Lamictal

Package leaflet: Information for the user

Lamictal 25 mg chewable/dispersible tablets, 50 mg chewable/dispersible tablets, 100 mg chewable/dispersible tablets, 200 mg chewable/dispersible tablets

Lamotrigine
Please 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, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 antiepileptics. It is used to treat two conditions – epilepsy and bipolar disorder.

Lamictal treats epilepsy by blocking signals in the brain that trigger epileptic seizures (convulsions).

• In adults and children aged 13 years and older, Lamictal may be used alone or in combination with other medicines to treat epilepsy. Lamictal may also be used in combination with other medicines to treat convulsive seizures occurring in a condition called Lennox-Gastaut syndrome.
• In children aged between 2 and 12 years, Lamictal may be used in combination with other medicines to treat these conditions. It may be used alone to treat a type of epilepsy called typical absence seizures.

Lamictal also treats bipolar disorder.
People with bipolar disorder (also known as manic depression) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamictal may be used alone or in combination with other medicines to prevent depressive episodes associated with bipolar disorder. It is not yet known how Lamictal acts on the brain to produce this effect.

2. What you should know before taking Lamictal

Do not take Lamictal:

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

If this applies to you:
➔ inform your doctor and do not take Lamictal.
Warnings and precautions
Be especially careful with Lamictal
Talk to your doctor or pharmacist before taking Lamictal:

• if you have any kidney problems
• if you have ever developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you develop a skin rash or sunburn (sunburnt skin) after taking medicines containing lamotrigine and being exposed to sunlight or artificial light (e.g. a sunbed). Your doctor will review your treatment and may advise you to avoid exposure to sunlight or to protect yourself from the sun (e.g. by using sunscreen and/or wearing protective clothing)
• if you have ever had meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare undesirable effects)
• if you are already taking medicines containing lamotrigine
• if you have a condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic condition causing abnormal electrical activity in the heart. ECG abnormalities that may lead to arrhythmia (abnormal heart rhythm) can be caused by lamotrigine.

If any of these apply to you:
➔ inform your doctor, who may decide to reduce your dose or determine that Lamictal is not suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking Lamictal have experienced an allergic reaction or a skin reaction that could be potentially life-threatening. If not treated, these reactions may progress to more serious conditions. These may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to be aware of the symptoms while taking Lamictal. The risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai origin). If you are of this origin and previous testing has shown you carry this genetic variant (HLA-B*1502), discuss this with your doctor before taking Lamictal.
➔ Read the description of these symptoms in section 4 of this leaflet under "Potentially life-threatening reactions: seek immediate medical help."
Haemophagocytic Lymphohistiocytosis (HLH)
There have been reports of a rare but very serious immune system reaction in patients treated with lamotrigine.
➔ Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, skin rash, neurological symptoms (e.g. jerks or tremors, confusion, disturbances in brain function).
Thoughts of harming yourself or suicide
Antiepileptic medicines are used to treat various conditions, including epilepsy and bipolar disorder. People with bipolar disorder may sometimes have thoughts of harming themselves or of suicide. If you have bipolar disorder, you may be more likely to have these thoughts:

• when starting treatment for the first time

• if you have previously had thoughts of harming yourself or related to suicide

• if you are under 25 years of age. If you have thoughts or experiences that trouble you, or if you notice feeling worse or developing new symptoms while taking Lamictal: ➔ contact your 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 might become depressed or experience significant mood changes, and ask them to read this leaflet. You may
  ask them to tell you if they are concerned about your depression or other changes in your behaviour.
  A small number of people taking antiepileptic medicines such as Lamictal have also had thoughts of harming themselves or of suicide. If you have such thoughts at any time, contact your doctor immediately.
  If you are taking Lamictal for epilepsy
  In some types of epilepsy, seizures may occasionally worsen or occur more frequently during treatment with Lamictal.
  Some patients may experience severe seizures, which can lead to serious health problems. If your seizures become more frequent or if you experience a severe seizure while taking Lamictal:
  ➔ contact your doctor as soon as possible.
  Lamictal must not be given to people under 18 years of age for the treatment of bipolar disorder. Medicines that treat depression and other mental health conditions may increase the risk of suicidal thoughts and behaviours 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 herbal preparations or other non-prescription medicines.
  Your doctor needs to know if you are taking other medicines for epilepsy or mental health conditions to ensure you are receiving 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 conditions

• bupropion, used to treat mental health conditions or to quit smoking

• paracetamol, used to treat pain and fever ➔ Inform your doctor if you are taking any of these medicines.

Some medicines interact with Lamictal or make side effects more likely. These include:

• valproate, used to treat epilepsy and mental health conditions
• carbamazepine, used to treat epilepsy and mental health conditions
• phenytoin, primidone, or phenobarbital, used to treat epilepsy
• risperidone, used to treat mental health conditions
• rifampicin, an antibiotic
• medicines used to treat Human Immunodeficiency Virus (HIV) infection (combination of lopinavir and ritonavir or atazanavir and ritonavir)
• medicines containing estrogens, including hormonal contraceptives, such as the pill (see below) and hormone replacement therapy. ➔ Inform your doctor if you are taking or starting or stopping any of these medicines.

Hormonal contraceptives (such as the pill) may alter how Lamictal works
Your doctor may recommend that you use a particular type of hormonal contraceptive or another method of contraception, such as condoms, diaphragm, or intrauterine device. If you are using hormonal contraceptives such as the pill, your doctor may take blood samples to monitor your Lamictal levels. If you are using or considering starting a hormonal contraceptive:
➔ inform your doctor, who will discuss suitable contraceptive methods with you.
Lamictal may also alter how hormonal contraceptives work, although it is unlikely to make them less effective. If you are using a hormonal contraceptive and notice any changes in your menstrual cycle, such as unexpected bleeding or spotting between periods:
➔ inform your doctor. These may be signs that Lamictal is affecting how the contraceptive works.
Hormone replacement therapy may alter how Lamictal works
If you are using hormone replacement therapy containing estrogens, your doctor may take blood samples to monitor your Lamictal levels.
Pregnancy and breastfeeding
➔ If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

• Do not stop treatment without speaking to your doctor. This is especially important if you have epilepsy.
• Pregnancy may alter the effectiveness of Lamictal, so blood tests and dose adjustments may be necessary.
• There may be a small increased risk of birth defects, including cleft lip and cleft palate, if Lamictal is taken during the first three months of pregnancy.
• Your doctor may advise you to take additional folic acid, especially if you are planning a pregnancy or are already pregnant.

➔ If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine. The active ingredient in Lamictal passes into breast milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamictal and may monitor your baby occasionally for symptoms such as drowsiness, skin rash, or poor weight gain, if you decide to breastfeed. Inform your doctor if you notice any of these symptoms in your baby.
Driving and using machines
Lamictal may cause dizziness and double vision.
➔ Do not drive or operate machinery unless you are certain you do not experience these symptoms.
If you have epilepsy, talk to your doctor about driving and using machinery.
Information about the excipients of Lamictal
Lamictal chewable/dispersible tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Lamictal

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, consult your doctor or pharmacist.
How much Lamictal should you take?
It may take some time to find the optimal dose of Lamictal for you. Your dose will depend on:

• your age
• whether you are taking Lamictal with other medicines
• whether you have any kidney or liver problems.

Your doctor will prescribe a low starting dose, and gradually increase it over several
weeks until the dose that works for you is reached (called the effective dose). Do not take more
Lamictal than your doctor has prescribed.
The usual effective dose of Lamictal in adults and children aged 13 years and older is between 100 mg and
400 mg daily.
In children aged between 2 and 12 years, the effective dose depends on body weight – generally, it is
between 1 mg and 15 mg per kilogram of the child's body weight, up to a maximum maintenance dose of
200 mg per day.
Lamictal is not recommended for children under 2 years of age.
How to take your dose of Lamictal
Take your dose of Lamictal once or twice a day, as prescribed by your doctor. It can be taken with or
without food.

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

Your doctor may also advise you to start or stop taking other medicines, depending on the conditions being
treated and your response to therapy.
Lamictal dispersible/masticable tablets can be swallowed whole with a little water, chewed, or mixed in water to make a liquid medicine. Never take only part of the
liquid.
Removing a tablet
These tablets are in special packaging designed to prevent children from accessing them.
Each blister unit is numbered. Take the tablets in order, starting with tablet number 1.

1. Separate one tablet: tear along the perforation lines to separate one "pocket" from the blister pack.

2. Remove the outer layer: starting at the corner, lift and peel it away from the pocket.

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

To chew the tablet:
You may need to drink some water at the same time to help the tablet dissolve in the mouth. Then drink some more water to ensure that all the medicine has been swallowed.

To make the medicine into a liquid:

• Place the tablet in a glass with enough water to cover the entire tablet.
• To dissolve the tablet, stir or wait until the tablet has completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it to make sure no medicine is left in the glass.

If you take more Lamictal than you should
➔ Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the Lamictal packaging.
If you take too much Lamictal, you are more likely to experience serious side effects which may be fatal.
People who have taken too much Lamictal may experience one of the following symptoms:

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of coordination affecting balance (ataxia)
• changes in heart rhythm (usually detected by ECG)
• loss of consciousness, seizures, or coma.

If you forget to take a single dose of Lamictal
➔ Do not take extra tablets to make up for the missed dose. Take the next dose at your usual time.
If you forget to take several doses of Lamictal
➔ Consult your doctor for advice on how to restart treatment. It is important that you do so.
Do not stop taking Lamictal without consulting your doctor.
Lamictal should be taken for as long as your doctor has recommended. Do not stop unless your doctor tells you to do so.

If you are taking Lamictal for epilepsy
To stop taking Lamictal, it is important to gradually reduce the dose over a period of about 2 weeks. If you stop taking Lamictal suddenly, your seizures may return or worsen.

If you are taking Lamictal for bipolar disorder
Lamictal may take some time to work, so you are unlikely to feel better immediately. If you stop taking Lamictal, you do not necessarily need to taper the dose gradually. However, if you wish to stop taking Lamictal, you must always discuss this with your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Potentially life-threatening reactions: seek medical help immediately

A small number of people taking Lamictal have had an allergic reaction or a potentially life-threatening skin reaction, which, if untreated, may progress to more serious problems.

These symptoms are more likely to occur 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 together with another medicine called valproate. Some of these symptoms are more common in children, so parents should pay particular attention to their appearance.

Signs of such reactions include:

• Skin rash or redness, which may progress to severe or sometimes life-threatening skin reactions including rash with target-like lesions (erythema multiforme), widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin detachment (more than 30% of body surface area – toxic epidermal necrolysis), or widespread rashes involving the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS hypersensitivity syndrome)
• Ulcers in the mouth, throat, nose, or genitals
• Mouth pain or red, swollen eyes (conjunctivitis)
• High temperature (fever), flu-like symptoms, or drowsiness
• Swelling of the face or swelling of the glands in the neck, armpits, or groin
• Unexpected bleeding or bruising or fingers turning blue
• Sore throat or more frequent infections (such as colds) than usual
• Increased liver enzyme levels observed in blood tests
• Increase in a type of white blood cells (eosinophils)
• Swollen lymph nodes
• Organ involvement including liver and kidneys.

In many cases, these symptoms may indicate less serious side effects. However, you must be aware that they may be potentially life-threatening and, if left untreated, may progress to more serious conditions, such as organ failure. If you notice any of these symptoms: ➔ contact your doctor immediately. The doctor may decide to perform diagnostic tests on your liver, kidneys, or blood and may instruct you to stop taking Lamictal. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you never to take lamotrigine again.

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

Very common side effects
May affect more than 1 in 10 people:

• Headache
• Rash

Common side effects
May affect up to 1 in 10 people:

• Aggression or irritability
• Drowsiness
• Dizziness
• Shakes or tremors
• Difficulty sleeping (insomnia)
• Restlessness
• Diarrhoea
• Dry mouth
• Nausea or vomiting
• Tiredness
• Back, joint, or other site pain

Uncommon side effects
May affect up to 1 in 100 people:

• Clumsiness and lack of coordination (ataxia)
• Double vision or blurred vision
• Unusual hair loss or thinning (alopecia)
• Skin rash or sunburn (sunburn-like reaction) after exposure to sunlight or artificial light (photosensitivity)

Rare side effects
May affect up to 1 in 1,000 people:

• Skin reaction causing red spots or patches on the skin, which may resemble a target or “bull’s eye” with a dark red center surrounded by paler red rings (erythema multiforme)
• A life-threatening skin reaction (Stevens-Johnson syndrome): (see also information at the beginning of section 4)
• A group of associated symptoms including: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light. This may be caused by inflammation of the membranes covering the brain and spinal cord (meningitis). These symptoms usually resolve once treatment is stopped; however, if symptoms persist or worsen, contact your doctor
• Rapid, uncontrollable eye movements (nystagmus)
• Itchy eyes with discharge and crusts on the eyelids (conjunctivitis)

Very rare side effects
May affect up to 1 in 10,000 people:

• Life-threatening skin reaction (toxic epidermal necrolysis) (see also information at the beginning of section 4)
• Drug reaction with eosinophilia and systemic symptoms (DRESS) (see also information at the beginning of section 4)
• High temperature (fever) (see also information at the beginning of section 4)
• Swelling of the face (edema) or swelling of the glands in the neck, armpits, or groin (lymphadenopathy) (see also information at the beginning of section 4)
• Changes in liver function, shown by blood tests, or liver failure (see also information at the beginning of section 4)
• A severe blood clotting disorder, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4)
• Haemophagocytic lymphohistiocytosis (HLH) (see section 2: What you need to know before taking Lamictal)
• Changes that may be shown by blood tests – including reduced number of red blood cells in the blood (anaemia), reduced number of white blood cells in the blood (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all these cell types (pancytopenia), and a bone marrow disorder called aplastic anaemia
• Hallucinations (“seeing” or “hearing” things that are not actually real)
• Confusion
• Feeling “wobbly” or unsteady in movement
• Uncontrollable, repetitive body movements and/or sounds or words (tics), uncontrollable muscle spasms affecting eyes, head, and trunk (choreoathetosis), or other unusual body movements such as jerks, tremors, or stiffness
• In people who already have epilepsy, seizures may occur more frequently
• In people who already have Parkinson’s disease, worsening of symptoms
• Lupus-like reactions (symptoms may include: back or joint pain, sometimes accompanied by fever and/or general malaise)

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

• There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids
• Kidney inflammation (tubulointerstitial nephritis) or inflammation of both the kidneys and eyes (tubulointerstitial nephritis and uveitis syndrome)
• Nightmares
• Reduced immunity due to lower levels of antibodies in the blood called immunoglobulins, which help protect against infections
• Red skin nodules or patches (pseudolymphoma)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lamictal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging or bottle.
The expiry date refers to the last day of that month.
Lamictal does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lamictal chewable/dispersible tablets contain
The active substance is lamotrigine. Each chewable/dispersible tablet contains 25 mg, 50 mg, 100 mg, or
200 mg of lamotrigine.
The excipients are: calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminium silicate, sodium starch glycolate (Type A), povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavour.

Description of the appearance of Lamictal chewable/dispersible tablets and package contents
Lamictal chewable/dispersible tablets (all strengths) are white to off-white in colour and may have slightly bevelled edges. They have a blackcurrant flavour.
It is possible that not all pack sizes are marketed in your country.

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

The 50 mg chewable/dispersible tablets are square with rounded corners. They are marked with “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 tablets.

The 100 mg chewable/dispersible tablets are square with rounded corners. They are marked with “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 tablets.

The 200 mg chewable/dispersible tablets are square with rounded corners. They are marked with “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 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy

Manufacturer responsible for batch release:
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware,
Hertfordshire SG12 0DJ, United Kingdom.
Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland.

This medicinal product is authorised in the European Economic Area countries under the following names:

Austria Lamictal	Belgium Lamictal	Bulgaria Lamictal
Croatia Lamictal	Cyprus Lamictal	Czech Republic Lamictal
Denmark Lamictal	Estonia Lamictal	Finland Lamictal
France Lamictal	Germany Lamictal	Greece Lamictal
Hungary Lamictal	Iceland Lamictal	Ireland Lamictal
Italy Lamictal	Latvia Lamictal	Lithuania Lamictal
Luxembourg Lamictal	Malta Lamictal	Netherlands Lamictal
Norway Lamictal	Poland Lamitrin Lamitrin S	Portugal Lamictal
Romania Lamictal	Slovak Republic Lamictal	Slovenia Lamictal
Spain Lamictal	Sweden Lamictal

Package leaflet: information for the user

Lamictal 2 mg chewable/dispersible tablets, 5 mg chewable/dispersible tablets

Lamotrigine
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Lamictal is and what it is used for
2. What you need to know before taking 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 antiepileptics. It is used to treat two conditions – epilepsy and bipolar disorder.

Lamictal treats epilepsy by blocking signals in the brain that trigger epileptic seizures (convulsions).

• In adults and children aged 13 years and older, Lamictal can be used alone or in combination with other medicines to treat epilepsy. Lamictal may also be used together with other medicines to treat seizures occurring in a condition called Lennox-Gastaut syndrome.
• In children aged between 2 and 12 years, Lamictal can be used in combination with other medicines to treat these conditions. It may be used alone to treat a type of epilepsy called typical absence seizures.

Lamictal also treats bipolar disorder.
People with bipolar disorder (also called manic depression) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamictal can be used alone or in combination with other medicines to prevent depressive episodes associated with bipolar disorder. It is not yet known how Lamictal acts on the brain to produce this effect.

2. What you should know before taking Lamictal

Do not take Lamictal:

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

If this applies to you:
➔ inform your doctor and do not take Lamictal.
Warnings and precautions
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 skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you develop a skin rash or sunburn (sunburn) after taking medicines containing lamotrigine and exposure to sunlight or artificial light (e.g. a sunbed). Your doctor will review your treatment and may advise you to avoid exposure to sunlight or to protect yourself from the sun (e.g. by using sunscreen and/or wearing protective clothing)
• if you have ever had meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare adverse effects)
• if you are already taking medicines containing lamotrigine
• if you have a condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic condition that causes abnormal electrical activity in the heart. ECG abnormalities that may lead to arrhythmia (abnormal heart rhythm) can be caused by lamotrigine.

If any of these apply to you:
➔ inform your doctor, who may decide to reduce your dose or determine that Lamictal is not suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking Lamictal have had an allergic reaction or potentially life-threatening skin reactions, which, if not treated, may progress to more serious problems. These may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to be aware of the symptoms so you can remain vigilant while taking Lamictal. The risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai origin). If you are of this origin and previous testing has shown you carry this genetic variant (HLA-B*1502), discuss this with your doctor before taking Lamictal.
➔ Read the description of these symptoms in section 4 of this leaflet under "Potentially life-threatening reactions: seek immediate medical help."
Haemophagocytic Lymphohistiocytosis (HLH)
In patients treated with lamotrigine, there have been reports of a rare but very serious reaction of the immune system.
➔ Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. jerking or tremors, confusion, impaired brain function).
Thoughts of harming yourself or suicide
Antiepileptic medicines are used to treat various conditions, including epilepsy and bipolar disorder. People with bipolar disorder may sometimes have thoughts of harming themselves or of suicide. If you have bipolar disorder, you are more likely to have these thoughts:

• when starting treatment for the first time
• if you have previously had thoughts of harming yourself or of suicide
• if you are under 25 years of age. If you have thoughts or experiences that trouble you, or if you notice feeling worse or developing new symptoms while taking Lamictal: ➔ contact your 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 may become depressed or experience significant mood changes, and ask them to read this leaflet. You may ask them to inform you if they are concerned about your depression or other changes in your behaviour.

A small number of people being treated with antiepileptic medicines such as Lamictal have also had thoughts of harming themselves or of suicide. If you have such thoughts at any time, contact your doctor immediately.
If you are taking Lamictal for epilepsy
In some types of epilepsy, seizures may occasionally worsen or occur more frequently during treatment with Lamictal.
Some patients may have severe seizures, which can cause serious health problems. If seizures become more frequent or if you have a severe seizure while taking Lamictal:
➔ contact your doctor as soon as possible.
Lamictal must not be given to people under 18 years of age for the treatment of bipolar disorder. Medicines that treat depression and other mental health problems increase the risk of suicidal thoughts and behaviours 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 herbal preparations or other non-prescription medicines.
Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems to ensure you are taking 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, used to treat pain and fever ➔ Inform your doctor if you are taking any of these medicines.

Some medicines interact with Lamictal or make side effects more likely.
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, an antibiotic
• medicines used to treat Human Immunodeficiency Virus (HIV) infection (combination of lopinavir and ritonavir or atazanavir and ritonavir)
• medicines containing oestrogens, including hormonal contraceptives such as the pill (see below) and hormone replacement therapy (HRT). ➔ Inform your doctor if you are taking or starting or stopping any of these medicines.

Hormonal contraceptives (such as the pill) can change how Lamictal works
Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, diaphragm, or intrauterine device (IUD). If you are using hormonal contraceptives such as the pill, your doctor may take blood samples to monitor your Lamictal levels. If you are using or planning to start using a hormonal contraceptive:
➔ inform your doctor, who will discuss suitable contraceptive methods with you.
Lamictal may also change how hormonal contraceptives work, although it is unlikely to make them less effective. If you are using a hormonal contraceptive and notice any changes in your menstrual cycle, such as unexpected bleeding or spotting between periods:
➔ inform your doctor. These may be signs that Lamictal is affecting how the contraceptive works.
Hormone replacement therapies may change how Lamictal works
If you are using hormone replacement therapy containing oestrogens, your doctor may take blood samples to monitor your Lamictal levels.
Pregnancy and breastfeeding
➔ If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your
doctor or pharmacist before taking this medicine.

• Do not stop treatment without talking to your doctor. This is particularly important if you have epilepsy.
• Pregnancy may alter the effectiveness of Lamictal, so blood tests and dose adjustments may be needed.
• There may be a small increased risk of birth defects, including cleft lip or cleft palate, if Lamictal is taken during the first three months of pregnancy.
• Your doctor may advise you to take additional folic acid, especially if you are planning a pregnancy or are already pregnant.

➔ If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. The active ingredient in Lamictal passes into breast milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamictal and will monitor the baby occasionally for symptoms such as drowsiness, rash, or poor weight gain, if you decide to breastfeed. Inform your doctor if you notice any of these symptoms in the baby.
Driving and using machines
Lamictal can cause dizziness and double vision.
➔ Do not drive or operate machinery unless you are certain you do not experience these symptoms.
If you have epilepsy, talk to your doctor about driving and using machinery.
Information on excipients in Lamictal
Lamictal dispersible/masticable tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Lamictal

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, consult your doctor or pharmacist.
How much Lamictal should you take?
It may take some time to find the optimal dose of Lamictal for you. Your dose will depend on:

• your age
• whether you are taking Lamictal with other medicines
• whether you have any kidney or liver problems.

Your doctor will start you on a low dose and gradually increase it over several
weeks until the dose that works for you (called the effective dose) is reached. Do not take more
Lamictal than your doctor has prescribed.
The usual effective dose of Lamictal in adults and children aged 13 years and older is between 100 mg and
400 mg daily.
In children aged between 2 and 12 years, the effective dose depends on body weight – generally, it ranges from 1 mg to 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day.
Lamictal is not recommended in children under 2 years of age.
How to take your dose of Lamictal
Take your dose of Lamictal once or twice daily, as prescribed by your doctor. It can be taken with or
without food.

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

Your doctor may also advise you to start or stop taking other medicines, depending on the conditions being treated and your response to therapy.
Lamictal orally disintegrating/dispersible tablets can be swallowed whole with a little water, chewed, or mixed in water to make a liquid medicine. Never take only part of the liquid.
To chew the tablet:
You may need to drink some water at the same time to help the tablet dissolve in your mouth. Then drink more water to ensure that all the medicine has been swallowed.
To make a liquid medicine:

• Place the tablet in a glass with enough water to cover the entire tablet.
• Stir or wait until the tablet has completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to ensure no medicine is left in the glass.

If you take more Lamictal than you should
➔ Contact your doctor or the nearest hospital emergency department immediately. If possible,
show them the Lamictal packaging.
If you take too much Lamictal, you are more likely to experience serious side effects that may be
fatal.
Symptoms in people who have taken too much Lamictal may include:

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of coordination affecting balance (ataxia)
• changes in heart rhythm (usually detected by ECG)
• loss of consciousness, seizures, or coma.

If you forget to take a single dose of Lamictal
➔ Do not take extra tablets to make up for the missed dose. Take your next dose at the usual
time.
If you forget to take several doses of Lamictal
➔ Ask your doctor for advice on how to restart taking it. It is important that you do this.
Do not stop taking Lamictal without consulting your doctor
You should continue taking Lamictal for as long as your doctor has recommended. Do not stop unless your
doctor tells you to.
If you are taking Lamictal for epilepsy
To stop taking Lamictal, it is important to gradually reduce the dose over approximately 2
weeks. If you stop taking Lamictal suddenly, your epilepsy may return or worsen.
If you are taking Lamictal for bipolar disorder
Lamictal may take some time to work, so you are unlikely to feel better immediately. If you stop taking Lamictal, you do not necessarily need to reduce the dose gradually. However, if you wish to stop taking Lamictal, you must always discuss this with your doctor first.

4. Possible side effects

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

Potentially life-threatening reactions: seek medical help immediately

A small number of people taking Lamictal have had an allergic reaction or potentially life-threatening skin reactions, which, if untreated, may progress to more serious problems.

These symptoms are more likely to occur 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 these symptoms are more common in children, so parents should pay particular attention to their appearance.

Symptoms of such reactions include:

• skin rash or redness of the skin, which may progress to severe or sometimes life-threatening skin reactions including rash with target-like lesions (erythema multiforme), widespread rash with blistering and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (more than 30% of body surface area – toxic epidermal necrolysis), or extensive rashes involving the liver, blood and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome)
• ulcers in the mouth, throat, nose or genitals
• mouth pain or red and swollen eyes (conjunctivitis)
• high temperature (fever), flu-like symptoms or drowsiness
• swelling of the face or swelling of the glands in the neck, armpits or groin
• unexpected bleeding or bruising or fingers turning blue
• sore throat or more frequent infections (such as colds) than usual
• increased levels of liver enzymes observed in blood tests
• increase in a type of white blood cells (eosinophils)
• swollen lymph nodes
• organ involvement including liver and kidneys.

In many cases, these symptoms will be signs of less serious side effects. However, you must be aware that they are potentially life-threatening and, if left untreated, may progress to more serious problems, such as organ failure. If you notice any of these symptoms: ➔ contact your doctor immediately. Your doctor may decide to carry out diagnostic tests on your liver, kidneys or blood and may instruct you to stop taking Lamictal. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you that you must never take lamotrigine again.

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

Very common side effects
May affect more than 1 in 10 people:

• headache
• rash

Common side effects
May affect up to 1 in 10 people:

• aggression or irritability
• drowsiness
• dizziness
• shaking or tremors
• difficulty sleeping (insomnia)
• restlessness
• diarrhoea
• dry mouth
• nausea or vomiting
• fatigue
• back pain or joint pain or pain in other areas.

Uncommon side effects
May affect up to 1 in 100 people:

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

Rare side effects
May affect up to 1 in 1,000 people:

• skin reaction causing red spots or patches on the skin, which may resemble a target or "bull's eye" with a dark red center surrounded by paler red rings (erythema multiforme)
• a life-threatening skin reaction (Stevens-Johnson syndrome): (see also information at the beginning of section 4)
• a group of associated symptoms including: fever, nausea, vomiting, headache, neck stiffness and extreme sensitivity to bright light. This may be caused by inflammation of the membranes covering the brain and spinal cord (meningitis). These symptoms usually resolve once treatment is stopped; however, if symptoms persist or worsen, contact your doctor
• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crusting of the eyelids (conjunctivitis).

Very rare side effects
May affect up to 1 in 10,000 people:

• life-threatening skin reaction (toxic epidermal necrolysis) (see also information at the beginning of section 4)
• drug reaction with eosinophilia and systemic symptoms (DRESS) (see also information at the beginning of section 4)
• high temperature (fever) (see also information at the beginning of section 4)
• swelling of the face (edema) or swelling of the glands in the neck, armpits or groin (lymphadenopathy) (see also information at the beginning of section 4)
• changes in liver function, shown by blood tests, or liver failure (see also information at the beginning of section 4)
• a serious blood clotting disorder, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4)
• haemophagocytic lymphohistiocytosis (HLH) (see section 2: What you need to know before taking Lamictal)
• changes that may be shown by blood tests – including reduced number of red blood cells in the blood (anaemia), reduced number of white blood cells in the blood (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia),
  reduced number of all these types of cells (pancytopenia) and a bone marrow disorder called aplastic anaemia
• hallucinations (“seeing” or “hearing” things that are not really there)
• confusion
• feeling “wobbly” or unsteady in movement
• uncontrollable, repetitive body movements and/or sounds or words (tics), uncontrollable muscle spasms affecting eyes, head and trunk (choreoathetosis), or other unusual body movements such as jerking, tremors or stiffness
• in people who already have epilepsy, seizures may occur more frequently
• in people who already have Parkinson’s disease, worsening of symptoms
• lupus-like reactions (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or general malaise).

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

• there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic treatment, if you have a history of osteoporosis, or if you are taking steroids
• kidney inflammation (tubulointerstitial nephritis) or inflammation of both the kidneys and the eyes (tubulointerstitial nephritis and uveitis syndrome)
• nightmares
• reduced immunity due to lower levels of antibodies in the blood called immunoglobulins that help protect against infections
• red skin nodules or patches (pseudolymphoma).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamictal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging or bottle.
The expiry date refers to the last day of that month.
Lamictal does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lamictal chewable/dispersible tablets contain
The active substance is lamotrigine. Each chewable/dispersible tablet contains 2 mg or 5 mg of
lamotrigine.
The excipients are: calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminium silicate, sodium starch glycolate (Type A), povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavour.
Description of the appearance of Lamictal chewable/dispersible tablets and contents of the pack
Lamictal chewable/dispersible tablets (all strengths) are white to off-white in colour and may be slightly bevelled. They have a blackcurrant flavour.
It is possible that not all pack sizes are marketed in your country.
The 2 mg chewable/dispersible tablets are round. They are marked with “LTG” above the number “2” on one side and two overlapping ovals at right angles on the other side. Each bottle contains 30 tablets.
The 5 mg chewable/dispersible tablets are elongated in shape with curved edges. They are marked with “GSCL2” on one side and “5” on the other. Each pack contains blisters of 10, 14, 28, 30, 42, 50 or 56 tablets or bottles of 14, 28, 30, 42, 56 or 60 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Manufacturer responsible for batch release:
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware,
Hertfordshire SG12 0DJ, United Kingdom.
Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland.
This medicinal product is authorised in the European Economic Area Member States under the following
names:

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