Package Insert: Information for the User

LamotrigineCombix50 mg Dispersible/Masticable Tablets EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist. See section 4.

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

2.Before taking Lamotrigine Combix

3.How to take Lamotrigine Combix

4.Possible adverse effects

5Storage of Lamotrigine Combix

6.Additional information

Lamotrigina Combix belongs to a group of medications known asantiepilepticdrugs. It can be used to treat two diseases: epilepsy and bipolar disorder.

Lamotrigina Combix is used to treat epilepsy becauseit blocks the signals in the brain that trigger seizures (convulsions).

• In adults and children 13 years of age and older, Lamotrigina can be used alone or in combination with other medications, for the treatment ofepilepsy. Lamotriginacan also be used in combination with other medications 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 medications for the treatment of the same diseases. It can also be used without combining with other medications for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigina Combix is also used to treat bipolar disorder.

People with bipolar disorder (previously known as manic-depressive disorder) experience extreme 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 Combix can be used, to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. The exact mechanism of action of lamotrigina in the brain is not known.

Do not take Lamotrigina Combix:

• if you are allergic(hypersensitive) to the active ingredient or to any of the other components of Lamotrigina Combix (listed in section 6).

If this is your case:

?Inform your doctor, and do not take Lamotrigina Combix.

Be especially careful with Lamotrigina Combix

Your doctor needs to know before taking Lamotrigina Combix:

• If you have kidney problems
• If you have had a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you suffer from skin rashes or sunburn after taking lamotrigine and exposure to the sun or artificial light (for example, in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (for example, use sunscreen and/or protective clothing).
• If you are already taking medicines that contain lamotrigine

If this is your case:

?Inform your doctor, who will decide to reduce your dose or determine that Lamotrigina Combix is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamotrigina Combix have had allergic reactions or skin reactions that can be 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 Lamotrigina Combix. 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 Combix.

Be aware of the symptoms

Ask your doctor immediatelyif after starting to take Lamotrigina Combix you experience any of the following symptoms:

• Skin reaction, such as redness or rashes
• Irritation in the mouth or eyes
• High temperature(fever), symptoms similar to the flu or drowsiness (somnolence)
• Swelling around the faceorinflammationof the lymph nodesin the neck, armpits, and groin
• Bleeding or unexpected bruising, or fingers turn blue
• Irritation of the throat, or more frequent infections (such as colds) than usual.

These symptoms are more likely to occur during the first few months of treatment with Lamotrigina Combix, especially if you start treatment with a too high dose or if your dose is increased too quickly; they are also more likely to occur if you are taking Lamotrigina Combix with another medicine calledvalproate.Children are more likely than adults to experience these adverse effects.

If the symptoms listed above are not treated, they can become more serious problems, such as organ failure (organ failure) or a very serious skin disease.

If you notice any of these symptoms:

?Go to a doctor immediately. Your doctor will decide if you need to undergo tests to assess the function of the liver, kidneys, or blood, and may advise you to stop taking Lamotrigina Combix.

Suicidal thoughts or ideas

Antiepileptic drugs are used to treat various conditions, including epilepsy and bipolar disorder. People with bipolar disorder may have had suicidal thoughts or ideas at some point. If you have bipolar disorder, you may be more likely to have these thoughts in the following situations:

• When starting treatment.
• If you have had suicidal thoughts or ideas before.
• If you are under 25 years old.

If you have worrisome thoughts or experiences, or if you feel worse or develop new symptoms while taking Lamotrigina Combix:

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

A small number of people who were treated with antiepileptic drugs like lamotrigine have also had suicidal thoughts or ideas. If you ever have these thoughts, contact your doctor immediately.

If you are taking Lamotrigina Combix for epilepsy

In some types of epilepsy, during treatment with lamotrigine, seizures may worsen or occur more frequently. Some patients may experience severe seizures that can cause serious health problems. If you notice that you are having seizures more often or experiencing severe seizures while taking Lamotrigina Combix:

?Go to a doctor immediately.

Brugada syndrome

Brugada syndrome is a genetic disease that causes abnormal heart electrical activity. Lamotrigine can 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)

Cases of a rare but serious immune system reaction have been reported 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, confusion, cerebral function alterations).

Lamotrigina Combix should not be administered to children under 18 years old for the treatment of bipolar disorder. Medications used to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years old.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription or herbal remedies.

If you are using certain medicines, your doctor may need to check the dose of Lamotrigina Combix. These include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, orzonisamide, indicated for the treatment ofepilepsy
• lithium, indicated for the treatment ofmental health problems
• bupropion, indicated for the treatment ofmental health problemsor toquit smoking

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

Some medicines interact with Lamotrigina Combix or make adverse effects more likely. These include:

• valproate, indicated for the treatment ofepilepsyandmental health problems
• carbamazepine, indicated for the treatment ofepilepsyandmental health problems
• phenytoin, primidone, or phenobarbital, indicated for the treatment ofepilepsy
• olanzapine, indicated for the treatment ofmental health problems
• risperidone, indicated for the treatment ofmental health problems
• rifampicin, which is anantibiotic
• A combination oflopinavir and ritonavir, indicated for the treatment ofHIV (AIDS) infection
• hormonal contraceptives, such asthe Pill(see below).

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

Hormonal Contraceptives (such as the Pill) may affect the way Lamotrigina Combix works

Your doctor may recommend a specific hormonal contraceptive or suggest using a different method, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive like the Pill, your doctor may ask you to have blood tests to check the levels of lamotrigine, and adjust your dose accordingly.

If you are planning to start using a hormonal contraceptive:

?Inform your doctor, as they will advise you on the most suitable methods for you.

Lamotrigine may modify the way hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and experience 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 and breastfeeding

?Consult your doctor if you are pregnant, if you may be pregnant, or if you are planning to become pregnant.

You should not stop treatment for epilepsy while pregnant. However, there is a higher risk of birth defects in newborns whose mothers took lamotrigine during pregnancy. These defects include cleft lip or palate. Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and also during pregnancy.

Pregnancy may modify the effectiveness of Lamotrigina Combix treatment, so your doctor may ask you to have blood tests to check the levels of lamotrigine and adjust your dose accordingly.

?If you are breastfeeding or planning to start breastfeeding, consult your doctor or pharmacist before using this medicine. The active ingredient in Lamotrigina Combix 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 notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina Combix may cause dizziness and double vision.

?Do not drive or use machines until you are sure you do not feel these effects.

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

Follow exactly the administration instructions for Lamotrigina Combix as indicated by your doctor. Consult with your doctor or pharmacist if you have any doubts.

What dose of Lamotrigina Combix to take

It may take some time for your doctor to find the appropriate dose of Lamotrigina Combix for you. The dose you should take will depend on:

• your age
• whether you are taking Lamotrigina Combix with other medications
• whether you have liver or kidney problems

Your doctor will ask you to start treatment with a low dose, and gradually increase the dose until you reach the most appropriate dose for you (called the effective dose).Do not take more Lamotrigina Combix than your doctor has prescribed.

Normally, the effective dose of Lamotrigina Combix for adults and children over 12 years old 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 of 400 mg per day.

How to take the dose of Lamotrigina Combix

Take your dose of Lamotrigina Combix once or twice a day, as advised by your doctor. You can take it 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 conditions you are being treated for and how you respond to treatment.

Take the dispersible/masticable tablets of Lamotrigina Combix by swallowing them whole with a little water, or by dissolving them in water:

If you chew the tablet:

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

To dissolve the medication (make a liquid medication):

• Put the tablet in a glass that contains enough water to cover the tablet completely.
• Shake to dissolve, or wait for a minute, until the tablet is completely dissolved.
• Drink the entire liquid.
• Add a little more water to the glass and drink it, to make sure you have taken the entire medication.

If you take more Lamotrigina Combix than you should

If someone takes too much Lamotrigina Combix :

• Consult with your doctor or pharmacist immediately, ifpossible, show them the Lamotrigina Combix packaging.
• You can also call the Toxicological Information Service, phone: 91 562 04 20.

Someone who takes too much Lamotrigina Combix may have some of these symptoms:

• rapid and uncontrolled eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• loss of consciousness or coma

If you forget to take Lamotrigina Combix

Do not take an extra tablet or a double dose to make up for the missed doses.

If you have not taken a dose of Lamotrigina Combix :

?Ask your doctor to explain how to start treatment again. It is important that you do this.

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

You must take Lamotrigina Combix for as long as your doctor recommends. Do not stop treatment until your doctor tells you to.

If you are taking Lamotrigina Combix for epilepsy treatment

To stop taking Lamotrigina Combix,it is important to gradually reduce the dose over approximately 2 weeks. If you stop taking Lamotrigina Combix suddenly, you may experience a relapse of epilepsy symptoms or the condition may worsen.

If you are taking Lamotrigina Combix for bipolar disorder

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

Like all medicines, Lamotrigine Combix can cause side effects, although not everyone will experience them.

Severe allergic reactions or potentially life-threatening skin reactions: consult your doctor immediately.

A reduced number of people taking lamotrigine have severe allergic reactions or potentially life-threatening skin reactions. If left untreated, these reactions can worsen and even be fatal. Symptoms of these reactions include:

• skin rashes or redness
• mouth sores and eye pain
• high temperature (fever), flu-like symptoms, or drowsiness (somnolence)
• swelling of the face or inflammation of the neck, armpit, or groin lymph nodes
• unexplained bleeding or bruising, or fingers turning blue
• sore throat, or experiencing more frequent infections (such as colds)

In many cases, these symptoms can be signs of less severe side effects.However, you should be aware that they are potentially serious- if you experience any of these symptoms:

?Seek medical attention immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function, and may also advise you to discontinue treatment with Lamotrigine Combix.

Very common side effects

These affect more than 1 in 10 people:

• headache
• dizziness
• drowsiness or somnolence
• clumsiness and loss of coordination (ataxia)
• double vision or blurred vision
• nausea or vomiting
• skin rash

Common side effects

These affect up to 1 in 10 people:

• aggressiveness or irritability
• rapid, uncontrolled eye movements (nystagmus)
• spasms or tremors
• difficulty sleeping
• diarrhea
• dry mouth
• fatigue
• back or joint pain, or pain in other areas.

Rare side effects

These affect up to 1 in 100 people:

• skin rash or sun sensitivity after exposure to sunlight or artificial light

Rare side effects

These affect up to 1 in 1,000 people:

• eye itching, with discharge and conjunctivitis (pink eye)
• Rare skin disease, characterized by severe blisters and bleeding in the lips, eyes, mouth, nose, and genital area (Stevens-Johnson syndrome)

Very rare side effects

These affect up to 1 in 10,000 people:

• hallucinations (hearing or seeing things that are not really there)
• confusion or agitation
• feeling shaky or unstable when moving
• repetitive body movements, or incontrollable sounds or words (tics), muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as jerking, spasms, or rigidity
• severe skin reaction, starting with a painful red area, followed by large blisters, and eventually peeling of the skin (toxic epidermal necrolysis)
• increased frequency of seizures in people with epilepsy
• changes in liver function, which can be seen in blood tests, or liver failure
• changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), a reduced number of all types of blood cells (pancytopenia), and aplastic anemia
• blood clotting disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation)
• high temperature (fever)
• swelling around the face (edema) or inflammation of the neck, armpit, or groin lymph nodes (lymphadenopathy)
• emergence of Parkinson's disease symptoms in people with the condition

Other side effects

• Lymphohistiocytosis hemophagocytic (LHH) (see section 2. Before taking Lamotrigine Combix)
• Decreased 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 to the Spanish System for Pharmacovigilance of Medicinal Products 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 out of the reach and sight of children.

Do not use Lamotrigina Combix after the expiration date that appears on the packaging and in the blister, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

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

Composition of Lamotrigina Combix Dispersible/Masticable Tablets

The active ingredient is lamotrigine. Each dispersible/masticable tablet contains 50 mg of lamotrigine.

The other components are:Heavy magnesium carbonate (E504), microcrystalline cellulose (E460), povidone (E1201), low-substitution hydroxypropyl cellulose (E463), sodium saccharin (E954), crospovidone (E1202), microcrystalline cellulose (E460), guar gum (E412), blackcurrant flavor and magnesium stearate (E470b).

Appearance of the Product and Contents of the Package of Lamotrigina Combix 50 mg Dispersible/Masticable Tablets

Lamotrigina Combix 50 mg dispersible/masticable tablets are round, flat, white or almost white.

Each package contains a blister with 56 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for Manufacturing:

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51

Greece

This leaflet has been reviewed inMarch 2024