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LAMOTRIGINE 200 MG TABLETS

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PATIENT INFORMATION LEAFLET LAMOTRIGINE 25 mg, 50 mg, 100 mg and 200 mg TABLETS
(lamotrigine) The name of this medicine is Lamotrigine 25 mg, 50 mg, 100 mg and 200 mg Tablets, which will be referred to as Lamotrigine Tablets throughout 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 your 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 the leaflet, please tell your doctor or pharmacist In this leaflet 1. What Lamotrigine Tablets are and what they are used for 2. Before you take Lamotrigine Tablets 3. How to take Lamotrigine Tablets 4. Possible side effects 5. How to store Lamotrigine Tablets 6. Further Information

1. WHAT LAMOTRIGINE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in this product is lamotrigine, which belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder. Lamotrigine Tablets treat epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits). For adults and children aged 13 years and over, Lamotrigine Tablets can be used on their own or with other medicines, to treat epilepsy. Lamotrigine Tablets 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, Lamotrigine Tablets 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. Lamotrigine Tablets also treat 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, lamotrigine 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 lamotrigine works in the brain to have this effect.

2. BEFORE YOU TAKE LAMOTRIGINE TABLETS
Do not take Lamotrigine Tablets if you: are allergic (hypersensitive) to lamotrigine, or any of the other ingredients in Lamotrigine Tablets (these are listed in section 6, Further Information) If this applies to you: Tell your doctor,and dont take Lamotrigine Tablets. Take special care with Lamotrigine Tablets Your doctor needs to know before you take Lamotrigine Tablets if you: have problems with your kidneys have ever developed a rash when youve taken lamotrigine or other medicines for epilepsy or bipolar disorder are already taking medicine that contains lamotrigine If any of these applies to you: Tell your doctor,who may decide to lower your dose or that Lamotrigine Tablets are not suitable for you. Watch out for important symptoms A small number of people taking lamotrigine 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 Lamotrigine Tablets. 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 If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while youre taking Lamotrigine Tablets: 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 Lamotrigine Tablets have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. If youre taking Lamotrigine Tablets for epilepsy The seizures in some types of epilepsy may occasionally become worse or happen more often while youre taking Lamotrigine Tablets. 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 Lamotrigine Tablets: See a doctor as soon as possible. Lamotrigine Tablets should not be given to people 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, if youve taken any recently, or if you start taking new ones these include herbal medicines or other medicines you bought without a prescription. If you are taking certain medicines, your doctor may need to check the dose of Lamotrigine Tablets. These 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 Lamotrigine Tablets or make it more likely that youll 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 a combination of lopinavir and ritonavir or atazanavir and ritonavir, used to treat Human Immunodeficinecy Virus (HIV) infection hormonal contraceptives, such as the Pill (see below). Tell your doctor if you are taking any of these. Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine Tablets work Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil. If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of lamotrigine. If you plan to start using a hormonal contraceptive: Talk to your doctor, who will discuss suitable methods of contraception with you. Lamotrigine Tablets 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 lamotrigine 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. It is important that you do this because there may be an increased risk of birth defects in babies whose mothers took lamotrigine 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 Lamotrigine Tablets, so your doctor may take samples of your blood to check the level of lamotrigine, and may adjust your dose. Talk to your doctor if youre breast-feeding or planning to breast-feed. The active ingredient of lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while youre taking Lamotrigine Tablets, and will check your baby from time to time if you decide to breast-feed. Driving and using machines Lamotrigine Tablets 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 Lamotrigine Tablets Lamotrigine 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 Lamotrigine Tablets.

3. HOW TO TAKE LAMOTRIGINE TABLETS
Always use Lamotrigine Tablets exactly as your doctor has told you to. Check with your doctor or pharmacist if youre not sure. For doses not realisable / practicable with these strengths of tablet, other strengths of this medicinal product are available. How much lamotrigine to take It may take a while to find the best dose of Lamotrigine Tablets for you. The dose you take will depend on: your age whether you are taking Lamotrigine Tablets with any other medicine whether you have problems with your kidneys or liver. Your doctor will start you on a low dose, 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 Lamotrigine Tablets than your doctor tells you to. The usual effective dose of Lamotrigine Tablets for adults and children aged over 12 years is between 100 mg and 400 mg each day. Lamotrigine is not recommended for children aged under 2 years.

LAMOTRIGINE 25 mg, 50 mg, 100 mg and 200 mg TABLETS

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LAMOTRIGINE 25 mg, 50 mg, 100 mg and 200 mg TABLETS

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. How to take your dose of Lamotrigine Tablets Take your dose of Lamotrigine Tablets once or twice a day, as your doctor advises. You can take it 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 take more Lamotrigine Tablets than you should If anyone takes too much lamotrigine : Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine Tablets packet. Someone who has taken too much lamotrigine may have any of these symptoms; rapid, uncontrollable eye movements (nystagmus) clumsiness and lack of co-ordination, affecting their balance (ataxia) loss of consciousness or coma If you forget to take Lamotrigine Tablets Dont take extra tablets or a double dose to make up for a forgotten dose. If you have missed taking a dose of Lamotrigine Tablets: Ask your doctor for advice on how to start taking it again. Its important that you do this. Dont stop taking Lamotrigine Tablets without advice Take Lamotrigine Tablets for as long as your doctor recommends. Dont stop unless your doctor advises you to. If you are taking Lamotrigine Tablets for epilepsy To stop taking Lamotrigine Tablets, it is important that your dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine Tablets, your epilepsy may come back or get worse. If you are taking Lamotrigine Tablets for bipolar disorder Lamotrigine Tablets may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine Tablets, your dose will not need to be reduced gradually. But you should still talk to your doctor first, if you want to stop taking Lamotrigine Tablets.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Lamotrigine Tablets can cause side effects, but not everybody gets them. Allergic reaction or potentially serious skin reaction: get a doctors help straight away. A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially serious skin reaction, which may develop into more serious and even life-threatening problems if they are not treated. These symptoms are more likely to happen during the first few months of treatment with Lamotrigine Tablets, especially if you start on too high a dose or if your dose is increased too quickly, or if youre taking Lamotrigine Tablets 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 your fingers turning blue a sore throat or more infections (such as colds) than usual. 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 Lamotrigine Tablets. 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) 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 rare skin condition, (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 changes which may show up in blood tests including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopoenia, neutropenia, agranulocytosis), 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 symptoms 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) 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 but if the symptoms continue or get worse contact your doctor. 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 LAMOTRIGINE TABLETS
Keep Lamotrigine Tablets out of the reach and sight of children. Do not use Lamotrigine Tablets after the expiry date shown on the blisters, carton or bottle. The expiry date refers to the last day of that month. Lamotrigine does not require any special storage conditions. If you have any unwanted Lamotrigine Tablets, dont dispose of them in your wastewater or 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 Lamotrigine Tablets contain The active ingredient is lamotrigine. Each tablet contains 25, 50, 100 or 200 mg of lamotrigine. The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, maize starch, magnesium stearate and iron oxide yellow (E172). What Lamotrigine Tablets look like and contents of the pack Lamotrigine 25 mg, 50mg and 100mg Tablets are yellow, round tablets with '25' or '50' or '100' on one side and a score-line on the other. Lamotrigine 200 mg Tablets are yellow, capsule-shaped tablets with 200 on one side and a score-line on the other. Your medicine is available in packs of 21, 28, 42, 56, or 100 tablets (not all pack sizes may be marketed). Marketing Authorisation Holder: STD Chemicals Ltd, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW. Manufacturer responsible for batch release: Neolab Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK. This leaflet was last revised in October 2011 XXXXX

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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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