Lamictal 100mg Dispersible/Chewable Tablets
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LAMICTAL® 100MG DISPERSIBLE/CHEWABLE TABLETS
(lamotrigine)
Lamictal Dispersible/Chewable Tablets are available in the following strengths: 2mg, 5mg, 25mg, & 100mg. This leaflet only applies to the 100mg Dispersible/Chewable Tablets. Your medicine is available using the above name but will be referred to as Lamictal 100mg Dispersible Tablets throughout this 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 any of the side effects gets serious, 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 100mg Dispersible Tablets are and what they are used for
2. What you need to know before you take Lamictal 100mg Dispersible Tablets
3. How to take Lamictal 100mg Dispersible Tablets
4. Possible side effects
5. How to store Lamictal 100mg Dispersible Tablets
6. Contents of the pack and other information
1. What Lamictal 100mg Dispersible Tablets are and what they are used for
Lamictal 100mg Dispersible Tablets belong to a group of medicines called anti-epileptics. They are used to treat two conditions - epilepsy and bipolar disorder.
Lamictal 100mg Dispersible Tablets treat epilepsy by
blocking the signals in the brain that trigger epileptic seizures (fits).
■ For adults and children aged 13 years and over, Lamictal 100mg Dispersible Tablets can be used on its own or with other medicines, to treat epilepsy. Lamictal 100mg Dispersible 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, Lamictal 100mg Dispersible Tablets can be used with other medicines, to treat those conditions. They can be used on their own to treat a type of epilepsy called typical absence seizures.
Lamictal 100mg Dispersible 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, Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets work in the brain to have this effect.
2. What you need to know before you take Lamictal 100mg Dispersible Tablets
Do not take Lamictal 100mg Dispersible Tablets:
■ if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamictal 100mg Dispersible Tablets (listed in Section 6).
If this applies to you:
^ Tell your doctor, and don't take Lamictal 100mg Dispersible Tablets.
Take special care with Lamictal 100mg Dispersible Tablets
Talk to your doctor or pharmacist before taking Lamictal 100mg Dispersible 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.
If any of these applies to you:
Tell your doctor, who may decide to lower the dose or that Lamictal 100mg Dispersible Tablets are not suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets.
^ Read the description of these symptoms in Section 4 of this leaflet under 'Potentially life-threatening reactions: get a doctor's 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 you're taking Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
If you're taking Lamictal 100mg Dispersible Tablets for epilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamictal 100mg Dispersible 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 you're taking Lamictal 100mg Dispersible Tablets:
^ See a doctor as soon as possible.
Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible 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
^ Tell your doctor if you are taking any of these.
Some medicines interact with Lamictal 100mg Dispersible 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). 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 100mg Dispersible 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 Lamictal 100mg Dispersible 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.
Lamictal 100mg Dispersible Tablets can also affect the way hormonal contraceptives work, although it's 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 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.
Pregnancy may also alter the effectiveness of Lamictal 100mg Dispersible Tablets, so you may need blood tests and your dose of Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while you're taking Lamictal 100mg Dispersible Tablets and will check your baby from time to time if you decide to breast-feed.
Driving and using machines
Lamictal 100mg Dispersible Tablets can cause dizziness and double vision.
^ Don't drive or use machines unless you are sure you're not affected.
If you have epilepsy, talk to your doctor about driving and using machines.
3. How to take Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets to take
It may take a while to find the best dose of Lamictal 100mg Dispersible Tablets for you. The dose you take will depend on:
■ your age
■ whether you are taking Lamictal 100mg Dispersible Tablets with other medicines
■ whether you have any kidney or liver problems.
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 100mg Dispersible Tablets than your doctor tells you to.
The usual effective dose of Lamictal 100mg Dispersible Tablets for adults and children aged 13 years or over is between 100mg and 400mg each day.
For children aged 2 to 12 years, the effective dose depends on their body weight - usually, it's between 1mg and 15mg for each kilogram of the child's weight, up to a maximum maintenance dose of 200mg daily.
Lamictal 100mg Dispersible Tablets are not recommended for children aged under 2 years.
How to take your dose of Lamictal 100mg Dispersible Tablets
Take your dose of Lamictal 100mg Dispersible 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.
Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment.
Lamictal 100mg Dispersible 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.
POM
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.
If you take more Lamictal 100mg Dispersible Tablets than you should
^ Contact a doctor or pharmacist immediately. If
possible, show them the Lamictal 100mg Dispersible Tablets packet.
Someone who has taken too many Lamictal 100mg Dispersible 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.
If you forget to take Lamictal 100mg Dispersible Tablets
Don't 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. It's important that you do this.
Don't stop taking Lamictal 100mg Dispersible Tablets without advice
Lamictal 100mg Dispersible Tablets must be taken for as long as your doctor recommends. Don't stop unless your doctor advises you to.
If you're taking Lamictal 100mg Dispersible Tablets for epilepsy
To stop taking Lamictal 100mg Dispersible Tablets, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamictal 100mg Dispersible Tablets, your epilepsy may come back or get worse.
If you're taking Lamictal 100mg Dispersible Tablets for bipolar disorder
Lamictal 100mg Dispersible Tablets may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets.
4. Possible side effects
Like all medicines, Lamictal 100mg Dispersible Tablets can cause side effects, but not everyone gets them.
Potentially life-threatening reactions: get a doctor's help straight away
A small number of people taking Lamictal 100mg Dispersible 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 Lamictal 100mg Dispersible Tablets, especially if the starting dose is too high or if the dose is increased too quickly, or if Lamictal 100mg Dispersible 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 life-threatening 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.
In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially life-threatening 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 100mg Dispersible 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.
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.
Uncommon side effects
These may affect up to 1 in 100 people:
■ clumsiness and lack of co-ordination (ataxia)
■ double vision or blurred vision
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)
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, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia
■ hallucinations ('seeing' or 'hearing' things that aren't 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 Parkinson's 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).
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 antiepileptic medication, have a history of osteoporosis, or take steroids.
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.
5. How to store Lamictal 100mg Dispersible Tablets
Lamictal 100mg Dispersible Tablets do not require any special storage conditions.
Keep out of the sight and reach of children.
Do not use the tablets after the expiry date shown on the blisters and carton. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking the tablets, please return any which are left over to your pharmacist. Only keep them if your doctor tells you to.
If the tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Lamictal 100mg Dispersible Tablets contain
Each dispersible tablet contains 100mg of the active ingredient lamotrigine.
Lamictal 100mg Dispersible Tablets also contain the following: calcium carbonate, low substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycollate, povidone K30, saccharin sodium, magnesium stearate and blackcurrant flavour.
What Lamictal 100mg Dispersible Tablets look like and contents of the pack
The tablets are white to off-white, uncoated, rounded square tablets, multifaceted on one side, marked '100' and marked 'GSCL7' on the other, with an odour of blackcurrant.
Lamictal 100mg Dispersible Tablets are available in blister packs of 56 tablets.
Manufacturer
Manufactured by: GLAXO WELLCOME OPERATIONS, Priory Street, Ware, Hertfordshire, SG12 0DJ, UK.
Or
GlaxoSmithKline Pharmaceuticals S.A., UI. Grunwaldzka 189, 60-322 Poznan, Poland.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0172
Leaflet Revision and issue date (Ref): 29.10.13
Lamictal® is a registered trademark of the GlaxoSmithKline group of companies.
If you have any other questions about epilepsy, contact a doctor or pharmacist. Alternatively, the British Epilepsy Association will try to and answer them for you. You can telephone their National Information Centre free from anywhere in the country on 0808 800 5050 or write to them at: New Anstey House,
Gate Way Drive, Yeadon, Leeds LS19 7XY.
To request a copy of this leaflet in Braille, large print or audio, please call 01302 552940 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name: Lamictal 100mg
Dispersible/Chewable Tablets
Reference number: 08929/0172
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