How does it work?

Lamictal tablets and dispersible tablets contain the activeingredient lamotrigine, which is a medicine used to treat epilepsy. (NB.Lamotrigine is also available without a brand name, ie as thegeneric medicine.) Lamotrigine works by stabilisingelectrical activity in the brain.

The brain and nerves are made up of many nerve cells thatcommunicate with each other through electrical signals. These signals must becarefully regulated for the brain and nerves to function properly. Whenabnormally rapid and repetitive electrical signals are released in the brain,the brain becomes over-stimulated and normal function is disturbed. Thisresults in fits or seizures.

Lamotrigine prevents epileptic fits by preventing excessiveelectrical activity in the brain. It does this by preventing sodium fromentering nerve cells when they begin to fire rapid and repetitive electricalsignals. A build up of sodium in the nerve cells is necessary for theelectrical signal to build up and be passed on to other nerve cells. Aslamotrigine prevents this, it helps stabilise the electrical activity in thebrain.

Preventing the build-up of the electrical signal also preventsthe release of a neurotransmitter called glutamate from the nerve cells in thebrain. Neurotransmitters are chemicals that are stored in nerve cells and areinvolved in transmitting messages between the nerve cells. Glutamate is aneurotransmitter that acts as a natural 'nerve-exciting' agent. It is releasedwhen electrical signals build up in nerve cells and subsequently excites morenerve cells. It is thought to play a key role in causing epileptic seizures.Reducing the release of glutamate from the nerve cells in the brain is anotherway in which lamotrigine helps stabilise the electrical activity in the brainand prevent epileptic fits.

In addition to its use for treating epilepsy,lamotrigine is used by specialists as a mood stabiliser fortreating people with the psychiatric illness, bipolar affective disorder. Lamotrigine is used to help prevent episodes of depression in people who suffer mostly from this side of the illness. It is not fully understood how lamotrigine works inthis illness, but is thought to be to do with the reduction of glutamate in thebrain.

Lamictal tablets should be swallowed whole with a drink ofwater. Lamictal dispersible tablets may be chewed, dispersed in a small volumeof water (at least enough to cover the whole tablet) or swallowed whole with alittle water.

What is it used for?

• Epilepsy. Lamotrigine is used to treat generalised tonic-clonic seizures (grand mal epilepsy) and partial seizures, as well as absence seizures in children.
• Type of severe childhood epilepsy (Lennox-Gastaut syndrome).
• Preventing depressive episodes in people with bipolar affective disorder who experience mostly depressive epidoses.

Warning!

• Adverse skin reactions have been reported with lamotrigine. These reactions are usually mild and get better on their own, but can on rare occasions be more serious and potentially life-threatening. The risk is higher in children under 12 years of age and in people who are also taking the medicine valproate. When starting treatment with lamotrigine the dose is increased gradually to minimise the risk of developing a skin rash. For this reason it is very important to follow the instructions you are given with this medicine, and not to exceed the prescribed dose. If you or your child develop a rash, fever, facial swelling or swollen glands while taking this medicine you should consult your doctor immediately. If the doctor decides the reaction is related to this medicine you will need to stop taking it.
• You should not stop taking this medicine suddenly unless your doctor tells you to, as this may result in your seizures returning or getting worse. If it is decided that you should stop taking this medicine, it should be withdrawn gradually, following the instructions given by your doctor. If for any reason you stop treatment for longer than five days and then restart, your doctor may want you to increase your dose gradually, as when you first started the medicine, to minimise the risk of getting a skin reaction.
• If you have epilepsy it is important to take your medication regularly, as directed by your doctor, because missing doses can trigger seizures in some people. If you have trouble remembering to take your medicine you should ask your pharmacist for advice. You may find a pill reminder box helpful.
• This medicine may cause dizziness and double vision. As a result it could reduce your ability to drive or operate machinery safely. You should discuss this with your doctor. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you should consult your doctor immediately if you experience any of the following symptoms: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. Your doctor may want to take a blood test to check your blood cells.
• There may be a small increased risk of suicidal thoughts and behaviour in people taking antiepileptic medicines such as lamotrigine for any indication. For this reason, it is very important to seek medical advice if you, or someone else taking this medicine, experience any changes in mood, distressing thoughts, orfeelings about suicide or self-harm at any point while taking this medicine. For more information speak to your doctor or pharmacist.
• The safety and efficacy of this medicine in children under two years of age has not been established by the manufacturer.

Use with caution in

• Elderly people.
• Decreased liver function.
• Kidney failure.
• Parkinson's disease.
• History of allergic reactions or rash due to other antiepileptic medicines.

Not to be used in

• Known sensitivity or allergy to any ingredient.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• It is vital that women with epilepsy receive specialist advice before getting pregnant, so they are well informed of potential risks and benefits of continuing antiepileptic treatment during pregnancy. Pregnant women taking antiepileptic medicine have a higher risk of carrying a baby with developmental problems and malformations. However, if a woman with epilepsy stops treatment because she is pregnant, there is a risk of seizures that can harm both mother and baby.
• If you decide to try for a baby while taking lamotrigine you should seek medical advice from your doctor as soon as possible. It may be recommended that you start taking folic acid 5mg daily as soon as contraception is stopped, as this may reduce the risk of neural tube defects such as spina bifida in the baby.
• Women who continue to take lamotrigine during a pregnancy should, wherever possible, be prescribed lamotrigine on its own, in the lowest effective dose. Your doctor may need to adjust your lamotrigine dose from time to time, because changes to your body during pregnancy may affect the amount of lamotrigine in your blood and its effectiveness.
• Lamotrigine passes into breast milk. Mothers who need to take lamotrigine should discuss the pros and cons of breastfeeding with their doctor. You should only breastfeed if the potential benefits of breastfeeding are considered to be greater than the risk of side effects from the medicine on the nursing infant. Seek medical advice from your doctor.

Label warnings

• Do not stop taking this medication except on your doctor's advice.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

• Skin rashes.
• Headache.
• Drowsiness.
• Dizziness.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Pain in the joints or back pain.
• Difficulty in sleeping (insomnia).
• Visual disturbances, such as double vision or blurred vision.
• Shaking, usually of the hands (tremor).
• Confusion.
• Agitation.
• Irritability.
• Aggression.
• Hallucinations.
• Disturbances in the numbers of blood cells in the blood.
• Shaky movements and unsteady walk (ataxia).
• Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome).
• Disturbances of liver function.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

Valproate (as sodium valproate, valproate semisodium or valproicacid) increases the blood level of lamotrigine. If you are taking a valproatemedicine when you start treatment with lamotrigine, your starting dose oflamotrigine will be increased more gradually than normal. You should carefullyfollow the instructions given to you by your doctor or pharmacist.

Hormonal contraceptives (eg the pill) can reduce the amount oflamotrigine in the blood and make it less effective at controlling seizures. Inaddition, lamotrigine can make the pill less effective at preventing pregnancy.For this reason, women taking lamotrigine who need a contraceptive shouldpreferably use a non-hormonal method such as condoms. When you start takinglamotrigine your doctor will review your contraception and advise on methodsthat are safe and effective for you to use. A hormonal contraceptive shouldonly be used as the sole method of contraception if there is no otheralternative. If the pill is chosen as your only method of contraception, youmust tell your doctor if you experience changes in your menstrual pattern (egbleeding between periods), as this may indicate that your pill is becoming lesseffective at preventing pregnancy. It is also important to tell your doctor ifyou plan to start or stop using hormonal contraceptives such as the pill whiletaking lamotrigine, as your lamotrigine dose may need re-adjusting.

The use of hormone replacement therapy (HRT) in combination withlamotrigine has not been studied, but it may interact in a similar way tohormonal contraceptives, by reducing the amount oflamotrigine in the blood and making it less effective at controlling seizures.

The following medicines may also reduce the blood level oflamotrigine:

• carbamazepine
• phenobarbital
• phenytoin
• primidone
• rifampicin.

If you are taking any of these medicines with lamotrigine yourdoctor may need to increase your lamotrigine dose.

It is recommended that people who are taking any antiepileptic medicines should avoid taking the herbal remedy St John's wort (Hypericum perforatum). This is because St John's wort may affect the level of antiepileptic medicines in the blood and could increase the risk of seizures.

There may be an increased chance of side effects such asheadache, dizziness, blurred vision, double vision, sleepiness and nausea ifcarbamazepine or oxcarbazepine are taken with lamotrigine. If this occurs yourdoctor may need to reduce the dose of the carbamazepine oroxcarbazepine.

Other medicines containing the same active ingredient

Lamotrigine tablets and dispersible tablets are also availablewithout a brand name, ie as thegeneric medicine.