Lamictal Tablets 25mg
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Package Leaflet: Information for the User
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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:
I* your age
• whether you are taking Lamictal with other
'• 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 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, it's between 1 mg and 15 mg for each kilogram of the child's weight, up to a maximum maintenance dose of 200 mg daily.
Lamictal is not recommended for children aged under 2 years.
How to take your dose of Lamictal
Take your dose of Lamictal once or twice a day, as your doctor advises. It can be taken with or
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.
• Swallow your tablets whole. Don't break, chew or crush them.
• Always take the full dose that your doctor has prescribed. Never take only part of a tablet.
If you take more Lamictal than you should
Contact a doctor or nearest hospital emergency department immediately. If possible, show them the Lamictal packet.
If you take too much Lamictal you may be more likely to have serious side effects which may be fatal.
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)
• heart rhythm changes (detected usually on ECG)
• loss of consciousness, fits (convulsions) or coma.
If you forget to take Lamictal
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 without advice
Lamictal must be taken for as long as your doctor recommends. Don't stop unless your doctor advises
If you're 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
If you're 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.
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 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.
Symptoms of these reactions include:
• skin rashes or redness, which may develop into life-threatening skin reactions including
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 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)
• 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. 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
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
• 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)
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 (feve (see also the information at the beginning of Section 4)
■ swelling around the face ( ) 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 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)
• feeling 'wobbly' or unsteady when you move
• 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
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the blisters or carton. The expiry date refers to the last day of that month.
Lamictal does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Lamictal tablets contain
The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg
The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (Type A), iron oxide yellow (E172) and magnesium stearate.
What Lamictal tablets look like and contents of the pack
Lamictal tablets (all strengths) are square with rounded corners and pale, yellowish brown in colour. Not all listed pack sizes may be marketed. Lamictal 25 mg tablets are marked 'GSEC7' on one side and '25' on the other Each pack contains blisters of 14, 21, 28, 30, 42, 50, 56 or 100 tablets. . Lamictal 50 mg tablets are marked 'GSEE1' on one side and '50' on the other Each pack contains blisters of 14, 28, 30, 42, 56, 90, 98 or 100 tablets.
Lamictal 100 mg tablets are marked 'GSEE5' on one side and '100' on the other. Each pack contains blisters of 28, 30, 42, 50, 56, 60, 90, 98 or 100 tablets.
Lamictal 200 mg tablets are marked 'GSEE7' on one side and '200' on the other. Each pack contains blisters of 28, 30, 42, 56 or 100 tablets.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder:
The Wellcome Foundation Ltd., Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufacturer: GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189, 60-322 Poznan, Poland This leaflet was last revised in January 2015 Lamictal is a registered trade mark of the GSK group of companies
© 2015 GSK group of companies. All rights reserved
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