LAMOTRIGINE AUROVITAS 50 mg CHEWABLE/DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Lamotrigine Aurovitas 50 mg Chewable/Dispersible Tablets EFG

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

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

Contents of the Package Leaflet

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

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

Lamotrigine belongs to a group of medications called antiepileptics. It can be used to treat two diseases: epilepsyand bipolar disorder.

Lamotrigine is used to treat epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children aged 13 years and over, lamotrigine can be used alone or in combination with other medications to treat epilepsy. Lamotrigine can also be used in combination with other medications to treat seizures caused by a disease 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 combining it with other medications to treat a type of epilepsy called typical absence seizures.

Lamotrigine is also used to treat bipolar disorder.

People with bipolar disorder (formerly called manic-depressive disorder) experience radical 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 can be used to prevent depressive episodes that occur in bipolar disorder, either alone or in combination with other medications. It is not known how lamotrigine works in the brain to have this effect.

2. What you need to know before taking Lamotrigine Aurovitas

Do not take Lamotrigine Aurovitas:

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

If this is the case:

?Tell your doctor, and do not take Lamotrigine Aurovitas.

Warnings and precautions

Be especially careful with Lamotrigine Aurovitas

Consult your doctor or pharmacist before starting to takeLamotrigine Aurovitas:

• If you have any kidney problems.
• If you have ever had a skin rashafter taking lamotrigine or other medications for bipolar disorder or epilepsy.
• If you suffer from skin rashes or sunburn after taking lamotrigine and exposure to sunlight or artificial light(e.g., in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g., use 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 package leaflet: Rare side effects).
• If you are already taking medications that contain lamotrigine.
• If you have a disease called Brugada Syndrome or other heart problems. Brugada Syndrome is a genetic disease that causes abnormal electrical activity in the heart. Lamotrigine can cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm).

If this is the case:

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

Important information about potentially life-threatening reactions

A small number of people who take lamotrigine have allergic reactions or skin reactions that can be life-threatening, which can lead to more serious problems if left untreated. These reactions can include Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). It is essential that you know the symptoms of these reactions and are aware of them while taking lamotrigine. This risk may be associated with a genetic variant in people of Asian origin (mainly Chinese Han 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.

?Read the description of these symptoms in section 4 of this package leaflet“Life-threatening reactions: 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 medications are used to treat various diseases, 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 concern you, or if you notice that you feel worse or develop new symptoms while being treated with lamotrigine:

?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 have significant mood changes, and ask them to read this package leaflet. You can ask them to tell you if they are concerned about your depression or other changes in your behavior.

A small number of people who have been treated with antiepileptics 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 Lamotrigine Aurovitas for epilepsy

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

?Go to a doctor immediately.

Lamotrigine should not be given to children under 18 years of age for the treatment of bipolar disorder. Medications for the treatment of depression and other mental health problems increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years of age.

Other medications and Lamotrigine Aurovitas

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

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

• Oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used to treat epilepsy.
• Lithium, olanzapine or aripiprazole, used to treat mental health problems.
• Bupropion, used to treat mental health problemsor to stop smoking.
• Paracetamol, used to treat painand fever.

?Tell your doctorif you are using any of these medications.

Some medications interact with lamotrigine or make it more likely that people will have side effects. These include:

• Valproate, used to treat epilepsyand mental health problems.
• Carbamazepine, used to treat epilepsyand mental health problems.
• Phenytoin, primidoneor phenobarbital, used to treat epilepsy.
• Risperidone, used to treat mental health problems.
• Rifampicin, which is an antibiotic.
• Medications used to treat 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 using any of these medications, or if you start or stop using any of these medications.

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

Your doctor may recommend that you use a specific hormonal contraceptive or use a different contraceptive method, 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, as they will advise you on the most suitable contraceptive methods for you.

Lamotrigine 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 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 medication.

• Do not stop your treatment without consulting your doctor. This is especially important if you have epilepsy.
• Pregnancy may change the effectiveness of treatment with lamotrigine, so you may need to have a blood test and have your dose adjusted.
• If lamotrigine 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 acid supplementsif 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 medication.The active ingredient of Lamotrigine Aurovitas passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamotrigine Aurovitas and will perform regular checks on your baby if you decide to start breastfeeding, as they may experience drowsiness, rash, or poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigine can 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.

3. How to take Lamotrigine Aurovitas

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

What dose of Lamotrigine Aurovitas to take

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

• Your age.
• Whether you are taking lamotrigine with other medications.
• Whether you have any liver or kidney problems.

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

Normally, the effective dose of lamotrigine 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, usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.

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

How to take the dose of Lamotrigine Aurovitas

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

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 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 medication is left in the glass.

If you take more Lamotrigine Aurovitas 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 Lamotrigine Aurovitas than you should, you may be more likely to have serious side effects that can be fatal.

Someone who has taken too much lamotrigine may experience some of these 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 a dose of Lamotrigine Aurovitas

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

If you forget to take multiple doses of Lamotrigine Aurovitas

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

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

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

If you are taking Lamotrigine Aurovitas for the treatment of epilepsy

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

If you are taking Lamotrigine Aurovitas for bipolar disorder

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

A small number of people taking lamotrigine have allergic reactions or skin reactions that can potentially threaten their life, which can lead to more serious problems if left untreated.

It is more likely that these symptoms will appear during the first few months of treatment with lamotrigine, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking lamotrigine with another medicine 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 rashes or redness, which can lead to skin reactions that can be severe or, on occasion, potentially life-threatening, 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 skin (more than 30% of the body surface - toxic epidermal necrolysis) or widespread skin rash with involvement of the liver, blood, and other organs of the body (drug reaction with eosinophilia and systemic symptoms also known as DRESS).
• Ulcers in the mouth, throat, nose, or genitals.
• 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 bruisingor turning blue.
• Sore throator 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.
• Affecting organs of the body, including the liver and kidneys.

In many cases, these symptoms can be signs of less serious adverse effects. However, you should be aware that they can potentially threaten life and can lead to more serious problems,such as organ failure, if left untreated. If you notice any of these symptoms:

?Contact your doctor immediately. Your doctor will decide if you need to have tests to assess the function of your liver, kidneys, or blood and may advise you to stop treatment with lamotrigine. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you to never take lamotrigine again.

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

Very common adverse effects

These affect more than 1 in 10people:

• Headache.
• Skin rash.

Common adverse 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.
• Pain in the back, joints, or other areas.

Uncommon adverse 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 sunlight or artificial light (photosensitivity).

Rare adverse effects

These affect up to 1 in 1,000people:

• A skin reaction characterized by red, target-like patches on the skin, which can resemble a "bull's-eye"; that is, with a dark red center surrounded by lighter red rings (erythema multiforme).
• A life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4).
• A set of symptoms that include: 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 stopped. 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 adverse 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 seen 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).
• Hemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigine Aurovitas).
• Changes that can be seen in blood tests, including low red blood cell count (anemia), low white blood cell count (leukopenia, neutropenia, agranulocytosis), low platelet count (thrombocytopenia), low count 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.
• Lupus-like reaction (symptoms can include: back or joint pain, which can sometimes be accompanied by fever and/or generalized illness).

Other adverse effects

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

• Bone disorders have been reported, including osteopenia and osteoporosis (decrease in 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.
• Nodes or red spots on the skin (pseudolymphoma).

Reporting adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use 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 Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lamotrigine Aurovitas

• The active ingredient is lamotrigine. Each chewable/dispersible tablet contains 50 mg of lamotrigine.

• The other ingredients are: microcrystalline cellulose, heavy magnesium carbonate, potassium polacrylate, sucralose, povidone (K30), magnesium stearate, blackcurrant flavor (maltodextrin, artificial flavors, triacetin, benzyl alcohol, acetic acid, caramel color).

Appearance of the product and package contents

Chewable/dispersible tablet.

Uncoated, rounded square-shaped tablets, white to off-white in color, with an "H" engraved on the polyhedral face and the number "79" on the flat face.

PVC/Aclar/Aluminum blister pack

Packaging containing 42 and 56 chewable/dispersible tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of the last revision of this leaflet:April 2025

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