Package Insert: Information for the User

Lamotrigine Viatris 200 mg Chewable/Dispersible Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

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

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

2.What you need to know before starting to take Lamotrigine Viatris

3.How to take Lamotrigine Viatris

4.Possible side effects

5Storage of Lamotrigine Viatris

6.Contents of the pack and additional information

Lamotrigina Viatris belongs to a group of medications calledantiepilepticdrugs. It can be used to treat two diseases: epilepsy and bipolar disorder.

Lamotrigina is used to treat epilepsy becauseit blocks signals in the brain that trigger seizures (attacks).

• In adults and children 13 years of age and older, lamotrigina may be used alone or in combination with other medications, to treat epilepsy. Lamotrigina may 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 may be used in combination with other medications to treat the same diseases. It may 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 illness) experience extreme 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 may be used to prevent periods of depression that occur in bipolar disorder, either alone or in combination with other medications. It is not known how lamotrigina acts in the brain to produce this effect.

You should consult a doctor if you get worse or do not improve.

Do not take Lamotrigina Viatris:

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

If this is your case:

?Inform your doctor, and do not take lamotrigine.

Warnings and precautions

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

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

The Brugada syndrome is a genetic disease that causes abnormal heart electrical activity. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm). Consult your doctor if you have this disease.

• Lymphohistiocytosis hemophagocytic (LHH)

Cases of a rare but severe 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, confused state, cerebral function alterations).

• If you have had a skin rashafter taking lamotrigine or other medications for bipolar disorder or epilepsy,or if you suffer from skin rashes or sunburns after taking lamotrigine and exposure to the sun or artificial light (e.g., in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g., use a sunscreen and/or protective clothing).

If this is your case:

?Inform your doctor, who will decide 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 have had allergic reactions or skin reactions that can be 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 may 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 had thoughts of self-harm or suicide at some point. 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 to explain to a family member, caregiver, or close friend that you may become depressed or have significant mood changes, and ask them to read this leaflet. You can ask them to tell you if they are worried about your depression or other changes in your behavior.

A reduced 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 lamotrigine for epilepsy

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

?Go to a doctor immediately.

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

Other medications and Lamotrigina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including herbal medications or other medications obtained without a prescription.

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

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

?Inform your doctor if you are using any of these medications.

Some medications interact with lamotrigine or make adverse effects more likely. These include:

• Valproate, indicated for the treatment of epilepsy and mental health problems.
• Carbamazepine, indicated for the treatment of epilepsy and mental health problems.
• Phenobarbital, phenytoin, or primidone, indicated for the treatment of epilepsy.

• Risperidone, indicated for the treatment of mental health problems.
• Rifampicin, which is an antibiotic.
• Medications indicated for the treatment of HIV infection (AIDS) (combination of lopinavir/ritonavir or atazanavir/ritonavir).
• Oral contraceptives, such as the birth control pill (see below).

?Inform your doctor if you are using, or if you start or stop using, any of these medications.

Oral Contraceptives (such as the birth control pill)may affect the way lamotrigine works

Your doctor may recommend a specific oral contraceptive or suggest using a different method of contraception, such as condoms, diaphragm, or IUD. If you are taking an oral contraceptive, such as the birth control pill, your doctor may ask you to have blood tests to check the concentration of lamotrigine. If you are thinking of starting to use an oral contraceptive:

?Inform your doctor,who will indicate which contraceptive methods are most suitable for you.

Lamotrigine may modify the way oral contraceptives work, although it is unlikely to reduce their effectiveness. If you are using an oral 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 the way your contraceptive works.

Pregnancy, breastfeeding, and fertility

?If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• 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 blood tests and adjust your dose.
• 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 if you plan to start breastfeeding,consult your doctor or pharmacist beforeusing this medication.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 start breastfeeding, your doctor will check your baby from time to time,since your baby may experience drowsiness, rash, or poor weight gain. Inform your doctor if you observe any of these symptoms in your baby.

Driving and operating machinery

Lamotrigine may cause dizziness and double vision.

?Do not drive or operate machinery until you are sure you do not feel these effects.

If you have epilepsy, consult your doctor about the possibility of driving or operating machinery.

Lamotrigina Viatris contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult with your doctor or pharmacist.

How much lamotrigine to take

It may take some time for your doctor to find the most appropriate 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 liver or kidney problems.

Your doctor will ask you to start treatment with a low dose, and gradually increase the dose until you reach the most appropriate 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 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 the child's weight, up to a maximum maintenance dose of 200 mg per day.

Lamotrigine is not recommended for children under 2 years.

How to take the lamotrigine dose

Take your lamotrigine dose one or two times a day, as advised by your doctor. You can take it with or without food.

• Always take the complete dosethat your doctor has prescribed. Never take part of the tablet.

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

Take the chewable/dispersible lamotrigine tablets whole with a little water, or dissolve 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 medication.

To dissolve the medication (make a liquid medication):

• Put the tablet in a glass that contains enough water to cover the tablet completely.
• Shake to dissolve, or wait for a minute, until the tablet is completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to make sure you have taken all the medication.

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, phone: 91 5620420, indicating the medication and the amount ingested.

If you take more lamotrigine than you should, you may be more prone to severe side effects that can be fatal.

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

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

If you forgot to take Lamotrigine Viatris

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

If you forget to take multiple doses of lamotrigine:

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

Do not stop taking lamotrigine without your doctor's advice

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

If you are taking lamotrigine for epilepsy treatment

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

If you are taking lamotrigine for bipolar disorder treatment

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

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

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

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

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

The symptoms of these reactions include:

• skin rashes or redness, which can lead to potentially serious or even life-threatening skin reactions, including:multiforme erythema (a rash with lesions),disseminated rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome),extensive skin peeling (more than 30% of the body surface – toxic epidermal necrolysis), orextensive 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).
• mouth sores, throat sores, nasal sores, or genital sores.
• high temperature (fever), flu-like symptoms, or drowsiness (somnolence).
• eye redness or swelling (conjunctivitis).
• swelling of the face or inflammation of the neck, armpit, or groin lymph nodes.
• unexplained bleeding or bruising, or fingers turning blue.
• throat pain, or experiencing more frequent infections (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.

Many of these symptoms can be signs of less severe side effects.However, you should be aware that they can potentially threaten life and lead to more serious problems, such as organ failure, if left untreated. If you notice any of these symptoms:contact your doctor immediately.

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

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

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

• headache.
• skin rash.

Common side effects (affect up to 1 in 10 people)

• aggression or irritability.

• drowsiness or somnolence.
• dizziness.

• muscle spasms or tremors.
• difficulty sleeping (insomnia).
• restlessness.
• diarrhea.
• dry mouth.

• nausea or vomiting.

• fatigue.
• back or joint pain, or pain in other areas.

Uncommon side effects (affect up to 1 in 100 people)

• ataxia (clumsiness and loss of coordination).
• double vision or blurred vision.
• hair loss (alopecia).
• photosensitivity (skin rash or sunburn after exposure to sunlight or artificial light).

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

• erythema multiforme (a rash with lesions that resemble a "target" pattern).
• conjunctivitis (eye redness, discharge, and crusting).
• Stevens-Johnson syndrome (a rare skin condition characterized by severe blisters and skin peeling).
• 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 resolve when treatment is stopped. However, if symptoms persist or worsen, contact your doctor.

• uncontrolled, rapid eye movements (nystagmus).

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

• hallucinations (hearing or seeing things that are not really there).
• confusion or agitation.
• feeling shaky or unstable when moving.
• repetitive body movements or incoherent sounds or words (tics), muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as twitching, spasms, or rigidity.
• severe skin reaction, which begins with the appearance of a painful, red area, followed by large blisters, and finally, these blisters peel off in layers (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• pharmacological reaction with eosinophilia and systemic symptoms (DRESS).
• increased frequency of seizures in people who have a history of epilepsy.
• liver function changes that can be seen in blood tests, or liver failure (see section 4 for more information).
• changes that can be seen in blood tests, including:anemia (reduced red blood cell count),leucopenia (reduced white blood cell count),neutropenia (reduced neutrophil count),agranulocytosis (reduced granulocyte count),trombocytopenia (reduced platelet count),pancytopenia (reduced count of all blood cell types), andaplastic anemia (a condition where the bone marrow fails to produce blood cells).
• coagulation disorders that can cause bleeding or unexpected bruising (disseminated intravascular coagulation).
• high temperature (fever).
• swelling around the face (edema) or inflammation of the neck, armpit, or groin lymph nodes (lymphadenopathy).
• emergence of Parkinson's disease symptoms in people who already have the condition.
• reaction similar to lupus (symptoms may include back or joint pain, which can be accompanied by fever and/or generalized illness).
• lymphohistiocytosis hemophagocytic (LHH) (see section 2. What you need to know before starting Lamotrigine Viatris). Reduced immunity due to decreased levels of antibodies called immunoglobulins in the blood that help protect against infection.

Frequency not known (cannot be estimated from available data)

Other side effects

• pseudolymphoma (nodules or red spots on the skin).

Reporting of side effects

Ifyou experience any typeofpossibleside effects,consult your doctor or pharmacist, even ifthey do notappearin this leaflet.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging or blister, after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt,ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lamotrigina Viatris

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

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

Appearance of the product and contents of the packaging

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

Each package contains blisters of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

McDermott Laboratories Ltd. t/a Gerard Laboratories Ltd.

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

Last review date of this leaflet:March 2025

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