Leaflet: information for the user

Lamotrigine Sandoz 25 mg chewable tablets

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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. The way lamotrigina acts in the brain to produce this effect is not known.

Do not take Lamotrigina Sandoz:

• if you are allergicto 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 doctoror pharmacistbefore 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 sunbed). 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: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“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 doctor if you have this disease.

Lymphohistiocytosis hemophagocytic (LHH)

There have been reports of a rare but severe immune system reaction 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, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

Antiepileptic drugs, including lamotrigine, 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 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 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 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 suicidal thoughts and behaviors in children and adolescents under 18 years.

Other medicines and Lamotrigina Sandoz

Inform your doctor or pharmacist if you are taking,have recently takenor 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 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 zonisamideused for the treatment of epilepsy,
• lithium,olanzapine or aripiprazoleused for the treatment of mental health problems,
• bupropion, used for the treatment of mental health problems or to quit smoking.

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

Some medicines interact with lamotrigine or make it more likely to have side effects. These include:

• valproate, used for the treatment of epilepsy and mental health problems,
• carbamazepine, indicated for the treatment of epilepsy and mental health problems,
• phenytoin, primidone, or phenobarbital, indicated for the treatment of epilepsy,
• risperidone, indicated for the treatment of mental health problems,
• rifampicin, which is an antibiotic,
• medicines used to treat HIV infection (SIDA) (a combination of lopinavir and ritonavir or atazanavir and ritonavir),
• hormonal contraceptives, such as the 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 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 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 advise you on the most suitable methods of contraception 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 spotting 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 medicine.

• Do not stop your treatment without consulting your doctorespecially if you have epilepsy.This is particularly important if you have epilepsy.
• The pregnancy may modify the effectiveness of lamotrigine treatment, so you may need to have blood tests and adjust your dose.
• If lamotrigine 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.

Ifyou are breastfeeding or plan to start breastfeeding, consult your doctor or pharmacist before using this medicine.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.

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

Lamotrigina Sandoz contains sorbitol and sodium

This medicine contains 9.725 mg of sorbitol calcium carbonate in each dispersible/masticable tablet,equivalent to2.92 mg of sorbitol

This medicine contains less than 1 mmol of sodium (23 mg) per dispersible/masticable 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 again with your doctor or pharmacist.

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 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

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 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 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 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.

In case of forgetting multiple doses of lamotrigine.

?Ask your doctor for advice 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 recurrence 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.

Life-threatening reactions: consult your doctor immediately.

A small number of people taking lamotrigine have experienced allergic reactions or skin reactions that may be life-threatening, which can 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 initial dose is very high or if the dose is increased too quickly, or if you are taking lamotrigine with another medication calledvalproate. 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 andpeeling of theskin, which occurs especially around the mouth, nose, eyes, and genitals (Stern-Johnson syndrome), peeling of a large area of theskin (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, nose, or genital ulcers,
• mouth or eye pain, or red or swollen eyes (conjunctivitis),
• high temperature (fever), flu-like symptoms, or drowsiness (somnolence),
• swelling around the face or inflammationof 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,
• organ damage, 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 assess the function of the liver, kidneys, or blood and may instruct 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.

Lymphohistiocytosis hemophagocytic (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, joint, or other pain.

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 group 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, groin, or armpits (lymphadenopathy): see also information at the beginning of section 4),
• liver function changes, 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),
• blood test changes, including reduced red blood cells (anemia), reduced white blood cells (leucopenia, neutropenia, agranulocytosis), reduced platelets (thrombocytopenia), reduced 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), uncontrolled muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as jerking, 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 their exact frequency is unknown:

• bone changes, including 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 reduced 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 throughthe Spanish System for 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 packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lamotrigina Sandoz 25 mg chewable tablets

• The active ingredient is lamotrigine. Each chewable tablet contains 25 mg of lamotrigine.
• The other components are: calcium carbonate sorbitol, microcrystalline cellulose, crospovidone, cornstarch, talc, blackcurrant aroma, sodium saccharin, stearate and sodium fumarate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Lamotrigina Sandoz 25 mg chewable tablets are white to off-white, square-shaped tablets, engraved with a “L” and “25” on one face, and smooth on the other face.

Each package contains 21, 42, or 56 chewable tablets in blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Bluepharma Industria Farmacêutica SA

Cimo de Fala, S. Martino do Bispo

Coimbra 3041-801

Portugal

Last review date of this leaflet: October 2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/