LAMOTRIGINE SANDOZ 100 mg DISPERSIBLE/CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Lamotrigina Sandoz 100 mg Dispersible/Chewable 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

1. What is Lamotrigina Sandoz and what is it used for
2. What you need to know before you take Lamotrigina Sandoz
3. How to take Lamotrigina Sandoz
4. Possible side effects
5. Storage of Lamotrigina Sandoz
6. Contents of the pack and other information

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

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

Lamotrigina is used for the treatment of epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children aged 13 years and above, lamotrigina can be used alone 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 alone for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigina is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic-depressive illness) 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 above, lamotrigina can be used to prevent the periods of depression that occur in bipolar disorder, either alone 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 Sandoz

Do not take Lamotrigina Sandoz:

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

If this is the case:

• Tell your doctor, and do not take lamotrigina.

Warnings and precautions

Consult your doctor or pharmacist before taking Lamotrigina Sandoz:

• if you have any kidney problems,
• if you have ever developed a rashafter taking lamotrigina or other medicines for bipolar disorder or epilepsy, or if you get a rash or sunburn after taking lamotrigina and exposure to sunlight or artificial light (e.g. in a sunbed). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g. by using a sunscreen and/or protective clothing).
• if you have ever had meningitisafter taking lamotrigina (read the description of these symptoms in section 4 of this leaflet: Rare side effects),
• if you are already taking medicines that contain lamotrigina.

If this is the case:

• Tell your doctor, who will decide whether to reduce your dose or determine that lamotrigina 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"Life-threatening reactions: consult your doctor immediately".
• Brugada syndrome
• Brugada syndrome is a genetic disease that causes abnormal electrical activity of the heart. Lamotrigina may cause abnormalities in the electrocardiogram (ECG) that can cause arrhythmias (abnormal heart rhythm). Consult your doctor if you have this disease.
• Hemophagocytic lymphohistiocytosis (HLH)
• There have been reports of a rare but very serious reaction of the immune system 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:

• 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 you have these thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigina Sandoz for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more often while you are taking lamotrigina. Some patients may experience severe seizures that can cause serious health problems. If seizures occur more often or if you experience severe seizures while taking lamotrigina

• Go to a doctor immediately.

Lamotrigina 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.

Other medicines and Lamotrigina Sandoz

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. 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 using any of these medicines.

Some medicines interact with lamotrigina or make it more likely that you will experience 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 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 how lamotrigina works

Your doctor may recommend that you use a specific hormonal contraceptive or another method of contraception, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive like the contraceptive pill, your doctor may perform blood tests to check the levels of lamotrigina. If you are using a hormonal contraceptive or plan to start using one:

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

Lamotrigina may also affect how hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and notice changes in your menstrual cycle, such as intermenstrual bleeding or spotting:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 how well lamotrigina works, so you may needto have a blood test and have your dose adjusted.
• If lamotrigina 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 supplementsif you are planning to become pregnant and during pregnancy.

If you are breastfeeding or plan to start breastfeeding, consult your doctor or pharmacist before using this medicine.The active ingredient lamotrigina passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigina and will perform regular checks on your baby if you decide to breastfeed, as they may become drowsy, develop a rash, or have poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina may 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 Sandoz contains sorbitol and sodium

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

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

3. How to take Lamotrigina Sandoz

Follow exactly the instructions given to you by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

What dose of Lamotrigina to take

It may take some time to find the dose of lamotrigina that is right for you. The dose you should take will depend on:

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

Your doctor will prescribe a low dose to start with and will gradually increase the dose over a few weeks until you reach the dose that is right for you (called the effective dose). Never take more lamotrigina than your doctor has told you to.

Normally, the effective dose of lamotrigina for adults and children aged 13 years and above 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 children under 2 years of age.

How to take your dose of Lamotrigina

Take your dose of lamotrigina once or twice a day, as advised by your doctor. They can be taken 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 problem you are being treated for and how you respond to treatment.

The dispersible/chewable tablets of lamotrigina can be swallowed whole with a little water, chewed, or added to water to dissolve them.

Chewing 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

• put the tablet in a glass that contains enough water to cover the whole tablet,
• stir to dissolve, or wait until the tablet is completely dissolved,
• drink all the liquid,
• add a little more water to the glass and drink it to make sure there is no medicine left in the glass.

If you take more Lamotrigina than you should

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

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

Someone who has taken too much lamotrigina 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, seizures, or coma.

If you forget to take Lamotrigina

Do not take a double doseto make up for forgotten doses. Take the next dose at the usual time.

If you forget to take multiple doses of lamotrigina.

Ask your doctor for advice on how to start treatment again.It is important that you do this.

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

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

If you are taking Lamotrigina for the treatment of epilepsy

To stop taking lamotrigina, it is important that the dose is reduced gradually, over approximately 2 weeks. If you stop taking lamotrigina suddenly, you may experience the symptoms of epilepsy again or the disease may worsen.

If you are taking Lamotrigina for bipolar disorder

Lamotrigina may take some time to work, so it is unlikely that you will feel better immediately. If you stop taking lamotrigina, you do not need to reduce your dose gradually. However, before stopping treatment with lamotrigina, 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 appear during the first few months of treatment with lamotrigine, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking lamotrigine 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 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), 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),
• ulcers in the mouth, throat, nose, or genitals,
• pain in the mouth or red or swollen eyes(conjunctivitis),
• high temperature(fever), flu-like symptoms, or drowsiness (somnolence),
• swelling around the faceor inflammation of the lymph nodes in the neck, armpits, or groin,
• bleeding or unexpected bruising, or blue discoloration of the fingers,
• sore throat, or more frequent infections (such as colds),
• increased liver enzyme levels in blood tests,
• increased eosinophils (a type of white blood cell),
• enlarged lymph nodes,
• organ involvement, including the liver and kidneys.

In many cases, these symptoms can be signs of less serious adverse effects. However, you should be aware that they can be life-threatening 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 undergo tests to assess liver, kidney, or blood function and may advise you to stop treatment with this lamotrigine. If you have developed Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, your doctor will advise you to never take lamotrigine again.

Hemophagocytic Lymphohistiocytosis (HLH)(see section 2. What you need to know before taking Lamotrigina Sandoz).

Very Common Adverse Effects

May affect more than 1 in 10people

• headache,
• skin rash.

Common Adverse Effects

May affect up to 1 in 10people

• aggression or irritability,
• feeling of sleepiness or drowsiness,
• feeling of dizziness,
• spasms or tremors,
• difficulty sleeping (insomnia),
• feeling agitated,
• diarrhea,
• dry mouth,
• nausea and vomiting,
• feeling of fatigue,
• back pain, joint pain, or pain in other areas.

Uncommon Adverse Effects

May affect up to 1 in 100people

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

Rare Adverse Effects

May affect up to 1 in 1,000people

• life-threatening skin reaction (Stevens-Johnson Syndrome) (see also information at the beginning of section 4),
• a set of symptoms that include: fever, nausea, vomiting, headache, stiff neck, 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 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

May affect up to 1 in 10,000people

• life-threatening skin reaction (Toxic Epidermal Necrolysis) (see also information at the beginning of section 4),
• drug reaction with eosinophilia and systemic symptoms (DRESS) (see also information at the beginning of section 4),
• high temperature (fever) (see also information at the beginning of section 4),
• swelling around the face (edema) or inflammation of the lymph nodes in the neck, groin, or armpits (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 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 not controllable (tics), uncontrolled muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness,
• in people with epilepsy, more frequent seizures,
• in people with Parkinson's disease, worsening of symptoms,
• lupus-like reaction (symptoms may include: back or joint pain, which may be accompanied by fever and/or general illness).

Other Adverse Effects

Other adverse effects have been reported in a small number of people, but their exact frequency is unknown:

• bone disorders, including osteopenia and osteoporosis (decreased bone thickness) 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 take 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 or pharmacist, even if it is a possible adverse effect that is not listed in this 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 contribute to providing more information on the safety of this medicine.

5. Storage of Lamotrigina Sandoz

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

Do not use this medicine after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lamotrigina Sandoz 100 mg dispersible/chewable tablets

• The active ingredient is lamotrigine. Each dispersible/chewable tablet contains 100 mg of lamotrigine.
• The other ingredients are: sorbitol, calcium carbonate, microcrystalline cellulose, crospovidone, cornstarch, talc, blackcurrant flavor, sodium saccharin, stearic acid, and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Lamotrigina Sandoz 100 mg dispersible/chewable tablets are white to off-white, square-shaped tablets, engraved with an "L" and "100" on one side, and smooth on the other side.

Each package contains 56 dispersible/chewable tablets, packaged in blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Bluepharma Industria Farmaceutica SA

Cimo de Fala, S. Martino do Bispo

Coimbra 3041-801

Portugal

Date of the Last Revision of this Leaflet:October 2023

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