CRISOMET 50 mg CHEWABLE/DISPERSIBLE TABLETS

2. What you need to know before you take Crisomet

Do not take Crisomet:

• (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 Crisomet.

Warnings and precautions

Be especially careful with Crisomet

Consult your doctor or pharmacist before startingto take Crisomet:

• after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• (such as in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or use protective measures (such as sun protection cream and/or protective clothing)
• (read the description of these symptoms in section 4 of this leaflet:Rare but serious 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 Crisomet is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Crisomet 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 Crisomet. 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 Crisomet.

? Read the description of these symptoms in section 4 of this leaflet"Reactions that can be life-threatening: 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., spasms 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 Crisomet:

? 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 can get 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 behavior.

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

Seizures in some types of epilepsy may occasionally worsen or occur more often while you are taking Crisomet. 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 Crisomet:

? Go to a doctor immediately.

Crisomet 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 Crisomet

Tell your doctor or pharmacist if you are taking, have recently taken, or might takeany other medicines, including herbal medicines or other medicines that you have bought 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 Crisomet. 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 Crisomet 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, primidone or 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 Crisomet 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, such as the pill, your doctor may perform a blood test to check the levels of Crisomet. If you are using a hormonal contraceptive or plan to start using one:

? Consult your doctor, as he will indicate which contraceptive methods are most suitable for you.

Crisomet 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 Crisomet is affecting how your contraceptive works.

Pregnancy and breastfeeding

? If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

• Do not stop your treatment without consulting your doctor. This is especially important if you have epilepsy.
• Pregnancy may change the effectiveness of treatment with Crisomet, so you may need to have a blood test and have your dose adjusted.
• If Crisomet 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 acid supplementsif 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 Crisomet passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Crisomet and will perform regular checks on your baby if you decide to start breastfeeding, as it may cause drowsiness, rash, or poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Crisomet 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, consult your doctor about the possibility of driving or using machines.

Important information about some of the ingredients of Crisomet

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

3. How to Take Crisomet

Follow your doctor's or pharmacist's administration instructions for this medication exactly.If in doubt, consult your doctor or pharmacist again.

What dose of Crisomet to take

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

• your age
• whether you are taking Crisomet with other medications
• whether 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 the most suitable dose for you is reached (called the effective dose). Never take more Crisomet than your doctor has indicated.

Normally, the effective dose of Crisomet for adults and children aged 13 and over is between 100 mg and 400 mg per day.

For children between 2 and 12 years old, 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.

Crisomet is not recommended for use in children under 2 years of age.

How to take the dose of Crisomet

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

• Always take the full 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.

Crisomet 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.

To remove a tablet:

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

Each unit of the blister pack 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 pack 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 whole 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 is left in the glass.

If you take more Crisomet 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 Crisomet than you should, you may be more prone to having serious adverse effects that can be life-threatening.

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

• rapid, 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 takea dose ofCrisomet

?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 Crisomet

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

Do not stop taking Crisomet without your doctor's advice

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

If you are taking Crisomet for the treatment of epilepsy

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

If you are taking Crisomet for bipolar disorder

Crisomet may take some time to work, so it is unlikely that you will feel better immediately. If you stop taking Crisomet, you do not need to gradually reduce your dose. However, before interrupting treatment with Crisomet, 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 Crisomet 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 Crisomet, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Crisomet 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 life-threatening, 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 pain or red, swollen eyes(conjunctivitis)
• high temperature(fever), flu-like symptoms, or drowsiness (drowsiness)
• swelling around the face, or 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-threateningand 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 tests to assess liver, kidney, or blood function and may advise you to stop treatment with Crisomet. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you to never take lamotrigine again.

Hemophagocytic Lymphohistiocytosis (HLH)(see section 2. What you need to know before taking Crisomet).

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 including 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, 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 Crisomet)
• changes that can be seen in blood tests, including a low red blood cell count (anemia), a low white blood cell count (leukopenia, neutropenia, agranulocytosis), a low platelet count (thrombocytopenia), a low count 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 Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Crisomet

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack, carton, or bottle. The expiration date is the last day of the month indicated.

Crisomet does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications 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 Crisomet 50 mg chewable/dispersible tablets

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

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

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

Crisomet chewable/dispersible tablets are white to off-white and may be slightly speckled. The tablets have a blackcurrant flavor.

Crisomet 50 mg chewable/dispersible tablets are square with rounded corners. The tablets are engraved with "GSCX7" on one face and "50" on the other face. Each package contains blister packs 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

[email protected]

Manufacturer:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Date of the last revision of this leaflet: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/