Consumer Medicine Information
MOGINE
Lamotrigine 25 mg, 50 mg, 100 mg and 200 mg dispersible/chewable tablets
What is in this leaflet
This leaflet answers some common questions about MOGINE. It does not contain all the available information.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking MOGINE against the benefits this medicine is expected to 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 MOGINE tablets are used for
MOGINE tablets contain the active ingredient lamotrigine. It is used to treat epilepsy in children and adults.
MOGINE is used in partial (seizures that affect only one part of the brain) or generalised seizures (seizures that affect the whole brain) including Lennox-Gastaut Syndrome.
Lennox-Gastaut Syndrome (LGS) is a severe form of epilepsy and is characterised by several seizure types.
MOGINE tablets are initially used in addition to other medicines for the treatment of epilepsy.
The brain consists of a million nerve cells, or neurons. These neurons receive electrical signals from other neurons and pass them on to the next neurons.
The functions of a normal brain depend on the electrical signals being passed from one neuron to the next. The brain constantly generates electrical rhythms in an orderly manner.
Epilepsy is caused by a disruption in the electrical activity of the brain.
The abnormal electrical impulses occur due to altered levels of some of the chemicals in the brain.
MOGINE tablets work by altering the levels of some of the chemicals causing the seizures.
MOGINE tablets may also be used to treat Bipolar Depression in Adults.
Your doctor may have prescribed MOGINE tablets for another reason. Ask your doctor if you have any questions about why MOGINE has been prescribed for you.
This medicine is available only with a doctor's prescription.
MOGINE tablets are not known to be addictive.
Before you take MOGINE tablets
When you must not take it
Do not this medicine if:
- You have an allergy to MOGINE, lamotrigine or any ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty breathing, swelling of the face, lips or tongue and even fainting.
- You are pregnant, intend to become pregnant or are breast-feeding, unless advised by your doctor. There is not enough information available on the use of MOGINE tablets during pregnancy to determine whether or not it is safe. However, MOGINE is thought to pass into breast milk. Your doctor will discuss the risks and benefits of using MOGINE tablets if you are pregnant or breast-feeding.
- The packaging is torn or shows signs of tampering.
- The expiry date on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well (or it may make you feel sick).
If you are not sure whether you should start taking MOGINE tablets, talk to your doctor.
Before you start taking it
You must tell your doctor:
- If you are allergic to any other medicines, foods, dyes or preservatives.
- If you have or have ever had any other health problems/medical
conditions, including:
- kidney disease
- liver disease
If you have not told your doctor about any of the above, tell them before you are given MOGINE tablets.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with MOGINE. These include:
- Sodium valproate (Epilim™) .
- Oral contraceptive pill
These medicines may be affected by MOGINE or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MOGINE.
How MOGINE tablets are taken
Taking MOGINE tablets for the first time
During the first few weeks of treatment, you may experience blurred vision, dizziness, tiredness or unsteadiness when you are walking.
Your reactions may be slower at this time, therefore you should not operate any machinery or appliances and you should not drive a car. If any of these effects persist for a long time or are troublesome, you should consult your doctor.
There have been reports of skin rash associated with treatment. These may be serious and can cause severe illness.
If you notice the development of any skin rash (e.g. hives or spots) during treatment, contact your doctor immediately.
How much to take
Your doctor will decide at what dose and for how long you will need MOGINE tablets.
It is usual for the dose of MOGINE tablets to start at a low level and to gradually increase during the first few weeks of treatment.
The dose prescribed by your doctor is dependent upon other epileptic medications you are taking and your response to MOGINE.
MOGINE for children is dependent upon their weight and changes to the dose must be made accordingly.
How to take it
MOGINE tablets may be swallowed whole, chewed or dispersed in a glass of water (at least enough to cover the whole tablet).
If you forget to take it
If you have forgotten to take your dose of MOGINE tablets, you must contact your doctor immediately.
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.
If you take too much which is an overdose
Immediately telephone your doctor, or the Poisons Information Centre (telephone 0800 POISON or 0800 764 766) or go to your nearest Accident and Emergency department or clinic if you think that you or anyone else may have taken too much MOGINE. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places/services handy.
If you take too much MOGINE, you may have:
- nausea
- problems with eyesight
- tiredness/drowsiness
- vomiting
While you are taking MOGINE tablets
Things you must do
Tell all the doctors, dentists and pharmacists who are treating you that you are receiving MOGINE.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking MOGINE.
Do not take any other medicines whether they require a prescription or not without first telling your doctor.
If you develop any skin rash (e.g. hives or spots) while being treated with MOGINE, contact your doctor immediately.
Tell your doctor if you become pregnant or are trying to become pregnant while taking MOGINE.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Things you must not do
Do not stop taking MOGINE or change the dose because you are feeling better.
Consult your doctor first; if you stop taking MOGINE tablets abruptly, your condition may worsen or even come back. This is known as a rebound effect.
Do not give MOGINE to anyone else, even if they have the same condition as you.
Do not use MOGINE to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how MOGINE affects you.
MOGINE may cause dizziness and drowsiness and affect alertness in some individuals. If this occurs, avoid operating machinery; driving a car or doing anything that could be dangerous.
If consuming alcohol, dizziness or light-headedness may be worse.
Children should avoid riding a bike, climbing trees or anything that could be dangerous if they are feeling dizzy or sleepy.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MOGINE.
Like other medicines MOGINE can cause some side effects. If they occur, most of them are likely to be minor and temporary but some may be serious and will need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
While taking it
The common side effects are:
- agitation
- blurred vision
- confusion
- depression
- dizziness/unsteadiness
- double vision
- drowsiness
- feeling sick- nausea
- feeling weak
- headache
- increased activity in children
- irritability/aggression
- loss of memory
- tremor
- trouble sleeping
- vomiting
These side effects will occur during the first few weeks of treatment. However, if any of these side effects persist, consult your doctor.
Tell your doctor immediately or go to the nearest Accident and Emergency department or clinic if you notice any of the following:
- any skin reactions (eg. rash or hives)
- drowsiness
- fever
- sore mouth or sore eyes
- swollen glands
- unusual bleeding and easy bruising
- yellow skin Jaundice)
These are all serious side effects of MOGINE. You may need urgent medical attention.
Serious side effects are rare.
Another rare side effect is "Lupus-like reactions" which may present as a collection of symptoms consisting of fever, pain in the joints and general ill health.
If any of the following happens, stop using MOGINE and tell your doctor immediately or go to your nearest Accident and Emergency department or clinic:
- life threatening allergic reactions which may include skin rash, itching, difficulty breathing, swelling of the face, lips or tongue.
These are all very serious side effects of MOGINE. If you have them, you may have had a serious allergic reaction to MOGINE. You may need urgent medical attention or hospitalisation.
If you are female, you must tell your doctor if there is a change in your menstrual cycle.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using MOGINE
Storage conditions
Keep your MOGINE tablets in their original pack until it is time to use them. If you leave the tablets out of the pack, they may not keep well.
Keep the pack in a cool, dry place where the temperature stays below 25°C and away from light.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on windowsills.
Heat and dampness can destroy some medicines.
Always keep the tablets out of reach of children.
A locked cupboard at least one and a half metres above the ground is a
good place to store medicines.
Disposal
If your doctor tells you to stop taking MOGINE or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
Product description
What MOGINE tablets look like
MOGINE 25 mg:
White to off-white, modified square shape, engraved with "L" and "25" on one
side, plain on the other side.
MOGINE 50 mg:
White to off-white, modified square shape, engraved with "L" and "50" on one
side, plain on the other side.
MOGINE 100 mg:
White to off-white, modified square shape, engraved with "L" and "100" on one
side, plain on the other side.
MOGINE 200 mg:
White to off-white, modified square shape, engraved with "L" and "200" on one
side, plain on the other side.
MOGINE tablets are available in blister packs of 56 tablets.
Ingredients
Active ingredient
Lamotrigine
Other ingredients (excipients)
Calcium carbonate, sorbitol, colloidal silicon dioxide, cellulose-microcrystalline, crospovidone, starch-maize, talc, saccharin-sodium, sodium stearylfumarate, blackcurrant flavour.
If you want to know more
Should you have any questions regarding this product, please contact your doctor or pharmacist.
Supplier
Douglas Pharmaceuticals Limited
P.O. Box 45027
Te Atatu Peninsula
Auckland 0651
Telephone: (09) 835 0660
Date of information:
4 December 2006