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LAMOTRIGINE TABLETS 200MG

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305-06-07 LEAFLET Lamictal 20120608

PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMICTAL TABLETS 50mg/ LAMOTRIGINE TABLETS 50mg LAMICTAL TABLETS 100mg/ LAMOTRIGINE TABLETS 100mg LAMICTAL TABLETS 200mg/ LAMOTRIGINE TABLETS 200mg (lamotrigine)
Your medicine is known with either of the above names but will be referred to as Lamictal throughout the following leaflet. Information for other strength of Lamictal (Lamictal 25mg tablets) is also present in this leaflet. Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Lamictal is and what it is used for 2. Before you take Lamictal 3. How to take Lamictal 4. Possible side effects 5. How to store Lamictal 6. Further information 1. WHAT LAMICTAL IS AND WHAT IT IS USED FOR Lamictal belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder. Lamictal treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits). For adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines, to treat epilepsy. Lamictal can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome. For children aged between 2 and 12 years, Lamictal can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.

Lamictal should not be given to people aged under 18 years to treat bipolar disorder. Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years. Taking other medicines Tell your doctor or pharmacist if youre taking any other medicines, have taken any recently, or start taking new ones these include herbal medicines or other medicines you bought without a prescription. Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems. This is to make sure you take the correct dose of Lamictal. These medicines include: oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy lithium or olanzapine, used to treat mental health problems bupropion, used to treat mental health problems or to stop smoking

Tell your doctor if you are taking any of these. Some medicines interact with Lamictal or make it more likely that people will have side effects. These include: valproate, used to treat epilepsy and mental health problems carbamazepine, used to treat epilepsy and mental health problems phenytoin, primidone or phenobarbitone, used to treat epilepsy risperidone, used to treat mental health problems rifampicin, which is an antibiotic medicines, used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir) hormonal contraceptives, such as the Pill (see below).



Tell your doctor if you are taking any of these, or if you start or stop taking any. Hormonal contraceptives (such as the Pill) can affect the way Lamictal works Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or coil. If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamictal. If you are using a hormonal contraceptive, or if you plan to start using one: Talk to your doctor, who will discuss suitable methods of contraception with you. Lamictal can also affect the way hormonal contraceptives work, although its unlikely to make them less effective. If you are using a hormonal contraceptive, and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods: Tell your doctor. These may be signs that Lamictal is affecting the way your contraceptive is working. Pregnancy and breast feeding Talk to your doctor if youre pregnant, if you might be pregnant, or if youre planning to become pregnant. Its important that you do this because there may be an increased risk of birth defects in babies whose mothers took Lamictal during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you to take extra folic acid if youre planning to become pregnant and while youre pregnant. Pregnancy may also alter the effectiveness of Lamictal, so your doctor may take samples of your blood to check the level of Lamictal, and may adjust your dose. Talk to your doctor if youre 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 youre taking Lamictal, and will check your baby from time to time if you decide to breast feed. Driving and using machines Lamictal can cause dizziness and double vision. Dont drive or operate machines unless you are sure youre not affected. If you have epilepsy, talk to your doctor about driving and using machines. Important information about some of the ingredients of Lamictal Lamictal tablets contain small amounts of a sugar called lactose. If you have an intolerance to lactose or any other sugars: Tell your doctor, and dont take Lamictal. 3. HOW TO TAKE LAMICTAL Always use Lamictal exactly as your doctor has told you to. Check with your doctor or pharmacist if youre not sure. How much Lamictal to take It may take a while to find the best dose of Lamictal for you. The dose you take will depend on: your age whether you are taking Lamictal with other medicines whether you have any kidney or liver problems.



Lamictal also treats bipolar disorder. People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). For adults aged 18 years and over, Lamictal can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamictal works in the brain to have this effect. 2. BEFORE YOU TAKE LAMICTAL Do not take Lamictal: if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamictal (listed in Section 6).

If this applies to you: Tell your doctor, and dont take Lamictal. Take special care with Lamictal Your doctor needs to know before you take Lamictal: if you have any kidney problems if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy if you have ever developed meningitis after taking lamotrigine (read the description of these symptoms in Section 4 of this leaflet: Other side effects) if you are already taking medicine that contains lamotrigine.



If any of these applies to you: Tell your doctor, who may decide to lower the dose, or that Lamictal is not suitable for you. Important information about potentially serious reactions A small number of people taking Lamictal get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know the symptoms to look out for while you are taking Lamictal. Read the description of these symptoms in Section 4 of this leaflet under Potentially serious reactions: get a doctors help straight away. Thoughts of harming yourself or suicide Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide. If you have bipolar disorder, you may be more likely to think like this: When you first start treatment If you have previously had thoughts about harming yourself or about suicide If you are under 25 years old.

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 (called the effective dose). Never take more Lamictal than your doctor tells you to. The usual effective dose of Lamictal for adults and children aged 13 years or over is between 100 mg and 400 mg each day. For children aged 2 to 12 years, the effective dose depends on their body weight - usually, its between 1 mg and 15 mg for each kilogram of the childs weight, up to a maximum of 400 mg daily. Lamictal is not recommended for children aged under 2 years. How to take your dose of Lamictal Take your dose of Lamictal once or twice a day, as your doctor advises. It can be taken with or without food. Your doctor may also advise you to start or stop taking other medicines, depending on what condition youre being treated for and the way you respond to treatment. Swallow your tablets whole. Dont break, chew or crush them. Always take the full dose that your doctor has prescribed. Never take only part of a tablet.

If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while youre taking Lamictal: See a doctor as soon as possible or go to the nearest hospital for help. A small number of people being treated with anti-epileptics such as Lamictal have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. If youre taking Lamictal for epilepsy The seizures in some types of epilepsy may occasionally become worse or happen more often while youre taking Lamictal. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often, or if you experience a severe seizure while youre taking Lamictal: See a doctor as soon as possible.

If you take more Lamictal than you should Contact a doctor or pharmacist immediately. If possible, show them the Lamictal packet. Someone who has taken too much Lamictal may have any of these symptoms: rapid, uncontrollable eye movements (nystagmus) clumsiness and lack of co-ordination, affecting their balance (ataxia)



changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation) a high temperature (fever) swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy) in people who already have Parkinsons disease, worsening of the symptoms.



loss of consciousness or coma. If you forget to take Lamictal Dont take extra tablets or a double dose to make up for a forgotten dose. If you have missed taking a dose of Lamictal: Ask your doctor for advice on how to start taking it again. Its important that you do this. Dont stop taking Lamictal without advice Lamictal must be taken for as long as your doctor recommends. Dont stop unless your doctor advises you to. If youre taking Lamictal for epilepsy To stop taking Lamictal, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamictal, your epilepsy may come back or get worse. If youre taking Lamictal for bipolar disorder Lamictal may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamictal, your dose will not need to be reduced gradually. But you should still talk to your doctor first, if you want to stop taking Lamictal. 4. POSSIBLE SIDE EFFECTS Like all medicines, Lamictal can cause side effects, but not everyone gets them. Potentially serious reactions: get a doctors help straight away A small number of people taking Lamictal get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. These symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if the starting dose is too high or if the dose is increased too quickly, or if Lamictal is taken with another medicine called valproate. Some of the symptoms are more common in children, so parents should be especially careful to watch out for them. Symptoms of these reactions include: skin rashes or redness, which may develop into severe skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis) a sore mouth or eyes a high temperature (fever), flu-like symptoms or drowsiness swelling around your face, or swollen glands in your neck, armpit or groin unexpected bleeding or bruising, or the fingers turning blue a sore throat, or more infections (such as colds) than usual.



Other side effects Other side effects have occurred in a small number of people but their exact frequency is unknown: A group of symptoms together including : 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 (meningitis). These symptoms usually disappear once treatment is stopped however if the symptoms continue or get worse contact your doctor. There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids. If you get side effects If any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. 5. HOW TO STORE LAMICTAL KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store in a dry place. Do not store above 30C. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do. If you have any unwanted Lamictal tablets, dont dispose of them in your waste water or your household rubbish. Take them back to your pharmacist, who will dispose of them in a way that wont harm the environment.







6. FURTHER INFORMATION What Lamictal contains The active substance in Lamictal Tablets 50mg is lamotrigine. Each Lamictal 50mg tablet contains 50mg of the active ingredient lamotrigine. The active substance in Lamictal Tablets 100mg is lamotrigine. Each Lamictal 100mg tablet contains 100mg of the active ingredient lamotrigine. The active substance in Lamictal Tablets 200mg is lamotrigine. Each Lamictal 200mg tablet contains 200mg of the active ingredient lamotrigine. The other ingredients are: lactose, microcrystalline cellulose, sodium starch glycollate, povidone, iron oxide (E172), magnesium stearate.



In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious and can develop into more serious problems, such as organ failure, if they are not treated. If you notice any of these symptoms: Contact a doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamictal. Very common side effects These may affect more than 1 in 10 people: headache feeling dizzy feeling sleepy or drowsy clumsiness and lack of co-ordination (ataxia) double vision or blurred vision feeling sick (nausea) or being sick (vomiting)





What Lamictal looks like and contents of the pack Lamictal Tablets 50mg are pale yellowish, rounded square tablets, multi-faceted and marked 50on one side, and flat with GSEE1 marked on the other. They are available as blister packs of 30 tablets. Lamictal Tablets 100mg are pale yellowish, rounded square tablets, multi-faceted and marked 100 on one side, and flat with GSEE5 marked on the other. They are available as blister packs of 30 tablets. Lamictal Tablets 200mg are pale yellowish, rounded square tablets, multi-faceted and marked 200 on one side, and flat with GSEE7 marked on the other. They are available as blister packs of 30 tablets. Product Licence holder Procured from within the EU and repackaged by the Parallel Import Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Glaxo Wellcome Operations, Ware, Hertfordshire, UK and The Wellcome Foundation Ltd, Dartford, Kent. POM PL No: 08747/0307 Lamictal Tablets 50mg PL No: 08747/0306 Lamictal Tablets 100mg PL No: 08747/0305 Lamictal Tablets 200mg Leaflet revision date: 8 June 2012 Lamictal is a registered trade mark of GlaxoSmithKline Group of companies. If you have any other questions about epilepsy, contact a doctor or pharmacist. Alternatively, the British Epilepsy Association will try to answer them for you. You can telephone their National Information Centre free from anywhere in the country on 0808 800 5050 or write to them at New Anstey House, Gate Way Drive, Yeadon, Leeds LS19 7XY
305-06-07 LEAFLET Lamictal 20120608

skin rash. Common side effects These may affect up to 1 in 10 people: aggression or irritability rapid, uncontrollable eye movements (nystagmus) shaking or tremors difficulty in sleeping diarrhoea dry mouth feeling tired

pain in your back or joints, or elsewhere. Rare side effects These may affect up to 1 in 1,000 people: itchy eyes, with discharge and crusty eyelids (conjunctivitis) a severe skin reaction (Stevens-Johnson syndrome: see also the information at the beginning of Section 4).

Very rare side effects These may affect up to 1 in 10,000 people: hallucinations (seeing or hearing things that arent really there) confusion or agitation feeling wobbly or unsteady when you move about uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness a severe skin reaction (toxic epidermal necrolysis: see also the information at the beginning of Section 4) in people who already have epilepsy, seizures happening more often changes in liver function, which will show up in blood tests, or liver failure

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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