Lamotrigine Teva 50 mg chewable and dispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lamotrigine Teva 50 mg chewable and dispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lamotrigine Teva is and what it is used for
2. What you need to know before taking Lamotrigine Teva
3. How to take Lamotrigine Teva
4. Possible side effects
5. How to store Lamotrigine Teva
6. Contents of the pack and other information

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

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

Lamotrigina Teva is used to treat epilepsy because it blocks signals in the brain that trigger epileptic seizures (fits).

• In adults and children aged 13 years and older, lamotrigine may be used alone or in combination with other medicines to treat epilepsy. Lamotrigine may also be used together with other medicines to treat 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 to treat the same conditions. It may also be used without combination with other medicines to treat a type of epilepsy called typical absence seizures.

Lamotrigina Teva is also used to treat bipolar disorder.

People with bipolar disorder (previously 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, Lamotrigina Teva may be used to prevent depressive episodes associated with bipolar disorder, either alone or in combination with other medicines. It is not known how lamotrigine works in the brain to produce this effect.

2. What you need to know before taking Lamotrigine Teva

Do not take Lamotrigine Teva

• If you are allergic (hypersensitive) 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 Teva.

Warnings and precautions

Be especially careful with this medicine.

Consult your doctor or pharmacist before starting to take Lamotrigine Teva:

• If you have any kidney problems
• If you have ever developed a skin rash after taking lamotrigine or other medicines for epilepsy or bipolar disorder
• If you develop 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 the sun (e.g., by using sunscreen and/or protective clothing).
• If you have ever had meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare adverse effects).
• If you are already taking medicines containing lamotrigine
• If you have a condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic disease causing abnormal electrical activity in the heart. Lamotrigine may lead to abnormalities in the electrocardiogram (ECG) that could cause arrhythmias (abnormal heart rhythm).

If this applies to you:

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

Important information about potentially life-threatening reactions

A small number of people taking lamotrigine may experience allergic reactions or skin reactions that could potentially be life-threatening, which may 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). You need to be 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".

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., seizures or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

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

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

If you have distressing thoughts or experiences, or if you feel worse or develop new symptoms while being treated with Lamotrigine Teva:

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

It may be helpful for you to explain to a family member, 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 also had thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigine Teva for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more frequently while taking lamotrigine. Some patients may experience severe seizures, which could cause serious health problems. If seizures occur more frequently or if you experience severe seizures while taking Lamotrigine Teva:

? Seek medical attention immediately.

Lamotrigine Teva must not be administered 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 may increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years of age.

Other medicines and Lamotrigine Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including herbal remedies or other medicines obtained without a prescription.

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 Teva. These medicines include:

• Oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used to treat epilepsy
• Lithium, olanzapine, or aripiprazole, used to treat mental health conditions
• Bupropion, used to treat mental health conditions or to quit smoking
• 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, used to treat epilepsy and mental health conditions
• Carbamazepine, used to treat epilepsy and mental health conditions
• Phenytoin, primidone, or phenobarbital, used to treat epilepsy
• Risperidone, used to treat mental health conditions
• Rifampicin, an antibiotic
• Medicines used to treat Human Immunodeficiency Virus (HIV) infection (AIDS) (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• Hormonal contraceptives, such as the birth control 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 birth control pill) may affect how Lamotrigine Teva 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 birth control pill, your doctor may perform a blood test to check your lamotrigine levels. If you are using a hormonal contraceptive or plan to start using one:

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

Lamotrigine may also affect how hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and notice 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 and breastfeeding

? If you are pregnant, think you may 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 especially important if you have epilepsy.
• Pregnancy may alter the effectiveness of treatment with Lamotrigine Teva, so you may need blood tests and dose adjustments.
• If Lamotrigine Teva 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: The active ingredient in Lamotrigine Teva passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine and will schedule periodic check-ups for your baby if you decide to breastfeed, as your baby may experience drowsiness, rash, or poor weight gain. Inform your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigine Teva may cause dizziness and double vision.

? Do not drive or operate machinery unless you are certain you are not affected by these effects.

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

Lamotrigine Teva contains sorbitol and sodium

This medicine contains 5.82 mg of sorbitol.

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

3. How to take Lamotrigine Teva

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

What dose of Lamotrigine Teva to take

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

• your age
• whether you are taking Lamotrigine Teva together with other medicines
• whether you have liver or kidney problems

Your doctor will prescribe a low starting dose at the beginning of treatment and gradually increase the dose over several weeks until reaching the most appropriate dose for you (called the effective dose). Never take more of this medicine than your doctor has prescribed.

Normally, the effective dose of this medicine for adults and children aged 13 years and older is between 100 mg and 400 mg per day.

For children between 2 and 12 years of age, the effective dose depends on 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 Teva

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.

The chewable and dispersible tablets of this medicine may be swallowed whole with a little water, chewed, or mixed with water to form a liquid.

Chewing the tablet:

When 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 ensure you have taken the entire dose.

To dissolve the medicine (to make a liquid):

• Place the tablet in a glass containing enough water to cover the entire tablet.
• Shake to dissolve, or wait until the tablet is completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to make sure no medicine is left in the glass.

If you take more Lamotrigine Teva than you should

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

If you take more Lamotrigine Teva than you should, you may be more likely to experience serious adverse effects that could 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 Teva

?Do not take an extra tablet or double dose to make up for a missed dose. Take the next dose at your usual time. If you miss multiple doses of Lamotrigine Teva

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

Do not stop taking Lamotrigine Teva without consulting your doctor

You should take this medicine for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to do so.

If you are taking Lamotrigine Teva for the treatment of epilepsy

To stop taking this medicine, 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 Teva for bipolar disorder

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

4. Possible adverse effects

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

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

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

These symptoms are more likely to occur during the first few months of treatment with Lamotrigine Teva, especially if the initial dose is too high, if the dose is increased too quickly, or if you are taking Lamotrigine Teva 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 fatal, including rash with target-shaped lesions (erythema multiforme), widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling over a large area of 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))
• sores in the mouth, throat, nose, or genitals
• mouth pain or red, swollen eyes (conjunctivitis)
• high temperature (fever), flu-like symptoms, or drowsiness (sopor)
• swelling around the face, or swelling of the lymph nodes in the neck, armpits, or groin
• unexpected 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 cell (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 left untreated. 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 treatment with Lamotrigine Teva. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will instruct you never to take lamotrigine again.

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

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
• back pain, joint pain, or pain in 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)
• skin reaction that may be life-threatening (Stevens-Johnson syndrome) (see also information at the beginning of section 4)
• a group of symptoms including: fever, nausea, vomiting, headache, stiff neck, 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)
• itchy eyes with discharge and crusts on the eyelids (conjunctivitis)

Very rare adverse effects

May affect up to 1 in 10,000 people:

• a skin reaction that may be life-threatening (toxic epidermal necrolysis) (see also information at the beginning of section 4)
• drug reaction with eosinophilia and systemic symptoms (DRESS) (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 swelling of glands in the neck, groin, or armpits (lymphadenopathy) (see also information at the beginning of section 4)
• changes in liver function, which may be seen in blood tests, or liver failure (see also information at the beginning of section 4)
• serious blood clotting disorder, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4)
• Hemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigine Teva).
• changes that may be observed 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 bone marrow disorder called aplastic anemia
• hallucinations (hearing or seeing things that are not really there)
• confusion
• feeling unsteady or unstable when moving
• repeated body movements and/or uncontrollable sounds or words (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness
• in people with epilepsy, more frequent seizures
• 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).

Other adverse effects

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

• bone disorders including osteopenia and osteoporosis (decreased bone thickness) and fractures have been reported. Consult your doctor or pharmacist if you have taken antiepileptic medicines for a long time, if you have a history of osteoporosis, or if you are taking steroids.
• 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
• red nodules or spots on the skin (pseudolymphoma)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through 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 Teva

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

Do not use this medicine after the expiry date stated on the container or blister pack, after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamotrigine Teva 50 mg

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

The other components (excipients) are: sorbitol, calcium carbonate (E-420), microcrystalline cellulose (E-460i)/anhydrous colloidal silica, crospovidone, corn starch, talc (E-553b), sodium saccharin (E-954ii), blackcurrant flavouring (contains sodium), anhydrous colloidal silica and sodium stearyl fumarate.

Appearance of the product and contents of the pack

Lamotrigine Teva 50 mg chewable and dispersible tablets are presented as white or almost white, square-shaped tablets with rounded corners, marked on one side with the characters “L” and “50”, the other side being smooth.

Each pack contains blisters of 42 or 56 chewable and dispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid, Spain

Manufacturer:

Bluepharma Industria Farmaceutica S.A.

• Martino do Bispo, Cimo de Fala

3045-016 Coimbra

Portugal

or

Sofarimex Industria Química e Farmaceutica

Avda. Das Industrias – Alto do Colaride

Agualva-Cacém

2735-213 Portugal

or

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Date of the most recent review of this package leaflet: March 2026.

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67352/P_67352.html