Lamotrigine Kern Pharma 200 mg dispersible/chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lamotrigine Kern Pharma 200 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 must not give it to other people 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse effects
5. How to store Lamotrigine Kern Pharma
6. Contents of the pack and other information

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

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

Lamotrigina 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 caused by 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.

Lamotrigina Kern Pharma is also used to treat bipolar disorder. People with bipolar disorder (previously called 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, Lamotrigina 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 to take Lamotrigina Kern Pharma

Do not take Lamotrigina 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 developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you experience 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 to 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.
• Irritation in the mouth or eyes.
• High temperature (fever), flu-like symptoms, or drowsiness (somnolence).
• Swelling around the face or swollen glands in the neck, armpits, or groin.
• Unexpected bleeding or bruising, or fingers turning blue.
• 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. They are also more likely 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 become more serious, such as organ failure or a very severe skin disease.

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of lamotrigine. These initially appear as red spots or circular lesions, 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 few 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 experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking lamotrigine, you must never take lamotrigine again.

If you develop a rash or these skin symptoms, stop taking lamotrigine immediately, seek medical attention right away, and inform your doctor that you are taking this medicine. Your doctor will decide whether blood 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 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 starting treatment.
• If you have previously had thoughts of self-harm or suicide.
• If you are under 25 years of age.

If you have troubling thoughts or experiences, 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 taking antiepileptic drugs such as lamotrigine have had thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately.

If you are taking Lamotrigina 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 attention 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 ingredient in Lamotrigina 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 Lamotrigina Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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, or if you start or stop taking, 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 use 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 check lamotrigine levels. If you are considering starting a hormonal contraceptive:

• Inform your doctor, as they 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 efficacy. 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.

You should not stop treatment for epilepsy 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 to become pregnant and also 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 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 other activities requiring special attention, until your doctor has assessed your response to this medicine.

Lamotrigina Kern Pharma contains sorbitol

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

Lamotrigina Kern Pharma contains sodium

Patients on low-sodium diets should be aware that this medicine contains 1.64 mg (0.072 mmol) of sodium per 200 mg.

3. How to take Lamotrigine Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. 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 per day.

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 your 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 a tablet.

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

Take lamotrigine dispersible 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 telephone number: 91 562 04 20, stating 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 a missed dose.

If you have missed a dose of lamotrigine:

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

Do not stop taking Lamotrigine Kern Pharma unless your doctor tells you to.

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

If you are taking Lamotrigine Kern Pharma for epilepsy:

When stopping 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 that you will feel better immediately. When stopping lamotrigine, you do not need to gradually reduce the dose. However, you must still consult your doctor before stopping treatment with this medicine.

4. Possible adverse effects

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

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

Life-threatening skin rashes may occur (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 serious. 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 crusts on the eyelids (conjunctivitis)
• a rare skin disorder causing severe blisters and bleeding on 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 trembling or unsteadiness when moving
• repetitive and/or uncontrollable body movements and/or 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 off in layers of skin (toxic epidermal necrolysis)
• in people who already have epilepsy, seizures occurring more frequently
• 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 called aplastic anaemia
• blood clotting disorders, 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)
• decreased immunity due to reduced 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 type of adverse effect, talk to your doctor or pharmacist, even if it is an 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 bottle, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 200 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 “200” on one side and flat on the other.

Each pack contains 30 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/