Lamotrigine Viatris 50 mg dispersible/chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lamotrigine Viatris 50 mg chewable/dispersible tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Lamotrigine Viatris

3. How to take Lamotrigine Viatris

4. Possible side effects

5. Storage of Lamotrigine Viatris

6. Contents of the pack and other information

1. What Lamotrigina Viatris is and what it is used for

Lamotrigina Viatris belongs to a group of medicines called antiepileptic drugs. It can be used to treat two conditions: epilepsy and bipolar disorder.

Lamotrigine is used in the treatment of epilepsy because it blocks signals in the brain that trigger seizures (fits).

• In adults and children aged 13 years and older, lamotrigine may be used alone or in combination with other medicines for the treatment of epilepsy. Lamotrigine may also be used together with other medicines for the treatment of seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, lamotrigine may be used in combination with other medicines for the treatment of the same conditions. It may also be used without combination with other medicines for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigine is also used for the treatment of bipolar disorder.

People with bipolar disorder (formerly known as manic-depressive illness) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, lamotrigine may be used, either alone or in combination with other medicines, to help prevent depressive episodes associated with bipolar disorder. It is not known how lamotrigine works in the brain to produce this effect.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before taking Lamotrigine Viatris

Do not take Lamotrigine Viatris:

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

If this applies to you:

? Inform your doctor and do not take lamotrigine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Lamotrigine Viatris:

• If you have kidney problems.
• If you are already taking medicines containing lamotrigine.
• If you have ever had meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare adverse effects).
• Brugada syndrome or other heart problems

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

• Haemophagocytic lymphohistiocytosis (HLH)

Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine. Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., spasms or tremor, confusion, changes in brain function).

• If you have developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you suffer from skin rashes or sunburn after taking lamotrigine and being exposed to sunlight or artificial light (e.g., in a tanning bed). Your doctor will review your treatment and may advise you to avoid sunlight or protect yourself from it (e.g., by using sunscreen and/or protective clothing).

If this applies to you:

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

Important information about potentially life-threatening reactions

A small number of people taking lamotrigine experience allergic or skin reactions that may potentially be life-threatening and could lead to more serious problems if not treated. These reactions may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). It is important that you are aware of the symptoms of these reactions and monitor for them while taking lamotrigine. 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 found to carry this genetic variant (HLA-B*1502), speak 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".

Thoughts of self-harm or suicide

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

• When starting treatment.
• If you have previously had thoughts of self-harm or suicide.
• If you are under 25 years of age.

If you have troubling thoughts or experiences, or if you notice that you feel worse or develop new symptoms while being treated with lamotrigine:

? Contact your doctor as soon as possible or go to the nearest hospital.

It may be helpful to inform a family member, caregiver, or close friend that you may become depressed or experience significant mood changes, and ask them to read this leaflet. You may ask them to inform you if they are concerned about your depression or other changes in your behavior.

A small number of people treated with antiepileptic drugs such as lamotrigine have had thoughts of self-harm or suicide. If at any time you have such thoughts, contact your doctor immediately.

If you are taking lamotrigine for epilepsy

In some types of epilepsy, seizures may occasionally worsen or occur more frequently during treatment with lamotrigine. Some patients may experience severe seizures that could lead to serious health problems. If you notice that your seizures are occurring more frequently or if you experience severe seizures while taking lamotrigine:

? Contact a doctor immediately.

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

Other medicines and Lamotrigine Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or other non-prescription medicines.

Your doctor needs to know if you are taking other medicines for epilepsy or mental health conditions. This is to ensure you receive the correct dose of lamotrigine. These include:

• Oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, indicated for the treatment of epilepsy.
• Lithium, olanzapine, or aripiprazole, indicated for the treatment of mental health conditions.
• Bupropion, indicated for the treatment of mental health conditions or for smoking cessation.
• Paracetamol, used to treat pain and fever.

? Inform your doctor if you are taking any of these medicines.

Some medicines interact with lamotrigine or increase the likelihood of adverse effects. These include:

• Valproate, indicated for the treatment of epilepsy and mental health conditions.

• Carbamazepine, indicated for the treatment of epilepsy and mental health conditions.

• Phenytoin, primidone, or phenobarbital, indicated for the treatment of epilepsy.

• Risperidone, indicated for the treatment of mental health conditions.

• Rifampicin, an antibiotic.

• Medicines indicated for the treatment of Human Immunodeficiency Virus (HIV) infection (AIDS) (combination of lopinavir/ritonavir or atazanavir/ritonavir).

• Hormonal contraceptives, such as the contraceptive pill (see below).

? Inform your doctor if you are taking, or if you start or stop taking, any of these medicines.

Hormonal contraceptives (such as the contraceptive pill) may affect how lamotrigine works

Your doctor may recommend that you use a specific hormonal contraceptive or use another contraceptive method, such as condoms, diaphragm, or intrauterine device (IUD). If you are taking a hormonal contraceptive such as the contraceptive pill, your doctor may ask you to have blood tests to check lamotrigine levels. If you are considering starting a hormonal contraceptive:

? Inform your doctor, who will advise you on the most suitable contraceptive methods for you.

Lamotrigine may alter the way hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and experience changes in your menstrual cycle, such as intermenstrual bleeding or spotting between periods:

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

Pregnancy, breastfeeding, and fertility

? If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Do not stop your treatment without consulting your doctor. This is particularly important if you have epilepsy.
• Pregnancy may alter the effectiveness of lamotrigine treatment, so you may need blood tests and dose adjustments.
• If lamotrigine is taken during the first three 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 supplements if you are planning to become pregnant and also during pregnancy.

? If you are breastfeeding or planning to breastfeed, 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 lamotrigine. If you decide to breastfeed, your doctor will periodically monitor your baby, as they 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 operate machinery unless you are certain you are not affected by these symptoms.

If you have epilepsy, consult your doctor about your ability to drive or use machinery.

Lamotrigine Viatris contains sodium and benzyl alcohol

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

This medicine contains up to 0.013 mg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children.

Do not administer this medicine to newborns (up to 4 weeks of age) unless recommended by your doctor.

Should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

3. How to take Lamotrigine Viatris

Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

What dose of lamotrigine to take

It may take some time for your doctor to find the most appropriate lamotrigine dose for you. The dose you should take depends on:

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

Your doctor will ask you to start treatment with a low dose, gradually increasing it until reaching the most suitable dose for you (called the effective dose). Never take more lamotrigine than your doctor has prescribed.

The recommended dose of lamotrigine for adults and children over 13 years of age is between 100 mg and 400 mg per day.

For children between 2 and 12 years of age, the recommended dose depends on 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.

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

How to take your dose of lamotrigine

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

• Always take the full dose prescribed by your doctor. Never take only part of a tablet.

Your doctor may advise you to start or stop taking other medicines, depending on your condition and how you respond to treatment.

Take lamotrigine orodispersible tablets by swallowing them whole with a little water, or by dissolving them in water.

If you chew the tablet:

When chewing the tablet, you may need to drink a little water to help it dissolve in your mouth. After swallowing, drink a little more water to ensure you have taken all the medicine.

To dissolve the medicine (to make a liquid medicine):

• Place the tablet in a glass containing at least enough water to completely cover the tablet.
• Shake to dissolve, or wait for one minute, until the tablet is completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to ensure you have taken all the medicine.

If you take more Lamotrigine Viatris than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested.

If you take more lamotrigine than you should, you may be more likely to experience serious adverse effects, which can be fatal.

Someone who has taken too much lamotrigine may experience one or more of the following symptoms:

• Rapid, uncontrolled eye movements (nystagmus).
• Clumsiness and loss of coordination, affecting balance (ataxia).
• Changes in heart rhythm (usually detected by ECG).
• Loss of consciousness, seizures, or coma.

If you forget to take Lamotrigine Viatris

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

If you forget to take multiple doses of lamotrigine:

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

Do not stop taking lamotrigine without your doctor telling you to do so

You should take lamotrigine for as long as your doctor recommends. Do not stop treatment until your doctor tells you to.

If you are taking lamotrigine 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, your epilepsy symptoms may return or your condition may worsen.

If you are taking lamotrigine for bipolar disorder

Lamotrigine may take some time to work, so you are unlikely to feel better immediately. When stopping lamotrigine, you do not need to gradually reduce the dose. However, even so, you must consult your doctor before stopping treatment with lamotrigine.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

A small number of people taking lamotrigine may experience allergic reactions or potentially serious skin reactions. If left untreated, these reactions can worsen and may even become fatal.

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

Symptoms of these reactions include:

• Skin rash or redness, which may lead to skin reactions that can be serious or, in some cases, potentially life-threatening, including rash with target-like lesions (erythema multiforme), widespread blistering rash and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis), or widespread rash with involvement of the liver, blood, and other body organs (drug reaction with eosinophilia and systemic symptoms also known as hypersensitivity syndrome (DRESS)).
• Ulcers in the mouth, throat, nose, or genitals.
• High temperature (fever), flu-like symptoms, or drowsiness (sopor).
• Pain in the mouth or red, swollen eyes (conjunctivitis).
• Swelling of the face or inflammation of the glands in the neck, armpits, or groin.
• Unexplained bleeding or bruising, or fingers turning blue.
• Sore throat, or experiencing more infections than usual (such as colds).
• Increased levels of liver enzymes in blood tests.
• Increase in a type of white blood cells (eosinophils).
• Enlarged lymph nodes.
• Involvement of body organs including the liver and kidneys.

In many cases, these symptoms may be signs of less serious adverse effects. However, you should be aware that they may potentially be life-threatening and could lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

?Contact a doctor immediately. Your doctor will decide whether you need tests to assess liver, kidney, or blood function and may advise 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.

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

Very common adverse effects (may affect more than 1 in 10 people)

• Headache.
• Skin rash.

Common adverse effects (may affect up to 1 in 10 people)

• Aggression or irritability.
• Feeling sleepy or drowsy.
• Dizziness.
• Spasms or tremors.
• Difficulty sleeping (insomnia).
• Feeling restless.
• Diarrhea.
• Dry mouth.
• Nausea or vomiting.
• Feeling tired.
• Pain in the back, joints, or other areas.

Uncommon adverse effects (may affect up to 1 in 100 people)

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

Rare adverse effects (may affect up to 1 in 1,000 people)

• Skin reaction characterized by concentric red spots on the skin, which may look like a "target"; that is, a dark red center surrounded by paler red rings (erythema multiforme).
• Itchy eyes with discharge and crusty eyelids (conjunctivitis).
• A rare skin disease causing severe blistering and bleeding on the lips, eyes, mouth, nose, and genital area (Stevens-Johnson syndrome).
• A group of symptoms including: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light.

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

• Rapid, uncontrolled eye movements (nystagmus).

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Hallucinations (hearing or seeing things that are not really there).
• Confusion or agitation.
• Feeling of tremor or instability when moving.
• Repetitive and/or uncontrollable body movements and/or sounds or words (tics), muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness.
• Severe skin reaction, starting with a painful red area, followed by large blisters, and eventually the blisters peel off in layers of skin (Stevens-Johnson syndrome or toxic epidermal necrolysis) (see also information at the beginning of section 4).
• Drug reaction with eosinophilia and systemic symptoms (DRESS).
• In people who have previously had epilepsy, seizures occurring more frequently.
• Changes in liver function, which may be seen in blood tests, or liver failure (see also information at the beginning of section 4).
• Changes that may be seen in blood tests including reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all types of blood cells (pancytopenia), and a disorder of the bone marrow called aplastic anemia.
• Impaired blood clotting, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4).
• High temperature (fever) (see also information at the beginning of section 4).
• Swelling around the face (edema) or inflammation of glands in the neck, groin, or armpits (lymphadenopathy) (see also information at the beginning of section 4).
• In people with Parkinson's disease, worsening of symptoms.
• Lupus-like reaction (symptoms may include back or joint pain, sometimes accompanied by fever and/or general illness).
• Haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigine Viatris). Decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood, which help protect against infection.

Frequency not known (cannot be estimated from available data)

• Inflammation of the kidney (tubulointerstitial nephritis) or inflammation of the kidney and eye (acute tubulointerstitial nephritis and uveitis syndrome).
• Nightmares.
• Decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood, which help protect against infection.

Other adverse effects

• Red nodules or spots on the skin (pseudolymphoma)

Reporting of adverse effects

If you experience any possible adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human 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 Viatris

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

Do not use this medicine after the expiry date stated on the packaging or blister, after EXP or CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Lamotrigina Viatris

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

The other components are: microcrystalline cellulose (E-460(i)), mannitol (E-421), sodium carboxymethyl starch type A (derived from potato), colloidal anhydrous silica, blackcurrant flavour (contains benzyl alcohol and sodium), magnesium stearate (E-470b), povidone, and sodium saccharin (E-954).

Appearance of the medicinal product and contents of the pack

Lamotrigina Viatris is presented as round, white to off-white tablets with bevelled edges. One side is marked with LY over the number 50.

Each pack contains blisters of 42 or 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

Date of the most recent revision of this package leaflet: February 2026.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).