LAMICTAL 100 mg CHEWABLE/DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

LAMICTAL 100 mg Chewable/Dispersible Tablets

lamotrigine

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lamictal and what is it used for
2. What you need to know before you take Lamictal
3. How to take Lamictal
4. Possible side effects
5. Storage of Lamictal
6. Contents of the pack and other information

1. What is Lamictal and what is it used for

Lamictal belongs to a group of medicines called antiepileptics. It can be used for the treatment of two conditions: epilepsyand bipolar disorder.

Lamictal is used for the treatment of epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (fits).

• In adults and children aged 13 years and over, Lamictal can be used on its own or in combination with other medicines for the treatment of epilepsy. Lamictal can also be used in combination with other medicines for the treatment of seizures that occur in a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamictal can be used in combination with other medicines for the treatment of the same conditions. It can also be used on its own for the treatment of a type of epilepsy called typical absence seizures.

Lamictal is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic-depressive illness) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). In adults aged 18 years and over, Lamictal can be used to prevent the periods of depression that occur in bipolar disorder, either on its own or in combination with other medicines. It is not known how Lamictal works in the brain to have this effect.

2. What you need to know before you take Lamictal

Do not take Lamictal:

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

If this applies to you:

? Tell your doctorand do not take Lamictal.

Warnings and precautions

Be especially careful with Lamictal

Tell your doctor or pharmacist before you start taking Lamictal:

• after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• . Your doctor will check your treatment and may advise you to avoid sunlight or use protective measures when exposed to sunlight (such as using a sunscreen and/or protective clothing)
• (read the description of these symptoms in section 4 of this leaflet: Rare side effects)
• Brugada syndrome is a genetic condition that affects the electrical activity of the heart. Lamotrigine can cause changes in the electrocardiogram (ECG) that can lead to abnormal heart rhythms.

If this applies to you:

? Tell your doctor, who will decide whether to lower the dose or whether Lamictal is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamictal have allergic reactions or skin reactions that can be life-threatening, which can lead to more serious problems if not treated. These reactions 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 of these reactions and be aware of them while taking Lamictal. This risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been detected with this genetic variant (HLA-B*1502), talk to your doctor before taking Lamictal.

? Read the description of these symptoms in section 4 of this leaflet“Reactions that can be life-threatening: consult your doctor immediately”.

Hemophagocytic lymphohistiocytosis (HLH)

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

• Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., spasms or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat different conditions, including epilepsy and bipolar disorder. People with bipolar disorder may sometimes have thoughts of self-harm or suicide. If you have bipolar disorder, you may be more likely to have these thoughts in the following situations:

• when you start treatment
• if you have had thoughts of self-harm or suicide before
• if you are under 25 years old.

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

? Consult your doctor as soon as possible or go to the nearest hospital.

It may be helpful for you to tell a family member, caregiver, or close friend that you are taking Lamictal 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 who have taken antiepileptics, including Lamictal, have also had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor immediately.

If you are taking Lamictal for epilepsy

Seizures in some types of epilepsy may occasionally become worse or more frequent while you are taking Lamictal. Some patients may experience severe seizures, which can cause serious health problems. If seizures become more frequent or if you experience severe seizures while taking Lamictal:

? Go to a doctor immediately.

Lamictal should not be given to children under 18 years for the treatment of bipolar disorder. Medicines for the treatment of depression and other mental health conditions increase the risk of thoughts and behaviors of suicide in children and adolescents under 18 years.

Other medicines and Lamictal

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines that you have bought without a prescription.

Your doctor needs to know if you are taking other medicines for the treatment of epilepsy or for mental health conditions. This is to ensure that you take the correct dose of Lamictal. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used for the treatment of epilepsy
• lithium, olanzapine or aripiprazole, used for the treatment of mental health conditions
• bupropion, used for the treatment of mental health conditionsor for smoking cessation
• paracetamol, used to treat painand fever.

? Tell your doctorif you are taking any of these medicines.

Some medicines interact with Lamictal or make it more likely that you will have side effects. These include:

• valproate, used for the treatment of epilepsyand mental health conditions
• carbamazepine, used for the treatment of epilepsyand mental health conditions
• phenytoin, primidoneor phenobarbital, used for the treatment of epilepsy
• risperidone, used for the treatment of mental health conditions
• rifampicin, which is an antibiotic
• medicines used for the treatment of HIV infection(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the pill(see below).

? Tell your doctorif you are taking any of these medicines, or if you start or stop taking any of these medicines.

Hormonal contraceptives (such as the pill) can affect how Lamictal works.

Your doctor may recommend that you use a specific hormonal contraceptive or another method of contraception, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive, such as the pill, your doctor may do a blood test to check the levels of Lamictal. If you are taking a hormonal contraceptive or plan to start using one:

? Consult your doctor, as they will advise you on the most suitable contraceptive methods for you.

Lamictal can also affect how hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and notice changes in your menstrual cycle, such as intermenstrual bleeding or spotting:

? Tell your doctor. These may be signs that Lamictal is affecting how your contraceptive is working.

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.

• Do not stop your treatment without consulting your doctor. This is particularly important if you have epilepsy.
• Pregnancy may affect how well Lamictal works, so you may need to have a blood test and have your dose adjusted.
• If Lamictal is taken during the first 3 months of pregnancy, there may be a small increased risk of birth defects, including cleft lip and/or cleft palate.
• Your doctor may advise you to take folic acidsupplements if you are planning to become pregnant and during pregnancy.

? If you are breastfeeding or plan to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.The active ingredient of Lamictal passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamictal and will perform regular checks on your baby if you decide to breastfeed, as they may become sleepy, develop a rash, or have a low weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamictal can cause dizziness and double vision.

? Do not drive or use machines unless you are sure that you are not affected by these effects.

If you have epilepsy, ask your doctor about the possibility of driving or using machines.

Important information about some of the ingredients of Lamictal

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Lamictal

Follow your doctor's or pharmacist's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

What dose of Lamictal to take

It may take some time for your doctor to find the most suitable dose of Lamictal for you. The dose you should take will depend on:

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

Your doctor will prescribe a low dose at the start of treatment and, gradually, increase the dose over several weeks until the most suitable dose for you is reached (called the effective dose). Never take more Lamictal than your doctor has indicated.

Normally, the effective dose of Lamictal for adults and children aged 13 years and over is between 100 mg and 400 mg per day.

For children between 2 and 12 years of age, the effective dose depends on their body weight, normally between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day.

Lamictal is not recommended for use in children under 2 years of age.

How to take the dose of Lamictal

Take your dose of Lamictal once or twice a day, as advised by your doctor. They can be taken with or without food.

• Always take the complete dosethat your doctor has prescribed. Never take part of the tablet.

Your doctor may advise you to start or stop taking other medications, depending on the problem being treated and how you respond to treatment.

Lamictal chewable/dispersible tablets can be swallowed whole with a little water, chewed, or added to water to dissolve them. Never take only part of the liquid.

Removing a tablet:

These tablets come in a special package to prevent children from removing them.

Each unit of the blister pack has a number. Take each tablet in order, starting with tablet number 1.

1. Separate a tablet: tear along the cutting line to separate one of the blister pack units.

1. Remove the outer layer: starting from a corner, lift and remove the foil that covers the unit.

1. Remove the tablet: gently press one side of the tablet through the foil to extract it.

Chewing the tablet:

You may need to drink a little water to help the tablet dissolve in your mouth when chewing it. After swallowing, drink a little more water to make sure you have taken all the medication.

To dissolve the medication:

• put the tablet in a glass containing enough water to cover the whole tablet
• shake to dissolve or wait until the tablet is completely dissolved
• drink all the liquid
• add a little more water to the glass and drink it to make sure no medication is left in the glass.

If you take more Lamictal than you should

?In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you take more Lamictal than you should, you may be more prone to serious adverse effects that can be fatal.

Someone who has taken too much Lamictal may have some of these symptoms:

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

If you forget to take a dose of Lamictal

?Do not take a double doseto make up for forgotten doses. Takethe next dose at the usual time.

If you forget to take multiple doses of Lamictal

?Ask your doctor for advice on how to start treatment again. It is important that you do this.

Do not stop taking Lamictal without your doctor's advice

You should take Lamictal for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to.

If you are taking Lamictal for the treatment of epilepsy

To stop taking Lamictal, it is essential to gradually reduce the doseover approximately 2 weeks. If you stop taking Lamictal suddenly, you may experience a return of epilepsy symptoms or the disease may worsen.

If you are taking Lamictal for bipolar disorder

Lamictal may take some time to work, so it is unlikely that you will feel better immediately. If you stop taking Lamictal, you do not need to gradually reduce your dose. However, before stopping treatment with Lamictal, you should consult your doctor.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Reactions that can potentially threaten life: consult your doctor immediately.

A small number of people taking Lamictal have allergic reactions or skin reactions that can potentially threaten their life, which can lead to more serious problems if not treated.

It is more likely that these symptoms will appear during the first few months of treatment with Lamictal, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Lamictal with another medication called valproate. Some of these symptoms are more frequent in children, so parents should pay special attention to them.

The symptoms of these reactions include:

• skin rash or redness, which can lead to skin reactions that can be serious or, on occasion, potentially fatal, including rash with target-like lesions (erythema multiforme), widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling over a large area of the skin (more than 30% of the body surface - toxic epidermal necrolysis) or widespread skin rash with liver, blood, and other organ involvement (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome)
• mouth ulcers, throat, nose, or genital ulcers
• mouth pain or red, swollen eyes(conjunctivitis)
• high temperature(fever), flu-like symptoms, or drowsiness (drowsiness)
• swelling around the faceor inflammation of the lymph nodesin the neck, armpits, or groin
• bleeding or unexpected bruising, or fingers turning blue
• sore throator experiencing more infections than usual (such as colds)
• increased liver enzyme levels in blood tests
• increased levels of a type of white blood cell (eosinophils)
• enlarged lymph nodes
• organ involvement, including the liver and kidneys.

In many cases, these symptoms can be signs of less serious side effects. However, you should be aware that they can potentially threaten your lifeand can lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

?Contact your doctor immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function and may indicate that you should stop treatment with Lamictal. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will indicate that you should never take lamotrigine again.

Hemophagocytic lymphohistiocytosis (HLH)(see section 2. What you need to know before taking Lamictal).

Very common side effects

These affect more than 1 in 10people:

• headache
• skin rash.

Common side effects

These affect up to 1 in 10people:

• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• spasms or tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, joint pain, or pain in other areas.

Uncommon side effects

These can affect up to 1 in 100people:

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

Rare side effects

These affect up to 1 in 1,000people:

• a skin reaction characterized by reddish spots with a target-like appearance; i.e., with a dark red center surrounded by paler red rings (erythema multiforme)
• a potentially life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4)
• a set of symptoms including: fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to bright light.

This can be caused by inflammation of the membranes covering the brain and spinal cord (meningitis). These symptoms usually disappear when treatment is discontinued. However, if the symptoms continue or worsen, contact your doctor.

• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crust on the eyelids (conjunctivitis).

Very rare side effects

These affect up to 1 in 10,000people:

• a potentially 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)
• high temperature (fever) (see also the information at the beginning of section 4)
• swelling around the face (edema) or inflammation of the lymph nodes in the neck, groin, or armpits (lymphadenopathy) (see also the information at the beginning of section 4)
• changes in liver function, which can be seen in blood tests, or liver failure (see also the information at the beginning of section 4)
• a severe blood clotting disorder that can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamictal)
• changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), a reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anemia
• hallucinations (hearing or seeing things that are not really there)
• confusion
• feeling unsteady or unstable when moving
• repetitive body movements and/or sounds or words (tics), uncontrolled muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerks, spasms, or stiffness
• in people with epilepsy, more frequent seizures
• in people with Parkinson's disease, worsening of symptoms
• a reaction similar to lupus (symptoms may include: back or joint pain, which may be accompanied by fever and/or generalized illness).

Other side effects

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

• bone disorders have been reported, including osteopenia and osteoporosis (decreased bone thickness) and fractures. Consult your doctor or pharmacist if you have taken antiepileptics for a long time, if you have a history of osteoporosis, or if you take steroids
• kidney inflammation (tubulointerstitial nephritis) or kidney and eye inflammation (acute tubulointerstitial nephritis and uveitis syndrome)
• nightmares
• decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection
• skin nodules or red spots (pseudolymphoma).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lamictal

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack, carton, or bottle. The expiration date is the last day of the month indicated.

Lamictal does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Lamictal 100 mg chewable/dispersible tablets

The active ingredient is lamotrigine. Each chewable/dispersible tablet contains 100 mg of lamotrigine.

The other ingredients are: calcium carbonate, low-substituted hydroxypropylcellulose, aluminum and magnesium silicate, sodium carboxymethyl starch (Type A) potato, povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavor.

Appearance of the product and package contents of Lamictal chewable/dispersible tablets

Lamictal chewable/dispersible tablets are white to off-white and may be slightly speckled. The tablets have a blackcurrant flavor.

Lamictal 100 mg chewable/dispersible tablets are square with rounded corners. The tablets are marked with "GSCL7" on one side and "100" on the other. Each package contains blister packs of 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196, or 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Delpharm Poznan Spólka Akcyjna ul. Grunwaldzka 189 60-322 Poznan Poland

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this leaflet:April 2024.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/