LAMOTRIGINE KERN PHARMA 100 mg DISPERSIBLE/CHEWABLE TABLETS

2. What you need to know before you take Lamotrigine Kern Pharma

Do not take Lamotrigine Kern Pharma

• If you are allergic (hypersensitive) to the active substance 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 this medicine.

Warnings and precautions

Before taking lamotrigine, your doctor needs to know:

• If you have kidney problems.
• If you have ever developed a skin rash when taking lamotrigine or other medicines for epilepsy.
• If you are already taking medicines that contain lamotrigine.
• 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 sunlight or artificial light (e.g. in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g. use a sunscreen and/or protective clothing).

If this is the case:

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

It is essential to be aware of the symptoms:

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

• Skin reaction, such as redness or rash.
• Irritation in the mouth or eyes.
• High temperature (fever), flu-like symptoms or drowsiness (lethargy).
• Swelling around the face or inflammation of the glands in the neck, armpits, and groin.
• Bleeding or unexpected bruising, or fingers turning blue.
• Irritation of the throat, or more infections (such as colds) than usual.

These symptoms are more likely to occur during the first few months of treatment with lamotrigine, especially if you start treatment with a 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 to experience these side effects than adults.

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

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of lamotrigine, initially appearing as red spots or circular patches, often with a central blister.

Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to the formation of widespread blisters or peeling of the skin.

The period of highest risk for the occurrence of severe skin reactions is during the first few 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 lamotrigine.

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

If you develop a rash or these skin symptoms, stop taking lamotrigine, go immediately to a doctor, and inform them that you are taking this medicine. Your doctor will decide whether you need to undergo tests to assess liver, kidney, or blood function.

Thoughts of self-harm or suicide:

Antiepileptic medicines are used to treat various 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 feel worse or develop new symptoms while taking lamotrigine:

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

A small number of people who were being treated with antiepileptics like lamotrigine 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 Lamotrigine Kern Pharma for epilepsy:

In some types of epilepsy, during treatment with lamotrigine, 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 more seizures or if you experience severe seizures while taking this medicine:

• Go to a doctor immediately.

Lamotrigine should not be given to children under 18 years of age for the treatment of bipolar disorder. Medicines for the treatment of depression and other mental health problems increase the risk of thoughts and behaviors of suicide in children and adolescents under 18 years of age.

Brugada syndrome

Brugada syndrome is a genetic disease that causes abnormal electrical activity in the heart. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm). Consult your doctor if you have this condition.

Hemophagocytic lymphohistiocytosis (HLH)

Cases of a rare but very serious reaction of the immune system 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, changes in brain function).

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 Lamotrigine Kern Pharma passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking this medicine and will perform regular check-ups on your baby if you decide to start breastfeeding, as it may cause drowsiness, rash, or poor weight gain. Inform your doctor if you notice any of these symptoms in your baby.

Using Lamotrigine Kern Pharma with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

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

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

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

Some medicines interact with lamotrigine or make it more likely to experience side effects. These include:

• valproate, used for the treatment of epilepsy and mental health problems
• carbamazepine, used for the treatment of epilepsy and mental health problems
• phenytoin, primidone, or phenobarbitone, used for the treatment of epilepsy
• olanzapine, used for the treatment of mental health problems
• risperidone, used for the treatment of mental health problems
• rifampicin, which is an antibiotic
• a combination of lopinavir and ritonavir, used for the treatment of HIV infection (AIDS)
• hormonal contraceptives, such as the Pill (see below).

• Tell your doctor if you are using, or if you start or stop using, any of these medicines.

Hormonal contraceptives (such as the Pill) may affect how this medicine 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 Pill, your doctor may ask you to have blood tests to check the level of lamotrigine. If you are thinking of starting to use a hormonal contraceptive:

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

It is possible that the administration of lamotrigine may affect the efficacy of hormonal contraceptives, although it is unlikely to decrease their effectiveness. If you are using a hormonal contraceptive and experience changes in your menstrual cycle, such as intermenstrual bleeding or spotting:

• Tell your doctor. These may be signs that lamotrigine is affecting the efficacy of your contraceptive.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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 alter the effectiveness of treatment with lamotrigine, so your doctor may ask you to have a blood test to check the levels of lamotrigine and adjust your dose accordingly.

• Consult your doctor if you are breastfeeding or plan to start breastfeeding: the active ingredient (lamotrigine) 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, the doctor will perform regular check-ups on your baby.

Driving and using machines

Lamotrigine may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction time. These effects, as well as the underlying disease, may impair your ability 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 medicine.

Lamotrigine 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.

Lamotrigine Kern Pharma contains sodium

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

3. How to take Lamotrigina Kern Pharma

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

What dose of Lamotrigina Kern Pharma to take:

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

• your age
• if you are taking lamotrigine with other medicines
• if you have liver or kidney problems

Your doctor will ask you to start treatment with a low dose, and gradually increase the dose until the most suitable dose for you is reached (called the effective dose). Never take more lamotrigine than your doctor has prescribed.

Normally, the effective dose of lamotrigine for adults and children over 12 years of age 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, 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 Kern Pharma:

Take your dose of lamotrigine once or twice a day, as advised by your doctor. You can take it with or without food.

• Always take the full dose that your doctor has prescribed. Never take part of the tablet.

Your doctor may advise you to start or stop taking other medicines, depending on the conditions you are being treated for and how you respond to treatment.

Take the dispersible tablets of lamotrigine 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 more 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 (make a liquid medicine):

• 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 fully 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 Kern Pharma than you should

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

Someone who takes too much lamotrigine may experience some of these symptoms:

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

If you forget to take Lamotrigina Kern Pharma

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

If you have not taken a dose of lamotrigine:

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

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

You should take this medicine for as long as your doctor recommends. Do not stop treatment until your doctor advises you to do so.

If you are taking Lamotrigina Kern Pharma for the treatment of epilepsy:

To stop taking this medicine, it is essential to gradually reduce the dose over approximately 2 weeks. If you stop taking lamotrigine abruptly, you may experience seizures again or your condition may worsen.

If you are taking Lamotrigina Kern Pharma for bipolar disorder:

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

4. Possible Adverse Effects

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

Allergic reactions or potentially serious skin reactions: consult your doctor immediately.

Skin rashes may appear that can threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2)

Frequency: Very rare

In many cases, these symptoms can be signs of less serious adverse effects. But you should be aware that they are potentially serious. If you experience any of these symptoms:

• Go to a doctor immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function and may also tell you to interrupt treatment with lamotrigine.

Very frequent adverse effects:

These affect more than 1 in 10 people:

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

Frequent adverse effects:

These affect up to 1 in 10 people:

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

Infrequent adverse effects:

These may affect up to 1 in 100 people:

• skin rash or sunburn after exposure to sun or artificial light (photosensitivity)

Rare adverse effects:

These affect up to 1 in 1,000 people:

• itchy eyes, with discharge and crust on 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 adverse effects:

These affect up to 1 in 10,000 people:

• hallucinations (hearing or seeing things that are not really there)
• confusion or agitation
• feeling of tremors or instability when moving
• repeated body movements and/or sounds or words that are uncontrollable (tics), muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerks, spasms, or stiffness
• severe skin reaction, which starts 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)
• changes in liver function, which can be observed in blood tests, or liver failure
• changes that can be observed in blood tests, including reduced red blood cell count (anemia), reduced white blood cell count (leukopenia, neutropenia, agranulocytosis), reduced platelet count (thrombocytopenia), reduced count of all types of blood cells (pancytopenia), and a spinal cord disorder called aplastic anemia
• alteration in blood coagulation, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation)
• high fever
• swelling around the face (edema) or inflammation of the glands in the neck, groin, or armpits (lymphadenopathy)
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigine).
• decreased immunity, due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection.

Other adverse effects

• nodules or reddish spots on the skin (pseudolymphoma).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is 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 contribute to providing more information on the safety of this medicine.

5. Storage of Lamotrigina Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister, package, or bottle, after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Lamotrigina Kern Pharma dispersible/chewable tablets

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

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

Appearance of the product and package contents

The tablets are white or off-white, with a modified square shape, engraved with "L" and "100" on one side and flat on the other.

Each package contains 56 dispersible/chewable tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S. L.

C/Venus, 72 – Pol. Ind. Colón II,

08228 Terrassa (Barcelona)

Spain

Date of the last revision of this leaflet: October 2023

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