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Logem

Chewable/Dispersible tablets

contains the active ingredient lamotrigine
CONSUMER MEDICINE INFORMATION
 
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 drug related.
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Logem. It does not contain all the information that is known about Logem. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Logem is used for

Lamotrigine (the active ingredient in Logem tablets) belongs to a group of medicines called "anti-epileptic drugs".
Anti-epileptic drugs such as Logem are used to control epilepsy in adults and children aged 2 years and older. Epilepsy is a condition where you have repeated seizures (fits).
Initially, Logem tablets are usually used in addition to other medicines for the treatment of epilepsy. Logem is used in partial or generalised seizures and Lennox-Gastaut Syndrome.
It is thought that Logem tablets work 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 Logem for another reason.
Logem is only available with a doctor's prescription.
Logem is not addictive.

Before you take Logem

When you must not take it

Do not take Logem tablets if you have ever had an allergic reaction to
any other medicines containing 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 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 this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if:
you are taking any other medicines that contain lamotrigine
you are allergic to any other foods, dyes, preservatives or any other medicines
you have a history of allergy or rash to other anti-epileptic drugs
you are suffering, or have ever suffered, from any liver or kidney disorders
you have Parkinson's disease
you have ever developed meningitis after taking lamotrigine
you are pregnant or trying to become pregnant.
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 Logem during pregnancy.
It is recommended that women on anti-epileptic drugs, such as Logem, 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 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.
you are breast feeding or planning to breast feed.
Logem can pass into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of taking Logem tablets if you are breast feeding.

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 Logem. 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, a medicine 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.
Your doctor or pharmacist has more information on medicines to avoid while taking Logem.

How to take Logem

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the container label, ask your doctor or pharmacist for help.

Using Logem for the first time

You may notice that you feel dizzy, tired, or unsteady in the first few weeks of treatment with Logem 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.
If you develop any skin rash (eg. spots or 'hives') during Logem treatment contact your doctor immediately.
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 drug related.
If you have any questions about taking Logem tablets ask your doctor or pharmacist.

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 change the dose yourself. Do not increase the dose more quickly than you have been told.
Your doctor and pharmacist will be able to tell you:
how many tablets to take at each dose
how many doses to take each day
when to take each of your doses.
If you have any questions about the dose that you have been prescribed, you should ask your doctor or pharmacist.
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.
You should 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 Logem as the "pill" may not work as effectively for contraception whilst taking it.

How to take it

Logem tablets may be swallowed whole, chewed or dispersed in sufficient water 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

Continue taking your medicine for as long as your doctor tells you.
This medicine 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 tablets, or change the dose without first checking with your doctor.
Your doctor will advise you if you need to stop taking Logem tablets and how to do this gradually over a period of two weeks.

Use in children

Logem is not recommended for treatment of epilepsy in children under 2 years of age.
Children's weight should be checked and the dose reviewed as weight changes with growth occur.

If you forget to take it

If you have forgotten to take your dose of Logem tablets contact your doctor immediately.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Logem. Do this even if there are no signs of discomfort or poisoning.
If you take too many Logem tablets you may be more likely to have serious side effects which may be fatal.
Symptoms of Logem overdose can include rapid uncontrollable eye movements, clumsiness and lack of coordination affecting your balance, impaired or loss of consciousness, fits or coma.

While you are taking Logem

Your doctor or pharmacist will be able to tell you whether there are any special instructions while you are taking Logem tablets.

Things you must do

Take Logem exactly as your doctor has prescribed.
If you develop any skin rash (e.g. spots or 'hives') during Logem treatment contact your doctor immediately.
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 drug related.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking Logem, 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.
Logem may interfere with some laboratory tests to detect other drugs.
If you become pregnant while taking Logem, tell your doctor immediately.
Your doctor will discuss the risks and benefits of taking Logem during pregnancy.
Talk to your doctor if you are breastfeeding or planning to breast feed.
The active ingredient of Logem passes into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of breastfeeding while you are taking Logem.
Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Do not take a double dose to make up for the one you have missed.
Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Things you must not do

Do not stop taking Logem Tablets or change the dose just because you feel better, without first checking with your doctor.
Stopping Logem suddenly may allow your epilepsy to return 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 this gradually over about 2 weeks.
Do not take Logem to treat any other complaints unless your doctor tells you to.
Do not give Logem to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery 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.
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 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).

Side effects

Tell your doctor as soon as possible if you do not feel well while you are taking Logem.
Like all other medicines, Logem can cause some side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you have some of the 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.
The most commonly reported side effects of Logem are:
skin rash
headache
dizziness
movement problems such as tics, unsteadiness and jerkiness
feeling drowsy or tired
feeling sick (nausea)
feeling sleepy
blurred or double vision
rapid, uncontrollable eye movements
trouble sleeping
loss of memory
vomiting
tremors
joint, back or stomach pain
irritability, aggression or agitation
hallucinations, confusion
increased activity in children
respiratory or lung problems
depression
dry mouth
diarrhoea
liver problems
In general these side effects usually happen during the first few weeks of treatment with Logem. If any of these side effects persist, or are troublesome, see your doctor.
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 tablets.
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.
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. 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
a high temperature (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
unusual bleeding or bruising more easily than normal
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 Logem if you experience these rare 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 this medicine and are not referred to in this leaflet.
Other side effects not listed above may also occur in some people.

After taking Logem

Storage

Keep Logem 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.
Keep your tablets in their pack until it is time to take them.
If you take the tablets out of the pack they will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Logem or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Logem, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Logem tablets are available in 4 strengths:
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
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
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
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.
Logem tablets are available in packs of 56 tablet.

Ingredients

The active ingredient in Logem is lamotrigine.
Each Logem 25 tablet contains
25 mg of lamotrigine.
Each Logem 50 tablet contains
50 mg of lamotrigine.
Each Logem 100 tablet contains
100 mg of lamotrigine.
Each Logem 200 tablet contains
200 mg of lamotrigine.
The tablets also contain the following inactive ingredients:
cellulose - microcrystalline
sodium starch glycollate
povidone
purified water
silicon dioxide
saccharin sodium
artificial blackcurrant flavour
mannitol
magnesium stearate.
Logem tablets do not contain lactose or gluten..

Manufacturer/ Supplier

Logem is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au
Medical Information
Phone: 1800 028 365
Australian registration numbers:
Logem 25 - AUST R 99059, 99061
Logem 50 - AUST R 99360, 99361
Logem 100 - AUST R 99062, 99063
Logem 200 - AUST R 99064, 99065
This leaflet was prepared on
13 February 2015.
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