Lamotrigine Normon 100 mg dispersible/chewable tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamotrigine Normon 100 mg dispersible/chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Lamotrigine Normon is and what it is used for
What you need to know before taking Lamotrigine Normon
How to take Lamotrigine Normon
Possible adverse effects
How to store Lamotrigine Normon
Contents of the pack and other information

1. What Lamotrigine Normon is and what it is used for

Lamotrigine Normon belongs to a group of medicines called antiepileptics. It can be used to treat two conditions: epilepsy and bipolar disorder.

Lamotrigine Normon is used to treat epilepsy because it blocks signals in the brain that trigger epileptic seizures (fits).

In adults and children aged 13 years and older, lamotrigine may be used alone or in combination with other antiepileptic medicines. Lamotrigine may also be used together with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
In children between 2 and 12 years of age, lamotrigine may be used in combination with other medicines to treat the same conditions. It may also be used without combination with other medicines for the treatment of a type of epilepsy known as typical absence seizures.

Lamotrigine Normon is also used to treat bipolar disorder.

People with bipolar disorder (previously known as manic-depressive illness) 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, lamotrigine may be used to prevent depressive episodes associated with bipolar disorder, either alone or in combination with other medicines. It is not known how lamotrigine works in the brain to produce this effect.

2. What you need to know before taking Lamotrigina Normon

Do not take Lamotrigina Normon:

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:

? Tell your doctor and do not take Lamotrigina Normon.

Warnings and precautions

Take special care with Lamotrigina Normon

Talk to your doctor or pharmacist before taking Lamotrigina Normon

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 skin rashes or sunburn after taking lamotrigine and being exposed to sunlight or artificial light (e.g., in a tanning bed). Your doctor will review your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g., by using sunscreen and/or 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 disease causing abnormal electrical activity in the heart. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that could lead to arrhythmias (abnormal heart rhythm).

If this applies to you:

? Tell your doctor, who will decide whether to reduce your dose or determine that Lamotrigina Normon is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking lamotrigine experience allergic or skin reactions that may potentially be life-threatening, which could lead to more serious problems if not treated. These reactions 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 of these reactions and monitor for them while taking Lamotrigina Normon. 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 found to carry this genetic variant (HLA-B*1502), speak with your doctor before taking Lamotrigina Normon.

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

Hemophagocytic lymphohistiocytosis (HLH)

Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine.

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

Thoughts of self-harm or suicide

Antiepileptic drugs are used to treat various 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 starting treatment,
if you have previously had thoughts of self-harm or suicide,
if you are under 25 years of age.

If you have troubling thoughts or experiences, or if you notice that you feel worse or develop new symptoms while being treated with Lamotrigina Normon:

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

It may be helpful for you to explain to 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 behavior.

A small number of people treated with antiepileptic drugs such as lamotrigine have also had thoughts of self-harm or suicide. If at any time you have such thoughts, contact your doctor immediately.

If you are taking Lamotrigina Normon for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more frequently while you are taking Lamotrigina Normon. Some patients may experience severe seizures, which could cause serious health problems. If seizures occur more frequently or if you experience severe seizures while taking Lamotrigina Normon:

? Seek medical attention immediately.

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

Other medicines and Lamotrigina Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or other non-prescription medicines.

Your doctor needs to know if you are taking other medicines for epilepsy or mental health conditions. This is to ensure you receive the correct dose of Lamotrigina Normon. 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

? Tell your doctor if you are taking any of these medicines.

Some medicines interact with Lamotrigina Normon or make it more likely that people will experience adverse effects. 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, which is an antibiotic
medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
hormonal contraceptives, such as the contraceptive pill (see below).

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

Hormonal contraceptives (such as the contraceptive pill) may affect how Lamotrigina Normon works

Your doctor may recommend that you use a specific hormonal contraceptive or use another contraceptive method, such as condoms, diaphragm, or intrauterine device (IUD). If you are taking a hormonal contraceptive such as the contraceptive pill, your doctor may perform a blood test to check lamotrigine levels. If you are using or plan to start using a hormonal contraceptive:

? Talk to your doctor, who will advise you on the most suitable contraceptive methods for you.

Lamotrigine may 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 lamotrigine is affecting how your contraceptive works.

Pregnancy and breastfeeding

? If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not stop your treatment without consulting your doctor. This is particularly important if you have epilepsy.
Pregnancy may alter the effectiveness of treatment with Lamotrigina Normon, so you may need a blood test and dose adjustment.
If Lamotrigina Normon is taken during the first three 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 acid supplements if you are planning a pregnancy and also during pregnancy.

? If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using this medicine. The active ingredient in Lamotrigina Normon passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamotrigina Normon and will arrange periodic check-ups for your baby if you decide to breastfeed, as your baby may experience drowsiness, rash, or poor weight gain. Inform your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina Normon may cause dizziness and double vision.

? Do not drive or operate machinery unless you are certain you are not affected by these symptoms.

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

Important information about some of the ingredients of Lamotrigina Normon

Lamotrigina Normon contains benzyl alcohol and sodium

This medicine contains 0.0016 mg of benzyl alcohol per tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor.

This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

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

3. How to take Lamotrigina Normon

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

What dose of Lamotrigina Normon to take

It may take some time for your doctor to find the most appropriate dose of this medicine for you. The dose you should take depends on:

your age
whether you are taking this medicine together with other medicines
whether you have any liver or kidney problems

Your doctor will initially prescribe a low dose and gradually increase it over several weeks until reaching the most appropriate dose for you (called the effective dose). Never take more of this medicine than your doctor has told you to.

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

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

The use of this medicine is not recommended in children under 2 years of age.

How to take your dose of Lamotrigina Normon

Take your dose of lamotrigine once or twice daily, as advised by your doctor. It may 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 advise you to start or stop taking other medicines, depending on the condition being treated and your response to treatment.

The dispersible/masticable tablets of Lamotrigina Normon may be swallowed whole with a little water, chewed, or dissolved in water: Never take only part of the liquid.

Chewing the tablet:

When chewing the tablet, you may need to drink a little water to help dissolve the tablet in your mouth. After swallowing, drink a little more water to ensure you have taken all the medicine.

To dissolve the medicine:

Place the tablet in a glass containing enough water to cover the entire 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 medicine remains in the glass.

If you take more Lamotrigina Normon than you should

? In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you take more lamotrigine than you should, you may be more likely to experience serious adverse effects, which can be fatal.

Someone who has taken too much lamotrigine may experience one or more of the following symptoms:

rapid, uncontrolled eye movements (nystagmus)
clumsiness and loss 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 dose of Lamotrigina Normon

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

If you forget to take multiple doses of this medicine:

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

Do not stop taking lamotrigine without your doctor's advice

You must take this medicine for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to do so.

If you are taking Lamotrigina Normon for the treatment of epilepsy

To stop taking this medicine, it is important that the dose be gradually reduced over approximately 2 weeks. If you stop taking lamotrigine suddenly, your epilepsy symptoms may return or your condition may worsen.

If you are taking Lamotrigina Normon for bipolar disorder

Lamotrigine may take some time to work, so you are unlikely to feel better immediately. If you stop taking this medicine, you do not need to gradually reduce the dose. However, even so, you must consult your doctor before interrupting treatment.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Reactions that may potentially be life-threatening: consult your doctor immediately.

A small number of people taking lamotrigine experience allergic reactions or skin reactions that may potentially be life-threatening, which could lead to more serious problems if not treated.

These symptoms are more likely to occur during the first months of treatment with Lamotrigina Normon, especially if the initial dose is too high, if the dose is increased too quickly, or if you are taking Lamotrigina Normon together with another medicine called valproate. Some of these symptoms are more common in children, so parents should pay special attention.

The symptoms of these reactions include:

skin rash or redness, which may lead to skin reactions that can be serious or, in some cases, potentially fatal, 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 peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis), or widespread rash with involvement of the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as hypersensitivity syndrome (DRESS));
ulcers in the mouth, throat, nose, or genitals;
mouth pain or red, swollen eyes (conjunctivitis);
high temperature (fever), flu-like symptoms, or drowsiness (sopor);
swelling around the face or swollen lymph nodes in the neck, armpits, or groin;
unexpected bleeding or bruising, or fingers turning blue;
sore throat or experiencing more infections than usual (such as colds);
increased levels of liver enzymes in blood tests;
increase in a type of white blood cells (eosinophils);
enlarged lymph nodes;
involvement of body organs including the liver and kidneys.

In many cases, these symptoms may be signs of less serious adverse effects. However, you should be aware that they may potentially be life-threatening and could lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

? Contact a doctor immediately. Your doctor will decide whether you need tests to assess liver, kidney, or blood function and may advise you to stop treatment with Lamotrigina Normon. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will instruct you never to take lamotrigine again.

Haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigina Normon).

Very common adverse effects

These affect more than 1 in 10 people:

headache
skin rash

Common adverse effects

These affect up to 1 in 10 people:

aggression or irritability
feeling sleepy or drowsy
dizziness
spasms or tremors
difficulty sleeping (insomnia)
feeling restless
diarrhoea
dry mouth
nausea or vomiting
feeling tired
back, joint, or other pain.

Uncommon adverse effects

These may affect up to 1 in 100 people:

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

Rare adverse effects

These affect up to 1 in 1,000 people:

skin reaction characterized by concentric red spots on the skin, which may look like a "target"; that is, with a dark red center surrounded by paler red rings (erythema multiforme)
skin reaction that may be life-threatening (Stevens-Johnson syndrome) (see also information at the beginning of section 4)
a set of 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 disappear when treatment is stopped. However, if symptoms persist or worsen, contact your doctor
rapid, uncontrolled eye movements (nystagmus)
itchy eyes, with discharge and crusts on the eyelids (conjunctivitis)

Very rare adverse effects

These affect up to 1 in 10,000 people:

a skin reaction that may be life-threatening (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 around the face (edema) or swollen glands in the neck, groin, or armpits (lymphadenopathy) (see also information at the beginning of section 4)
changes in liver function, which may be seen in blood tests, or liver failure (see also information at the beginning of section 4)
serious blood clotting disorder, which may cause bleeding or unexpected 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 Lamotrigina Normon)
changes that may be seen in blood tests including reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anaemia
hallucinations (hearing or seeing things that are not really there)
confusion
feeling unsteady or unstable when moving
repeated and/or uncontrollable body movements and/or sounds or words (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness
in people with epilepsy, more frequent seizures
in people with Parkinson's disease, worsening of symptoms
lupus-like reaction (symptoms may include: back or joint pain, sometimes accompanied by fever and/or general illness)

Other adverse effects

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamotrigine Normon

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

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C. Keep in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamotrigina Normon dispersible/chewable tablets

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

The other components are: crospovidone, sodium saccharin (E-954), orange flavour (contains benzyl alcohol and sodium), magnesium stearate and colloidal silicon dioxide.

Appearance of the product and contents of the pack of Lamotrigina Normon dispersible/chewable tablets

Lamotrigina Normon 100 mg dispersible/chewable tablets are round, white or almost white tablets.

Each pack contains blisters with 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 2026.

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).