LAMOTRIGINE AUROVITAS 25 mg CHEWABLE/DISPERSIBLE TABLETS

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

Do not take Lamotrigine Aurovitas:

• 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 Aurovitas.

Warnings and precautions

Be especially careful with Lamotrigine Aurovitas

Consult your doctor or pharmacist before you start takingLamotrigine Aurovitas:

• If you have any kidney problems.
• If you have ever developed a rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy.
• If you get a rash or blisters after taking lamotrigine and being exposed to sunlight or artificial light (such as in a sunbed).Your doctor will check your treatment and may advise you to avoid sunlight or use a sunscreen and/or protective clothing.
• If you have ever had meningitisafter taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare side effects).
• If you are already taking medicines that contain lamotrigine.
• If you have a condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic condition that affects the electrical activity of the heart. Lamotrigine may cause changes in your ECG and can lead to irregular heart rhythms.

If this applies to you:

?Tell your doctor, who will decide whether to lower your dose or whether lamotrigine is suitable for you.

Important information about reactions that may potentially be life-threatening

A small number of people taking lamotrigine have had allergic reactions or serious skin reactions, which can be life-threatening. These 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 watchful for them while taking lamotrigine. This risk may be higher in people of Asian descent, particularly Han Chinese and Thai people, who have been shown to have a genetic factor that makes them more prone to these reactions. If you are of Asian descent and have been found to have this genetic factor (HLA-B*1502), discuss this with your doctor before taking lamotrigine.

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

Hemophagocytic lymphohistiocytosis (HLH)

There have been reports of a rare but serious reaction of the immune system in patients taking lamotrigine.

?Contact your doctor immediatelyif you get 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

Anti-epileptic medicines, including lamotrigine, 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:

• 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:

?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 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 taking anti-epileptics, including lamotrigine, have also had thoughts of self-harm or suicide. If you have any of these thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigine Aurovitas for epilepsy

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

?See a doctor immediately.

Lamotrigine 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 suicidal thoughts and behavior in children and adolescents under 18 years.

Other medicines and Lamotrigine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought 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. 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 help you stop smoking.
• Paracetamol, used to treat painand fever.

?Tell your doctorif you are taking any of these medicines.

Some medicines interact with lamotrigine 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, primidoneor 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) infections, such as a combination of lopinavir and ritonavir or atazanavir and ritonavir.
• Hormonal contraceptives, such as the 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 pill) may affect how lamotrigine works.

Your doctor may recommend that you use a particular hormonal contraceptive or another method of contraception, such as condoms, a diaphragm, or an intrauterine device (IUD). If you are taking a hormonal contraceptive, such as the pill, your doctor may take blood samples to check the levels of lamotrigine. If you are using a hormonal contraceptive or plan to start using 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 the contraceptive effect. If you are using a hormonal contraceptive and you notice changes in your menstrual cycle, such as breakthrough bleeding or spotting:

?Tell your doctor. These could be signs that lamotrigine is affecting how your contraceptive is working.

Pregnancy and breastfeeding

?If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 works, so you may need to have a blood test and 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 or cleft palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and while you are pregnant.

?If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.The active ingredient of Lamotrigine Aurovitas passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while taking Lamotrigine Aurovitas and will perform regular checks on your baby if you decide to breast-feed. Tell your doctor if you notice any of the following symptoms in your baby: drowsiness, rash, or poor weight gain.

Driving and using machines

Lamotrigine may cause dizziness and double vision.

?Do not drive or use machines unless you are sure you are not affected by these effects.

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

3. How to take Lamotrigine Aurovitas

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

What dose of Lamotrigine Aurovitas to take

It may take a while to find the best dose of lamotrigine for you. The dose you need to take will depend on:

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

Your doctor will start you on a low dose and gradually increase the dose over a few weeks until you reach a dose that is effective for you (called the effective dose). Never take more lamotrigine than your doctor has told you to take.

For adults and children aged 13 years and over, the effective dose of lamotrigine is between 100 mg and 400 mg each day.

For children aged between 2 and 12 years, 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 your dose of Lamotrigine Aurovitas

Take your dose of lamotrigine once or twice a day, as advised by your doctor. You can take it with or without food.

• Always take the full dosethat your doctor has prescribed for you. Never take only part of a tablet.

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

The chewable/dispersible tablets of lamotrigine can be swallowed whole with a little water, chewed, or mixed with 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. After swallowing, drink a little more water to make sure you have taken all the medicine.

To dissolve the medicine:

• Put the tablet in a glass that contains enough water to cover the tablet.
• Stir to dissolve or wait until the tablet is fully dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it to make sure you have taken all the medicine.

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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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 have some of the following symptoms:

• Rapid, uncontrollable 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 forgotten 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 taking it again. It is important 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.

If you are taking Lamotrigine Aurovitas for epilepsy

To stop taking lamotrigine, it is important that the dose is gradually reduced, over approximately 2 weeks. If you stop taking lamotrigine suddenly, you may get seizures again or your epilepsy may get worse.

If you are taking Lamotrigine Aurovitas for bipolar disorder

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

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 serious or, on occasion, potentially life-threatening, including a rash with target-like lesions (erythema multiforme), a 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 a 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 (sopor).
• 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. But 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 spots with a target-like appearance on the skin, which can resemble a "bull's eye"; i.e., 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 crusts 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 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), uncontrolled 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 sometimes be accompanied by fever and/or generalized illness).

Other Adverse Effects

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

• Bone disorders have been reported, including osteopenia and osteoporosis (decreased bone thickness) and fractures. Consult your doctor or pharmacist if you have been taking antiepileptics for a long time, if you have a history of osteoporosis, or if you are taking 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects that are 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 25 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, square-shaped tablets with rounded edges, white to off-white in color, with an "H" engraved on the polyhedral face and the number "80" on the flat face.

PVC/Aclar/Aluminum blister packs.

Packaging containing 21, 42, and 56 chewable/dispersible tablets.

Not all 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 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)