Lamictal 100mg Dispersible/Chewable Tablets
LAMICTAL® 100MG DISPERSIBLE/CHEWABLE TABLETS
(lamotrigine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lamictal Dispersible/Chewable Tablets are available in the following strengths: 2mg, 5mg, 25mg & 100mg. This leaflet only applies to the 100mg Dispersible/Chewable Tablets which will be referred to as Lamictal Dispersible/Chewable 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 you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Lamictal Dispersible/Chewable Tablets are and what they are used for
2. What you need to know before you take Lamictal Dispersible/Chewable Tablets
3. How to take Lamictal Dispersible/Chewable Tablets
4. Possible side effects
5. How to store Lamictal Dispersible/Chewable Tablets
6. Contents of the pack and other information
1. What Lamictal Dispersible/Chewable Tablets are and what they are used for
Lamictal Dispersible/Chewable Tablets belong to a group of medicines called anti-epileptics. They are used to treat two conditions - epilepsy and bipolar disorder.
Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets can be used on its own or with other medicines, to treat epilepsy. Lamictal Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable Tablets can be used on their own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamictal Dispersible/Chewable Tablets work in the brain to have this effect.
2. What you need to know before you take Lamictal Dispersible/Chewable Tablets
Do not take Lamictal Dispersible/Chewable Tablets:
■ if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in Section 6).
If this applies to you:
^ Tell your doctor and don't take Lamictal Dispersible/Chewable Tablets.
Take special care with Lamictal Dispersible/Chewable Tablets Talk to your doctor or pharmacist before taking Lamictal Dispersible/Chewable 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: Rare 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 Dispersible/Chewable Tablets are not suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking Lamictal Dispersible/Chewable Tablets get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets:
^ See a doctor as soon as possible or go to the nearest hospital for help.
You may find it helpful to tell a family member, caregiver or close friend that you can become depressed or have significant changes in mood, and ask them to read this leaflet. You might ask them to tell you if they are worried about your depression or other changes in your behaviour.
A small number of people being treated with anti-epileptics such as Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets for epilepsy
The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets:
^ See a doctor as soon as possible.
Lamictal Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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
Dispersible/Chewable Tablets are affecting the way your contraceptive is working.
Pregnancy and breast-feeding
^ 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.
■ Pregnancy may alter the effectiveness of Lamictal Dispersible/Chewable Tablets, so you may need blood tests and your dose of Lamictal Dispersible/Chewable Tablets may be adjusted.
■ There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if Lamictal Dispersible/Chewable Tablets are taken during the first 3 months of pregnancy.
■ Your doctor may advise you to take extra folic acid if you’re planning to become pregnant and while you’re pregnant.
^ If you are breast-feeding or planning to breastfeed ask your doctor or pharmacist for advice before taking this medicine. The active ingredient of Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets and will check your baby from time to time if you decide to breast-feed.
Driving and using machines
Lamictal Dispersible/Chewable 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
Dispersible/Chewable 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 Dispersible/Chewable Tablets to take
It may take a while to find the best dose of Lamictal Dispersible/Chewable Tablets for you. The dose you take will depend on:
■ your age
■ whether you are taking Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets than your doctor tells you to.
The usual effective dose of Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets are not recommended for children aged under 2 years.
How to take your dose of Lamictal Dispersible/Chewable Tablets
Take your dose of Lamictal Dispersible/Chewable 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 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.
If you take more Lamictal Dispersible/Chewable Tablets than you should
^ Contact a doctor or nearest hospital emergency department immediately. If possible, show them the Lamictal Dispersible/Chewable Tablets packet.
If you take too many Lamictal Dispersible/Chewable Tablets you may be more likely to have serious side effects which may be fatal.
Someone who has taken too many Lamictal Dispersible/Chewable Tablets may have any of these symptoms:
■ rapid, uncontrollable eye movements (nystagmus)
■ clumsiness and lack of co-ordination, affecting their balance (ataxia)
■ heart rhythm changes (detected usually on ECG)
■ loss of consciousness, fits (convulsions) or coma.
If you forget to take a single dose of Lamictal Dispersible/Chewable Tablets
^ Don't take extra tablets to make up for a missed dose. Just take your next dose at the usual time.
In case you forget to take multiple doses of Lamictal Dispersible/Chewable Tablets ^ Ask your doctor for advice on how to start taking it again. It’s important that you do this.
Don't stop taking Lamictal Dispersible/Chewable Tablets without advice
Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets for epilepsy
To stop taking Lamictal Dispersible/Chewable Tablets, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamictal Dispersible/Chewable Tablets, your epilepsy may come back or get worse.
If you're taking Lamictal Dispersible/Chewable Tablets for bipolar disorder
Lamictal Dispersible/Chewable Tablets may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamictal Dispersible/Chewable 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 Dispersible/Chewable Tablets.
4. Possible side effects
Like all medicines, this medicine 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 Dispersible/Chewable 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 Dispersible/Chewable Tablets, especially if the starting dose is too high or if the dose is increased too quickly or if Lamictal Dispersible/Chewable 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) or extended rashes with liver, blood and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS hypersensitivity syndrome)
■ 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
■ increased levels of liver enzymes seen in blood tests
■ an increase in a type of white blood cell (eosinophils)
■ enlarged lymph nodes
■ involvement of the organs of the body including liver and kidneys.
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 Dispersible/Chewable 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
■ unusual hair loss or thinning (alopecia).
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)
■ Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): (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 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 anti-epileptic medication, have a history of osteoporosis or take steroids
■ Nightmares.
Reporting of 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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lamictal Dispersible/Chewable 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 Dispersible/Chewable 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 Dispersible/Chewable 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., Ul. 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 POM
Leaflet Revision and issue date (Ref): 06.05.16
Lamictal® is a registered trademark of the GlaxoSmithKline group of companies.
Other formats:
To request a copy of this leaflet in Braille, large print or audio, please call 01302 365000 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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