Prospecto: information for the user

Lamotrigina Teva 100 mg chewable and dispersible tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

1.Lamotrigina Teva and its use

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

3.How to take Lamotrigina Teva

4.Adverse effects

5.Storage of Lamotrigina Teva

6.Contents of the package and additional information

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

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

• In adults and children 13 years of age and older, lamotrigine can be used alone or in combination with other medications, for the treatment of epilepsy. Lamotrigine can also be used with other medications for the treatment of seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, lamotrigine can be used in combination with other medications for the treatment of the same diseases. It can also be used without combining with other medications for the treatment of 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 disorder) experience radical mood changes, 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 Teva can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. The way lamotrigine acts in the brain to produce this effect is not known.

Do not take Lamotrigina Teva

• if you are allergic(hypersensitive) to the active ingredient or to any of the other components of Lamotrigina Teva (listed in section 6).

If this is your case:

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

Warnings and precautions

Your doctor needs to know before taking Lamotrigina Teva:

• If you have kidney problems
• If you have ever developed any skin rashwhen taking lamotrigine or other medications for epilepsy or bipolar disorder, or if you suffer from skin rashes or sunburn after taking lamotrigine and exposure to the sun or artificial light (for example, in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (for example, use a sunscreen and/or protective clothing.
• If you have ever had meningitis after taking lamotrigine(see the description of these symptoms in section 4 of this leaflet: Rare side effects).
• If you are already taking medications that contain lamotrigine.

If this is your case:

?Inform 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 lamotrigine have allergic 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.

??See the description of these symptoms in section 4 of this leaflet“Life-threatening reactions: consult your doctor immediately”.

Brugada syndrome

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 doctorif you have this disease.

Haemophagocytic lymphohistiocytosis (HLH)

There have been reports of a rare but severe immune system reaction in patients taking lamotrigine.Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., spasms or tremors, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

Antiepileptic drugs, including lamotrigine, 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 Lamotrigina 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 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 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 Lamotrigina Teva for epilepsy

In some types of epilepsy, during treatment with lamotrigine, seizures may 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 administered to children under 18 years 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.

Taking Lamotrigina Teva with other medications

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 Lamotrigina Teva. These medications include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used for the treatment ofepilepsy
• lithium,olanzapine or aripiprazole, used for the treatment ofmental health problems
• bupropion, used for the treatment ofmental health problemsor toquit smoking

?Inform your doctorif you are using any of these medications.

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

• valproate, used for the treatment ofepilepsyandmental health problems
• carbamazepine, used for the treatment ofepilepsyandmental health problems
• phenytoin, primidone, or phenobarbital, used for the treatment ofepilepsy
• risperidone, used for the treatment ofmental health problems
• rifampicin, which is anantibiotic
• medications used to treat HIV infection (SIDA(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such asthe pill(see below).

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

Hormonal Contraceptives (such as the pill) may affect the way Lamotrigina Teva works

Your doctor may recommend a specific hormonal contraceptive, or suggest using a different method of contraception, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive, such as the pill, your doctor may ask you to have blood tests to check the concentration of lamotrigine. If you are using a hormonal contraceptive or plan to start using one:

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

Lamotrigine may modify the way 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 loss 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, think you may be pregnant, or plan to become 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 treatment with Lamotrigina Teva, so you may need to have blood tests and adjust your dose.
• If Lamotrigina Teva 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 plan to start breastfeeding, consult your doctor or pharmacist before using 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 and will perform regular checks on your baby if you decide to start breastfeeding, as 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

Lamotrigina Teva 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 Teva contains sorbitol and sodium

This medication contains 38.9 mg of sorbitol carbonate calcium in each tablet, equivalent to 11.67 mg of sorbitol.

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 your doctor or pharmacist again.

What dose of Lamotrigine Teva to take

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

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

Your doctor will prescribe a low starting dose, and gradually increase the dose over several weeks to reach the most suitable dose for you (called the effective dose).Do not take more Lamotrigine Teva than your doctor has prescribed.

Normally, the effective dose of Lamotrigine Teva for adults and children 13 years of age 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 their body weight, usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.

Lamotrigine is not recommended for children under 2 years of age.

How to take the dose of Lamotrigine Teva

Take your dose of Lamotrigine Teva once or twice 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 you are being treated for and how you respond to treatment.

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

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 Teva than you should

If someone takes too much Lamotrigine Teva:

• Consult your doctor or pharmacist immediately, should they be possible, show them the Lamotrigine Teva packaging.
• You can also call the Toxicology Information Service, phone:91 5620420.

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

Someone who takes too much Lamotrigine Teva may experience some of the following symptoms:

• rapid and 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 Lamotrigine Teva

Do not take an extra tablet or a double dose to compensate for the missed doses. Take the next dose at the usual time. In case of forgetting to take multiple doses of Lamotrigine Teva

?Ask your doctor to explain how to start again with the treatment. It is essential to do this.

Do not stop taking Lamotrigine Teva without consulting your doctor

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

If you are taking Lamotrigine Teva for epilepsy treatment

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

If you are taking Lamotrigine Teva for bipolar disorder

Lamotrigine Teva may take some time to act, so it is unlikely that you will feel better immediately. If you stop taking Lamotrigine Teva, you do not need to gradually reduce the dose. However, before interrupting treatment with Lamotrigine Teva, 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 reduced number of people taking lamotrigine have allergic reactions or skin reactions that may potentially threaten their life, which may lead to more serious problems if not treated.

It is more likely that these symptoms will appear during the first 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 medication called valproate.Some of these symptoms are more common in children, so parents should pay special attention.

The symptoms of these reactions include:

• skin eruptions or redness,which may lead to life-threatening skin reactions, including widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread skin peeling in an extensive area of the body (more than 30% of the body surface –toxic epidermal necrolysis) or widespread 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, throat, nose, or genital ulcers
• mouth or eye pain or redness or swelling(conjunctivitis)
• high temperature(fever), symptoms similar to the flu or drowsiness (somnolence)
• swelling around the face or inflammationof the neck, armpit, or groin lymph nodes
• unexplained bleeding or bruising or that fingers turn blue
• throat pain, or having more infections than normal (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.

In many cases, these symptoms may be signs of less serious side effects.However, you should be aware that they may potentially threaten life and may lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

?Contact your doctor immediately.. Your doctor will decide if tests should be done to evaluate the function of the liver, kidneys, or blood and may also tell you to stop taking 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 side effects

May affect more than 1 in 10 people:

• headache
• skin rash

Common side effects

May affect up to 1 in 10 people:

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

Uncommon side effects

May affect up to 1 in 100 people:

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

Rare side effects

May affect up to 1 in 1,000 people:

• 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 may 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 symptoms continue or worsen,contact your doctor
• rapid, uncontrolled eye movements (nystagmus)
• eye itching, with discharge and crusts on the eyelids (conjunctivitis)

Very rare side effects

May affect up to 1 in 10,000 people:

• life-threatening skin reaction (toxic epidermal necrolysis) (see also the information at the beginning of section 4)
• pharmacological reaction with eosinophilia and systemic symptoms (DRESS) (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)
• liver function changes that 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 a reduced number of red blood cells (anemia), a reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), a reduced number of platelets (trombocytopenia), a reduced number of all types of blood cells (pancytopenia), and aplastic anemia

• hallucinations (hearing or seeing things that are not really there)
• confusion
• feeling insecure or unstable when moving
• repeated body movements or incontrollable sounds or words (tics), incontrollable muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as shaking, spasms, or stiffness
• more frequent seizures in people with epilepsy
• emergence of symptoms in people with Parkinson's disease
• reaction similar to lupus (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or generalized illness).
• hemophagocytic lymphohistiocytosis (LHH) (see section 2. What you need to know before starting to take Lamotrigina Teva).

Other side effects

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

• bone changes, including osteopenia and osteoporosis (bone thinning) and fractures. Consult your doctor or pharmacist if you are taking antiepileptic medication for a long time, have a history of osteoporosis, or are taking steroids.
• nightmares.
• reduced immunity, due to a reduction in the levels of antibodies called immunoglobulins in the blood that help protect against infection.
• red or brown spots on the skin (pseudolymphoma).

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in the leaflet. You can also report them directly through the Spanish Medicines Agency's Pharmacovigilance System 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. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lamotrigina Teva 100 mg

The active ingredient is lamotrigine. Each chewable and dispersible tablet contains 100 mg of lamotrigine.

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

Appearance of the product and content of the packaging

Lamotrigina Teva 100 mg chewable and dispersible tablets are presented in the form of white or almost white, square tablets with rounded edges, bearing the characters “L” and “100” on one face and a smooth surface on the other.

Each package contains blisters of 56 chewable and dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

Alcobendas, 28108, Madrid

Responsible for manufacturing:

BLUEPHARMA INDUSTRIA FARMACEUTICA S.A.

S. 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

Last review date of thisleaflet:October 2023

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

You can access detailed and updated information on this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67350/P_67350.html