Package Leaflet: Information for the User

Lamotrigine Sandoz 200 mg Dispersible/Chewable Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Lamotrigine Sandoz

3. How to take Lamotrigine Sandoz

4. Possible side effects

5. Storage of Lamotrigine Sandoz

6. Contents of the pack and additional informationadditional information

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

Lamotrigina is used to treat epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children 13 years of age and older, lamotrigina can be used alone or in combination with other medications, to treat epilepsy. Lamotrigina can also be used with other medications to treat seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, lamotrigina can be used in combination with other medications to treat the same diseases. It can also be used without other medications to treat a type of epilepsy called typical absence seizures.

Lamotrigina is also used to treat bipolar disorder.

People with bipolar disorder (previously known as manic-depressive disorder) experience radical mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or desperation). In adults 18 years of age and older, lamotrigina can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. It is not known how lamotrigina acts in the brain to have this effect.

Do not take Lamotrigina Sandoz:

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

If this is the case:

• Inform your doctor,and do not take lamotrigine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lamotrigina Sandoz:

• if you have any kidney problems,
• if you have ever had a skin rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy, 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 sun protection cream 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:Very rare side effects),
• if you are already taking medicines that contain lamotrigine.

If this is the case:

• Inform your doctor, who will decide to reduce your dose, or determine that lamotrigine is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking lamotrigine have had allergic reactions or skin reactions that can be potentially life-threatening, which can lead to more serious problems if not treated. These reactions may include Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to know the symptoms of these reactions and be aware of them while taking lamotrigine. This risk may be associated with a genetic variant in people of Asian origin (mainly Chinese Han and Thai). If you are of such origin and have been detected with this genetic variant (HLA-B* 1502), talk to your doctor before taking lamotrigine.

• Read the description of these symptoms in section 4 of this leaflet“Reactions that can be potentially life-threatening: consult your doctor immediately”.
• Brugada syndrome
• Lamotrigine can cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm). Consult your doctor if you have this condition.
• Lymphohistiocytosis hemophagocytic (LHH)
• There have been reported cases 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 tremor, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

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

• when starting treatment,
• if you have had thoughts of self-harm or suicide before,
• if you are under 25 years old.

If you have thoughts or experiences that worry you, or if you notice that you feel worse or develop new symptoms while taking lamotrigine:

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

It may be helpful 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 were 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 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 can cause serious health problems. If seizures occur more frequently or if you experience severe seizures while taking lamotrigine:

• Go to a doctor immediately.

Lamotrigina Sandoz should not be administered to children under 18 years for the treatment of bipolar disorder.Medicines used to treat depression and other mental health problems increase the risk of thoughts and behaviors of self-harm or suicide in children and adolescents under 18 years.

Other medicines and Lamotrigina Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including herbal medicines or other medicines obtained 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 ensure that you take the correct dose of lamotrigine. These medicines 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 tostop smoking.

• Inform your doctorif you are using any of these medicines.

Some medicines interact with lamotrigine or make it more likely for adverse effects to occur. These include:

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

• Inform your doctorif you are using any of these medicines, or if you start or stop using any of these medicines.

Hormonal contraceptives (such as the contraceptive pill) may affect the way lamotrigine 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 contraceptive pill, your doctor may perform blood tests to check your lamotrigine levels. If you are using a hormonal contraceptive or plan to start using one:

• Consult your doctor, who will indicate which methods of contraception are most suitable for you.

Lamotrigine may also affect 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

Consult your doctor or pharmacist before using this medicine if you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant.

• Do not stop your treatment without consulting your doctorwith your doctor. This is particularly important if you have epilepsy.
• Pregnancy may modify the effectiveness of lamotrigine treatment, so you mayneedto have blood tests and adjust your dose.
• Iflamotrigine 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 takefolate supplementsif you are planning to become pregnant and also during pregnancy.

Consult your doctor or pharmacist before using this medicine if you are breastfeeding or plan to start breastfeeding. 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 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 machines

Lamotrigine may cause dizziness and double vision.

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

Consult your doctor about the possibility of driving or operating machines if you have epilepsy

Lamotrigina Sandoz contains sorbitol and sodium

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

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

Follow the exact administration instructions for this medication as indicated 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 for your doctor to find the appropriate dose of lamotrigine for you. The dose you should take will depend on:

• your age,
• whether you are taking lamotrigine with other medications,
• whether you have liver or kidney problems.

Your doctor will prescribe a low initial dose and gradually increase the dose over several weeks to reach the most appropriate dose for you (called theeffective dose).Do not take more lamotrigine than your doctor has indicated.

Normally, the effective dose of lamotrigine 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 the child's 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 Lamotrigine dose

Take your lamotrigine dose once or twice a day, as advised by your doctor. They can be taken with or without food.

• Always take the complete doseprescribed by your doctor. Never take part of the tablet.

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

Lamotrigine dispersible/masticable tablets can be swallowed whole with a little water, chewed, or water added to dissolve them.

Masticate 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 medication.

To dissolve the medication

• place the tablet in a glass that contains 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 to ensure no medication remains in the glass.

If you take more Lamotrigine Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

Someone who has taken too much lamotrigine may experience some of the following 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, seizures, or coma.

If you forgot to take Lamotrigine

Do not take a double doseto compensate for the missed doses.Take the next dose at the usual time.

If you forget to take multiple doses of lamotrigine.

?Ask your doctor to advise you on how to start treatment again. It is essential that you do this.

Do not stop takingLamotriginewithout consulting your doctor

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

If you are taking Lamotrigine for epilepsy treatment

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

If you are taking Lamotrigine for bipolar disorder

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

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

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

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

It is more likely that these symptoms will appear during the first few months of treatment with lamotrigine, especially if the initial dose is very high or if the dose is increased very quickly, or if you are taking lamotrigine 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 can lead to life-threatening skin reactions including widespread rash with blisters and peeling of the skin, which occurs especially around the mouth, nose, eyes, and genitals (Stern-Johnson syndrome), peeling of a large area of the skin (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 sores, throat sores, nose sores, or genital sores,
• mouth or eye pain, or red or swollen eyes (conjunctivitis),
• high temperature (fever), symptoms similar to the flu, or drowsiness (somnolence),
• swelling around the face or inflammation of the lymph nodes in the neck, armpits, or groin,
• unexplained bleeding or bruising, or fingers turning blue,
• throat pain, or more frequent infections (such as colds),
• increased levels of liver enzymes in blood tests,
• increased levels of a type of white blood cell (eosinophils),
• enlarged lymph nodes,
• involvement of organs in the body, including the liver and kidneys.

In many cases, these symptoms can be signs of less severe side effects.However, you should be aware that they can be life-threatening and can 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 you need to undergo tests to evaluate the function of the liver, kidneys, or blood and may instruct you to stop taking this lamotrigine. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will instruct you never to take lamotrigine again.

Lymphohistiocytosis hemophagocytosis (LHH)(see section 2. What you need to know before starting to take Lamotrigine Sandoz).

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 drowsy,
• feeling dizzy,
• muscle spasms or tremors,
• difficulty sleeping (insomnia),
• feeling agitated,
• diarrhea,
• dry mouth,
• nausea and vomiting,
• feeling tired,
• back pain, joint pain, or pain in other areas.

Uncommon side effects

May affect up to 1 in 100 people

• clumsiness and loss of coordination (ataxia),
• double vision or blurred vision,
• hair loss (alopecia),
• skin rash or sunburn 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 (Stern-Johnson syndrome)(see also 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 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 information at the beginning of section 4),
• pharmacological 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 inflammation of the lymph nodes in the neck, armpits, or groin (lymphadenopathy)(see also information at the beginning of section 4),
• changes in liver function, which can be seen in blood tests, or liver failure (see also information at the beginning of section 4),
• severe blood clotting disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation)(see also 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 a bone marrow disorder called aplastic anemia,
• hallucinations (hearing or seeing things that are not really there),
• confusion,
• feeling insecure or unstable when moving,
• repetitive body movements and/or incontrollable sounds or words (tics), incontrollable muscle spasms that affect the eyes, head, and torso (coreoatetosis), or other unusual movements such as twitching, 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).

Other side effects

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

• bone changes that include osteopenia and osteoporosis (bone thinning) and fractures. Consult your doctor or pharmacist if you have taken antiepileptics for a long time, if you have a history of osteoporosis, or if you 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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 above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lamotrigine Sandoz 200 mg chewable tablets

• The active ingredient is lamotrigine. Each chewable tablet contains 200 mg of lamotrigine.
• The other components are: calcium carbonate, microcrystalline cellulose, crospovidone, cornstarch, talc, blackcurrant flavor, sodium saccharin, stearic acid fumarate, and anhydrous colloidal silica.

Appearance of the product and content of the container

Lamotrigine Sandoz 200 mg chewable tablets are white to off-white, square-shaped tablets, engraved with a “L” and “200” on one face, and smooth on the other face.

Each container contains 30 chewable tablets conditioned in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von- Guericke -Alle 1

39179 Barleben

Germany

or

Bluepharma Industria Farmaceutica SA

Cimo de Fala, S. Martino do Bispo

Coimbra 3041-801

Portugal

Last review date of this leaflet:October2023

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