LAMOTRIGINE 100MG DISPERSIBLE TABLETS
Active substance: LAMOTRIGINE
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5. How to store Lamictal KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30C. Store in a dry place. Protect from light. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell 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.
S299 LEAFLET Lamictal 20130228
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 life-threatening reactions A small number of people taking Lamictal get an allergic reaction or potentially life-threatening 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 life-threatening 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL 100mg DISPERSIBLE TABLETS (lamotrigine)
Your medicine is known as Lamictal 100mg Dispersible Tablets but will be referred to as Lamictal throughout the remainder of the leaflet. Please note that information regarding Lamictal 25mg Dispersible Tablets, Lamictal 2mg Dispersible Tablets and Lamictal 5mg Dispersible Tablets may also be present in the below leaflet. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Lamictal is and what it is used for 2. What you need to know before you take Lamictal 3. How to take Lamictal 4. Possible side effects 5. How to store Lamictal 6. Contents of the pack and other 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.
6. Contents of the pack and other information What Lamictal contains Each 100mg dispersible tablet contains 100mg lamotrigine. Lamictal Dispersible also contain the following inactive ingredients: calcium carbonate, low substituted hydroxypropylcellulose, aluminium magnesium silicate, sodium starch glycollate, povidone K30, saccharin sodium, magnesium stearate and blackcurrant flavouring.
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. 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. Other medicines and Lamictal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines 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, olanzapine or aripiprazole used to treat mental health problems bupropion, used to treat mental health problems or to stop smoking
What Lamictal looks like and contents of the pack The tablets are white multifaceted, round tablets marked GSCL7 on one side and 100 on the other. Lamictal 100mg dispersible Tablets are available as blister packs of 56 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX. Manufacturer This product is manufactured by Glaxo Operations UK Ltd, Priory Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI Grunwaldzka 189, 60-322 Poznan, Poland. POM PL No: 19488/0299
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. What you need to know before you take Lamictal Do not take Lamictal: if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in Section 6).
Leaflet revision date: 28 February 2013 Lamictal is a registered trade mark of GlaxoSmithKline Group of companies.
S299 LEAFLET Lamictal 20130228
If this applies to you: Tell your doctor and dont take Lamictal. Take special care with Lamictal Talk to your doctor or pharmacist before taking 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.
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 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 you may need blood tests and your dose of Lamictal may be adjusted. If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy. If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. 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 breastfeed. Driving and using machines Lamictal can cause dizziness and double vision. Dont drive or use machines unless you are sure youre not affected. If you have epilepsy, talk to your doctor about driving and using machines. 3. How to take Lamictal Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are 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.
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. Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
Symptoms of these reactions include: skin rashes or redness, which may develop into lifethreatening 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) ulcers in the mouth, throat, nose or genitals a sore mouth or red or swollen eyes (conjunctivitis) 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.
Very rare side effects These may affect up to 1 in 10,000 people: a life-threatening skin reaction (toxic epidermal necrolysis): see also the information at the beginning of Section 4 a high temperature (fever): see also the information at the beginning of Section 4 swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of Section 4 changes in liver function, which will show up in blood tests or liver failure: see also the information at the beginning of Section 4 a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of Section 4 changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, 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 hallucinations (seeing or hearing things that arent really there) confusion 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 in people who already have epilepsy, seizures happening more often in people who already have Parkinsons disease, worsening of the symptoms lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).
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. Lamictal dispersible/chewable tablets can either be swallowed whole with a little water, chewed or mixed with water to make a liquid medicine. To chew the tablet: You may need to drink a little water at the same time to help the tablet dissolve in the mouth. Then drink some more water to make sure all the medicine has been swallowed. To make a liquid medicine: Put the tablet in a glass with at least enough water to cover the whole tablet. Either stir to dissolve or wait until the tablet is fully dissolved. Drink all the liquid. Add a little more water to the glass and drink that, to make sure no medicine is left in the glass.
In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially lifethreatening 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. In case you have developed StevensJohnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again. Very common side effects These may affect more than 1 in 10 people: headache skin rash.
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) loss of consciousness or coma.
Common side effects These may affect up to 1 in 10 people: aggression or irritability feeling sleepy or drowsy feeling dizzy shaking or tremors difficulty in sleeping (insomnia) feeling agitated diarrhoea dry mouth feeling sick (nausea) or being sick (vomiting) feeling tired pain in your back or joints, or elsewhere.
If you forget to take Lamictal Dont take extra tablets to make up for a missed dose. Just take your next dose at the usual time. 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, this medicine can cause side effects, but not everyone gets them. Potentially life-threatening reactions: get a doctors help straight away A small number of people taking Lamictal get an allergic reaction or potentially life-threatening 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.
Other side effects Other side effects have occurred in a small number of people but their exact frequency is unknown: 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 anti-epileptic medication, have a history of osteoporosis or take steroids.
Uncommon side effects These may affect up to 1 in 100 people: clumsiness and lack of co-ordination (ataxia) double vision or blurred vision.
If you get side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Rare side effects These may affect up to 1 in 1,000 people: a life-threatening skin reaction (Stevens-Johnson syndrome): see also the information at the beginning of Section 4 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 rapid, uncontrollable eye movements (nystagmus) itchy eyes, with discharge and crusty eyelids (conjunctivitis).
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 maintenance dose of 200 mg daily. Lamictal is not recommended for children aged under 2 years.
5. How to store Lamotrigine Tablets KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30C. Store in a dry place. Protect from light. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. If you have any unwanted Lamotrigine 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.
S299 LEAFLET Lamotrigine 20130228
PACKAGE LEAFLET: INFORMATION FOR THE USER
If any of these applies to you: Tell your doctor, who may decide to lower the dose or that Lamotrigine Tablets are not suitable for you. Important information about potentially life-threatening reactions A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially life-threatening 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 life-threatening 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.
LAMOTRIGINE 100mg DISPERSIBLE TABLETS
Your medicine is known as Lamotrigine 100mg Dispersible Tablets but will be referred to as Lamotrigine Tablets throughout the remainder of the leaflet. Please note that information regarding Lamotrigine 25mg Dispersible Tablets, Lamotrigine 2mg Dispersible Tablets and Lamotrigine 5mg Dispersible Tablets may also be present in the below leaflet. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Lamotrigine Tablets are and what they are used for 2. What you need to know before you take Lamotrigine Tablets 3. How to take Lamotrigine Tablets 4. Possible side effects 5. How to store Lamotrigine Tablets 6. Contents of the pack and other information
6. Contents of the pack and other information What Lamotrigine Tablets contain Each 100mg dispersible tablet contains 100mg lamotrigine. Lamotrigine Tablets also contain the following inactive ingredients: calcium carbonate, low substituted hydroxypropylcellulose, aluminium magnesium silicate, sodium starch glycollate, povidone K30, saccharin sodium, magnesium stearate and blackcurrant flavouring.
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 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. Other medicines and Lamotrigine Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines 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 Lamotrigine Tablets. These medicines include: oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy lithium, olanzapine or aripiprazole used to treat mental health problems bupropion, used to treat mental health problems or to stop smoking
What Lamotrigine Tablets look like and contents of the pack The tablets are white multifaceted, round tablets marked GSCL7 on one side and 100 on the other. Lamotrigine Tablets are available as blister packs of 56 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX. Manufacturer This product is manufactured by Glaxo Operations UK Ltd, Priory Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI Grunwaldzka 189, 60-322 Poznan, Poland. POM PL No: 19488/0299 Lamotrigine Tablets also treat bipolar disorder. Leaflet revision date: 28 February 2013
S299 LEAFLET Lamotrigine 20130228
1. What Lamotrigine Tablets are and what they are used for Lamotrigine Tablets belong to a group of medicines called antiepileptics. 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 its 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.
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 Tablets 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 Tablets work in the brain to have this effect. 2. What you need to know before you take Lamotrigine Tablets Do not take Lamotrigine Tablets: if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in Section 6).
Tell your doctor if you are taking any of these. Some medicines interact with Lamotrigine Tablets 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).
If this applies to you: Tell your doctor and dont take Lamotrigine Tablets. Take special care with Lamotrigine Tablets Talk to your doctor or pharmacist before taking Lamotrigine Tablets: 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.
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 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 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 Tablets. 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. 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 Tablets are affecting the way your contraceptive is working. Pregnancy and breast-feeding There may be an increased risk of birth defects in babies whose mothers took Lamotrigine Tablets 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 you may need blood tests and your dose of Lamotrigine Tablets may be adjusted. If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy. If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. The active ingredient of Lamotrigine Tablets 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 use machines unless you are sure youre not affected. If you have epilepsy, talk to your doctor about driving and using machines. 3. How to take Lamotrigine Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much Lamotrigine Tablets 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 other medicines whether you have any kidney or liver problems.
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 maintenance dose of 200 mg daily. Lamotrigine Tablets are not recommended for children aged under 2 years. How to take your dose of Lamotrigine Tablets Take your dose of Lamotrigine Tablets once or twice a day, as your doctor advises. It can be taken with or without food. Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
4. Possible side effects Like all medicines, this medicine can cause side effects, but not everyone gets them. Potentially life-threatening reactions: get a doctors help straight away A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially life-threatening 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 Lamotrigine Tablets, especially if the starting dose is too high or if the dose is increased too quickly or if Lamotrigine Tablets are 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 lifethreatening 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) ulcers in the mouth, throat, nose or genitals a sore mouth or red or swollen eyes (conjunctivitis) 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.
Rare side effects These may affect up to 1 in 1,000 people: a life-threatening skin reaction (Stevens-Johnson syndrome): see also the information at the beginning of Section 4 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 rapid, uncontrollable eye movements (nystagmus) itchy eyes, with discharge and crusty eyelids (conjunctivitis).
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. Lamotrigine dispersible/chewable tablets can either be swallowed whole with a little water, chewed or mixed with water to make a liquid medicine. To chew the tablet: You may need to drink a little water at the same time to help the tablet dissolve in the mouth. Then drink some more water to make sure all the medicine has been swallowed. To make a liquid medicine: Put the tablet in a glass with at least enough water to cover the whole tablet. Either stir to dissolve or wait until the tablet is fully dissolved. Drink all the liquid. Add a little more water to the glass and drink that, to make sure no medicine is left in the glass.
Very rare side effects These may affect up to 1 in 10,000 people: a life-threatening skin reaction (toxic epidermal necrolysis): see also the information at the beginning of Section 4 a high temperature (fever): see also the information at the beginning of Section 4 swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of Section 4 changes in liver function, which will show up in blood tests or liver failure: see also the information at the beginning of Section 4 a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of Section 4 changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, 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 hallucinations (seeing or hearing things that arent really there) confusion 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 in people who already have epilepsy, seizures happening more often in people who already have Parkinsons disease, worsening of the symptoms lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).
If you take more Lamotrigine Tablets than you should Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine Tablets packet. Someone who has taken too much Lamotrigine Tablets 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.
In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially lifethreatening 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. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again. Very common side effects These may affect more than 1 in 10 people: headache skin rash.
If you forget to take Lamotrigine Tablets Dont take extra tablets to make up for a missed dose. Just take your next dose at the usual time. 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 Lamotrigine Tablets must be taken for as long as your doctor recommends. Dont stop unless your doctor advises you to. If youre taking Lamotrigine Tablets for epilepsy To stop taking Lamotrigine Tablets, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine Tablets, your epilepsy may come back or get worse. If youre 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.
Common side effects These may affect up to 1 in 10 people: aggression or irritability feeling sleepy or drowsy feeling dizzy shaking or tremors difficulty in sleeping (insomnia) feeling agitated diarrhoea dry mouth feeling sick (nausea) or being sick (vomiting) feeling tired pain in your back or joints, or elsewhere.
Other side effects Other side effects have occurred in a small number of people but their exact frequency is unknown: 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 anti-epileptic medication, have a history of osteoporosis or take steroids.
If you get side effects Uncommon side effects These may affect up to 1 in 100 people: clumsiness and lack of co-ordination (ataxia) double vision or blurred vision. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 Lamotrigine Tablets than your doctor tells you to. The usual effective dose of Lamotrigine Tablets for adults and children aged 13 years or over is between 100 mg and 400 mg each day.
S299 LEAFLET Lamictal 20130228
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 life-threatening reactions A small number of people taking Lamictal get an allergic reaction or potentially life-threatening 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 life-threatening 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMICTAL 100mg DISPERSIBLE TABLETS (lamotrigine)
Your medicine is known as Lamictal 100mg Dispersible Tablets but will be referred to as Lamictal throughout the remainder of the leaflet. Please note that information regarding Lamictal 25mg Dispersible Tablets, Lamictal 2mg Dispersible Tablets and Lamictal 5mg Dispersible Tablets may also be present in the below leaflet. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Lamictal is and what it is used for 2. What you need to know before you take Lamictal 3. How to take Lamictal 4. Possible side effects 5. How to store Lamictal 6. Contents of the pack and other 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.
6. Contents of the pack and other information What Lamictal contains Each 100mg dispersible tablet contains 100mg lamotrigine. Lamictal Dispersible also contain the following inactive ingredients: calcium carbonate, low substituted hydroxypropylcellulose, aluminium magnesium silicate, sodium starch glycollate, povidone K30, saccharin sodium, magnesium stearate and blackcurrant flavouring.
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. 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. Other medicines and Lamictal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines 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, olanzapine or aripiprazole used to treat mental health problems bupropion, used to treat mental health problems or to stop smoking
What Lamictal looks like and contents of the pack The tablets are white multifaceted, round tablets marked GSCL7 on one side and 100 on the other. Lamictal 100mg dispersible Tablets are available as blister packs of 56 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX. Manufacturer This product is manufactured by Glaxo Operations UK Ltd, Priory Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI Grunwaldzka 189, 60-322 Poznan, Poland. POM PL No: 19488/0299
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. What you need to know before you take Lamictal Do not take Lamictal: if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in Section 6).
Leaflet revision date: 28 February 2013 Lamictal is a registered trade mark of GlaxoSmithKline Group of companies.
S299 LEAFLET Lamictal 20130228
If this applies to you: Tell your doctor and dont take Lamictal. Take special care with Lamictal Talk to your doctor or pharmacist before taking 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.
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 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 you may need blood tests and your dose of Lamictal may be adjusted. If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy. If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. 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 breastfeed. Driving and using machines Lamictal can cause dizziness and double vision. Dont drive or use machines unless you are sure youre not affected. If you have epilepsy, talk to your doctor about driving and using machines. 3. How to take Lamictal Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are 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.
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. Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
Symptoms of these reactions include: skin rashes or redness, which may develop into lifethreatening 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) ulcers in the mouth, throat, nose or genitals a sore mouth or red or swollen eyes (conjunctivitis) 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.
Very rare side effects These may affect up to 1 in 10,000 people: a life-threatening skin reaction (toxic epidermal necrolysis): see also the information at the beginning of Section 4 a high temperature (fever): see also the information at the beginning of Section 4 swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of Section 4 changes in liver function, which will show up in blood tests or liver failure: see also the information at the beginning of Section 4 a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of Section 4 changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, 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 hallucinations (seeing or hearing things that arent really there) confusion 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 in people who already have epilepsy, seizures happening more often in people who already have Parkinsons disease, worsening of the symptoms lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).
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. Lamictal dispersible/chewable tablets can either be swallowed whole with a little water, chewed or mixed with water to make a liquid medicine. To chew the tablet: You may need to drink a little water at the same time to help the tablet dissolve in the mouth. Then drink some more water to make sure all the medicine has been swallowed. To make a liquid medicine: Put the tablet in a glass with at least enough water to cover the whole tablet. Either stir to dissolve or wait until the tablet is fully dissolved. Drink all the liquid. Add a little more water to the glass and drink that, to make sure no medicine is left in the glass.
In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially lifethreatening 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. In case you have developed StevensJohnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again. Very common side effects These may affect more than 1 in 10 people: headache skin rash.
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) loss of consciousness or coma.
Common side effects These may affect up to 1 in 10 people: aggression or irritability feeling sleepy or drowsy feeling dizzy shaking or tremors difficulty in sleeping (insomnia) feeling agitated diarrhoea dry mouth feeling sick (nausea) or being sick (vomiting) feeling tired pain in your back or joints, or elsewhere.
If you forget to take Lamictal Dont take extra tablets to make up for a missed dose. Just take your next dose at the usual time. 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, this medicine can cause side effects, but not everyone gets them. Potentially life-threatening reactions: get a doctors help straight away A small number of people taking Lamictal get an allergic reaction or potentially life-threatening 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.
Other side effects Other side effects have occurred in a small number of people but their exact frequency is unknown: 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 anti-epileptic medication, have a history of osteoporosis or take steroids.
Uncommon side effects These may affect up to 1 in 100 people: clumsiness and lack of co-ordination (ataxia) double vision or blurred vision.
If you get side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Rare side effects These may affect up to 1 in 1,000 people: a life-threatening skin reaction (Stevens-Johnson syndrome): see also the information at the beginning of Section 4 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 rapid, uncontrollable eye movements (nystagmus) itchy eyes, with discharge and crusty eyelids (conjunctivitis).
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 maintenance dose of 200 mg daily. Lamictal is not recommended for children aged under 2 years.
5. How to store Lamotrigine Tablets KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30C. Store in a dry place. Protect from light. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. If you have any unwanted Lamotrigine 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.
S299 LEAFLET Lamotrigine 20130228
PACKAGE LEAFLET: INFORMATION FOR THE USER
If any of these applies to you: Tell your doctor, who may decide to lower the dose or that Lamotrigine Tablets are not suitable for you. Important information about potentially life-threatening reactions A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially life-threatening 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 life-threatening 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.
LAMOTRIGINE 100mg DISPERSIBLE TABLETS
Your medicine is known as Lamotrigine 100mg Dispersible Tablets but will be referred to as Lamotrigine Tablets throughout the remainder of the leaflet. Please note that information regarding Lamotrigine 25mg Dispersible Tablets, Lamotrigine 2mg Dispersible Tablets and Lamotrigine 5mg Dispersible Tablets may also be present in the below leaflet. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Lamotrigine Tablets are and what they are used for 2. What you need to know before you take Lamotrigine Tablets 3. How to take Lamotrigine Tablets 4. Possible side effects 5. How to store Lamotrigine Tablets 6. Contents of the pack and other information
6. Contents of the pack and other information What Lamotrigine Tablets contain Each 100mg dispersible tablet contains 100mg lamotrigine. Lamotrigine Tablets also contain the following inactive ingredients: calcium carbonate, low substituted hydroxypropylcellulose, aluminium magnesium silicate, sodium starch glycollate, povidone K30, saccharin sodium, magnesium stearate and blackcurrant flavouring.
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 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. Other medicines and Lamotrigine Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines 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 Lamotrigine Tablets. These medicines include: oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy lithium, olanzapine or aripiprazole used to treat mental health problems bupropion, used to treat mental health problems or to stop smoking
What Lamotrigine Tablets look like and contents of the pack The tablets are white multifaceted, round tablets marked GSCL7 on one side and 100 on the other. Lamotrigine Tablets are available as blister packs of 56 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX. Manufacturer This product is manufactured by Glaxo Operations UK Ltd, Priory Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI Grunwaldzka 189, 60-322 Poznan, Poland. POM PL No: 19488/0299 Lamotrigine Tablets also treat bipolar disorder. Leaflet revision date: 28 February 2013
S299 LEAFLET Lamotrigine 20130228
1. What Lamotrigine Tablets are and what they are used for Lamotrigine Tablets belong to a group of medicines called antiepileptics. 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 its 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.
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 Tablets 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 Tablets work in the brain to have this effect. 2. What you need to know before you take Lamotrigine Tablets Do not take Lamotrigine Tablets: if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in Section 6).
Tell your doctor if you are taking any of these. Some medicines interact with Lamotrigine Tablets 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).
If this applies to you: Tell your doctor and dont take Lamotrigine Tablets. Take special care with Lamotrigine Tablets Talk to your doctor or pharmacist before taking Lamotrigine Tablets: 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.
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 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 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 Tablets. 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. 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 Tablets are affecting the way your contraceptive is working. Pregnancy and breast-feeding There may be an increased risk of birth defects in babies whose mothers took Lamotrigine Tablets 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 you may need blood tests and your dose of Lamotrigine Tablets may be adjusted. If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy. If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. The active ingredient of Lamotrigine Tablets 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 use machines unless you are sure youre not affected. If you have epilepsy, talk to your doctor about driving and using machines. 3. How to take Lamotrigine Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much Lamotrigine Tablets 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 other medicines whether you have any kidney or liver problems.
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 maintenance dose of 200 mg daily. Lamotrigine Tablets are not recommended for children aged under 2 years. How to take your dose of Lamotrigine Tablets Take your dose of Lamotrigine Tablets once or twice a day, as your doctor advises. It can be taken with or without food. Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
4. Possible side effects Like all medicines, this medicine can cause side effects, but not everyone gets them. Potentially life-threatening reactions: get a doctors help straight away A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially life-threatening 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 Lamotrigine Tablets, especially if the starting dose is too high or if the dose is increased too quickly or if Lamotrigine Tablets are 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 lifethreatening 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) ulcers in the mouth, throat, nose or genitals a sore mouth or red or swollen eyes (conjunctivitis) 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.
Rare side effects These may affect up to 1 in 1,000 people: a life-threatening skin reaction (Stevens-Johnson syndrome): see also the information at the beginning of Section 4 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 rapid, uncontrollable eye movements (nystagmus) itchy eyes, with discharge and crusty eyelids (conjunctivitis).
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. Lamotrigine dispersible/chewable tablets can either be swallowed whole with a little water, chewed or mixed with water to make a liquid medicine. To chew the tablet: You may need to drink a little water at the same time to help the tablet dissolve in the mouth. Then drink some more water to make sure all the medicine has been swallowed. To make a liquid medicine: Put the tablet in a glass with at least enough water to cover the whole tablet. Either stir to dissolve or wait until the tablet is fully dissolved. Drink all the liquid. Add a little more water to the glass and drink that, to make sure no medicine is left in the glass.
Very rare side effects These may affect up to 1 in 10,000 people: a life-threatening skin reaction (toxic epidermal necrolysis): see also the information at the beginning of Section 4 a high temperature (fever): see also the information at the beginning of Section 4 swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of Section 4 changes in liver function, which will show up in blood tests or liver failure: see also the information at the beginning of Section 4 a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of Section 4 changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, 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 hallucinations (seeing or hearing things that arent really there) confusion 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 in people who already have epilepsy, seizures happening more often in people who already have Parkinsons disease, worsening of the symptoms lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).
If you take more Lamotrigine Tablets than you should Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigine Tablets packet. Someone who has taken too much Lamotrigine Tablets 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.
In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially lifethreatening 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. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again. Very common side effects These may affect more than 1 in 10 people: headache skin rash.
If you forget to take Lamotrigine Tablets Dont take extra tablets to make up for a missed dose. Just take your next dose at the usual time. 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 Lamotrigine Tablets must be taken for as long as your doctor recommends. Dont stop unless your doctor advises you to. If youre taking Lamotrigine Tablets for epilepsy To stop taking Lamotrigine Tablets, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine Tablets, your epilepsy may come back or get worse. If youre 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.
Common side effects These may affect up to 1 in 10 people: aggression or irritability feeling sleepy or drowsy feeling dizzy shaking or tremors difficulty in sleeping (insomnia) feeling agitated diarrhoea dry mouth feeling sick (nausea) or being sick (vomiting) feeling tired pain in your back or joints, or elsewhere.
Other side effects Other side effects have occurred in a small number of people but their exact frequency is unknown: 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 anti-epileptic medication, have a history of osteoporosis or take steroids.
If you get side effects Uncommon side effects These may affect up to 1 in 100 people: clumsiness and lack of co-ordination (ataxia) double vision or blurred vision. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 Lamotrigine Tablets than your doctor tells you to. The usual effective dose of Lamotrigine Tablets for adults and children aged 13 years or over is between 100 mg and 400 mg each day.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
