions about taking APX-LAMOTRIGINE.
How much to take
It may take a while to find the best dose of APX-LAMOTRIGINE for you. The dose you take will depend on:
- your age and weight
- whether you are taking it with other medications
- whether you have any kidney or liver problems
Never take more APX-LAMOTRIGINE 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 with 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 this medicine. 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 change the dose of APX-LAMOTRIGINE as the ‘pill’ may not work effectively for contraception whilst taking it.
When to take APX-LAMOTRIGINE
Talk to your doctor or pharmacist to work out when it is best for you to take your doses of APX-LAMOTRIGINE.
How to take APX-LAMOTRIGINE
APX-LAMOTRIGINE 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
Do not stop taking APX-LAMOTRIGINE or change the dose without first checking with your doctor.
Your doctor will advise you if you need to stop taking this medicine and how to do this gradually over a period of two weeks.
If you forget to use APX-LAMOTRIGINE
APX-LAMOTRIGINE should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking it as you would normally.
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 take too much APX-LAMOTRIGINE
If you take too much APX-LAMOTRIGINE you may be more likely to have serious side effects which may be fatal.
Symptoms of overdose can include rapid, uncontrollable eye movements, clumsiness and lack of coordination affecting your balance, impaired or loss of consciousness, fits or coma.
If you think that you have used too much APX-LAMOTRIGINE, 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.
5. What should I know while using APX-LAMOTRIGINE?
Things you should do
Take APX-LAMOTRIGINE exactly as your doctor has prescribed. Call your doctor straight away if you develop any skin rash, like spots or hives, during APX-LAMOTRIGINE treatment.
There are reports of severe, potentially life-threatening rashes associated with APX-LAMOTRIGINE treatment particularly in children.
APX-LAMOTRIGINE 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 APX-LAMOTRIGINE 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 all the doctors, dentists and pharmacists who are treating you that you are taking APX-LAMOTRIGINE, especially if you are about to start on any new medicines.
If you require a laboratory test, tell your doctor or hospital that you are taking APX-LAMOTRIGINE.
It may interfere with some laboratory tests to detect other drugs.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it is not working as it should and change your dosage unnecessarily.
Things you should not do
Do not stop taking APX-LAMOTRIGINE, even if you feel better, or change the dose without first checking with your doctor.
Stopping this medicine suddenly may cause your epilepsy to come back or be worse. This is known as “rebound seizures”.
Your doctor will advise you if you need to stop taking APX-LAMOTRIGINE and how to do it gradually over about 2 weeks.
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Do not take APX-LAMOTRIGINE to treat any other complaints unless your doctor says to.
Things to be careful of
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 APX-LAMOTRIGINE should be especially watchful for any changing behaviour.
Anti-epileptic medicines such as APX-LAMOTRIGINE may increase the risk of suicidal behaviour (including suicidal thoughts and suicide attempts).
Driving or using machines
Be careful before you drive or use any machines or tools until you know how APX-LAMOTRIGINE affects you.
Make sure you know how you react to it 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets in a cool dry place, protected from light and moisture, where the temperature stays below 25C.
Keep your tablets in the container until it is time to take them. If you take the tablets out of the bottle they may not keep as well.
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 windowsills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking APX-LAMOTRIGINE or your tablets have passed their expiry date, return any unused or expired medicine to your pharmacist.
Do not use this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor as soon as possible if you do not feel well while you are taking APX-LAMOTRIGINE
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.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
In general, these side effects usually happen during the first few weeks of treatment with APX-LAMOTRIGINE.
Serious side effects
Serious side effects | What to do |
Liver and blood problems
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Your doctor may decide to carry out tests on your liver, kidneys or blood and may tell you to stop taking APX-LAMOTRIGINE if you experience these rare symptoms.
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 APX-LAMOTRIGINE.
All mentions of suicide or violence must be taken seriously. Families and caregivers of children and adolescents who are taking this medicine should be especially watchful for any changing behaviour.
Anti-epileptic medicines such as APX-LAMOTRIGINE may increase the risk of suicidal behaviour (including suicidal thoughts and suicide attempts).
Potentially serious skin reaction
A small number of people taking APX-LAMOTRIGINE 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 APX-LAMOTRIGINE especially if the dose is too high or if the dose is increased too quickly, or if it is taken with a medicine called valproate. Serious skin reactions are more common in children.
Potentially serious aseptic meningitis
APX-LAMOTRIGINE 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.
Potentially serious / life threatening arrhythmia
If you have had a fast heartbeat, heart failure, or other heart problems, you should not take lamotrigine. This drug may cause you to have an abnormal heartbeat, which could lead to sudden death. Symptoms include a fast, slow, or pounding heartbeat, shortness of breath, chest pain, and feeling lightheaded.
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 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 APX-LAMOTRIGINE contains
Active ingredient (main ingredient) | Lamotrigine |
Other ingredients (inactive ingredient) |
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Potential allergens | Lactose |
Do not take this medicine if you are allergic to any of these ingredients.
What APX-LAMOTRIGINE looks like
APX-LAMOTRIGINE tablets come in 4 strengths: 25 mg, 50 mg, 100 mg & 200 mg.
The tablets are white to off-white, round, flat-faced edge tablets, plain on both sides.
APX-LAMOTRIGINE 25mg (AUST R 340907): White to off-white, modified square shape, engraved with “L” and “25” on one side, plain on the other side.
APX-LAMOTRIGINE 50mg (AUST R 340908): White to off-white, modified square shape, engraved with “L” and “50” on one side, plain on the other side.
APX-LAMOTRIGINE 100mg (AUST R 340909): White to off-white, modified square shape, engraved with “L” and “100” on one side, plain on the other side.
APX-LAMOTRIGINE 200mg (AUST R 340910): White to off-white, modified square shape, engraved with “L” and “200” on one side, plain on the other side.
Available in blister packs of 56 tablets.
Who distributes APX-LAMOTRIGINE
Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au
This leaflet was revised in March 2025.
Published by MIMS May 2025