The name of your medicine is APO-Lamotrigine. It contains the active ingredient lamotrigine.
Lamotrigine belongs to a group of medicines called "anti-epileptic drugs".
It is used to treat epilepsy in adults and children aged 2 years and over.
Usually lamotrigine is used in addition to other medicines for the treatment of epilepsy. Lamotrigine is used in partial seizures (seizures that affect only one part of the brain) or generalised seizures (seizures that affect the whole brain), including Lennox-Gastaut Syndrome (a severe form of epilepsy characterised by several seizure types).
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
This medicine may be used to treat epilepsy in children 2 years of age and over.
Do not take this medicine if:
Tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
4. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. You are taking or are planning to take any other medicines, This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with lamotrigine. These include:
If you are taking any of these medicines you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with lamotrigine.
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Usually your doctor will prescribe a low dose to start and gradually increase the dose during the first few weeks of treatment. The dose that your doctor prescribes will often depend on other anti-epileptic medications you are taking and your response to lamotrigine.
If you start or stop taking hormonal contraceptives (e.g. "the pill") while taking lamotrigine, your doctor may need to adjust the dose of lamotrigine depending on how well your condition is being treated.
You should tell your doctor if there are any changes in your menstrual pattern, such as breakthrough bleeding.
If you become pregnant your doctor may need to change your dose of lamotrigine or switch you to a different medicine.
The dosage for children usually depends on their weight. Children's weight should be checked and the dose reviewed as weight changes occur.
The tablets may be swallowed whole, chewed or dispersed in a glass of water (at least enough water to dissolve the whole tablet).
Take this medicine at the same time each day. Taking your medicine at the same time each day will have the best effect and it will also help you remember when to take it.
Continue taking your medicine for as long as your doctor tells you to.
Make sure you have enough to last over weekends and holidays.
Do not stop taking your tablets or change the dose without first checking with your doctor.
Contact your doctor immediately if you have forgotten to take your dose of lamotrigine. Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Your doctor will tell you if there are any special instructions while you are taking lamotrigine tablets.
If you develop any skin rash (e.g. hives or spots) while being treated with lamotrigine, contact your doctor immediately.
There have been reports of skin rash associated with lamotrigine treatment. Skin rash can potentially be serious and cause severe illness.
Tell your doctor that you are taking this medicine if:
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Do not stop taking lamotrigine or change the dose because you are feeling better.
If you stop taking lamotrigine tablets abruptly your epilepsy may worsen or come back. This is known as "rebound seizures".
Your doctor will advise you if you need to stop taking lamotrigine and, if so, how to do this safely. If you are unsure whether you should stop taking lamotrigine talk to your doctor.
Be careful driving or operating machinery until you know how lamotrigine affects you.
Lamotrigine may cause dizziness and drowsiness, and affect alertness in some people.
Make sure you know how lamotrigine affects you 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. If you drink alcohol, your dizziness or light-headedness may be worse. If any of these effects do not go away or are troublesome you should see your doctor.
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 as soon as possible if you do not feel well while you are taking lamotrigine or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following.
This list includes the more common side effects. Mostly, these are mild:
Other reported side effects include:
Some people may have changes in their blood count, which may make them feel tired, short of breath and more susceptible to infections. They may also bleed or bruise very easily or have mouth ulcers or a sore throat.
In general these side effects usually happen only during the first few weeks of treatment with Lamotrigine. If any of these side effects persist, or are troublesome, see your doctor.
Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. Information from a large number of studies in patients being treated with anti-epileptic medicines such as lamotrigine has shown a small number of reports of suicidal behaviour (including suicidal thoughts and suicide attempts).
Tell your doctor immediately if you experience any of the following:
Tell your Doctor immediately or go to the Accident and Emergency department of your nearest hospital if you have any thoughts of harming yourself or committing suicide.
Tell your doctor immediately if you notice any of the following:
If you are taking Lamotrigine for epilepsy, rarely, you may start to experience more seizures than usual. Tell your doctor as soon as possible if your seizures get worse or if you have a new type of seizure.
These are all very serious side effects and you may need urgent medical attention or hospitalisation.
Serious side effects are rare.
Another rare side effect is "Lupus-like reactions" which can cause symptoms such as fever, pain in the joints and general ill health.
A very rare side effect is meningitis which may present as a group of symptoms consisting of 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.
Tell your doctor if you are female and your menstrual periods change.
This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.
If you think you are having an allergic reaction to lamotrigine, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
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.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
APO-Lamotrigine 25 mg:
White to off-white, uncoated, circular flat bevelled tablets debossed with "LI2" on one side, plain on the other side having a characteristic fruity odour.
APO-Lamotrigine 50 mg:
White to off-white, uncoated, circular flat bevelled tablets debossed with "LI3" on one side, plain on the other side having a characteristic fruity odour.
APO-Lamotrigine 100 mg:
White to off-white, uncoated, circular flat bevelled tablets debossed with "LI4" on one side, plain on the other side having a characteristic fruity odour.
APO-Lamotrigine 200 mg:
White to off-white, uncoated, circular flat bevelled tablets debossed with "LI5" on one side, plain on the other side having a characteristic fruity odour.
APO-Lamotrigine tablets are available in blister packs of 56 tablets.
Each tablet contains lamotrigine as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, tartrazine-free and free of other azo dyes.
APO-Lamotrigine 25 mg
(blister pack): AUST R 167520.
APO-Lamotrigine 50 mg
(blister pack): AUST R 167521.
APO-Lamotrigine 100 mg
(blister pack): AUST R 167523.
APO- Lamotrigine 200 mg
(blister pack): AUST R 167524.