Lamotrigine Kern Pharma 50 mg dispersible/chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lamotrigine Kern Pharma 50 mg dispersible/chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet:

1. What Lamotrigine Kern Pharma is and what it is used for
2. What you need to know before taking Lamotrigine Kern Pharma
3. How to take Lamotrigine Kern Pharma
4. Possible side effects
5. How to store Lamotrigine Kern Pharma
6. Contents of the pack and other information

1. What Lamotrigine Kern Pharma is and what it is used for

Lamotrigine Kern Pharma belongs to a group of medicines called antiepileptics. It can be used to treat two conditions: epilepsy and bipolar disorder.

Lamotrigine Kern Pharma is used to treat epilepsy because it blocks signals in the brain that trigger seizures (fits).

• In adults and children aged 13 years and older, lamotrigine may be used alone or in combination with other medicines to treat epilepsy. Lamotrigine may also be used together with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, lamotrigine may be used in combination with other medicines to treat the same conditions. It may also be used without combination with other medicines to treat a type of epilepsy called typical absence seizures.

Lamotrigine Kern Pharma is also used to treat bipolar disorder. People with bipolar disorder (previously known as manic-depressive illness) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamotrigine Kern Pharma may be used to prevent depressive episodes associated with bipolar disorder, either alone or in combination with other medicines. It is not known how lamotrigine works in the brain to produce this effect.

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

Do not take Lamotrigine Kern Pharma

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

If this applies to you:

• Inform 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 containing lamotrigine.
• If you have previously experienced a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you develop skin rashes or sunburn after taking lamotrigine and being exposed to sunlight or artificial light (e.g., in a tanning bed). Your doctor will review your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g., by using sunscreen and/or protective clothing).

If this applies to you:

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

Important: Be alert for symptoms:

Seek immediate medical help if, after starting this medicine, you experience any of the following symptoms:

• Skin reactions, such as redness or rashes.
• Mouth or eye irritation.
• High temperature (fever), flu-like symptoms, or drowsiness (somnolence).
• Swelling around the face or enlarged glands in the neck, armpits, or groin.
• Unexplained bleeding or bruising, or blue fingers.
• Sore 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 lamotrigine, especially if you start on too high a dose or if your dose is increased too quickly. The risk is also higher if you are taking this medicine together 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 may progress to 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. These usually start as red spots or circular patches, often with a central blister.

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

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

The period of highest risk 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 Han Chinese and Thai). If you are of such origin and have been found to carry this genetic variant (HLA-B*1502), speak with your doctor before taking lamotrigine.

If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking lamotrigine, you must never use lamotrigine again.

If you develop skin rashes or any of these skin symptoms, stop taking lamotrigine immediately, seek medical help right away, and inform your doctor that you are taking this medicine. Your doctor will decide whether blood tests or other tests are needed to assess liver, kidney, or blood function.

Suicidal thoughts or self-harm

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

• When starting treatment.
• If you have previously had thoughts of self-harm or suicide.
• If you are under 25 years of age.

If you have distressing thoughts or experiences, or if you notice your condition worsening or new symptoms developing while on lamotrigine treatment:

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

A small number of people treated with antiepileptic drugs such as lamotrigine have experienced thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigine Kern Pharma for epilepsy:

In some types of epilepsy, seizures may occasionally worsen or occur more frequently during treatment with lamotrigine. Some patients may experience severe seizures that could lead to serious health problems. If you notice that your seizures are occurring more often or if you experience severe seizures while taking this medicine:

• Seek medical help immediately.

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

Brugada syndrome

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

Hemophagocytic lymphohistiocytosis (HLH)

Cases of a rare but very 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, changes in brain function).

Pregnancy and breastfeeding

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using this medicine. The active substance in Lamotrigine Kern Pharma passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine and will schedule periodic check-ups for your baby if you decide to breastfeed, as your baby may experience drowsiness, rash, or poor weight gain. Inform your doctor if you notice any of these symptoms in your baby.

Use of Lamotrigine Kern Pharma with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

If you are taking certain medicines, your doctor may need to adjust your lamotrigine dose. These include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used to treat epilepsy

• lithium, used to treat mental health conditions

• bupropion, used to treat mental health conditions or to help stop smoking

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

Some medicines interact with lamotrigine or increase the likelihood of adverse effects. These include:

• valproate, used to treat epilepsy and mental health conditions

• carbamazepine, used to treat epilepsy and mental health conditions

• phenytoin, primidone, or phenobarbital, used to treat epilepsy

• olanzapine, used to treat mental health conditions

• risperidone, used to treat mental health conditions

• rifampicin, an antibiotic

• a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection (AIDS)

• hormonal contraceptives, such as the Pill (see below).

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

Hormonal contraceptives (such as the Pill) may affect how this medicine works. Your doctor may recommend a specific hormonal contraceptive or suggest using another contraceptive method, such as condoms, diaphragm, or intrauterine device (IUD). If you are taking a hormonal contraceptive such as the Pill, your doctor may ask you to have blood tests to monitor lamotrigine levels. If you are considering starting a hormonal contraceptive:

• Inform your doctor, who will advise you on the most suitable contraceptive methods for you.

Lamotrigine may alter the effectiveness of hormonal contraceptives, although it is unlikely to reduce their contraceptive efficacy. However, 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 how your contraceptive works.

Pregnancy and breastfeeding

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

Do not stop epilepsy treatment during pregnancy. However, there is an increased risk of birth defects in newborns whose mothers took lamotrigine during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you to take folic acid supplements if you are planning a pregnancy and during pregnancy.

Pregnancy may alter the effectiveness of lamotrigine treatment, so your doctor may ask you to have blood tests to monitor lamotrigine levels and adjust your dose accordingly.

• Consult your doctor if you are breastfeeding or planning to breastfeed: the active substance (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 breastfeed, your baby will be monitored periodically.

Driving and use of machines

Lamotrigine may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce your reaction time. These effects, as well as the underlying condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in any activity requiring special alertness, until your doctor has assessed 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 with your doctor before taking this medicine.

Lamotrigine Kern Pharma contains sodium

Patients on low-sodium diets should be aware that this medicine contains 0.41 mg (0.018 mmol) of sodium per 50 mg tablet.

3. How to take Lamotrigine Kern Pharma

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

What dose of Lamotrigine Kern Pharma to take:

It may take some time for your doctor to find the most appropriate lamotrigine dose for you. The dose you should take depends on:

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

Your doctor will ask you to start treatment with a low dose, gradually increasing it until reaching the most suitable dose for you (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 ranges between 100 mg and 400 mg daily.

For children between 2 and 12 years of age, the effective dose depends on body weight, usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum of 400 mg daily.

How to take the dose of Lamotrigine Kern Pharma:

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

• Always take the full dose prescribed by your doctor. Never take only part of the tablet.

Your doctor may advise you to start or stop taking other medicines, depending on your condition and how you respond to treatment.

Take the dispersible lamotrigine tablets 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 when chewing the tablet to help it dissolve in your mouth. After swallowing, drink a little more water to ensure you have taken all the medicine.

To dissolve the medicine (to make a liquid medicine):

• Place the tablet in a glass containing enough water to completely cover the tablet.
• Shake to dissolve, or wait for one minute, until the tablet is completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to ensure you have taken all the medicine.

If you take more Lamotrigine Kern Pharma than you should

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

Someone who takes too much lamotrigine may experience one or more of the following symptoms:

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

If you forget to take Lamotrigine Kern Pharma

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

If you have missed a dose of lamotrigine:

• Ask your doctor for advice on how to resume treatment. It is important that you do this.

Do not stop taking Lamotrigine Kern Pharma without your doctor telling you to do so.

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

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

To stop taking this medicine, it is important that the dose is gradually reduced over approximately 2 weeks. If you stop taking lamotrigine suddenly, your epilepsy symptoms may return or your condition may worsen.

If you are taking Lamotrigine Kern Pharma for bipolar disorder:

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

4. Possible adverse effects

Like all medicines, lamotrigine may cause adverse effects, although not everyone experiences them.

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

Skin rashes may occur that could be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Frequency: Very rare

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

• Seek medical advice immediately. Your doctor will decide whether you need tests to assess liver, kidney, or blood function, and may also advise you to stop treatment with lamotrigine.

Very common adverse effects:

These affect more than 1 in 10 people:

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

Common adverse effects:

These affect up to 1 in 10 people:

• aggression or irritability
• rapid, uncontrolled eye movements (nystagmus)
• spasms or tremors
• difficulty sleeping
• diarrhoea
• dry mouth
• tiredness
• back, joint, or other pain

Uncommon adverse effects:

These may affect up to 1 in 100 people:

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

Rare adverse effects:

These affect up to 1 in 1,000 people:

• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
• a rare skin disorder causing 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 tremor or unsteadiness when moving
• repetitive body movements and/or uncontrollable sounds or words (tics), muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness
• severe skin reaction, starting with a painful red area, followed by large blisters, and eventually peeling of the skin in layers (toxic epidermal necrolysis)
• in people who have previously had epilepsy, increased frequency of seizures
• changes in liver function, which may be seen in blood tests, or liver failure
• changes detectable in blood tests including reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder known as aplastic anaemia
• disturbance in blood clotting, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation)
• high temperature (fever)
• swelling around the face (oedema) or inflammation of glands in the neck, groin, or armpits (lymphadenopathy)
• in people with Parkinson's disease, worsening of symptoms
• haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking lamotrigine).
• reduced immunity due to decreased levels of antibodies called immunoglobulins in the blood, which help protect against infection.

Other adverse effects

• red lumps or spots on the skin (pseudolymphoma).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamotrigine Kern Pharma

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

Do not use this medicine after the expiry date stated on the blister, packaging, or container, following “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamotrigine Kern Pharma dispersible / chewable tablets

The active substance is lamotrigine. Each dispersible / chewable tablet contains 50 mg of lamotrigine.

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

Appearance of the product and contents of the pack

The tablets are white or almost white, modified quadrangular in shape, engraved with “L” and “50” on one side and flat on the other.

Each pack contains 42 or 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 most recent revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/