Lamotrigine Sandoz 50 mg dispersible/chewable tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamotrigine Sandoz 50 mg dispersible/chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to others, even if they have the same symptoms as you, because it could 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.

Leaflet contents

What Lamotrigine Sandoz is and what it is used for
What you need to know before taking Lamotrigine Sandoz
How to take Lamotrigine Sandoz
Possible adverse effects
How to store Lamotrigine Sandoz
Contents of the pack and other information

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

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

Lamotrigine 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 can be used alone or in combination with other medicines to treat epilepsy. Lamotrigine can 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 can be used in combination with other medicines to treat the same conditions. It can also be used without combination with other medicines to treat a type of epilepsy called typical absence seizures.

Lamotrigine 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, lamotrigine can be used, 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.

2. What you need to know before taking Lamotrigine Sandoz

Do not take Lamotrigine Sandoz:

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:

Tell your doctor, and do not take lamotrigine.

Warnings and precautions

Take special care with lamotrigine

Talk to your doctor or pharmacist before starting Lamotrigine Sandoz:

if you have any kidney problems,
if you have ever developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy,
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 it (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 cause abnormalities in the electrocardiogram (ECG) that could lead to arrhythmias (abnormal heart rhythm).

If this applies to you:

Tell 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 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). 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: “Potentially life-threatening reactions: consult your doctor immediately”.
Brugada syndrome
Brugada syndrome is a genetic disease causing abnormal electrical activity in the heart. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that could lead to arrhythmias (abnormal heart rhythm). Consult your doctor if you have this condition.
Hemophagocytic 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 tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Antiepileptic medicines 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 notice that you feel worse or develop new symptoms while being treated with lamotrigine:

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

It may be helpful for you 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 tell you if they are concerned about your depression or other changes in your behavior.

A small number of people treated with antiepileptic medicines such as lamotrigine have also had thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately.

If you are taking Lamotrigine Sandoz for epilepsy

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

Seek medical attention 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 Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, 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. 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 conditions,
bupropion, used for the treatment of mental health conditions or for smoking cessation,
paracetamol, used to treat pain and fever.
Tell your doctor if you are taking any of these medicines.

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

valproate, used 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, which is an antibiotic,
medicines used to treat Human Immunodeficiency Virus (HIV) infection (AIDS) (a combination of lopinavir and ritonavir or atazanavir and ritonavir),
products containing estrogens, including hormonal contraceptives, such as the contraceptive pill (see below) and hormone replacement therapy (HRT).
Tell your doctor if you are taking any of these medicines, or if you start or stop taking any of them.

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 perform blood tests to monitor 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:

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

HRT may affect how lamotrigine works

If you are using hormone replacement therapy (HRT) containing estrogens, your doctor may request blood tests to monitor lamotrigine levels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 lamotrigine treatment, so you may need a blood test and dose adjustment.
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 plan to start breastfeeding, consult your doctor or pharmacist before using this medicine. The active ingredient lamotrigine 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 the 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 may cause dizziness and double vision.

Do not drive or operate machinery unless you are certain you do not experience these effects.

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

Lamotrigine Sandoz contains sorbitol and sodium

This medicine contains 19.45 mg of sorbitol and calcium carbonate in each dispersible/chewable tablet, equivalent to 5.84 mg of sorbitol.

This medicine contains less than 1 mmol of sodium (23 mg) per dispersible/chewable tablet; i.e., “essentially sodium-free”.

3. How to take Lamotrigine Sandoz

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

What dose of Lamotrigine to take

It may take some time before your doctor finds the most appropriate dose of lamotrigine 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 initially prescribe a low dose and gradually increase it over several weeks until reaching the most appropriate dose for you (called the effective dose). Never take more lamotrigine than your doctor has prescribed.

Typically, the effective dose of lamotrigine for adults and children aged 13 years and older ranges 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

Take your dose of lamotrigine once or twice daily, as advised by your doctor. It can be taken 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 the condition being treated and your response to treatment.

Lamotrigine dispersible/chewable tablets can be swallowed whole with a little water, chewed, or dissolved in water.

Chewing the tablet

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

To dissolve the medicine

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 ensure no medicine remains in the glass.

If you take more Lamotrigine than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you take more lamotrigine 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

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

If you miss 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's advice

You should take lamotrigine 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 for the treatment of 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 should consult your doctor before discontinuing treatment with lamotrigine.

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 may experience allergic reactions or skin reactions that could potentially be life-threatening, which may lead to more serious problems if not treated.

These symptoms are more likely to occur during the first few months of treatment with lamotrigine, especially if the starting dose is too high or the dose is increased too quickly, or if you are taking lamotrigine 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-like lesions (Erythema multiforme), widespread blistering rash and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis), or widespread rash associated with liver involvement, blood abnormalities, and other organ damage (drug reaction with eosinophilia and systemic symptoms also known as hypersensitivity syndrome (DRESS)),
ulcers 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 inflammation of 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 liver enzyme levels 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 can be life-threatening and may lead to more serious complications, 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 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 Lamotrigina Sandoz).

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,
drowsiness or feeling sleepy,
dizziness,
spasms or tremors,
difficulty sleeping (insomnia),
feeling restless,
diarrhea,
dry mouth,
nausea and vomiting,
feeling tired,
back, joint, or other pain.

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, 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),
itchy eyes with discharge and crusty 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 swollen 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),
changes detectable 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 (seeing or hearing things that are not really there),
confusion,
feeling unsteady or unstable when moving,
repetitive body movements and/or uncontrollable sounds or words (tics), uncontrolled 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 been reported in a small number of people, but their exact frequency is unknown:

bone disorders including osteopenia and osteoporosis (reduced bone density) and fractures have been reported. Consult your doctor or pharmacist if you have taken antiepileptic medicines for a long time, have a history of osteoporosis, or are taking steroids,
nightmares,
reduced immunity due to decreased 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or blister, after EXP. The expiry date refers to 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 collection point at your pharmacy. If you are in doubt, ask your pharmacist how to 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 Sandoz 50 mg dispersible/chewable tablets

The active substance is lamotrigine. Each dispersible/chewable tablet contains 50 mg of lamotrigine.
The other components are: sorbitol, calcium carbonate, silicified microcrystalline cellulose, crospovidone, corn starch, talc, blackcurrant flavour, sodium saccharin, sodium fumarate and anhydrous colloidal silica.

Appearance of the medicine and contents of the pack

Lamotrigine Sandoz 50 mg dispersible/chewable tablets are white to off-white, square-shaped tablets, marked with an “L” and “50” on one side and smooth on the other.

Each pack contains 56 dispersible/chewable tablets in blister packs.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Bluepharma Industria Farmaceutica SA

Cimo de Fala, S. Martino do Bispo

Coimbra 3041-801

Portugal

Date of the most recent revision of this leaflet: October 2025

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