LAMOTRIGINE VIATRIS 200 mg DISPERSIBLE/CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Lamotrigina Viatris 200 mg Chewable/Dispersible Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Lamotrigina Viatris and what is it used for
2. What you need to know before you take Lamotrigina Viatris
3. How to take Lamotrigina Viatris
4. Possible side effects

5 Storage of Lamotrigina Viatris

1. Contents of the pack and other information

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

Lamotrigina Viatris belongs to a group of medicines called antiepileptics. It can be used for the treatment of two conditions: epilepsy and bipolar disorder.

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

• In adults and children over 13 years, lamotrigina can be used on its own or with other medicines, for the treatment of epilepsy. Lamotrigina can also be used with other medicines for the treatment of seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years, lamotrigina can be used with other medicines for the treatment of the same conditions. It can also be used on its own for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigina is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). In adults over 18 years, lamotrigina can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not known how lamotrigina works in the brain to have this effect.

You should see your doctor if your symptoms get worse or do not improve.

2. What you need to know before you take Lamotrigina Viatris

Do not take Lamotrigina Viatris:

• If you are allergic to lamotrigina 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 lamotrigina.

Warnings and precautions

Tell your doctor, pharmacist or nurse before taking Lamotrigina Viatris:

• If you have kidney problems.
• If you are already taking medicines that contain lamotrigina.
• If you have ever had meningitis after taking lamotrigina(read the description of these symptoms in section 4 of this leaflet: Rare side effects).
• Brugada Syndrome or other heart problems

Brugada Syndrome is a genetic disease that causes abnormal electrical activity of the heart. Lamotrigina may cause changes in your electrocardiogram (ECG) that can lead to irregular heart rhythms. Tell your doctor if you have this disease.

• Hemophagocytic Lymphohistiocytosis (HLH)

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

• If you have had a skin rash after taking lamotrigina or other medicines for bipolar disorder or epilepsy, or if you get a rash or sunburn while taking lamotrigina and being exposed to sunlight or artificial light (e.g. in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g. by using sunscreen and/or protective clothing).

If this applies to you:

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

Important information about potentially life-threatening reactions

A small number of people taking lamotrigina have allergic reactions or skin reactions that can be life-threatening, which can lead to more serious problems if not treated. These reactions can include Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms of these reactions and be aware of them while taking lamotrigina. 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 lamotrigina.

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

Thoughts of self-harm or suicide

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

• When you 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 lamotrigina:

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

It may be helpful to tell a relative, caregiver or close friend that you are taking lamotrigina 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 antiepileptics, such as lamotrigina, have also had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor immediately.

If you are taking lamotrigina for epilepsy

In some types of epilepsy, during treatment with lamotrigina, seizures may occasionally worsen or occur more often. Some patients may experience severe seizures that can cause serious health problems. If you notice that you have seizures more often or experience severe seizures while taking lamotrigina:

? See a doctor immediately.

Lamotrigina must not be given to children under 18 years for the treatment of bipolar disorder. Medicines for the treatment of depression and other mental health problems increase the risk of thoughts and behaviors of suicide in children and adolescents under 18 years.

Other medicines and Lamotrigina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines that you bought 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 make sure that you take the correct dose of lamotrigina. These medicines include:

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

? Tell your doctor if you are using any of these medicines.

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

• Valproate, used for the treatment of epilepsy and mental health problems.
• Carbamazepine, used for the treatment of epilepsy and mental health problems.
• Phenytoin, primidone or phenobarbital, used for the treatment of epilepsy.

• Risperidone, used for the treatment of mental health problems.
• Rifampicin, which is an antibiotic.
• Medicines used 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).

? Tell your doctor if you are using, or if you start or stop using, any of these medicines.

Hormonal Contraceptives (such as the contraceptive pill)can affect how lamotrigina works

Your doctor may recommend that you use a specific hormonal contraceptive, or that you use a different method of contraception, such as condoms, diaphragm or IUD. If you are taking a hormonal contraceptive, such as the contraceptive pill, your doctor may ask you to have blood tests to check the levels of lamotrigina in your blood. If you are thinking of starting to use a hormonal contraceptive:

? Tell your doctor, as they will advise you on the most suitable contraceptive methods for you.

It is possible that taking lamotrigina may affect how well your hormonal contraceptive works, although it is unlikely to reduce its effectiveness. If you are using a hormonal contraceptive and experience changes in your menstrual cycle, such as breakthrough bleeding or spotting:

? Tell your doctor. These may be signs that lamotrigina is affecting how well your contraceptive is working.

Pregnancy, breast-feeding and fertility

? If you are pregnant or breast-feeding, 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 lamotrigina works, so you may need to have blood tests and your dose adjusted.
• If lamotrigina 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 supplementsif you are planning to become pregnant and during pregnancy.

? If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.Lamotrigina passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while taking lamotrigina. If you decide to breast-feed, your doctor will monitor your baby from time to time, as they may become sleepy, get a rash or have difficulty gaining weight. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina can cause dizziness and double vision.

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

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

Lamotrigina Viatris contains sodium

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

3. How to take Lamotrigina Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

What dose of lamotrigina to take

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

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

Your doctor will start you on a low dose and gradually increase it until you reach the best dose for you (called the effective dose). Never take more lamotrigina than your doctor has prescribed.

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

For children between 2 and 12 years, the recommended 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.

Lamotrigina is not recommended for children under 2 years.

How to take your dose of lamotrigina

Take your dose of lamotrigina 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. Never take part of a tablet.

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

Take the chewable/dispersible tablets of lamotrigina by swallowing them whole with a little water, or by dissolving them in water.

If you 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 all the medicine.

To dissolve the medicine (make a liquid medicine):

• Put the tablet in a glass that contains enough water to cover the tablet completely.
• Stir to dissolve, or wait for about 1 minute, 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 Lamotrigina Viatris than you should

If you have taken too much lamotrigina, contact your doctor, pharmacist or call the Toxicology Information Service, telephone: 91 5620420, stating the medicine and the amount taken.

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

Someone who has taken too much lamotrigina may have some of these symptoms:

• Fast, 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 Lamotrigina Viatris

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

If you forget to take multiple doses of lamotrigina:

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

Do not stop taking lamotrigina without talking to your doctor

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

If you are taking lamotrigina for epilepsy

To stop taking lamotrigina, it is important that the dose is reduced gradually, over about 2 weeks. If you stop taking lamotrigina suddenly, you may have seizures again or your condition may get worse.

If you are taking lamotrigina for bipolar disorder

Lamotrigina may take some time to work, so it is unlikely that you will feel better immediately. To stop taking lamotrigina, you do not need to reduce the dose gradually. However, before stopping treatment with lamotrigina, you should talk to 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 potentially serious skin reactions. If left untreated, these reactions can worsen and even become life-threatening.

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:

• Rashes or redness of the skin,which can lead to skin reactions that can be serious 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 liver, blood, and other organ involvement (drug reaction with eosinophilia and systemic symptoms also known as DRESS syndrome).
• Ulcers in the mouth, throat, nose, or genitals.
• High temperature(fever), flu-like symptoms or drowsiness (sopor).
• Pain in the mouth or having red or swollen eyes(conjunctivitis).
• Swelling of the face or inflammationof the neck, armpit, and groin lymph nodes.
• Bleeding or unexpected bruising, or blue discoloration of the fingers.
• Sore throat, or suffering from 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 undergo tests to assess liver, kidney, or blood function and may advise you to interrupt treatment with lamotrigine. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you to never take lamotrigine again.

Lymphohistiocytosis hemophagocytica (LHH)(see section 2. What you need to know before taking Lamotrigina 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)

• Aggressiveness or irritability.

• Drowsiness or somnolence.
• Dizziness.

• Spasms or tremors.
• Difficulty sleeping (insomnia).
• Feeling agitated.
• Diarrhea.
• Dry mouth.

• Nausea or vomiting.

• Feeling tired.
• Pain in the back or joints, or in other places.

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

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

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

• Skin reaction characterized by reddish patches on the skin, which can resemble a "target"; i.e., with a dark red center surrounded by lighter red rings (erythema multiforme).
• Itching of the eyes, with discharge and crusts on the eyelids (conjunctivitis).
• Rare skin disease, in which severe blisters and bleeding occur on the lips, eyes, mouth, nose, and genital area (Stevens-Johnson syndrome).
• A set of symptoms that include: fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to bright light.

This may be caused by inflammation of the membranes that cover the brain and spinal cord (meningitis). These symptoms usually disappear when treatment is discontinued. However, if the symptoms continue or worsen, contact your doctor.

• Rapid, uncontrollable 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 tremors or instability when moving.
• Repetitive body movements and/or uncontrollable sounds or words (tics), muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerks, spasms, or stiffness.
• Severe skin reaction, which starts with the appearance of a painful red area, followed by large blisters, and finally, these blisters peel off in layers of skin (Stevens-Johnson syndrome or toxic epidermal necrolysis) (see also the information at the beginning of section 4).
• Drug reaction with eosinophilia and systemic symptoms (DRESS).
• In people who have already had epilepsy, that seizures occur more frequently.
• Changes in liver function, which can be observed in blood tests, or liver failure (see also the information at the beginning of section 4).
• Changes that can be observed in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), a reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anemia.
• Alteration in blood coagulation, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (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).
• In people with Parkinson's disease, worsening of symptoms.
• Lupus-like reaction (symptoms may include: back or joint pain, which may be accompanied by fever and/or generalized disease).
• Lymphohistiocytosis hemophagocytica (LHH) (see section 2. What you need to know before taking Lamotrigina Viatris). Decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection.

Frequency not known(cannot be estimated from available data)

• 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.

Other adverse effects

• Nodes or reddish patches on the skin (pseudolymphoma)

Reporting of adverse effects

If you experience any possible adverse effects, consult your doctor or pharmacist, even if they 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 contribute to providing more information on the safety of this medicine.

5. Storage of Lamotrigina 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 CAD or EXP. The expiry 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 any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Lamotrigina Viatris

The active ingredient is lamotrigine. Each chewable/dispersible tablet contains 200 mg of lamotrigine.

The other ingredients are: microcrystalline cellulose (E-460I), mannitol (E-421), sodium carboxymethyl starch type A (derived from potato), colloidal anhydrous silica, blackcurrant flavor, magnesium stearate (E-470B), povidone, and sodium saccharin (E-954).

Appearance of the product and package contents

Lamotrigina Viatris is presented in the form of round, white to off-white tablets with a beveled edge. On one side, they have the inscription LY over the number 200.

Each package contains blisters of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

Date of the last revision of this leaflet:March 2025

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