Package Insert: Information for the Patient

Lamotrigine Aurovitas 100 mg Chewable/Dispersible 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 read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isLamotrigine Aurovitasand for what it is used

2. What you need to know before starting to takeLamotrigine Aurovitas

3. How to takeLamotrigine Aurovitas

4. Possible adverse effects

5. Storage ofLamotrigine Aurovitas

6. Contents of the package and additional information

Lamotrigina belongs to a group of medications known asantiepilepticdrugs. It can be used to treat two diseases: epilepsyand bipolar disorder.

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

• In adults and children 13 years of age and older, lamotrigina can be used alone or in combination with other medications to treat epilepsy. Lamotrigina 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, lamotrigina 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 is also used to treat bipolar disorder.

People with bipolar disorder (formerly known as manic-depressive disorder) experience radical 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 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 lamotrigina in the brain is not known.

Do not take Lamotrigina Aurovitas:

• if you are allergicto lamotrigine or to any of the other ingredients ofthis medicine(see section 6).

If this is the case:

?Inform your doctor, and do not take Lamotrigina Aurovitas.

Warnings and precautions

Be particularly careful with Lamotrigina Aurovitas

Consult your doctor or pharmacist before starting to takeLamotrigina Aurovitas:

• If you have any kidney problems.
• If you have ever had a skin rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy.
• 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 sunlight or protect yourself from the sun (for example, use a sun protection cream and/or protective clothing).
• 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.
• Ifyou havea condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic condition that causes abnormal heart electrical activity. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm).

If this is the case:

?Inform 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 taking lamotrigine have had allergic reactions or skin reactions that can be potentially life-threatening, which can lead to more serious problems if not treated. These reactions may 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 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 leaflet“Reactions that can be potentially life-threatening: consult your doctor immediately”.

Lymphohistiocytosis hemophagocytic (LHH)

Cases of a rare but severe immune system reaction have been reported 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 tremor, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

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

• When starting 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:

?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 behavior.

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 Aurovitas for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more frequently while 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 administered to children under 18 years for the treatment of bipolar disorder. Medicines used to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years.

Other medicines and Lamotrigina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine,including herbal medicines or other medicines obtained 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 lamotrigine. These medicines include:

• Oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateorzonisamide, used for the treatment ofepilepsy.
• Lithium, olanzapine or aripiprazole, used for the treatment ofmental health problems.
• Bupropion, used for the treatment ofmental health problemsor tostop smoking.
• Paracetamol,used to treatpainandfever.

?Inform your doctorif you are using any of these medicines.

Some medicines interact with lamotrigine or make people more likely to have side effects. These include:

• Valproate, used for the treatment ofepilepsyandmental health problems.
• Carbamazepine, used for the treatment ofepilepsyandmental health problems.
• Phenobarbital, primidoneorphenytoin, used for the treatment ofepilepsy.
• Risperidone, used for the treatment ofmental health problems.
• Rifampicin, which is anantibiotic.
• Medicines used to treat HIV infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir).
• Combined oral 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.

Combined oral contraceptives (such as the pill) may affect the way lamotrigine works.

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

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

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

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

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 modify the effectiveness of lamotrigine treatment, 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 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.Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamotrigina Aurovitas, 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 notice any of these symptoms in your baby.

Driving and using machines

Lamotrigine 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.

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.

How much Lamotrigine Aurovitas to take

It may take some time for your doctor to find the right 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 beginning of treatment and gradually increase the dose over several weeks to reach the most appropriate dose for you (called theeffective dose).Do not take more lamotrigine than your doctor has indicated.

Normally, the effective dose of lamotrigine 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 body weight, up to a maximum maintenance dose of 200 mg per day.

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

How to take the dose of Lamotrigine Aurovitas

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

Chew 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 make sure 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 all the liquid.
• Add a little more water to the glass and drink to make sure there is no medication 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 moreLamotrigine Aurovitas than you should, you may be more prone to severe side effects that can be fatal.

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

• Uncontrolled, rapid 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 compensate for the 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 consulting your doctor

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

If you are taking Lamotrigine Aurovitas for epilepsy treatment

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

If you are taking Lamotrigine Aurovitas for bipolar disorder

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

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

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

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

These symptoms are more likely to occur during the first few months of treatment with lamotrigine, especially if the initial dose is very high or if the dose is increased too quickly, or if you are taking lamotrigine with another medication calledvalproate. Some of these symptoms are more common in children, so parents should pay special attention.

The symptoms of these reactions include:

• Skin rashes or redness, which can lead to skin reactions that can be severe or, in some cases, potentially life-threatening, including a rash with lesions in the shape of a target (erythema multiforme), a widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread skin peeling (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.
• Pain in the mouth or having red or swollen eyes(conjunctivitis).
• High temperature(fever), symptoms similar to the flu or drowsiness (somnolence).
• Swelling around the face,orinflammation of the lymph nodes in the neck, armpits, or groin.
• Bleeding or unexpected bruising, or fingers turning blue.
• Throat painor getting sick more often 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 can be signs of less serious side effects.However, you should be aware that they may be life-threatening and can lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

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

Lymphohistiocytosis hemophagocytic (LHH)(see section 2. What you need to know before starting to take Lamotrigine Aurovitas).

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.
• 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 side effects

These may affect up to 1 in 100 people:

• Clumsiness and loss of coordination (ataxia).
• Double vision or blurred vision.
• Thinning of the hair or unusual hair loss (alopecia).
• Skin rash or sunburn after exposure to the sun or artificial light (photosensitivity).

Rare side effects

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

• A skin reaction that can be life-threatening (erythema multiforme).
• A skin reaction that can be life-threatening (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 can 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).
• Itchy eyes, with discharge and crusts on the eyelids (conjunctivitis).

Very rare side effects

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

• A skin reaction that can be life-threatening (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 lymph nodes in the neck, armpits, or groin (lymphadenopathy) (see also the information at the beginning of section 4).
• Changes in liver function that can be seen in blood tests, or liver failure (see also the information at the beginning of section 4).
• Severe blood clotting disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4).
• Lymphohistiocytosis hemophagocytic (LHH) (see section 2. What you need to know before starting to take Lamotrigine Aurovitas).
• Changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), a reduced number of platelets (trombocytopenia), 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 insecure or unstable when moving.
• Repetitive body movements or uncontrollable sounds or words (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as jerks, spasms, or rigidity.
• More frequent seizures in people with epilepsy.
• Worsening of symptoms in people with Parkinson's disease.
• A reaction similar to lupus (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or generalized illness).

Other side effects

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

• Bone changes that include 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 take steroids.
• Inflammation of the kidney (tubulointerstitial nephritis) or inflammation of the kidney and eye (acute tubulointerstitial nephritis and uveitis).
• Nightmares.
• Reduced immunity, due to a reduction in the 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 medication.

Keepthis medicationout of sightand out of reachof children.

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medicationdoes notrequire special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Lamotrigina Aurovitas

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

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

Appearance of the product and content of the container

Chewable/dispersible tablet.

Uncoated square-rounded tablets, white to off-white in color, with an “H” engraved on the polyhedral face and the number “78” on the flat face.

PVC/Aclar/Aluminum blister

Containers of 56 chewable/dispersible tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet:April 2025

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