Package Insert: Information for the User

Lamotrigine Kern Pharma 100 mg Dispersible/Chewable Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lamotrigina Kern Pharma belongs to a group of medications known as antiepileptics. It can be used to treat two diseases: epilepsy and bipolar disorder.

Lamotrigina Kern Pharma is used to treat epilepsybecause it 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 of epilepsy. Lamotrigina can also be used along 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 Kern Pharma is also used to treat bipolar disorder. People with bipolar disorder (formerly 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 Kern Pharma 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 Kern Pharma

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medicine (listed in section 6).

If this is the case:

• Inform your doctor, and do not take this medicine.

Warnings and precautions

Before taking lamotrigina, your doctor needs to know:

• If you have kidney problems.
• If you have ever developed any skin rash when taking lamotrigina or other epilepsy medicines.
• If you are already taking medicines that contain lamotrigina.
• If you have developed a skin rash after taking lamotrigina or other medicines for bipolar disorder or epilepsy, or if you suffer from skin rashes or sunburn after taking lamotrigina 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 a sun protection cream and/or protective clothing).

If this is the case:

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

Be aware of symptoms:

Seek immediate help from your doctor if, after starting to take this medicine, you experience any of the following symptoms:

• Reactions on the skin, such as redness or rashes.
• Irritation in the mouth or eyes.
• High temperature (fever), symptoms similar to flu or drowsiness (somnolence).
• Swelling around the face or inflammation of the lymph nodes in the neck, armpits, and groin.
• Bleeding or unexpected bruising, or fingers turning blue.
• Irritation of the throat, or more frequent infections (such as colds) than usual.

These symptoms are more likely to occur during the first months of treatment with lamotrigina, 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 this medicine with another medicine called valproate..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 or a very serious skin disease.

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of lamotrigina, initially appearing as red, circular spots with a central blister.

Other additional signs that may appear are mouth ulcers, throat, nose, genital, and conjunctivitis (swollen and red eyes).

These life-threatening skin reactions, often accompanied by flu-like symptoms, can progress to widespread blistering or skin peeling.

The highest risk period for severe skin reactions is during the first weeks of treatment.

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.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of lamotrigina, do not use lamotrigina again at any time.

If you develop rashes or these symptoms on your skin, stop taking lamotrigina, go to a doctor immediately, and inform them that you are taking this medicine. Your doctor will decide if blood tests should be done to check the function of the liver, kidneys, or blood.

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 you start 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:

• 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 lamotrigina have also had suicidal thoughts or ideas. If you ever have these thoughts, contact your doctor immediately.

If you are taking Lamotrigina Kern Pharma for epilepsy:

In some types of epilepsy, during treatment with lamotrigina, seizures may occasionally 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 this medicine:

• Go to a doctor immediately.

Lamotrigina Kern Pharma should not be administered to children under 18 years old 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 old.

Brugada syndrome

Brugada syndrome is a genetic disease that causes abnormal heart electrical activity. Lamotrigina 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 severe immune system reaction have been reported in patients taking lamotrigina. Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigina: fever, rash, neurological symptoms (e.g., spasms or tremors, confusion, cerebral function alterations).

Pregnancy and breastfeeding

If you are breastfeeding or plan to start breastfeeding, consult your doctor or pharmacist before using this medicine. The active ingredient of Lamotrigina Kern Pharma 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 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.

Use of Lamotrigina Kern Pharma with other medicines

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medicine.

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

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, indicated for the treatment of epilepsy
• lithium, indicated for the treatment of mental health problems
• bupropion, indicated for the treatment of mental health problems or to quit smoking

• Inform your doctor if you are using any of these medicines.

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

• valproate, indicated 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
• olanzapine, indicated for the treatment of mental health problems
• risperidone, indicated for the treatment of mental health problems
• rifampicin, an antibiotic
• a combination of lopinavir and ritonavir, indicated for the treatment of HIV infection (AIDS)
• hormonal contraceptives, such as the Pill (see below).

• Inform your doctor if you are using, starting, or stopping any of these medicines.

Hormonal contraceptives (such as the Pill) may affect the way this medicine 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:

• Inform your doctor, as they will indicate which methods are most suitable for you.

The administration of lamotrigina 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 lamotrigina is affecting the way your contraceptive works.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, planning to become pregnant, or have become pregnant, consult your doctor before using this medicine.

Do not stop treatment for epilepsy while pregnant. However, there is a higher risk of birth defects in babies whose mothers took lamotrigina 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 treatment, so your doctor may ask you to have a blood test to check lamotrigina levels and adjust your dose accordingly.

• Consult your doctor if you are breastfeeding or planning to start breastfeeding: 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 this medicine. If you decide to start breastfeeding, your doctor will perform regular checks on your baby.

Driving and operating machinery

Lamotrigina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may 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 assesses your response to this medicine.

Lamotrigina Kern Pharma contains sorbitol

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Lamotrigina Kern Pharma contains sodium

Patients with low-sodium diets should note that this medicine contains 0.82 mg (0.036 mmol) of sodium per 100 mg.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Lamotrigina Kern Pharma dosage:

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

• your age
• whether you are taking lamotrigina 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). Never take more lamotrigina than your doctor has prescribed.

Normally, the effective dose of lamotrigina 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 the child's weight, up to a maximum of 400 mg per day.

How to take Lamotrigina Kern Pharma:

Take your lamotrigina dose one or two times a day, as advised by your doctor. You can take it with or without food.

• Always take the complete dose prescribed by your doctor. 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 tablets of lamotrigina by swallowing them whole with a little water, or dissolving them in water:

If you chew the tablet:

You may need to drink a little more 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 Kern Pharma than you should:

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

Someone who takes too much lamotrigina may experience some of the following symptoms:

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

If you forgot to take Lamotrigina Kern Pharma:

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:

• Ask your doctor to explain how to start treatment again. It is essential to do this.

Do not stop taking Lamotrigina Kern Pharma without your doctor's advice.

You must take this medication for as long as your doctor recommends. Do not stop treatment until your doctor advises you to.

If you are taking Lamotrigina Kern Pharma for epilepsy treatment:

To stop taking this medication, it is essential to gradually reduce the dose over approximately 2 weeks. If you stop taking lamotrigina abruptly, you may experience a relapse of epilepsy symptoms or the condition may worsen.

If you are taking Lamotrigina Kern Pharma for bipolar disorder:

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

Like all medications, lamotrigine may cause side effects, although not everyone will experience them.

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

Severe skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2)

Frequency: Very rare

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

• Seek medical attention immediately. Your doctor will decide whether to perform tests to assess liver, kidney, or blood function and may instruct you to discontinue lamotrigine treatment.

Very common side effects:

These affect more than 1 in 10 people:

• Headache
• Sensation of dizziness
• Sensation of sleepiness or drowsiness
• Clumsiness and loss of coordination (ataxia)
• Dual vision or blurred vision
• Nausea or vomiting
• Skin eruption

Common side effects:

These affect up to 1 in 10 people:

• Aggression 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

Uncommon side effects:

These may affect up to 1 in 100 people:

• Skin eruption or sunburn after exposure to the sun or artificial light (photosensitivity)

Rare side effects:

These affect up to 1 in 1,000 people:

• Eye itching, with discharge and conjunctivitis in the eyelids (conjunctivitis)
• 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 tremors or instability when moving
• Repetitive body movements and/or incontrollable sounds or words (tics), muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as jerks, spasms, or rigidity
• Severe skin reaction, which begins with the appearance of a painful red area, followed by large blisters, and finally, these blisters peel off in layers of skin (toxic epidermal necrolysis)
• Increased frequency of seizures in people who have had epilepsy
• Changes in liver function, which may be observed in blood tests, or liver failure
• Changes that may be observed in blood tests, including a reduced number of red blood cells (anemia), white blood cells (leucopenia, neutropenia, agranulocytosis), platelets (thrombocytopenia), or all types of blood cells (pancytopenia), and aplastic anemia
• Alteration in blood coagulation, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation)
• Fever
• Swelling around the face (edema) or inflammation of the neck, groin, or armpit lymph nodes (lymphadenopathy)
• Worsening of symptoms in people with Parkinson's disease
• Lymphohistiocytosis hemophagocytosis (LHH) (see section 2. What you need to know before starting to take Lamotrigine)
• Reduced immunity, due to a decrease in the levels of antibodies called immunoglobulins in the blood that help protect against infection.

Other side effects

• Reddish nodules or patches 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 side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 blister, packaging, or bottle, after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lamotrigina Kern Pharma chewable tablets

The active ingredient is lamotrigine. Each chewable tablet contains 100 mg of lamotrigine.

The other components are: calcium carbonate sorbitol (E-420i), microcrystalline cellulose silicified [microcrystalline cellulose (E-460i) and anhydrous colloidal silica], crospovidone, cornstarch, talc (E-553b), blackcurrant flavor, sodium saccharin (E-954ii), anhydrous colloidal silica, and sodium stearoylfumarate (E-470a).

Appearance of the product and content of the packaging

The tablets are white or off-white, with a modified quadrangular shape, engraved with “L” and “100” on one face and flat on the other.

Each package contains 56 chewable tablets.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S. L.

C/Venus, 72 – Pol. Ind. Colón II,

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/