LAMOTRIGINE PHARMA COMBIX 25 mg CHEWABLE AND DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Lamotrigina Pharma Combix 25 mg Chewable and Dispersible 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 Pharma Combix and what is it used for
2. What you need to know before you take Lamotrigina Pharma Combix
3. How to take Lamotrigina Pharma Combix
4. Possible side effects
5. Storing Lamotrigina Pharma Combix
6. Contents of the pack and other information

1. What is Lamotrigina Pharma Combix 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 over, lamotrigina can be used on its own or with other medicines to treat epilepsy. Lamotrigina can also be used with other medicines to treat seizures that are caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, lamotrigina can be used with other medicines to treat the same conditions. It can also be used on its own to treat 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 disorder) have 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 over, lamotrigina can be used to prevent the periods of depression that occur in bipolar disorder, either on its own 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 Pharma Combix

Do not takeLamotrigina Pharma Combix

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

If this applies to you:

• Tell your doctorand do not take lamotrigina.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Lamotrigina Pharma Combix:

• if you have any kidney problems,

• if you have ever developed a rashafter taking lamotrigina or other medicines for bipolar disorder or epilepsy,
• if you get a rash or blisters after taking lamotrigina and being exposed to sunlight or artificial light (such as in a solarium). 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 meningitis(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 you have a condition called Brugada Syndrome or other heart problems.Brugada Syndrome is a genetic condition that affects the electrical activity of the heart. Lamotrigina can cause changes in the electrocardiogram (ECG) that can lead to abnormal heart rhythms.

If this applies to you:

• Tell your doctor, who will decide whether to lower the 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”.

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 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 taking lamotrigina:

• Talk to 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 are taking lamotrigina 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 taken antiepileptics, including lamotrigina, have also had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

If you are taking lamotrigina 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, which 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 must not be givento 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 Pharma Combix

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 to treat 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 to treat epilepsy.
• Lithium, olanzapine or aripiprazole, used to treat mental health problems.
• Bupropion, used to treat mental health problemsor to stop smoking.
• Paracetamol, used to treat painand fever.

• Tell your doctorif you are taking any of these medicines.

Some medicines interact with lamotrigina or make it more likely that you 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.
• Medicines used to treat Human Immunodeficiency Virus (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 taking any of these medicines, or if you start or stop taking any of these medicines.

Hormonal contraceptives (such as the pill) can affect how lamotrigina works.

Your doctor may recommend that you use a specific hormonal contraceptive, or that you use 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 do a blood test to check the levels of lamotrigina. If you are using a hormonal contraceptive or plan to use one:

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

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

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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 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 or cleft palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and during pregnancy.

• If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.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 a low 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 can affect your ability to react. These effects, as well as the condition itself, can make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

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

Lamotrigina Pharma Combix contains sodium

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

3. How to take Lamotrigina Pharma Combix

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, talk to 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 any kidney or liver 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 take.

Normally, the effective dose of lamotrigina for adults and children aged 13 years and over 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 condition you are being treated for 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. 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 you have taken all the medicine.

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 medicine and the amount taken.

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:

• Fast and uncontrollable 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.

If you are taking lamotrigina for epilepsy

To stop taking lamotrigina, it is important that the dose is gradually reduced, over approximately 2 weeks. If you stop taking lamotrigina suddenly, you may start having seizures again or your condition may get worse.

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 talk to your doctor.

If you have any other questions about the use of this medicine, 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 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 having red or swollen eyes(conjunctivitis).
• High temperature(fever), flu-like symptoms, or drowsiness (sopor).
• Swelling around the faceor 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 have 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:

• 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, stiff neck, 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, uncontrolled 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 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 can include back or joint pain, which may be accompanied by fever and/or generalized illness).

Other Adverse Effects

Other adverse effects have occurred 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 taken antiepileptics for a long time, if you have a history of osteoporosis, or if you take 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.
• Red or purple 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 blister after CAD. 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. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lamotrigina Pharma Combix 25 mg

• The active ingredient is lamotrigine. Each chewable and dispersible tablet contains 25 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 Package Contents

Chewable and dispersible tablets are round, flat, white or off-white, slightly speckled, and have a blackcurrant flavor. The tablets are marked with "25" on one side and are smooth on the other side, with a diameter of approximately 5.2 mm.

Lamotrigina Pharma Combix 25 mg is available in PVC/PVDC-Aluminum blisters containing 21, 42, or 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 Last Revision of this Leaflet:March 2024

Detailed information on 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/).