LAMOTRIGINE PHARMA COMBIX 100 mg CHEWABLE AND DISPERSIBLE TABLETS

2. What you need to know before taking Lamotrigina Pharma Combix

Do not takeLamotrigina Pharma Combix

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

If this is the case:

• Tell your doctorand do not take lamotrigina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lamotrigina Pharma Combix:

• ,

• after taking lamotrigina or other medications for bipolar disorder or epilepsy,
• . Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g., use sunscreen and/or protective clothing),
• (read the description of these symptoms in section 4 of this package leaflet: Rare side effects),
• ,
• Brugada Syndrome is a genetic disease that causes abnormal electrical activity in the heart. Lamotrigina can cause anomalies in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm).

If this is the case:

• Tell your doctor, who will decide to reduce the dose or determine that lamotrigina is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people who take 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 (SSJ), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). It is necessary that you 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 package leaflet"Reactions that can be life-threatening: consult your doctor immediately".

Hemophagocytic Lymphohistiocytosis (HLH)

Cases of a rare but very serious reaction of the immune system have been reported in patients taking lamotrigina.

• Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigina: fever, rash, neurological symptoms (e.g., spasms or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Antiepileptic medications are used to treat different diseases, including epilepsy and bipolar disorder. People with bipolar disorder may sometimes have thoughts of self-harm or suicide. 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 being treated with lamotrigina:

• 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 package leaflet. You can ask them to tell you if they are concerned about your depression or other changes in your behavior.

A small number of people who have been treated with antiepileptics like 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 for epilepsy

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

• Go to a doctor immediately.

Lamotrigina should not be administeredto children under 18 years of age for the treatment of bipolar disorder. Medications indicated 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 of age.

Other medications and Lamotrigina Pharma Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication,including herbal medicines or other medications purchased without a prescription.

Your doctor needs to know if you are taking other medications for the treatment of epilepsy or mental health problems. This is to ensure that you take the correct dose of lamotrigina. These medications include:

• Oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used to treat epilepsy.
• Lithium, olanzapine or aripiprazole, used to treat mental health problems.
• Bupropion, used to treat mental health problemsor to quit smoking.
• Paracetamol,used to treat painand fever.

• Tell your doctorif you are using any of these medications.

Some medications interact with lamotrigina or make it more likely that people will have side effects. These include:

• Valproate, used to treat epilepsyand mental health problems.
• Carbamazepine, used to treat epilepsyand mental health problems.
• Phenytoin, primidoneor phenobarbital, used to treat epilepsy.
• Risperidone, used to treat mental health problems.
• Rifampicin, which is an antibiotic.
• Medications used to treat HIV infection(a combination of lopinavir and ritonavir or atazanavir and ritonavir).
• Hormonal contraceptives, such as the pill(see below).

• Tell your doctorif you are using any of these medications, or if you start or stop using any of these medications.

Hormonal contraceptives (such as the pill) can 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, such as the pill, your doctor may perform a blood test to check your lamotrigina levels. 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 can 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 and breastfeeding

• If you are pregnant or breastfeeding, 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 can change the effectiveness of treatment with lamotrigina, so you may need to 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 also during pregnancy.

• If you are breastfeeding or plan to start breastfeeding, consult your doctor or pharmacist before using this medication.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 experience drowsiness, rash, or poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina can cause symptoms such as drowsiness, dizziness, or changes in vision, and reduce your reaction time. These effects, as well as the disease itself, can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

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

Lamotrigina Pharma Combix contains sodium

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

3. How to take Lamotrigina Pharma Combix

Follow the instructions for taking this medication exactly as indicated 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 for your doctor to find the most suitable dose of lamotrigina for you. The dose you should take will depend on:

• Your age.
• If you are taking lamotrigina with other medications.
• If you have any liver or kidney problems.

Your doctor will prescribe a low dose at the start of treatment and, gradually, increase the dose over several weeks until you reach the most suitable dose for you (called the effective dose). Never take more lamotrigina than your doctor has indicated.

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

For children between 2 and 12 years old, 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.

Lamotrigina is not recommended for use in children under 2 years of age.

How to take the 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 complete dosethat the doctor has prescribed. Never take part of the tablet.

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

The chewable and dispersible tablets of lamotrigina can be swallowed whole with a little water, chewed, or added to water to dissolve them. Never take only part of the liquid.

Chewing the tablet

You may need to drink a little water to help the tablet dissolve in your mouth when chewing it. After swallowing, drink a little more water to make sure you have taken all the medication.

To dissolve the medication

• Put 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 it to make sure no medication is left in the glass.

If you take more Lamotrigina Pharma Combix than you should

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

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 experience some of these symptoms:

• Fast 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, seizures, or coma.

If you forget to take Lamotrigina Pharma Combix

If you forget to take a dose of lamotrigina

• Do not take a double dose to make up for forgotten doses.Takethe 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.

If you stop taking Lamotrigina Pharma Combix

Do not stop taking lamotrigina 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 do so.

If you are taking lamotrigina for epilepsy

To stop taking lamotrigina, it is important to gradually reduce the doseover approximately 2 weeks. If you stop taking lamotrigina suddenly, you may experience a return of epilepsy symptoms 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 gradually reduce your dose. However, before stopping treatment with lamotrigina, you should consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Reactions that can potentially threaten life: consult your doctor immediately.

A small number of people taking lamotrigine have allergic reactions or skin reactions that can potentially threaten their life, which can lead to more serious problems if left untreated.

It is more likely that these symptoms will appear during the first few months of treatment with 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 skin reactions that can threaten life, including widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling over a large area of skin (more than 30% of the body surface - toxic epidermal necrolysis) or widespread skin rash with liver, blood, and other organ involvement (drug reaction with eosinophilia and systemic symptoms also known as DRESS syndrome).
• Ulcers in the mouth, throat, nose, or genitals.
• Pain in the mouth or having red or swollen eyes(conjunctivitis).
• High temperature(fever), flu-like symptoms, or drowsiness (somnolence).
• Swelling around the face, or inflammation of the lymph nodesin the neck, armpits, or groin.
• Bleeding or unexpected bruising, or turning blue.
• Sore throator having more infections than usual (such as colds).
• Increased liver enzyme levels in blood tests.
• Increased eosinophils (a type of white blood cell).
• Enlarged lymph nodes.
• Affecting organs of the body, 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 potentially threaten life and can lead to more serious problems,such as organ failure, if left untreated. If you notice any of these symptoms:

• Contact your doctor immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function and may advise you to stop treatment with 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 Pharma Combix).

Very Common Adverse Effects

These affect more than 1 in 10people:

• Headache.
• Skin rash.

Common Adverse Effects

These affect up to 1 in 10people:

• Aggression or irritability.
• Feeling sleepy or drowsy.

• Feeling dizzy.
• Spasms or tremors.
• Difficulty sleeping (insomnia).
• Feeling agitated.
• Diarrhea.
• Dry mouth.
• Nausea or vomiting.
• Feeling tired.
• Pain in the back, joints, or other areas.

Uncommon Adverse Effects

These can 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

These affect up to 1 in 1,000people:

• Potentially life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4).
• A set of symptoms including fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light.

This can be caused by inflammation of the membranes covering 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

These affect up to 1 in 10,000people:

• A potentially life-threatening skin reaction (toxic epidermal necrolysis) (see also the information at the beginning of section 4).
• Drug reaction with eosinophilia and systemic symptoms (DRESS) (see also the information at the beginning of section 4).
• High temperature (fever) (see also the information at the beginning of section 4).
• Swelling around the face (edema) or inflammation of the lymph nodes in the neck, groin, or armpits (lymphadenopathy) (see also the information at the beginning of section 4).
• Changes in liver function, which can be seen in blood tests, or liver failure (see also the information at the beginning of section 4).
• A serious blood clotting disorder that can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4).
• Hemophagocytic Lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigina Pharma Combix).

• Changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), 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 unsteady or unstable when moving.
• Repetitive body movements and/or sounds or words (tics), uncontrolled muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerks, 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 generalized 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, have been reported. Consult your doctor or pharmacist if you have been taking antiepileptics for a long time, if you have a history of osteoporosis, or if you are taking steroids.

• Kidney inflammation (tubulointerstitial nephritis) or kidney and eye inflammation (acute tubulointerstitial nephritis and uveitis syndrome).
• Nightmares.
• Decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection.
• Reddish nodules or spots on the skin (pseudolymphoma).

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamotrigina Pharma Combix

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

Do not use this medicine after the expiration date stated on the packaging and on the blister pack after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lamotrigina Pharma Combix 100 mg

• The active ingredient is lamotrigine. Each chewable and dispersible tablet contains 100 mg of lamotrigine.
• The other ingredients are: microcrystalline cellulose, calcium carbonate, type A potato starch, low-substitution hydroxypropylcellulose, povidone, sodium saccharin, aluminum and magnesium silicate, magnesium stearate, anhydrous colloidal silica, and blackcurrant flavor.

Appearance and Packaging of the Product

Chewable and dispersible tablets are round, flat, white or almost white, slightly speckled, and have a blackcurrant flavor. The tablets are marked with "100" on one side and are smooth on the other side, with a diameter of approximately 8.5 mm.

Lamotrigina Pharma Combix 100 mg is available in PVC/PVDC-Aluminum blister packs containing 56 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

Z.A.C. des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

or

Misom Labs Ltd.

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Date of the Last Revision of this Leaflet:March 2024

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/ (http://www.aemps.gob.es/).