Dispersible/chewable tablets
contains the active ingredient lamotrigine
CONSUMER MEDICINE INFORMATION
THERE ARE REPORTS OF SEVERE, POTENTIALLY LIFE-THREATENING RASHES ASSOCIATED WITH LAMOGINE TREATMENT, PARTICULARLY IN CHILDREN. LAMOGINE SHOULD BE DISCONTINUED AT THE FIRST SIGN OF RASH UNLESS THE RASH IS CLEARLY NOT DRUG RELATED.
What is in this leaflet
This leaflet answers some common questions about LAMOGINE tablets. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking LAMOGINE tablets against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What LAMOGINE is used for
Lamogine tablets contain lamotrigine as the active ingredient and belongs to a group of medicines called "anti-epileptic drugs".
Anti-epileptic drugs such as LAMOGINE are used for the treatment of epilepsy in adults and children aged 2 years and older.
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 LAMOGINE tablets work by changing the levels of some chemicals associated with seizures.
Ask your doctor if you have any questions about why LAMOGINE tablets have been prescribed for you.
Your doctor may have prescribed LAMOGINE tablets for another reason.
This medicine is only available with a doctor's prescription.
LAMOGINE tablets are not addictive.
Before you take LAMOGINE
When you must not take it
Do not take LAMOGINE if you have ever had an allergic reaction to:
lamotrigine
any of the ingredients listed at the end of this leaflet. (See "Ingredients").
Some of the 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 damaged, 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.
LAMOGINE 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 LAMOGINE during pregnancy.
It is recommended that women on anti-epileptic drugs, such as LAMOGINE, 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 LAMOGINE 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.
LAMOGINE can pass into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of taking LAMOGINE 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 LAMOGINE. 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
medicine which is used to treat Human Immunodeficiency Virus (HIV) infection
risperidone, a medicine used to treat mental health problems.
These medicines may be affected by LAMOGINE 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 LAMOGINE.
How to take LAMOGINE
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
Using LAMOGINE for the first time
You may notice that you feel dizzy, tired or unsteady in the first few weeks of treatment with LAMOGINE 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 (e.g. spots or 'hives') during LAMOGINE treatment, contact your doctor immediately.
There are reports of severe, potentially life-threatening rashes associated with LAMOGINE treatment, particularly in children. LAMOGINE should be discontinued at the first sign of rash unless the rash is clearly not drug related.
If you have any questions about taking LAMOGINE tablets ask your doctor or pharmacist.
How much to take
It may take a while to find the best dose of LAMOGINE for you. The dose you take will depend on:
your age and weight
whether you are taking LAMOGINE with other medications
whether you have any kidney or liver problems
Never take more LAMOGINE than your doctor tells you to. 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.
The label on the container that the tablets were supplied in will give the same information. If there is something that you do not understand ask either 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 LAMOGINE. 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 LAMOGINE as the 'pill' may not work as effectively for contraception whilst taking it.
How to take it
LAMOGINE 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.
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 LAMOGINE tablets, or change the dose without first checking with your doctor.
Your doctor will advise you if you need to stop taking LAMOGINE tablets and how to do this gradually over a period of two weeks.
Use in children
LAMOGINE 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 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 many LAMOGINE tablets, even if there are no signs of discomfort or poisoning.
If you take too much LAMOGINE you may be more likely to have serious side effects which may be fatal.
Symptoms of LAMOGINE 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 LAMOGINE
Your doctor or pharmacist will be able to tell you whether there are any special instructions while you are taking LAMOGINE tablets.
Things you must do
Take LAMOGINE exactly as your doctor has prescribed.
If you develop any skin rash (e.g. spots or 'hives') during LAMOGINE treatment, contact your doctor immediately.
There are reports of severe, potentially life-threatening rashes associated with LAMOGINE treatment, particularly in children. LAMOGINE should be discontinued at the first sign of rash unless the rash is clearly not drug related.
Tell any other doctor, dentist or pharmacist who is treating you that you are taking LAMOGINE tablets, 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.
LAMOGINE may interfere with some laboratory tests to detect other drugs.
If you become pregnant, or if you are planning to become pregnant while taking this medicine, tell your doctor immediately.
Your doctor will discuss the risks and benefits of taking LAMOGINE during pregnancy.
Talk to your doctor if you are breastfeeding or planning to breast feed. The active ingredient of LAMOGINE passes into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of breastfeeding while you are taking LAMOGINE.
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 must not do
Do not stop taking LAMOGINE tablets or change the dose without first checking with your doctor.
If you stop taking LAMOGINE tablets 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 LAMOGINE tablets 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.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use LAMOGINE tablets to treat any other complaints unless your doctor says to.
Things to be careful of
Be careful driving or operating machinery until you know how LAMOGINE tablets affect you.
As with other anticonvulsant medicines for the treatment of epilepsy, LAMOGINE may cause dizziness and drowsiness in some people, and affect alertness.
Make sure you know how you react to LAMOGINE 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 LAMOGINE should be especially watchful for any changing behaviour. Anti-epileptic medicines such as LAMOGINE 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 LAMOGINE.
Like other medicines, LAMOGINE tablets can cause some side-effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
The most commonly reported side effects are:
skin rash
dizziness
movement problems such as tics, unsteadiness and jerkiness
headache
drowsiness or tired
feeling sick (nausea)
vomiting
double or blurred vision
rapid, uncontrollable eye movements
tremor (shakiness)
trouble sleeping
hallucinations, confusion
irritability, aggression or agitation
increased activity in children
joint, back or stomach pain
respiratory or lung problems
diarrhoea
loss of memory
liver problems
depression
dry mouth
In general these side effects usually happen during the first few weeks of treatment with LAMOGINE. 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 LAMOGINE tablets.
All mentions of suicide or violence must be taken seriously. Families and caregivers of children and adolescents who are taking LAMOGINE should be especially watchful for any changing behaviour. Anti-epileptic medicines such as LAMOGINE may increase the risk of suicidal behaviour (including suicidal thoughts and suicide attempts).
Potentially serious skin reaction
A small number of people taking LAMOGINE 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 LAMOGINE, especially if the dose is too high or if the dose is increased too quickly, or if LAMOGINE 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 LAMOGINE if you experience these rare symptoms.
If you are taking LAMOGINE 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 require 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 above may also occur in some people.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After taking LAMOGINE
Storage
Keep LAMOGINE tablets where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep LAMOGINE tablets in the container that they were supplied in until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep LAMOGINE tablets in a cool dry place where the temperature stays below 30°C. Protect from light.
Do not store LAMOGINE tablets or any other medicine in the bathroom or near a sink. Do not leave them on a window sill or in the car.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
LAMOGINE dispersible/chewable tablets come in 5 different strengths.
LAMOGINE dispersible/ chewable tablets 5 mg are white to off-white, elongated, biconvex tablets smelling of blackcurrant. They are marked "GSCL2" on one side and "5" on the other.
LAMOGINE dispersible/ chewable tablets 25 mg, 50 mg, 100 mg and 200 mg are white to off-white, unscored, elliptical tablets with many sides and smelling of blackcurrant. The 25 mg tablet is marked "GSCL5" on one side and "25" on the other, the 50 mg tablet is marked "GSCX7" on one side and "50" on the other, the 100 mg tablet is marked "GSCL7" on one side and "100" on the other, and the 200 mg tablet is marked "GSEC5" on one side and "200" on the other.
All strengths of LAMOGINE dispersible/ chewable tablets are available in packs of 56 tablets.
Ingredients
The active ingredient in LAMOGINE tablets is lamotrigine.
Each LAMOGINE tablet contains 5 mg (LAMOGINE tablets 5 mg), 25 mg (LAMOGINE tablets 25 mg), 50 mg (LAMOGINE tablets 50 mg), 100 mg (LAMOGINE tablets 100 mg) or 200 mg (LAMOGINE tablets 200 mg) of lamotrigine.
Each LAMOGINE dispersible/ chewable tablet also contains the following inactive ingredients:
calcium carbonate
hydroxypropylcellulose
aluminium magnesium silicate
sodium starch glycollate
povidone
saccharin sodium
magnesium stearate
blackcurrant flavour.
LAMOGINE tablets do not contain gluten or lactose.
