25 mg, 50 mg, 100 mg, 200 mg tablets / 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg chewable tablets / dispersible tablets
lamotrigine

What Lamictal is and what it is used for

Lamictal belongs to a group of medicines called antiepileptics. 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 (attacks).

  • For adults and children 13 years of age and older, Lamictal can be used alone or in combination with other medicines to treat epilepsy . Lamictal can also be used with other medicines to treat the seizures that occur in a condition known as Lennox-Gastaut syndrome.
  • For children between the ages of 2 and 12, Lamictal can be used with other medicines to treat these conditions. It can be used as the sole treatment to treat a type of epilepsy called typical absences.

Lamictal also treats bipolar disorder.

People with bipolar disorder (sometimes referred to as manic depression ) experience very sharp mood swings with periods of mania (excitement or rush of happiness) alternating with periods of depression (deep sadness or despair). For adults 18 years of age and older, Lamictal can be used alone or in combination 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.

What you need to know before you take Lamictal

Do not take Lamictal:

  • if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6).

If this applies to you:

→ Tell your doctor and do not take Lamictal.

Warnings and cautions

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 get a rash or get burnt while taking lamotrigine and have been in the sun or artificial light (eg solarium) . Your doctor will monitor your treatment and may recommend that you avoid sunlight or protect your skin from the sun’s rays (eg with sunscreen and / or protective clothing).
  • if you have ever developed meningitis ( meningitis ) after taking lamotrigine (read the description of its symptoms in section 4 of this leaflet: Rare side effects )
  • if you are already taking medicines containing lamotrigine.
  • if you have a condition called Brugada Syndrome. Brugada’s syndrome is a genetic disease that leads to abnormal electrical activity in the heart. ECG abnormalities that can lead to arrhythmias (abnormal heart rhythms) can be triggered by lamotrigine.

If any of this applies to you:

→ Tell your doctor who may decide that your dose needs to be reduced or that Lamictal is not suitable for you.

Important information about possible life-threatening reactions

A small number of people taking Lamictal have an allergic reaction or a skin reaction that can be life-threatening and develop into more serious problems if left untreated. This may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to know the symptoms that you should be aware of while taking Lamictal.

→ Read the description of these symptoms in section 4 of this leaflet under “Possible life-threatening reactions: contact a doctor immediately”.

Hemophagocytic syndrome (HLH)

There have been reports of a rare but very severe reaction in the immune system in patients taking lamotrigine. 

→ Contact a doctor or pharmacist immediately if you get any of the following symptoms: fever, rash, neurological symptoms (eg tremors or tremors, confused state, disorders of brain function).

Thoughts of harming yourself or suicide

Antiepileptic drugs are used to treat various 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 are more likely to have such thoughts:

  • when you start treatment
  • if you have previously had thoughts of harming yourself or committing suicide
  • if you are under 25 years of age.

If you have worrying thoughts or experiences or if you notice that you feel worse or develop new symptoms while taking Lamictal:

→ Contact a doctor as soon as possible or see your nearest hospital for help.

It may be helpful to tell a family member, caregiver, or close friend that you may be depressed or have noticeable changes in your mood, and ask them to read this leaflet. You can ask them to tell you if they are worried about your depression or other changes in your behavior.

A small number of people treated with antiepileptic drugs such as Lamictal have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.

If you are taking Lamictal for epilepsy

Seizures in certain types of epilepsy can sometimes get worse or occur more often while you are taking Lamictal. Some patients may experience severe seizures that can cause serious health problems. If your seizures occur more often or if you experience a severe seizure while taking Lamictal:

→ Contact a doctor as soon as possible.

Lamictal should not be given to people under the age of 18 for the treatment of bipolar disorderDrugs for the treatment of depression and other mental health problems increase the risk of suicidal thoughts and suicidal behavior in children and adolescents under 18 years of age.

Other medicines and Lamictal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines.

Your doctor needs to know if you are taking any other medicines to treat epilepsy or mental health problems. This is to ensure that 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 quit smoking
  • paracetamol , which is used to treat pain and fever .

→ Tell your doctor if you are taking any of these.

Some medicines affect Lamictal or make you more likely to get 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 phenobarbital used to treat epilepsy
  • risperidone used to treat mental health problems
  • rifampicin which is an antibiotic
  • medicines used to treat HIV (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
  • hormonal contraceptives such as birth control pills ( see below ).

→ Tell your doctor if you are taking or are starting or stopping any of these.

Hormonal contraceptives (eg birth control pills ) can affect the way Lamictal works

Your doctor may recommend that you use a special type of hormonal contraceptive or another method of contraception such as a condom, diaphragm, or IUD. If you are using a hormonal contraceptive such as a contraceptive pill, your doctor may take blood samples to check your Lamictal level. If you are using or planning to start using hormonal contraceptives:

→ Tell your doctor who is discussing appropriate contraceptive methods with you.

Lamictal can also affect the way hormonal contraceptives work, although they are unlikely to be less effective. If you are using a hormonal contraceptive and notice any change in your menstrual cycle, such as a menstrual-like bleeding or small bleeding between periods:

→ Tell your doctor. This may be a sign that Lamictal is affecting the way your contraceptive works.

Pregnancy and breastfeeding

→ 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 end your treatment without discussing it with your doctor. This is especially important if you have epilepsy .
  • Pregnancy may change the effectiveness of Lamictal, so you may need to take blood samples and your dose of Lamictal may need to be changed.
  • There may be a small increased risk of malformation in the fetus, including cleft lip or palate , if Lamictal is taken during the first three months of pregnancy.
  • Your doctor may advise you to take extra folic acid if you are planning to become pregnant and while you are pregnant.

→ If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine. The active substance in Lamictal is excreted in human milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding during treatment with lamotrigine. If you choose to breastfeed, your doctor will check the baby from time to time to see if the baby has drowsiness, rash, or poor weight gain. Tell your doctor if you notice any of these symptoms in your child. 

Driving and using machines

Lamictal can cause dizziness and double vision.

→ Do not drive a vehicle or use any tools or machines unless you are feeling well.

If you have epilepsy, talk to your doctor about driving and using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Lamictal contains

Lamictal tablets contain small amounts of a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Lamictal tablets (tablets / chewable tablets / dispersible tablets) contain less than 1 mmol (23 mg) sodium per tablet , ie essentially ‘sodium-free’.How to take Lamictal

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much Lamictal to take

It can take a while to find the Lamictal dose that is best for you. The dose you take depends on:

  • your age
  • whether you are taking Lamictal with other medicines or not
  • if you have any problems with your kidneys or liver.

Your doctor will start you on a low dose and increase the dose gradually over a few weeks until you reach a dose that works for you (called the effective dose of one ). Never take more Lamictal than your doctor has told you to.

The usual effective dose of Lamictal for adults and children from 13 years of age is between 100 mg and 400 mg daily.

For children between 2 and 12 years of age, the effective dose depends on the body weight – usually, it is between 1 mg and 15 mg for each kilogram of the child’s weight up to a maintenance dose of no more than 200 mg daily.

Lamictal is not recommended for children under 2 years.

How to take your dose of Lamictal

Tablets:

Take your dose of Lamictal once or twice daily according to your doctor’s instructions. It can be taken with or without food.

Your doctor may also tell you to start or stop taking other medicines, depending on the condition you are being treated for and how you are reacting to the treatment.

  • Swallow the tablets whole. You must not divide, chew or crush them.
  • Always take the full dose prescribed by your doctor. Never take just one part of a tablet.

Chewable tablets / dispersible tablets:

Take your dose of Lamictal once or twice daily according to your doctor’s instructions. It can be taken with or without food.

  • Always take the full dose prescribed by your doctor. Never take just one part of a tablet.

Your doctor may also tell you to start or stop taking other medicines, depending on the condition you are being treated for and how you are reacting to the treatment.

Lamictal chewable tablets / dispersible tablets can either be swallowed whole with water, chewed, or mixed with water for liquid medicine. Never take only part of the liquid medicine.

How to remove the tablet

Lamictal chewable tablets / dispersible tablets come in two different types of blister packs. The following image instructions only apply to the child-resistant blister packs:

These tablets are supplied in a special package that prevents children from taking them out.

Each blister unit has a number. Take the tablets in order and start with tablet number 1.

1. Remove a tablet: tear along the perforated line to remove a “pocket” from the blister.

Shows how a "pocket" is removed

2. Fold back the outer layer: start at the corner, lift and fold back over the pocket.

Indicates that the outer / rear bearing is being pulled off.

3. Push out the tablet: Gently push one end of the tablet through the foil layer.

Press up the tablet

To chew the tablet:

You may need to drink some water at the same time so that the tablet dissolves in your mouth. Then drink a little more water so that you are sure that you have swallowed all the medicine.

To make a liquid medicine:

  • Put the tablet in a glass with at least enough water to cover the whole tablet.
  • Stir to dissolve the tablet or wait until the tablet is completely dissolved.
  • Drink all the liquid.
  • Add a little more water to the glass and drink it to ensure that no medicine is left in the glass.

If you take more Lamictal than you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine:

→ Contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice. Show them the Lamictal packaging if possible.

If you take too much Lamictal, there is a greater risk that you will get serious side effects that can be life-threatening.

A person who has taken too much Lamictal may experience any of these symptoms:

  • rapid, uncontrolled eye movements ( nystagmus )
  • clumsiness and lack of coordination ability that affects balance ( ataxia )
  • changes in heart rate (usually detected on ECG )
  • loss of consciousness, seizures (convulsions) or coma .

If you forget to take a dose of Lamictal

→ Do not take extra tablets to compensate for a missed dose. Just take your next dose at the usual time.

If you forget to take multiple doses of Lamictal

→ Ask your doctor how to start taking the medicine again. You must ask about this.

Do not stop taking Lamictal without consulting your doctor.

Lamictal must be taken for as long as your doctor recommends it. Do not stop without your doctor telling you to.

If you are taking Lamictal for epilepsy

To stop taking Lamictal, the dose must be reduced gradually over about 2 weeks. If you suddenly stop taking Lamictal, your epilepsy may come back or get worse.

If you are taking Lamictal for bipolar disorder

It may take some time before Lamictal works and therefore you will probably not feel better right away. If you stop taking Lamictal, your dose does not need to be reduced gradually. However, you should still talk to your doctor first, if you want to stop taking Lamictal.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible life-threatening reactions: contact a doctor immediately

A small number of people taking Lamictal have an allergic reaction or a skin reaction that can be life-threatening and develop into more serious problems if left untreated.

You are most likely to get these symptoms during the first months of treatment with Lamictal, especially if you start on an overdose or if the dose is increased too fast, or if you take Lamictal with another medicine containing valproate. Some symptoms are more common in children so parents should pay extra attention.

Symptoms of such reactions include:

  • skin rash or redness , which can develop into a life-threatening skin reaction that includes widespread skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) , extensive flaking of the skin (more than 30% of body surface area – toxic epidermal necrolysis ) or extensive skin rash affecting the liver, blood and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS hypersensitivity syndrome).
  • sores in the mouth, throat, nose or abdomen
  • sore mouth or red swollen eyes ( conjunctivitis )
  • fever , flu-like symptoms or drowsiness
  • swelling around the face or swollen glands in the neck, armpits or groin
  • unexpected bleeding or bruising or that the fingers turn blue
  • sore throat or more infections (such as colds) than usual
  • elevated liver enzyme levels in blood tests
  • an increase in a kind of white blood cell ( eosinophils )
  • enlarged lymph nodes
  • effects on body organs, extensive liver and kidneys.

In many cases, these symptoms are signs of less serious side effects. But you need to be aware that they can be life-threatening and lead to more serious problems, such as organ failure if left untreated. If you notice any of these symptoms:

→ Contact a doctor immediately. Your doctor may decide to take samples of your liver, kidneys, or blood and may tell you to stop taking Lamictal. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you never to use lamotrigine again.

Haemophagocytic syndrome (HLH) (see section 2 What you need to know before taking Lamictal).

Very common side effects are

May affect more than 1 user in 10 :

  • headache
  • rash.

Common side effects are

May affect up to 1 in 10 users

  • aggression or irritability
  • drowsiness or drowsiness
  • dizziness
  • tremors or tremors
  • sleep disorders ( insomnia )
  • feelings of upset
  • diarrhea
  • dry mouth
  • nausea, vomiting
  • fatigue
  • back or joint pain or elsewhere

Uncommon side effects are

May affect up to 1 in 100 users:

  • clumsiness and lack of coordination ( ataxia )
  • double vision or blurred vision
  • abnormal hair loss or thinning ( alopecia )
  • skin rash or sun damage after exposure to sun or artificial light ( photosensitivity ).

Rare side effects are

May affect up to 1 in 1,000 users:

  • a life-threatening skin reaction (Stevens-Johnson syndrome), see also the information at the beginning of section 4 .
  • a group of symptoms that include:fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be due to an inflammation of the membrane that protects the brain and spine ( meningitis ) . These symptoms usually go away when treatment is stopped. Contact your doctor if symptoms persist or worsen.
  • rapid, uncontrolled eye movements ( nystagmus )
  • itching of the eyes with secretions and crusts on the eyelids ( conjunctivitis ) .

Very rare side effect s

May affect up to 1 in 10,000 users:

  • 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 ä vein information in the beginning of section 4
  • elevated temperature (fever), see also the information at the beginning of section 4
  • swelling around the face ( edema ) or swollen glands in the neck, armpit or groin ( lymphadenopathy ), see also the information at the beginning of section 4 .
  • changes in liver function, as evidenced by blood tests, or liver failure, see also the information at the beginning of section 4
  • a severe blood coagulation disorder that may cause unexpected bleeding or bruising ( disseminated intravascular coagulation ), see also the information at the beginning of section 4.
  • Haemophagocytic Syndrome (HLH) (see section 2 What you need to know before taking Lamictal)
  • changes that can be seen in blood samples – including decreased red blood cell count ( anemia ), decreased white blood cell count ( leukopenia , neutropenia , agranulocytosis ), decreased platelet count ( thrombocytopenia ), decreased number of all these blood cell types ( pancytopenia ) and a disease in bone marrow one called aplastic anemia
  • hallucinations (to “see” or “hear” things that do not really exist)
  • confusion
  • feeling of “wobbling” or being unsteady when you move
  • uncontrollable body movements ( tics ), uncontrollable muscle spasms that affect the eyes, head and torso ( choreoatetosis ) or other unusual body movements such as twitching, shaking or stiffness
  • more common seizures in those who already have epilepsy
  • worsening symptoms in those who already have Parkinson’s disease .
  • lupus-like reaction (symptoms may include: back or joint pain which may sometimes be accompanied by fever and / or general illness).

Other side effects are

Other side effects have been reported in a small number of people but the exact frequency is unknown:

  • There have been reports of skeletal effects including osteopenia and osteoporosis (thinning of the skeletal bone) and bone fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis or are taking steroids .
  • renal inflammation ( tubulointerstitial nephritis ), or inflammation of both kidney and eye ( tubulointerstitial nephritis and uveitis )
  • nightmares
  • weakened immune system due to lower levels of immunoglobulins , a type of blood cell that helps protect against infection .

How to store Lamictal

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the blister, carton, or jar. The expiration date is the last day of the specified month.

No special storage instructions.

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.

Contents of the pack and other information

Content declaration

Tablets:

The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of lamotrigine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (type A), yellow iron oxide (E172), and magnesium stearate.

Chewable tablets / dispersible tablets:

The active substance is lamotrigine. Each chewable tablet / dispersible tablet contains 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.

The other ingredients are calcium carbonate, low-substituted hydroxypropyl cellulose, aluminum magnesium silicate, sodium starch glycolate (type A), povidone K30, saccharin sodium, magnesium stearate, blackcurrant aroma.

What the medicine looks like and contents of the pack

Tablets:

Lamictal tablets (all strengths) are square with rounded corners and pale yellow-brown. Not all 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. There are also escalator packs of 21 or 42 tablets that can be used during the first weeks of treatment when the dose is slowly increased.

Lamictal 50 mg tablets are labeled “GSEE1” on one side and “50” on the other. Each pack contains blisters of 14, 28, 30, 42, 56, 90, 98 or 100 tablets. There are also escalator packs of 42 tablets that can be used during the first weeks of treatment when the dose is slowly increased.

Lamictal 100 mg tablets are labeled “GSEE5” on one side and “100” on the other. Each pack contains blisters of 28, 30, 42, 50, 56, 90, 98 or 100 tablets.

Lamictal 200 mg tablets are labeled “GSEE7” on one side and “200” on the other. Each pack contains blisters of 28, 30, 42, 56, or 100 tablets.

Chewable tablets / dispersible tablets:

Lamictal chewable tablets / dispersible tablets (all strengths) are white to off-white and can be easily marbled. They smell like blackcurrants. Not all pack sizes may be marketed.

Lamictal 2 mg chewable tablets / dispersible tablets are round. They are marked “LTG” above the number “2” on one side and with two overlapping ovals at right angles on the other side. Each jar contains 30 chewable tablets / dispersible tablets.

Lamictal 5 mg chewable tablets / dispersible tablets are elongated with curved sides. They are marked “GS CL2” on one side and “5” on the other. Each pack contains blisters of 10, 14, 28, 30, 42, 50 or 56 chewable tablets / dispersible tablets or a can of 14, 28, 30, 42, 56 or 60 chewable tablets / dispersible tablets.

Lamictal 25 mg chewable tablets / dispersible tablets are square with rounded corners. They are marked “GSCL5” on one side and “25” on the other. Each pack contains blisters of 10, 14, 21, 28, 30, 42, 50, 56 or 60 chewable / dispersible tablets.

Lamictal 50 mg chewable tablets / dispersible tablets are square with rounded corners. They are marked “GSCX7” on one side and “50” on the other. Each pack contains blisters of 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196 or 200 chewable / dispersible tablets.

Lamictal 100 mg chewable tablets / dispersible tablets are square with rounded corners. They are marked “GSCL7” on one side and “100” on the other. Each pack contains blisters of 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196 or 200 chewable / dispersible tablets.

Lamictal 200 mg chewable tablets / dispersible tablets are square with rounded corners. They are marked “GSEC5” on one side and “200” on the other. Each pack contains blisters of 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196 or 200 chewable / dispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline AB

Box 516

169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Manufacturer:

GlaxoSmithKline Pharmaceuticals SA, Ul. Grunwaldzka 189, 60-322 Poznan, Poland.

This medicinal product is authorized under the European Economic Area under the following names:

Lamictal:

Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Ireland, Iceland, Italy, Croatia, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom, Sweden, Czech Republic, Germany, Hungary, Austria

Lamitrin, / Lamitrin S:

Poland

Muhammad Nadeem

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