LAMOTRIGINE TEVA 50 mg CHEWABLE AND DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Lamotrigina Teva 50 mg Chewable and 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 Teva and what is it used for
2. What you need to know before you take Lamotrigina Teva
3. How to take Lamotrigina Teva
4. Possible side effects
5. Storing Lamotrigina Teva
6. Contents of the pack and other information

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

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

Lamotrigina Teva is used for the treatment of epilepsy becauseit blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children aged 13 years and over, lamotrigina can be used on its own or in combination with other medicines, for the treatment of epilepsy. Lamotrigina can also be used in combination with other medicines for the treatment of seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, lamotrigina can be used in combination 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 Teva is also used for the treatment of bipolar disorder.

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

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

Do not take Lamotrigina Teva

• (hypersensitive) to the active substance or any of the other ingredients of Lamotrigina Teva (listed in section 6).

If this is the case:

? Tell your doctor, and do not take Lamotrigina Teva.

Warnings and precautions

Your doctor needs to know before you take Lamotrigina Teva:

• when taking lamotrigina or other medicines for epilepsy or bipolar disorder, or if you get skin rashes or sunburns when taking lamotrigina and when 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. use a sunscreen and/or protective clothing.
• after taking lamotrigina (read the description of these symptoms in section 4 of this leaflet: Rare side effects).

If this is the case:

? Tell your doctor, who will decide to reduce your dose, or determine that Lamotrigina Teva is not 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".

Brugada Syndrome

Brugada syndrome is a genetic disease that causes abnormal electrical activity of the heart. Lamotrigina can cause abnormalities in the electrocardiogram (ECG) that can cause arrhythmias (abnormal heart rhythm). Consult your doctorif you have this disease.

Hemophagocytic Lymphohistiocytosis (HLH)

Cases of a rare but very serious reaction of the immune system have been reported in patients taking lamotrigina. Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigina: 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 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 in the following situations:

• 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 Teva:

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

It may be helpful for you to tell a family member, caregiver, or close friend that you can 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 small number of people who have been treated with antiepileptics such as lamotrigina have also had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.

If you are taking Lamotrigina Teva for epilepsy

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

? Go to a doctor immediately.

Lamotrigina Teva should 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 suicidal thoughts and behaviors in children and adolescents under 18 years.

Taking Lamotrigina Teva with other medicines

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 have 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 you take the correct dose of Lamotrigina Teva. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor 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 problemsor for smoking cessation

? Tell your doctorif you are taking 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 epilepsyand mental health problems
• carbamazepine, used for the treatment of epilepsyand 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 HIV infection (AIDS)(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the contraceptive pill(see below).

? Tell your doctorif you are taking, or if you start or stop taking, any of these medicines.

Hormonal Contraceptives (such as the contraceptive pill) can affect the way Lamotrigina Teva 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. If you are using a hormonal contraceptive or if you plan to start using one:

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

It is unlikely that lamotrigina will affect the way hormonal contraceptives work, but it may change the way they work. If you are using a hormonal contraceptive and you notice changes in your menstrual cycle, such as intermenstrual bleeding or spotting:

? Tell your doctor. These may be signs that lamotrigina is affecting the way your contraceptive is working.

Pregnancy, breast-feeding and fertility

? If you are pregnant, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

• Do not stop your treatment without consulting your doctor. This is particularly important if you have epilepsy.
• Pregnancy may affect the effectiveness of treatment with Lamotrigina Teva, so you may need to have a blood test and have your dose adjusted.
• If Lamotrigina Teva is taken during the first 3 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 breast-feeding or planning to breast-feed, consult your doctor or pharmacist before using this medicine:The active substance of Lamotrigina Teva passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while taking lamotrigina, and will perform regular checks on your baby if you decide to breast-feed, as it may cause drowsiness, rash, or poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina Teva can cause dizziness and double vision.

? Do not drive or use machines unless you are sure you do not feel these effects.

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

Lamotrigina Teva contains sorbitol and sodium

This medicine contains 19.45 mg of sorbitol carbonate calcium per tablet, equivalent to 5.82 mg of sorbitol.

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

3. How to take Lamotrigina Teva

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

What dose of Lamotrigina Teva to take

It may take some time for your doctor to find the dose of Lamotrigina Teva that is best for you. The dose you should take will depend on:

• your age
• if you are taking Lamotrigina Teva with other medicines
• if you have liver or kidney problems

Your doctor will prescribe a low dose to start with, and will gradually increase the dose over several weeks until you reach the dose that is best for you (called the effective dose). Never take more Lamotrigina Teva than your doctor has prescribed.

Normally, the effective dose of Lamotrigina Teva for adults and children aged 13 years and over is between 100 mg and 400 mg per day.

For children between 2 and 12 years of age, the effective dose depends on their body weight, normally 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 use in children under 2 years of age.

How to take your dose of Lamotrigina Teva

Take your dose of Lamotrigina Teva 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.

The chewable and dispersible tablets of Lamotrigina Teva can be swallowed whole with a little water, chewed or added to water to dissolve:

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 1 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 medicine.

If you take more Lamotrigina Teva than you should

If someone takes too much Lamotrigina Teva:

• Consult your doctor or pharmacist immediately, if possible, show them the pack of Lamotrigina Teva.
• You can also call the Toxicology Information Service, phone:91 5620420.

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

Someone who takes too much Lamotrigina Teva may have some of these symptoms:

• rapid, uncontrolled eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• changes in heart rhythm (usually detected with an ECG)
• loss of consciousness or coma

If you forget to take Lamotrigina Teva

Do not take an extra tablet or 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 Teva

? Ask your doctor to explain how to start treatment again. It is important that you do this.

Do not stop taking Lamotrigina Teva without your doctor's advice

You should take Lamotrigina Teva for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to.

If you are taking Lamotrigina Teva for the treatment of epilepsy

To stop taking Lamotrigina Teva, it is important that the dose is reduced gradually, over approximately 2 weeks. If you stop taking Lamotrigina Teva suddenly, you may experience seizures again or your condition may worsen.

If you are taking Lamotrigina Teva for bipolar disorder

Lamotrigina Teva may take some time to work, so it is unlikely that you will feel better immediately. If you stop taking Lamotrigina Teva, you do not need to reduce the dose gradually. However, before stopping treatment with Lamotrigina Teva, you should consult 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 skin reactions that can potentially threaten their life, which can lead to more serious problems if left untreated.

It is more likely that these symptoms will appear during the first few months of treatment with Lamotrigina Teva, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Lamotrigina Teva 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:

• skin rashes or redness,which can lead to skin reactions that can threaten life, including 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
• pain in the mouth or having red or swollen eyes(conjunctivitis)
• high temperature(fever), flu-like symptoms or drowsiness (sopor)
• swelling around the face or inflammationof the neck, armpit, or groin lymph nodes
• bleeding or unexpected bruising, or blue discoloration of the fingers
• sore throat, or having more infections than usual (such as colds).
• increase in 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 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 have tests to assess liver, kidney, or blood function and may also tell you to stop treatment with Lamotrigina Teva. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you that you should never take lamotrigine again.

Very Common Adverse Effects

Can affect more than 1 in 10people:

• headache
• skin rash

Common Adverse Effects

Can affect up to 1 in 10people:

• aggressiveness or irritability
• feeling sleepy or drowsy
• feeling dizzy
• shaking or tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain or joint pain, or pain in other areas.

Uncommon Adverse Effects

Can affect up to 1 in 100people:

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

Rare Adverse Effects

Can affect up to 1 in 1,000people:

• life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4)
• a set 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 disappear when treatment is stopped. However, if the symptoms continue or worsen, contact your doctor
• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crust on the eyelids (conjunctivitis)

Very Rare Adverse Effects

Can affect up to 1 in 10,000people:

• a life-threatening skin reaction (toxic epidermal necrolysis) (see also the information at the beginning of section 4)
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) (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)
• changes in liver function, which can be seen in blood tests, or liver failure (see also the information at the beginning of section 4)
• severe blood clotting disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• changes that can be seen in blood tests, including low red blood cell count (anemia), low white blood cell count (leukopenia, neutropenia, agranulocytosis), low platelet count (thrombocytopenia), low count 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
• repetitive body movements and/or sounds or words that are uncontrollable (tics), uncontrolled muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as shaking, spasms, or stiffness
• in people with epilepsy, more frequent seizures
• in people with Parkinson's disease, worsening of symptoms
• lupus-like reaction (symptoms can include: back or joint pain, which can sometimes be accompanied by fever and/or generalized illness).
• Hemophagocytic lymphohistiocytosis (LHH) (see section 2. What you need to know before taking Lamotrigina Teva).

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 (decrease in bone thickness) and fractures, have been reported. Consult your doctor or pharmacist if you are on long-term treatment with antiepileptics, have a history of osteoporosis, or are taking steroids.
• nightmares.
• decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection.
• nodules or red spots on the skin (pseudolymphoma).

Reporting Adverse Effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect that is not listed in the 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 help provide more information on the safety of this medicine.

5. Storage of Lamotrigina Teva

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

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

Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lamotrigina Teva 50 mg

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

The other ingredients (excipients) are: sorbitol, calcium carbonate (E-420), microcrystalline cellulose (E-460i)/anhydrous colloidal silica, crospovidone, cornstarch, talc (E-553b), sodium saccharin (E-954ii), blackcurrant flavor, anhydrous colloidal silica, sodium stearyl fumarate.

Appearance of the Product and Package Contents

Lamotrigina Teva 50 mg chewable and dispersible tablets are presented in the form of white or almost white square tablets with rounded edges, with the characters "L" and "50" engraved on one face and the other face smooth.

Each package 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, 1ª planta,

Alcobendas, 28108, Madrid

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 Last Revision of thisLeaflet:October 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67352/P_67352.html