LAMOTRIGINE NORMON 25 mg DISPERSIBLE/CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Lamotrigine Normon 25 mg Dispersible/Chewable Tablets EFG

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

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

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

Lamotrigine Normon is used for the treatment of epilepsy becauseit blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children aged 13 years and over, lamotrigine can be used on its own or in combination with other medicines for the treatment of epilepsy. Lamotrigine can also be used in combination with other medicines for the treatment of 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 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.

Lamotrigine Normon is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic-depressive disorder) 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, Lamotrigine Normon 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 lamotrigine works in the brain to have this effect.

2. What you need to know before you take Lamotrigine Normon

Do not take Lamotrigine Normon:

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

If this applies to you:

Tell your doctor, and do not take Lamotrigine Normon.

Warnings and precautions

Consult your doctor or pharmacist before taking Lamotrigine Normon:

• after taking lamotrigine or other medicines for bipolar disorder or epilepsy.
• after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare side effects).
• if you have had a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you get a rash or sunburn while taking lamotrigine and being exposed to sunlight or artificial light (e.g. in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or take protective measures (e.g. use a sunscreen and/or protective clothing).

If this applies to you:

Tell your doctor, who will decide whether to reduce the dose or whether Lamotrigine Normon is suitable for you.

Important information about reactions that may potentially be life-threatening

A small number of people taking lamotrigine have allergic reactions or skin reactions that may potentially 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 Lamotrigine 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 detected with this genetic variant (HLA-B* 1502), talk to your doctor before taking Lamotrigine Normon.

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

Thoughts of self-harm or suicide

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

• when you first 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 Lamotrigine Normon:

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 Lamotrigine Normon 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 were treated with antiepileptics such as lamotrigine have also had thoughts of self-harm or suicide. If you have these thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigine Normon for epilepsy

Seizures in some types of epilepsy may occasionally become worse or happen more often while you are taking Lamotrigine 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 Lamotrigine Normon:

See a doctor immediately.

Lamotrigine Normon 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.

Taking Lamotrigine Normon with other medicines

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

Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health conditions. This is to make sure you take the correct dose of Lamotrigine Normon. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used to treat epilepsy
• lithium, olanzapine or aripiprazole, used to treat mental health conditions
• bupropion, used to treat mental health conditionsor to stop smoking

Tell your doctorif you are taking any of these medicines.

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

• valproate, used to treat epilepsyand mental health conditions
• carbamazepine, used to treat epilepsyand 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 (AIDS)(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the contraceptive 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 contraceptive pill) may affect how Lamotrigine Normon 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 contraceptive pill, your doctor may do a blood test to check the levels of lamotrigine. If you are using a hormonal contraceptive or plan to use one:

Consult your doctor, as they will tell you which contraceptive methods are suitable for you.

Lamotrigine may also affect how hormonal contraceptives work, although this is unlikely to affect 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 is working.

Brugada Syndrome

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

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, 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 affect how well Lamotrigine Normon works, so you may need to have a blood test and have your dose adjusted.
• If Lamotrigine Normon is taken during the first 3 months of pregnancy, there may be a small increased risk of the baby having birth defects, including cleft lip 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 planning to breastfeed, consult your doctor or pharmacist before using this medicine.The active ingredient of Lamotrigine Normon passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamotrigine Normon and will perform regular checks on your baby if you decide to breastfeed, as they may become sleepy, get a rash or have poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigine Normon may 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, consult your doctor about the possibility of driving or using machines.

Lamotrigine Normon contains glucose, benzyl alcohol and sodium

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

This medicine contains 0.00026 mg 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 benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of serious side effects, including breathing problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

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

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

3. How to take Lamotrigina Normon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of 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 suitable dose of Lamotrigina Normon for you. The dose you should take will depend on:

• your age
• if you are taking Lamotrigina Normon with other medications
• if 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 reaching the most suitable dose for you (called the effective dose). Never take more Lamotrigina Normon than your doctor has indicated.

Normally, the effective dose of Lamotrigina 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, 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.

The use of Lamotrigina Normon is not recommended in children under 2 years of age.

How to take the dose of Lamotrigina Normon

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

• Always take the complete dosethat the 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.

The dispersible/chewable tablets of Lamotrigina Normon can be swallowed whole with a little water, chewed, or added to water to dissolve them.

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 ensure you have taken all the medication.

To dissolve the medication:

• put 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 ensure no medication is left 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Someone who has taken too much Lamotrigina Normon 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 Lamotrigina Normon

Do not take a double doseto make up for missed doses. Take the next dose at the usual time.

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

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

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

You should take Lamotrigina Normon 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 Lamotrigina Normon, it is important that the dose is gradually reduced over approximately 2 weeks. If you stop taking Lamotrigina Normon suddenly, you may experience a return of epilepsy symptoms or the disease may worsen.

If you are taking Lamotrigina Normon for bipolar disorder

Lamotrigina Normon may take some time to work, so it is unlikely that you will feel better immediately. If you stop taking Lamotrigina Normon, you do not need to gradually reduce your dose. However, before interrupting treatment with Lamotrigina Normon, 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 be life-threatening: consult your doctor immediately.

A small number of people taking lamotrigina have allergic reactions or skin reactions that can potentially be life-threatening, 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 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 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 life-threatening skin reactions, including widespread rash with blisters and skin peeling, 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;
• pain in the mouth or having red or swollen eyes(conjunctivitis);
• high temperature(fever), flu-like symptoms, or drowsiness (somnolence);
• 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 eosinophils (a type of white blood cell);
• enlarged lymph nodes;
• organ involvement, including liver and kidney problems.

In many cases, these symptoms can be signs of less serious side effects. However, you should be aware that they can potentially be life-threatening and can lead to more serious problemssuch 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 interrupt treatment with Lamotrigina Normon. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will indicate that you should never take lamotrigina again.

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:

• 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 interrupted. 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 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 observed in blood tests, or liver failure (see also the information at the beginning of section 4)
• a serious blood clotting disorder that can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• changes that can be observed 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 that are uncontrollable (tics), uncontrollable 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)
• Hemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigina Normon)

Other side effects

Other side 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. 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
• nightmares
• decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection
• nodules or red spots on the skin (pseudolymphoma)

Reporting side effects

If you experience any 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 Medicines and Healthcare Products Agency's pharmacovigilance system: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lamotrigina Normon

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging, after EXP. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lamotrigina Normon dispersible/chewable tablets

The active ingredient is lamotrigina. Each dispersible/chewable tablet contains 25 mg of lamotrigina.

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

Appearance of the product and package contents

The dispersible/chewable tablets of Lamotrigina Normon 25 mg are white or almost white round tablets.

Each package contains blisters of 21, 42, or 56 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet:October 2023

"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