Labeleno 100 mg chewable/dispersible tablets: information for the user

lamotrigine

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

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

1.What is Labeleno and what it is used for

2.What you need to know before starting to take Labeleno

3.How to take Labeleno

4.Possible side effects

5.Storage of Labeleno

6.Contents of the pack and additional information

Labileno belongs to a group of medications calledantiepileptic drugs. It can be used to treat two diseases: epilepsyand bipolar disorder.

Labileno is used to treat epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children 13 years of age and older, Labileno can be used alone or in combination with other medications to treat epilepsy. Labileno can also be used with other medications to treat 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 medications to treat the same diseases. It can also be used without other medications to treat a type of epilepsy called typical absence seizures.

Labileno 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, Labileno can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. The exact mechanism of action of Labileno in the brain is not known.

Do not take Labileno:

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

If this is your case:

?Inform your doctorand do not takeLabileno.

Warnings and precautions

Be especially careful with Labileno

Consult your doctor or pharmacist before starting to take Labileno:

• if you have any kidney problems
• if you have ever had a skin rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you suffer from skin rashes or sunburn after taking lamotrigine 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 you have ever had meningitis after taking lamotrigine(see the description of these symptoms in section 4 of this leaflet: Rare side effects)
• if you are already taking medicines that contain lamotrigine
• if you have a condition called Brugada syndrome or other heart problems.Brugada syndrome is a genetic disease that causes abnormal heart electrical activity. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm).

If this is your case:

?Inform your doctor, who will decide 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 taking Labileno have had allergic reactions or skin reactions that can be potentially life-threatening, which can lead to more serious problems if not treated. These reactions may include Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), 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“Life-threatening reactions: consult your doctor immediately”.

Haemophagocytic lymphohistiocytosis (HLH)

Cases of a rare but very serious immune system reaction have been reported 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., spasms or tremor, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

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 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 explain to a family member, carer or close friend that you may become depressed or have significant mood changes, 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 behaviour.

A small number of people who have been treated with antiepileptic drugs like Labileno have also had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

If you are taking Labileno for epilepsy

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

?Go to a doctor immediately.

Labileno should not be administered to children under 18 years for the treatment of bipolar disorder. Medicines used to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviours in children and adolescents under 18 years.

Other medicines and Labileno

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine,including herbal medicines or other medicines obtained 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 ensure that you take the correct dose of Labileno. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateorzonisamide, used for the treatment ofepilepsy
• lithium, olanzapine or aripiprazole, used for the treatment ofmental health problems
• bupropion, used for the treatment ofmental health problemsor to stop smoking
• paracetamol,used to treatpainandfever.

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

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

• valproate, used for the treatment ofepilepsyandmental health problems
• carbamazepine, used for the treatment ofepilepsyandmental health problems
• phenytoin, primidoneorphenobarbital, used for the treatment ofepilepsy
• risperidone, used for the treatment ofmental health problems
• rifampicin, which is anantibiotic
• medicines used to treat HIV infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such asthe pillcontraceptive(see below).

?Inform 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) may affect the way Labileno works.

Your doctor may recommend a specific hormonal contraceptive, or suggest using 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 perform a blood test to check your Labileno levels. If you are using a hormonal contraceptive or plan to start using one:

?Consult your doctor, who will advise you on the most suitable methods of contraception for you.

Labileno may also affect the way 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 loss between periods:

?Inform your doctor. These may be signs that Labileno is affecting the way your contraceptive is working.

Pregnancy and breastfeeding

?If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

• Do not stop your treatment without consulting your doctor. This is particularly important if you have epilepsy.
• The pregnancy may modify the effectiveness of the treatment with Labileno, 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 increase in the risk of congenital malformations, including cleft lip and/or palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and also during pregnancy.

?If you are breastfeeding or plan to start breastfeeding, consult your doctor or pharmacist before using 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 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.

Driving and operating machinery

Labileno may cause dizziness and double vision.

?Do not drive or operate machinery unless you are sure you do not feel these effects.

If you have epilepsy, consult your doctor about the possibility of driving or operating machinery.

Important information about some of the components ofLabileno

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

Follow exactly the administration instructions of this medication 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 appropriate 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 beginning of treatment and gradually increase the dose over several weeks to reach the most appropriate dose for you (called theeffective dose).Do not 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, usually between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day.

Labileno is not recommended for children under 2 years of age.

How to take the Labileno dose

Take your Labileno dose one or two times a day, as advised by your doctor. They can be taken with or without food.

• Always take the complete dosethat your 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 water added to dissolve them. Never take just a part of the liquid.

Removing a tablet:

These tablets come in a special container to prevent children from getting them.

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

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

1. Remove the outer layer: starting from a corner, lift and remove the sheet covering the unit.

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

Chew the tablet:

You may need to drink a little water to help the tablet dissolve in your mouth. After swallowing it, 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 to make sure there is no medication left 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you take moreLabileno than you should, you may be more prone to severe side effects that can be fatal.

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

• rapid and uncontrolled eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• changes in heart rhythm (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 compensate for the missed doses. Takethe next dose at the usual time.

If you forget to take multiple doses of Labileno

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

Do not stop taking Labileno without consulting your doctor

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

If you are taking Labileno for the treatment of epilepsy

To stop taking Labileno,it is essential to gradually reduce the dose over approximately 2 weeks. If you stop taking Labileno suddenly, you may experience a relapse of the symptoms of epilepsy or the disease may worsen.

If you are taking Labileno for bipolar disorder

Labileno may take some time to act, 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 withLabileno, you should consult with your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

These symptoms are more likely to appear during the first few months of treatment with Labileno, especially if the initial dose is very high or if the dose is increased very quickly, or if you are taking Labileno with another medicine calledvalproate. Some of these symptoms are more common in children, so parents should pay special attention.

The symptoms of these reactions include:

• skin rashes or redness, which can lead to skin reactions that can be serious or, in some cases, potentially life-threatening, including a rash with lesions in the shape of a target (erythema multiforme), a widespread rash with blisters and peeling of the skin, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling of a large area of the skin (more than 30% of the body surface –toxic epidermal necrolysis) or a widespread skin rash with liver, blood, and other organ involvement (pharmacological reaction with eosinophilia and systemic symptoms also known as drug reaction with eosinophilia and systemic symptoms (DRESS))
• mouth sores, throat, nose, or genital ulcers
• mouth painorhaving red or swollen eyes (conjunctivitis)
• high temperature (fever), symptoms similar to the flu or drowsiness (somnolence)
• swelling around the face, or inflammationof the lymph nodes in the neck, armpits, or groin
• unexplained bleeding or bruising, or fingers turning blue
• throat painor having more infections than usual (such as colds)
• increased levels of liver enzymes in blood tests
• increased levels of a type of white blood cell (eosinophils)
• enlarged lymph nodes
• organ damage, 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 may 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 have tests to assess the function of the liver, kidneys, or blood and may tell you to stop taking Labileno. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you never to take lamotrigine again.

Lymphohistiocytosis hemophagocytic (LHH)(see section 2. What you need to know before starting to take Labileno).

Very common side effects

These affectmore than 1 in 10people:

• headache
• skin rash.

Common side effects

These affectup to 1 in 10people:

• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• muscle 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.

Rare side effects

These may affectup to 1 in 100people:

• clumsiness and loss of coordination (ataxia)
• double vision or blurred vision
• hair loss or thinning (alopecia)
• skin rash or sun sensitivity after exposure to the sun or artificial light (photosensitivity).

Very rare side effects

These may affectup to 1 in 10000people:

• a skin reaction that can be life-threatening (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, armpits, or groin (lymphadenopathy) (see also the information at the beginning of section 4)
• liver function changes, which can be seen in blood tests, or liver failure (see also the information at the beginning of section 4)
• severe blood clotting disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• lymphohistiocytosis hemophagocytic (LHH) (see section 2. What you need to know before starting to take Labileno)
• blood test changesincluding a reduced number of red blood cells (anemia), a reduced number of white blood cells (leucopenia, 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 insecure or unstable when moving
• repeated body movements or uncontrollable sounds or words (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as jerking, spasms, or rigidity
• more frequent seizures in people with epilepsy
• emergence of symptoms in people with Parkinson's disease
• reaction similar to lupus(the symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or generalised illness).

Other side effects

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

• bone changes that include osteopenia and osteoporosis (bone thinning) 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 are taking steroids.
• inflammation of the kidney (interstitial nephritis) or inflammation of the kidney and eye (acute interstitial nephritis and uveitis)
• nightmares
• reduced immunity, due to a reduction in the levels of antibodies called immunoglobulins in the blood that help protect against infection
• red or brown spots on the skin (pseudolymphoma).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, includingif it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish 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 medicine.

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 pack and the container. The expiration date is the last day of the month indicated.

Labileno does not require special conditions for conservation.

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

Composition of Labileno 100 mg chewable/dispersible tablets

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

The other components are: calcium carbonate, low-substitution hydroxypropylcellulose, aluminium and magnesium silicate, sodium carboxymethylcellulose (Type A) from potato, povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavoring.

Appearance of the product and content of the container of Labileno chewable/dispersible tablets

Labileno chewable/dispersible tablets are white to off-white in color and may be slightly speckled. The tablets have a blackcurrant odor.Only some container 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 container contains blisters of 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Revision date of this prospectus:April 2024.

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