CRISOMET 200 mg CHEWABLE/DISPERSIBLE TABLETS

2. What you need to know before you take Crisomet

Do not take Crisomet:

If this applies to you:

? Tell your doctor and do not take Crisomet.

Warnings and precautions

Be especially careful with Crisomet

Tell your doctor or pharmacist before you start taking Crisomet:

• . Your doctor will check your treatment and may advise you to avoid sunlight or use protective measures (such as sun cream and clothing) to protect your skin.
• (read the description of these symptoms in section 4 of this leaflet: Rare side effects).
• Brugada Syndrome is a genetic condition that affects the electrical activity of the heart. Lamotrigine can cause changes in the electrocardiogram (ECG) that can lead to irregular heart rhythms.

If this applies to you:

? Tell your doctor, who will decide whether to lower your dose or whether Crisomet is suitable for you.

Important information about reactions that may potentially be life-threatening

A small number of people taking Crisomet have allergic reactions or skin reactions that may 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 Han Chinese 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 may potentially 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 get 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:

• when you first 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:

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

It may be helpful for you to tell a family member, carer, or close friend that you are taking Crisomet 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 were taking 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 become worse or happen more often while you are taking Crisomet. Some patients may experience severe seizures, which can cause serious health problems. If seizures happen more often or if you experience severe seizures while taking Crisomet:

? See 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 conditions increase the risk of suicidal thoughts and behaviors 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 take any 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 to treat epilepsy or mental health conditions. This is to make sure you take the correct dose of Crisomet. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used to treat epilepsy
• lithium, olanzapine or aripiprazole, used to treat mental health conditions
• bupropion, used to treat mental health conditionsor to stop smoking
• paracetamol, used to treat painand fever.

? Tell your doctor if you are taking any of these medicines.

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

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

? Tell your doctor if you are taking any of these medicines, or if you start or stop taking any of these medicines.

Hormonal contraceptives (such as the pill) may affect how Crisomet works.

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

? Talk to your doctor, as they will tell you which contraceptive methods are suitable for you.

Crisomet may also affect how hormonal contraceptives work, although this is unlikely to affect their effectiveness. If you are using a hormonal contraceptive and you notice changes in your menstrual cycle, such as breakthrough bleeding or spotting:

? Tell your doctor. These may be signs that Crisomet 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 talking to your doctor. This is particularly important if you have epilepsy.
• Pregnancy may affect how well Crisomet works, so you may need to have a blood test and 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 or cleft palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and during pregnancy.

? If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking 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 breastfeed, as they may become sleepy, get a rash, or have 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 that you are not affected by 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 Crisomet

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Crisomet

Follow exactly the administration instructions ofthis medicationindicated by your doctoror pharmacist. In case of 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
• if you are taking Crisomet along 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 effective dose). Never take more Crisomet than your doctor has indicated.

Normally, the effective dose of Crisomet 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.

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 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.

Crisomet chewable/dispersible tablets can be swallowed whole with a little water, chewed, or added to water to dissolve them. 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 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 ensure that no medication remains 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 fatal.

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 ofCrisomet

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

If you are taking Crisomet for the treatment of epilepsy

To stop taking Crisomet, it is essential 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.

Reactionsthatcan potentially be life-threatening:consult yourdoctor 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, on occasion, 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 pain or red, 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 severe adverse 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 to undergo tests to assess liver, kidney, or blood function and may advise you to interrupt 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
• drowsiness or sleepiness
• dizziness
• 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 concentric red patches on the skin, resembling a "target"; 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, neck stiffness, 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 discontinued. However, if the symptoms continue or worsen, contact your doctor

• rapid, uncontrollable eye movements (nystagmus)
• eye itching, 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 observed in blood tests, or liver failure (see also the information at the beginning of section 4)
• a severe 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 observed 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 (tics), uncontrolled muscle spasms affecting 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 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 contribute to providing 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your 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 200 mg chewable/dispersible tablets

The active ingredient is lamotrigine. Each chewable/dispersible tablet contains 200 mg of lamotrigine.

The other ingredients are: calcium carbonate, low-substituted hydroxypropylcellulose, aluminum and magnesium silicate, sodium carboxymethyl starch (Type A) from 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 200 mg chewable/dispersible tablets are square with rounded corners. The tablets show the legend “GSEC5” engraved on one face and the legend “200” on the other face. Each package contains blister packs of 30 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 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/