2. What should I know before I take LOGEM?
Do not take if you have ever had an allergic reaction to LOGEM 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,
pregnant or breastfeeding or plan to become pregnant or breastfeed.
3. What if I am taking other medicines?
Some medicines may interfere with LOGEM and affect how it works.
4. How do I take LOGEM?
LOGEM 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 take LOGEM? in the full CMI.
5. What should I know while taking LOGEM?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking LOGEM.
Contact your doctor immediately if you develop any skin rash such as spots or 'hives'
during LOGEM treatment.
|
|
Things you should not do
|
For epilepsy patients, do not stop taking LOGEM or change the dose without first checking
with your doctor.
Do not take a double dose to make up for any that you may have missed.
|
|
Driving or using machines
|
Make sure you know how you react to LOGEM before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy.
|
|
Looking after your medicine
|
Store LOGEM tablets below 25°C.
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the pack, it will not keep well.
|
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.
|
WARNING: There are reports of severe, potentially life-threatening rashes associated
with Lamotrigine treatment, particularly in children. LOGEM should be discontinued
at the first sign of rash unless the rash is clearly not medicine related.
|
Active ingredient(s):
Lamotrigine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking LOGEM. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking LOGEM.
Where to find information in this leaflet:
1. Why am I taking LOGEM?
LOGEM contains lamotrigine as the active ingredient and belongs to a group of medicines
called "anti-epileptic medicine".
Anti-epileptic medicine such as LOGEM, are used to treat epilepsy in patients over
2 years of age. Epilepsy is a condition where you have repeated seizures (fits).
In general, it is initially used in addition to other medicines, for the treatment
of epilepsy including partial or generalised seizures and Lennox- Gastaut syndrome.
It is thought that LOGEM works by changing the levels of some chemicals associated
with seizures.
Ask your doctor if you have any questions about why LOGEM has been prescribed for
you.
Your doctor may have prescribed it for another reason.
There is no evidence that LOGEM is addictive.
2. What should I know before I take LOGEM?
Warnings
Do not take LOGEM if:
you are allergic to any medicine containing lamotrigine, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can take LOGEM.
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 LOGEM after the expiry date printed on the pack has passed.
Do not take it if the packaging is torn or shows signs of tampering.
If it has expired or is damage, return it to your pharmacist for disposal.
If you are not sure whether you should start taking LOGEM, talk to your doctor.
Check with your doctor if you have or have had any of the following medical conditions:
a history of allergy or rash to other anti-epileptic medicine
liver or kidney disease
Parkinson’s disease
if you have ever developed meningitis after taking lamotrigine
Tell your doctor if you are:
taking any other medicines that contain lamotrigine
allergic to any other medicines or any foods, dyes or preservatives
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?
Pregnancy and breastfeeding
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 LOGEM during pregnancy.
LOGEM 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 medicine, such as LOGEM, 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 LOGEM
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.
LOGEM can pass into breast milk and may affect your baby. Your doctor will discuss
the risks and benefits of taking LOGEM if you are breastfeeding.
Use in children
LOGEM 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 LOGEM 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 medicine, e.g. phenytoin, primidone or phenobarbital
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 LOGEM 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 LOGEM.
4. How do I take LOGEM?
Taking LOGEM for the first time
You may notice that you feel dizzy, tired or unsteady in the first few weeks of treatment
with LOGEM. 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.
Ask your doctor or pharmacist if you have any questions about taking LOGEM.
How much to take
It may take a while to find the best dose of LOGEM for you. The dose you take will
depend on:
your age and weight
whether you are taking LOGEM with other medications
whether you have any kidney or liver problems
Never take more LOGEM 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 LOGEM. 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 LOGEM as the ‘pill’ may not work as effectively
for contraception whilst taking it.
When to take LOGEM
Talk to your doctor or pharmacist to work out when it is best for you to take your
doses of LOGEM.
How to take LOGEM
LOGEM 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
Continue taking your medicine for as long as your doctor tells you.
LOGEM helps to control your condition, but does not cure it. It is important to keep
taking your medicine even if you feel well.
Do not stop taking LOGEM or change the dose without first checking with your doctor.
Your doctor will advise you if you need to stop taking LOGEM and how to do this gradually
over a period of two weeks.
If you forget to take LOGEM
LOGEM 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 have trouble remembering to take LOGEM, ask your pharmacist for some hints.
If you take too much LOGEM
If you take too much LOGEM, 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 or anyone else has taken too much LOGEM, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, 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 taking LOGEM?
Things you should do
Take LOGEM exactly as your doctor has prescribed.
Contact your doctor immediately if you develop any skin rash, like spots or hives,
during LOGEM treatment.
There are reports of severe, potentially life-threatening rashes associated with LOGEM
treatment particularly in children. LOGEM should be discontinued at the first sign
of rash unless the rash is clearly not medicine related.
Contact your doctor if you experience a rash or sunburn after taking LOGEM 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 any other doctors, dentists and pharmacists who are treating you that you are
taking LOGEM, especially if you are about to start on any new medicines.
If you require a blood test or laboratory test, tell your doctor or hospital that
you are taking LOGEM.
LOGEM 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 LOGEM during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
LOGEM can pass into breast milk and may affect your baby. Your doctor will discuss
the risks and benefits of taking LOGEM if you are breastfeeding.
Keep all of your doctor's appointments so that your progress can be checked.
Seek immediate medical attention if you experience symptoms such as fever, rash or
enlarged/swollen lymph nodes whilst taking LOGEM.
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.
Remind any doctor, dentist or pharmacist you visit that you are taking LOGEM.
Things you should not do
Do not stop taking LOGEM, even if you feel better, or change the dose without first
checking with your doctor.
If you stop taking LOGEM 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
LOGEM and how to do it gradually over about 2 weeks.
Do not take a double dose to make up for the dose you may have missed.
Do not give LOGEM to anyone else even if their symptoms seem similar to yours.
Do not take LOGEM to treat any other complaints unless your doctor tells you 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 LOGEM should be especially watchful for
any changing behaviour.
Anti-epileptic medicines such as LOGEM may increase the risk of suicidal behaviour
(including suicidal thoughts and suicide attempts).
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling dizzy or sleepy.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how LOGEM
affects you.
As with other anticonvulsant medicines for the treatment of epilepsy, LOGEM may cause
dizziness and drowsiness in some people and affect alertness.
Make sure you know how you react to LOGEM 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store your tablets below 25°C.
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the pack, it will not keep 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.
Heat and dampness can destroy some medicines.
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 LOGEM or your tablets have passed their expiry
date, take it to your pharmacist for safe disposal.
Do not use LOGEM 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
LOGEM
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.
Do not be alarmed by the following list of side effects. You may not experience any
of them.
Ask your doctor or pharmacist to answer any questions you may have.
Less serious side effects
In general, these side effects usually happen during the first few weeks of treatment
with LOGEM.
Serious side effects
Your doctor may decide to carry out tests on your liver, kidneys or blood and may
tell you to stop taking LOGEM 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 LOGEM.
All mentions of suicide or violence must be taken seriously. Families and caregivers
of children and adolescents who are taking LOGEM should be especially watchful for
any changing behaviour.
Anti-epileptic medicines such as LOGEM may increase the risk of suicidal behaviour
(including suicidal thoughts and suicide attempts).
Potentially serious skin reaction
A small number of people taking LOGEM 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. This risk may be associated with a variant in
genes in people from Asian origin (mainly Han Chinese and Thai). If you are of such
origin and have been tested previously carrying this genetic variant (HLA-B* 1502),
discuss this with your doctor before taking LOGEM.
These symptoms are more likely to happen during the first few months of treatment
with LOGEM, especially if the dose is too high or if the dose is increased too quickly,
or if LOGEM is taken with a medicine called valproate. Serious skin reactions are
more common in children.
Potentially serious aseptic meningitis
LOGEM 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. LOGEM 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 if you notice any of these symptoms.
If you are taking LOGEM 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 is making you feel
unwell, even if you think the problems are not connected with LOGEM 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
LOGEM is only available with a doctor's prescription.
What LOGEM contains
|
Active ingredient
(main ingredient)
|
lamotrigine
|
|
Other ingredients
(inactive ingredients)
|
cellulose - microcrystalline
sodium starch glycollate
povidone
purified water
silicon dioxide
saccharin sodium
artificial blackcurrant flavour
mannitol
magnesium stearate.
|
|
Potential allergens
|
saccharin
sulfites
|
LOGEM dispersible/chewable tablets come in 4 different strengths: 25 mg, 50mg, 100
mg & 200 mg.
Do not take LOGEM if you are allergic to any of these ingredients.
What LOGEM looks like
LOGEM 25 - white to off-white, round, flat faced, bevelled edge tablets with "LY"
over "25" on one side and plain on the other side (AUST R 99059).
LOGEM 50 - white to off-white, round, flat faced, bevelled edge tablets with "LY"
over "50" on one side and plain on the other side (AUST R 99360).
LOGEM 100 - white to off-white, round, flat faced, bevelled edge tablets with "LY"
over "100" on one side and plain on the other side (AUST R 99062).
LOGEM 200 - white to off-white, round, flat faced, bevelled edge tablets with "LY"
over "200" on one side and plain on the other side (AUST R 99064).
LOGEM tablets are available in blister packs of 56 tablets.
Who distributes LOGEM
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2025.
LOGEM® is a Viatris company trade mark
LOGEM_cmi\Oct25/00