LABILENO 100 mg CHEWABLE/DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Labileno 100 mg Chewable/Dispersible Tablets

lamotrigine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Labileno and what is it used for

Labileno belongs to a group of medicines called antiepileptics. It can be used for the treatment of two conditions: epilepsyand bipolar disorder.

Labileno is used for the treatment of epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (fits).

• In adults and children aged 13 years and over, Labileno can be used alone or in combination with other medicines for the treatment of epilepsy. Labileno can also be used in combination with other medicines for the treatment of seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, Labileno can be used in combination with other medicines for the treatment of the same conditions. It can also be used alone for the treatment of a type of epilepsy called typical absence seizures.

Labileno is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic-depressive illness) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). In adults aged 18 years and over, Labileno can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medicines. It is not known how Labileno works in the brain to have this effect.

2. What you need to know before you take Labileno

Do not take Labileno:

• (hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in section 6).

If this applies to you:

? Tell your doctorand do not take Labileno.

Warnings and precautions

Be especially careful with Labileno

Tell your doctor or pharmacist before you start taking Labileno:

• after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• (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. by using sunscreen and/or protective clothing)
• (read the description of these symptoms in section 4 of this leaflet: Rare side effects)
• Brugada Syndrome is a genetic condition that causes abnormal electrical activity in the heart. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm).

If this applies to you:

? Tell your doctor, who will decide whether to reduce the dose or determine that Labileno is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people who take Labileno have allergic reactions or skin reactions that can be life-threatening, which can lead to more serious problems if not treated. These reactions can include Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), 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 Labileno. 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 Labileno.

? Read the description of these symptoms in section 4 of this leaflet“Potentially life-threatening reactions: consult your doctor immediately”.

Hemophagocytic Lymphohistiocytosis (HLH)

There have been reports of a rare but very serious reaction of the immune system in patients taking lamotrigine.

• Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. seizures or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat different 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 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 notice that you feel worse or develop new symptoms while taking Labileno:

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

It may be helpful for you to tell a family member, caregiver, or close friend that you are taking Labileno and ask them to read this leaflet.You can ask them to tell you if they are worried about your depression or other changes in your behavior.

A small number of people who have been treated with antiepileptics such as Labileno 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 Labileno for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more often while you are taking Labileno. Some patients may experience severe seizures, which can cause serious health problems. If seizures occur more often or if you experience severe seizures while taking Labileno:

? Go to a doctor immediately.

Labileno must not be given to children under 18 years 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.

Other medicines and Labileno

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other medicines that you buy without a prescription.

Your doctor needs to know if you are taking other medicines for the treatment of epilepsy or mental health problems. This is to make sure you take the correct dose of Labileno. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used for the treatment of epilepsy
• lithium, olanzapine or aripiprazole, used for the treatment of mental health problems
• bupropion, used for the treatment of mental health problemsor for smoking cessation
• paracetamol, used to treat painand fever.

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

Some medicines interact with Labileno or make it more likely that people will have side effects. These include:

• valproate, used for the treatment of epilepsyand mental health problems
• carbamazepine, used for the treatment of epilepsyand mental health problems
• phenytoin, primidoneor phenobarbital, used for the treatment of epilepsy
• risperidone, used for the treatment of mental health problems
• rifampicin, which is an antibiotic
• medicines used for the treatment of HIV infection(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the pill(see below).

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

Hormonal contraceptives (such as the pill) can affect how Labileno works.

Your doctor may recommend that you use a specific hormonal contraceptive, or that you use a different method of contraception, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive, such as the pill, your doctor may do a blood test to check the levels of Labileno. If you are using a hormonal contraceptive or plan to start using one:

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

Labileno can also affect how hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and notice changes in your menstrual cycle, such as intermenstrual bleeding or spotting:

? Tell your doctor. These may be signs that Labileno is affecting how your contraceptive is working.

Pregnancy and breastfeeding

? If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Do not stop your treatment without consulting your doctor. This is especially important if you have epilepsy.
• Pregnancy may affect how well Labileno works, so you may need to have a blood test and have your dose adjusted.
• If Labileno is taken during the first 3 months of pregnancy, there may be a small increased risk of birth defects, including cleft lip and/or cleft palate.
• Your doctor may advise you to take folic acidsupplements if you are planning to become pregnant and during pregnancy.

? If you are breastfeeding or plan to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.The active ingredient of Labileno passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Labileno and will perform regular checks on your baby if you decide to breastfeed, as they may become drowsy, develop a rash, or have poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Labileno can cause dizziness and double vision.

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

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

Important information about some of the ingredients of Labileno

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Labileno

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

What dose of Labileno to take

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

• your age
• if you are taking Labileno with other medications
• if you have any liver or kidney problems.

Your doctor will prescribe a low dose at the start of treatment and, gradually, increase the dose over several weeks until reaching the most suitable dose for you (called the effective dose). Never take more Labileno than your doctor has indicated.

Normally, the effective dose of Labileno for adults and children 13 years of age and older 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, normally between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day.

The use of Labileno is not recommended in children under 2 years of age.

How to take the dose of Labileno

Take your dose of Labileno once or twice a day, as advised by your doctor. They can be taken with or without food.

• Always take the complete dosethat the doctor has prescribed. Never take part of the tablet.

Your doctor may advise you to start or stop taking other medications, depending on the problem being treated and how you respond to treatment.

Labileno chewable/dispersible tablets can be swallowed whole with a little water, chewed, or added to water to dissolve. Never take only part of the liquid.

Removing a tablet:

These tablets come in a special package to prevent children from removing them.

Each unit of the blister has a number. Take each tablet in order, starting with tablet number 1.

1. Separate a tablet: tear along the cutting line to separate one of the blister units.

1. Remove the outer layer: starting from a corner, lift and remove the foil that covers the unit.

1. Remove the tablet: gently press one side of the tablet through the foil to extract it.

Chewing the tablet:

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

To dissolve the medication:

• put the tablet in a glass containing enough water to cover the entire tablet
• shake to dissolve or wait until the tablet is completely dissolved
• drink all the liquid
• add a little more water to the glass and drink it to make sure no medication remains in the glass.

If you take more Labileno than you should

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

If you take more Labileno than you should, you may be more prone to having serious adverse effects that can be fatal.

Someone who has taken too much Labileno may have some of these symptoms:

• rapid and uncontrollable eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• changes in heart rate (usually detected with an ECG)
• loss of consciousness, seizures, or coma.

If you forget to take a dose of Labileno

?Do not take a double dose to make up for forgotten doses. Takethe next dose at the usual time.

In case of forgetting to take multiple doses of Labileno

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

Do not stop taking Labileno without your doctor's advice

You should take Labileno for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to do so.

If you are taking Labileno for the treatment of epilepsy

To stop taking Labileno, it is important that the dose is gradually reduced, over approximately 2 weeks. If you stop taking Labileno suddenly, you may experience a return of epilepsy symptoms or the disease may worsen.

If you are taking Labileno for bipolar disorder

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Reactions that can potentially be life-threatening: consult your doctor immediately.

A small number of people taking Labileno have allergic reactions or skin reactions that can potentially be life-threatening, which can lead to more serious problems if not treated.

It is more likely that these symptoms will appear during the first few months of treatment with Labileno, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Labileno with another medication called valproate. Some of these symptoms are more frequent in children, so parents should pay special attention to them.

The symptoms of these reactions include:

• skin rash or redness, which can lead to skin reactions that can be serious or, in some cases, potentially fatal, including rash with target-like lesions (erythema multiforme), widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling over a large area of the skin (more than 30% of the body surface - toxic epidermal necrolysis) or widespread skin rash with liver, blood, and other organ involvement (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome)
• mouth ulcers, throat, nose, or genital ulcers
• mouth painor red or swollen eyes(conjunctivitis)
• high temperature(fever), flu-like symptoms, or drowsiness (drowsiness)
• swelling around the faceor inflammation of the lymph nodesin the neck, armpits, or groin
• bleeding or unexpected bruising, or fingers turning blue
• sore throator experiencing more infections than usual (such as colds)
• increased liver enzyme levels in blood tests
• increased eosinophils, a type of white blood cell
• enlarged lymph nodes
• organ involvement, including the liver and kidneys.

In many cases, these symptoms can be signs of less serious side effects. However, you should be aware that they can potentially be life-threatening and can lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

?Contact your doctor immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function and may indicate that you should stop treatment with Labileno. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will indicate that you should never take lamotrigine again.

Hemophagocytic lymphohistiocytosis (HLH)(see section 2. What you need to know before taking Labileno).

Very common side effects

These affect more than 1 in 10people:

• headache
• skin rash.

Common side effects

These affect up to 1 in 10people:

• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• spasms or tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, joint pain, or pain in other areas.

Uncommon side effects

These can affect up to 1 in 100people:

• clumsiness and loss of coordination (ataxia)
• double vision or blurred vision
• decreased hair growth or unusual hair loss (alopecia)
• skin rash or sunburn after exposure to sun or artificial light (photosensitivity).

Rare side effects

These affect up to 1 in 1,000people:

• a skin reaction characterized by red, target-like patches on the skin; that is, with a dark red center surrounded by paler red rings (erythema multiforme)
• a potentially life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4)
• a set of symptoms that include: fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to bright light.

This can be caused by inflammation of the membranes covering the brain and spinal cord (meningitis). These symptoms usually disappear when treatment is stopped. However, if the symptoms continue or worsen, contact your doctor

• rapid and uncontrollable eye movements (nystagmus)

• itchy eyes, with discharge and crust on the eyelids (conjunctivitis).

Very rare side effects

These affect up to 1 in 10,000people:

• a potentially life-threatening skin reaction (toxic epidermal necrolysis) (see also the information at the beginning of section 4)
• drug reaction with eosinophilia and systemic symptoms (DRESS) (see also the information at the beginning of section 4)
• high temperature (fever) (see also the information at the beginning of section 4)
• swelling around the face (edema) or inflammation of the lymph nodes in the neck, groin, or armpits (lymphadenopathy) (see also the information at the beginning of section 4)
• changes in liver function, which can be seen in blood tests, or liver failure (see also the information at the beginning of section 4)
• a serious blood clotting disorder that can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Labileno)
• changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), a reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anemia
• hallucinations (hearing or seeing things that are not really there)
• confusion
• feeling unsteady or unstable when moving
• repetitive body movements and/or sounds or words that are uncontrollable (tics), uncontrolled muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerks, spasms, or stiffness
• in people with epilepsy, more frequent seizures
• in people with Parkinson's disease, worsening of symptoms
• a reaction similar to lupus (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or generalized illness).

Other side effects

Other side effects have occurred in a small number of people, but their exact frequency is unknown:

• bone disorders have been reported, including osteopenia and osteoporosis (decreased bone thickness) and fractures. Consult your doctor or pharmacist if you have taken antiepileptics for a long time, if you have a history of osteoporosis, or if you take steroids.
• kidney inflammation (tubulointerstitial nephritis) or kidney and eye inflammation (acute tubulointerstitial nephritis and uveitis syndrome)
• nightmares
• decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection
• nodules or red patches on the skin (pseudolymphoma).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Labileno

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister and packaging. The expiration date is the last day of the month indicated.

Labileno does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Labileno 100 mg chewable/dispersible tablets

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

The other ingredients are: calcium carbonate, low-substituted hydroxypropylcellulose, aluminum and magnesium silicate, sodium carboxymethyl starch (Type A) of potato, povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavor.

Appearance of the product and package contents of Labileno chewable/dispersible tablets

Labileno chewable/dispersible tablets are white to off-white and may be slightly speckled. The tablets have a blackcurrant flavor. Only some package sizes may be marketed.

Labileno 100 mg chewable/dispersible tablets are square with rounded corners. The tablets show the inscription “GSCL7” engraved on one face and the inscription “100” on the other face. Each package contains blisters of 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

es-ci@gsk.com

Manufacturer:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Date of the last revision of thisleaflet:April 2024.

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