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Lamictal^® Dispersible/ChewableTablets

Lamotrigine 2mg, 5mg, 25mg, 50mg, 100mg

What is in this leaflet?

Please read this leaflet carefully before you start taking Lamictal tablets.

This leaflet answers some common questions about Lamictal 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 Lamictal tablets 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 Lamictal tablets are used for

Lamotrigine (the active ingredient in Lamictal tablets) belongs to a group of medicines called "anti-epileptic drugs".

Lamictal tablets are used for the treatment of epilepsy in adults and children aged 2 years and over. Lamictal tablets are used in addition to other medicines for the treatment of epilepsy. Lamictal is used in partial or generalised seizures including tonic-clonic seizures and seizures associated with Lennox-Gastaut Syndrome.

An epileptic seizure, fit or turn results when abnormal electrical impulses occur in nerve cells in the brain.

These abnormal electrical impulses are believed to be due to altered levels of some chemicals in the brain.

It is thought that Lamictal tablets work by changing the levels of some of the chemicals associated with seizures.

Your doctor may have prescribed Lamictal tablets for another reason.

Ask your doctor if you have any questions about why Lamictal tablets have been prescribed for you.

There is no evidence that Lamictal tablets are addictive.

When you must NOT take Lamictal tablets

• Do not take Lamictal tablets if you have ever had an allergic reaction to lamotrigine or any of the ingredients listed at the end of this leaflet.
  
  Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.
• Do not take Lamictal tablets if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should.
  Lamictal 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 using Lamictal tablets if you are pregnant or breastfeeding.
• Do not take Lamictal tablets after the expiry date (EXP) printed on the pack.
  
  If you take Lamictal tablets after the expiry date has passed, they may not work as well.
• Do not take Lamictal tablets if the packaging is torn or shows signs of tampering.

If you're not sure whether you should be taking Lamictal tablets, talk to your doctor.

Before you start taking Lamictal tablets

You must tell your doctor if:

• You are allergic to foods, dyes, preservatives or any other medicines.
• You are taking any form of hormonal contraceptive (e.g. "the pill") or HRT?
• You are suffering, or have ever suffered, from any liver or kidney disorders.
• You have Parkinson's disease.
• You are taking any other medication for epilepsy. This is particularly important for sodium valproate ("Epilim")
• If you ever had a rash during treatment with any other antiepileptic drugs.
• You are taking rifampicin, which is used to treat infections, including tuberculosis.
• You are taking a medicine to treat Human Immunodeficiency Virus (HIV) infection.

Tell your doctor if you are taking risperidone, a medicine used to treat bipolar disorder. You may be more likely to feel sleepy or drowsy when you take risperidone and lamotrigine together.

Tell your doctor if you are taking any other medicines, including the oral contraceptive pill or medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking Lamictal tablets with other medicines.

Your doctor will have a complete list of the medicines that may cause problems when taken with Lamictal tablets.

Make sure that your doctor is aware of any of the above before you start taking Lamictal tablets.

How to take Lamictal tablets

Lamictal tablets is not recommended for treatment of epilepsy in children under 2 years of age.

Using Lamictal Tablets for the first time

You may notice that you feel dizzy, tired, or unsteady in the first few weeks of treatment with Lamictal tablets. During this period you may also notice that you have slight problems with your vision such as blurred or double 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 Lamictal treatment contact your doctor immediately.

There are reports of skin rash associated with Lamictal treatment. Some of these may be serious and cause severe illness.

If you have any questions about taking Lamictal tablets ask your doctor or pharmacist.

How much to take

Take Lamictal tablets as directed by your doctor or pharmacist. Never 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.

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.

It is usual for the dose of Lamictal tablets to start at quite a low level and be slowly increased during the first few weeks of treatment. The doses that your doctor prescribes will generally depend on any other anti-epileptic medications you are taking, and your response to Lamictal tablets.

Children's weight should be checked and the dose reviewed as weight changes occur.

Hormonal contraceptives (such as the birth control pill): Most people need a higher maintenance dose of Lamictal when they take hormonal contraceptives, so if you are taking these, your doctor may increase your dose. 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.

Your doctor may need to change the dose of Lamictal during your pregnancy.

If you have any questions about the dose that you have been prescribed you should ask your doctor or pharmacist.

Lamictal tablets may be swallowed whole, chewed or dispersed in a small volume of water (at least enough to cover the whole tablet).

If you have any questions about how to take Lamictal tablets ask your doctor or pharmacist.

How long to take it for

Do not stop taking Lamictal tablets, or change the dose without first checking with your doctor.

If you forget to take Lamictal tablets

If you have forgotten to take your dose of Lamictal tablets contact your doctor immediately.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately contact your doctor or Poisons Information Centre 0800 POISON or 0800 764 766 for advice or go to Accident or Emergency department at your nearest hospital, if you think that you or anyone else may have taken too many Lamictal tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

If too many Lamictal tablets have been taken it is likely that the following symptoms will be experienced: nausea, vomiting, tiredness/drowsiness and problems with eyesight, twitching, impaired consciousness and coma.

While you are taking Lamictal tablets

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

Things you must do

If you develop any skin rash (eg. spots or 'hives') during Lamictal treatment contact your doctor immediately.

There are reports of skin rash associated with Lamictal treatment. Some of these may be serious and cause severe illness.

Tell your doctor or pharmacist that you are taking Lamictal tablets if you are about to be started on any new medicines.

Pregnancy and breastfeeding
Tell your doctor as soon as possible if you are pregnant, or if you are trying to become pregnant. There may be an increased risk of babies developing a cleft lip or cleft palate if Lamictal is taken during the first few months of pregnancy.

Talk to your doctor if you're breast feeding or planning to breast feed. The active ingredient of Lamictal passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast feeding while you're taking Lamictal.

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 Lamictal tablets just because you feel better.

If you stop taking Lamictal 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 Lamictal tablets and how.

If you are unsure whether you should stop taking Lamictal tablets talk to your doctor or pharmacist.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use Lamictal tablets to treat any other complaints unless your doctor says you should.

Side-Effects

Check with your doctor as soon as possible if you have any problems while taking Lamictal tablets, even if you are not sure the problems are connected with the medicine, or are not listed in this leaflet.

Like other medicines, Lamictal tablets can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side-effects are:

• dizziness/unsteadiness
• rash
• headache
• drowsiness
• feeling sick (nausea), vomiting
• diarrhoea
• liver problems
• feeling weak
• tremor (shakiness)
• double vision, blurred vision
• tiredness or feeling sleepy
• trouble sleeping
• confusion
• irritability/aggression
• agitation
• increased activity in children
• joint or back pain.

Side effects which occur rarely include:

• movement problems such as tics, unsteadiness and jerkiness
• hallucinations.

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 Lamictal. 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 Lamictal 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:

• Suicidal thoughts
• Suicide attempts.

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.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor immediately if you notice any of the following:

• Any skin reaction (eg. rash or 'hives').
• Swelling of the face, lips or tongue.
• Sore mouth or sore eyes.
• A high temperature (fever).
• Swollen glands.
• Drowsiness.
• Easy bruising or unusual bleeding
• Yellow skin (jaundice).

If you are taking Lamictal 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 may present as a collection of symptoms consisting of 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.

If you think you are having an allergic (hypersensitivity) reaction to Lamictal tablets, TELL YOUR DOCTOR IMMEDIATELY or go to the Accident or Emergency department at your nearest hospital. Symptoms usually include some or all of the following:

• wheezing
• swelling of the lips/mouth
• difficulty in breathing
• hay fever
• lumpy rash ("hives")
• fainting

If you are a female, tell your doctor if 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.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side-effects. You may not experience any of them.

Storage

Keep Lamictal tablets where young 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 your tablets in the container that they were supplied in.

The container has been designed to help protect the tablets. If you take the tablets out of the pack they may not keep well.

Keep Lamictal tablets in a cool dry place where the temperature stays below 30°C. Protect from light.

Do not store Lamictal tablets, or any other medicine, in a bathroom or near a sink.

Do not leave Lamictal tablets in the car or on window sills.

Heat and dampness may affect the tablets.

After taking Lamictal tablets

Disposal

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

Product description

What Lamictal tablets look like

Lamictal dispersible/chewable tablets come in 5 different strengths.

Lamictal tablets 2mg are white to off -white, round with "LTG"over "2" on one side and scored on the other. Lamictal tablets 5 mg are white to off-white, long, convex tablets, unscored, smelling of blackcurrant. They are marked "GS CL 2" on one side and "5" on the other.

Lamictal tablets 25mg, 50 mg and 100mg are white to off-white, elliptical tablets with many sides and smelling of blackcurrant.

The 25 mg tablet is marked "LAMICTAL 25" on one side and unscored on the other, the 50 mg tablet is marked "LAMICTAL 50" on one side and unscored on the other, the 100 mg tablet is marked "LAMICTAL 100" on one side and unscored on the other.

Lamictal tablets, 25mg, 50mg and 100mg are available in packs of 56 tablets. Lamictal 5mg is available in packs of 30 tablets and the 2mg tablets are in bottle packs of 30 tablets.

Ingredients

The active ingredient in Lamictal tablets is lamotrigine. Each Lamictal Tablet contains 2 mg (Lamictal tablets 2mg), 5mg (Lamictal tablets 5mg) 25 mg (Lamictal tablets 25 mg), 50 mg (Lamictal tablets 50 mg) or 100 mg (Lamictal tablets 100 mg) of lamotrigine.

Each Lamictal tablet also contains:
calcium carbonate, low-substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycollate, povidone K30, saccharin sodium, magnesium stearate and blackcurrant flavour.

Lamictal tablets do not contain gluten.

Lamictal tablets do not contain lactose.

Manufacturer

Your Lamictal tablets are supplied by:

GlaxoSmithKline NZ Limited
AMP Centre
Cnr Albert and Customs St
Private Bag 106600
Downtown Auckland
New Zealand

Ph: (09) 367 2900
Fax (09) 367 2910

Further Information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.

Do not throw this leaflet away.
You may need to read it again.

The information provided applies only to Lamictal tablets.

® Lamictal is a registered trademark of the GlaxoSmithKline Group of Companies.

This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.

This leaflet was prepared on 13 October 2009.

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