Package Insert: Information for the User

Lamotrigine Normon 200 mg Dispersible/Chewable Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

Lamotrigina Normon belongs to a group of medications calledantiepileptic drugs. It can be used to treat two diseases: epilepsyand bipolar disorder.

Lamotrigina Normon is used to treat epilepsy becauseit blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children 13 years of age and older, lamotrigine can be used alone or in combination with other medications to treat epilepsy. Lamotrigine can also be used with other medications to treat seizures caused by a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, lamotrigine can be used in combination with other medications to treat the same diseases. It can also be used without other medications to treat a type of epilepsy called typical absence seizures.

Lamotrigina Normon is also used to treat bipolar disorder.

People with bipolar disorder (previously known as manic-depressive disorder) experience extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or desperation). In adults 18 years of age and older, Lamotrigina Normon can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. The exact mechanism of action of lamotrigine in the brain is not known.

Do not take Lamotrigina Normon:

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

If this is the case:

Inform your doctor, and do not take Lamotrigina Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lamotrigina Normon:

• if you have any kidney problems.
• if you have ever had a skin rashafter takinglamotrigine or other medicines for bipolar disorder or epilepsy.
• if you have ever had meningitis after taking lamotrigine(see the description of these symptoms in section 4 of this leaflet:Very rare side effects).
• if you are already taking medicines that contain lamotrigine.
• if you have had a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you suffer from skin rashes or sunburn after taking lamotrigine and exposure to the sun or artificial light (for example, in a sunbed). Your doctor will check your treatment and may advise you to avoid the sun or protect yourself from the sun (for example, by using a sun cream and/or protective clothing).

If this is the case:

Inform your doctor, who will decide to reduce the 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 have had 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 (SSJ), toxic epidermal necrolysis (NET), 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 Lamotrigina Normon. This risk may be associated with a genetic variant in people of Asian origin (mainly Chinese Han and Thai). If you are of this origin and have been detected with this genetic variant (HLA-B* 1502), talk to your doctor before taking Lamotrigina Normon.

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

Thoughts of self-harm or suicide

Antiepileptic drugs are used to treat different conditions, including epilepsy and bipolar disorder. People with bipolar disorder may have had thoughts of self-harm or suicide at some point. 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 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, carer or close friend that you may become depressed or have significant mood changes, 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 behaviour.

A small number of people who have been treated with antiepileptic drugs like lamotrigine have also had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

If you are taking Lamotrigina Normon for epilepsy

Seizures in some types of epilepsy may occasionally get worse or happen more often while you are taking Lamotrigina Normon. Some patients may experience severe seizures, which can cause serious health problems. If seizures happen more often or if you experience severe seizures while taking Lamotrigina Normon:

Go to a doctor immediately.

Lamotrigina Normon should not be given to children under 18 years old for the treatment of bipolar disorder. Medicines used to treat depression and other mental health problems increase the risk of thoughts and behaviours of self-harm or suicide in children and adolescents under 18 years old.

Taking Lamotrigina Normon with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine,including medicines based on plants or other medicinesobtained without a prescription.

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

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateorzonisamide, used for the treatment ofepilepsy
• lithium, olanzapineoraripiprazole, used for the treatment ofmental health problems
• bupropion, used for the treatment ofmental health problemsor tostop smoking

Inform your doctorif you are using any of these medicines.

Some medicines interact with Lamotrigina Normon or make it more likely for people to have side effects. These include:

• valproate, used for the treatment ofepilepsyandmental health problems
• carbamazepine, used for the treatment ofepilepsyandmental health problems
• phenytoin, primidone or phenobarbital, used for the treatment ofepilepsy
• risperidone, used for the treatment ofmental health problems
• rifampicin, which is anantibiotic
• medicines used to treat HIV infection (AIDS) (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such asthe pill(see below).

Inform your doctorif you are using any of these medicines, or if you start or stop using any of these medicines.

Hormonal contraceptives (such as the pill) may affect the wayLamotrigina Normon works.

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

Consult your doctor, who will advise you on the most suitable methods of contraception for you.

Lamotrigina Normon may also affect the way hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are taking a hormonal contraceptive and notice changes in your menstrual cycle, such as intermenstrual bleeding or bleeding between periods:

Inform your doctor. These may be signs that lamotrigine is affecting the way your contraceptive works.

Brugada syndrome

Brugada syndrome is a genetic disorder that causes abnormal heart electrical activity. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm). Consult your doctor if you have this condition.

Lymphohistiocytosis hemophagocytic (LHH)

Cases of a rare but severe 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. spasms or tremors, confusion, cerebral function alterations).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning 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 Lamotrigina Normon treatment, so you may need to have a blood test and have your dose adjusted.
• If Lamotrigina Normon is taken during the first 3 months of pregnancy, there may be a small increase in the risk of birth defects, including cleft lip and/or palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and also during pregnancy.

If you are breastfeeding or plan to start breastfeeding, 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 perform regular checks on your baby if you decide to start breastfeeding,as your baby may experience drowsiness, rash or poor weight gain. Inform your doctor if you observe any of these symptoms in your baby.

Driving and using machines

Lamotrigina Normon may cause dizziness and double vision.

Do not drive or use machines unless you are sure you do not feel these effects.

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

Lamotrigina Normon contains glucose, benzyl alcohol and sodium

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may harm your teeth.

This medicine contains0.00208mg of benzyl alcohol in each 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 can 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 can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medicine to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years old unless your doctor or pharmacist advises it.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Lamotrigine Normon dosage

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

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

Your doctor will prescribe a low initial dose, and gradually increase the dose over several weeks to reach the most suitable dose for you (called the effective dose).Do not take more Lamotrigine Normon than your doctor has indicated.

Normally, the effective dose of Lamotrigine Normon for adults and children 13 years of age 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 their body weight, usually between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day. Lamotrigine Normon is not recommended for children under 2 years of age.

How to take the Lamotrigine Normon dose

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

• Always take the complete doseprescribed by your doctor. Never take part of the tablet.

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

Lamotrigine Normon dispersible/masticable tablets can be swallowed whole with a little water, chewed, or water added to dissolve them.

Masticate the tablet:

You may need to drink a little water to help the tablet dissolve in your mouth. After swallowing, drink a little more water to ensure you have taken the entire medication.

To dissolve the medication:

• 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 the entire liquid,
• add a little more water to the glass and drink to ensure no medication remains in the glass.

If you take more Lamotrigine Normon 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 moreLamotrigine Normon than you should, you may be more prone to severe side effects that can be fatal.

Someone who has taken too much Lamotrigine Normon may experience some of the following symptoms:

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

If you forget to take Lamotrigine Normon

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

In case of forgetting to take multiple doses of Lamotrigine Normon:

Ask your doctor for advice on how to start thetreatment again.It is essential that you do this.

Do not stop taking Lamotrigine Normon without your doctor's advice

You must take Lamotrigine Normon for the entire time your doctor recommends. Do not stop taking it unless your doctor advises you to.

If you are taking Lamotrigine Normon for epilepsy treatment

To stop taking Lamotrigine Normon, it is essential to gradually reduce the dose over approximately 2 weeks. If you stop taking Lamotrigine Normon suddenly, you may experience a recurrence of epilepsy symptoms or the condition may worsen.

If you are taking Lamotrigine Normon for bipolar disorder

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

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

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

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

It is more likely that these symptoms will appear during the first months of treatment with Lamotrigina Normon, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Lamotrigina Normon 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 eruptions or redness,which may lead to life-threatening skin reactions, including widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread skin peeling in a large area of the body (more than 30% of the body surface – toxic epidermal necrolysis) or widespread skin rash with liver, blood, and other organ involvement (pharmacological reaction with eosinophilia and systemic symptoms also known as drug reaction with eosinophilia and systemic symptoms (DRESS));
• ulcers in the mouth, throat, nose, or genitals.
• eye pain or having red or swollen eyes (conjunctivitis);
• high temperature(fever), symptoms similar to the flu or drowsiness (somnolence);
• swelling around the face or inflammationof the neck, armpit, or groin lymph nodes;
• unexplained bleeding or bruising, or fingers turning blue;
• throat painor having more infections than usual (such as colds);
• increased levels of liver enzymes in blood tests;
• increased levels of a type of white blood cell (eosinophils);
• enlarged lymph nodes;
• organ damage, including the liver and kidneys.

In many cases, these symptoms may be signs of less severe side effects.However, you should be aware that they may potentially threaten life and may 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 evaluate the function of the liver, kidneys, or blood and may instruct you to stop taking Lamotrigina Normon. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will instruct you never to take lamotrigine again.

Very common side effects

These affect more than 1 in 10 people:

• headache
• skin rash

Common side effects

These affect up to 1 in 10 people:

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

Rare side effects

These may affect up to 1 in 100 people:

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

Very rare side effects

These may affect up to 1 in 1,000 people:

• life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4)
• a group of symptoms that include: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light

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

• rapid, uncontrolled eye movements (nystagmus);

• eye itching, with discharge and crusts on the eyelids (conjunctivitis).

Very rare side effects

These may affect up to 1 in 10,000 people:

• life-threatening skin reaction (toxic epidermal necrolysis) (see also the information at the beginning of section 4)
• pharmacological 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 neck, groin, or armpit lymph nodes (lymphadenopathy) (see also the information at the beginning of section 4)
• liver function changes, which may be seen in blood tests, or liver failure (see also the information at the beginning of section 4)
• severe blood clotting disorder, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• blood test changes, including reduced red blood cells (anemia), reduced white blood cells (leucopenia, neutropenia, agranulocytosis), reduced platelets (thrombocytopenia), reduced 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 insecure or unstable when moving
• repeated body movements or incontrollable sounds or words (tics), uncontrolled muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as twitching, spasms, or stiffness
• more frequent seizures in people with epilepsy
• emphasized symptoms in people with Parkinson's disease
• reaction similar to lupus (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or generalized illness)
• Lymphohistiocytosis hemophagocytosis (LHH) (see section 2. What you need to know before starting to take Lamotrigina)

Other side effects

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

• bone changes, including osteopenia and osteoporosis (bone thinning) 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 are taking steroids
• nightmares
• reduced immunity, due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection.
• red or brown spots on the skin (pseudolymphoma).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lamotrigina Normon chewable tablets

The active ingredient is lamotrigine. Each chewable tablet contains 200 mg of lamotrigine.

The other components are: Crospovidone, sodium saccharin (E-954), orange essence (contains glucose and benzyl alcohol), magnesium stearate and colloidal silica.

Appearance of the product and contents of the packaging of Lamotrigina Normon chewable tablets

Lamotrigina Normon 200 mg chewable tablets are round white or almost white tablets.

Each package contains 30 blister packs.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:October 2023

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