Crisomet 100 mg chewable/dispersible tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Crisomet 100 mg chewable/dispersible tablets

lamotrigine

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, since 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 Crisomet is and what it is used for
2. What you need to know before taking Crisomet
3. How to take Crisomet
4. Possible side effects
5. How to store Crisomet
6. Contents of the pack and other information

1. What Crisomet is and what it is used for

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

Crisomet is used to treat epilepsy because it blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children aged 13 years and older, Crisomet may be used alone or in combination with other antiepileptic medicines for the treatment of epilepsy. Crisomet may also be used in combination with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Crisomet may be used in combination with other medicines to treat the same conditions. It may also be used as monotherapy (without combination with other medicines) for the treatment of a type of epilepsy known as typical absence seizures.

Crisomet is also used to treat bipolar disorder.

People with bipolar disorder (previously known as 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, Crisomet may be used, either alone or in combination with other medicines, to prevent depressive episodes associated with bipolar disorder. The way Crisomet works in the brain to produce this effect is not known.

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

Do not take Crisomet:

• if you are allergic (hypersensitive) to lamotrigine 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 Crisomet.

Warnings and precautions

Take special care with Crisomet

Consult your doctor or pharmacist before starting to take Crisomet:

• if you have any kidney problems
• if you have ever developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you develop 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 you have ever had meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare adverse effects)
• if you are already taking medicines containing lamotrigine
• if you have a condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic disease that causes abnormal electrical activity in the heart. Lamotrigine may lead to abnormalities in the electrocardiogram (ECG) that could cause arrhythmias (abnormal heart rhythm).

If this applies to you:

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

Important information about reactions that could potentially be life-threatening

A small number of people taking Crisomet experience allergic reactions or skin reactions that could potentially be life-threatening, which may lead to more serious problems if not treated. These reactions may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). It is important that you are aware of the symptoms of these reactions and monitor for 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 this genetic variant (HLA-B*1502) has been detected in you, speak with your doctor before taking Crisomet.

? Read the description of these symptoms in section 4 of this leaflet “Reactions that could potentially be life-threatening: 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 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).

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 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 notice that you feel worse or develop new symptoms while being treated with Crisomet:

? 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, caregiver, or close friend that you may become depressed or experience significant mood changes, and ask them to read this leaflet. You may ask them to tell you if they are concerned about your depression or other changes in your behavior.

A small number of people treated with antiepileptic drugs such as Crisomet have also had thoughts of self-harm or suicide. If at any time you have such thoughts, contact your doctor immediately.

If you are taking Crisomet for epilepsy

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

? See a doctor immediately.

Crisomet must 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 increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years of age.

Other medicines and Crisomet

Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 epilepsy or mental health conditions. This is to ensure you receive the correct dose of Crisomet. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used to treat epilepsy
• lithium, olanzapine, or aripiprazole, used to treat mental health conditions
• bupropion, used to treat mental health conditions or to quit smoking
• paracetamol, used to treat pain and fever.

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

Some medicines interact with Crisomet or make it more likely that people will experience 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
• risperidone, used to treat mental health conditions
• rifampicin, which is an antibiotic
• medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• products containing oestrogens, including hormonal contraceptives, such as the contraceptive pill (see below) and hormone replacement therapy (HRT).

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

Hormonal contraceptives (such as the contraceptive pill) may affect how Crisomet 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 contraceptive pill, your doctor may perform a blood test to check Crisomet levels. If you are using or plan to start using a hormonal contraceptive:

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

Crisomet may 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 between periods:

? Inform your doctor. These may be signs that Crisomet is affecting how your contraceptive works.

HRT may affect how Crisomet works

If you are using hormone replacement therapy (HRT) containing oestrogens, your doctor may request blood tests to monitor Crisomet levels.

Pregnancy and breastfeeding

? If you are pregnant, think you may be pregnant, or plan 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.
• Pregnancy may alter the effectiveness of Crisomet treatment, so you may need a blood test and dose adjustment.
• If Crisomet is taken during the first three 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 supplements if you are planning to become pregnant and also during pregnancy.

? If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medicine. The active ingredient in 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 arrange 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.

Driving and using machines

Crisomet may cause dizziness and double vision.

? Do not drive or operate machinery unless you are certain you do not experience these effects.

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

Important information about some of the components of Crisomet

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

3. How to take Crisomet

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. 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 appropriate dose of Crisomet for you. The dose you should take depends on:

• your age
• whether you are taking Crisomet with other medicines
• whether you have any liver or kidney problems.

Your doctor will initially prescribe a low dose and gradually increase it over several weeks until reaching the most appropriate dose for you (called the effective dose). Never take more Crisomet than your doctor has told you to.

Normally, the effective dose of Crisomet for adults and children aged 13 years 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 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.

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

How to take your dose of Crisomet

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

• Always take the full dose prescribed by your doctor. Never take part of a tablet.

Your doctor may advise you to start or stop taking other medicines, depending on the condition being treated and your response to treatment.

The chewable/dispersible tablets of Crisomet may be swallowed whole with a little water, chewed, or dissolved in water. Never take only part of the liquid.

Removing a tablet:

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

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

1. Separate one tablet: Tear along the perforated line to separate one unit from the blister pack.

1. Peel off the outer layer: Starting at one corner, lift and remove the foil covering the unit.

1. Remove the tablet: Gently press on one side of the tablet through the foil to push it out.

Chewing the tablet:

When chewing the tablet, you may need to drink a little water to help dissolve the tablet in your mouth. After swallowing, drink a little more water to ensure you have taken all the medicine.

To dissolve the medicine:

• place 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 medicine 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you take more Crisomet than you should, you may be more likely to experience serious adverse effects, which can be fatal.

Someone who has taken too much Crisomet may experience one or more of the following symptoms:

• rapid, uncontrolled eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• changes in heart rhythm (usually detected by ECG)
• loss of consciousness, seizures, or coma.

If you forget to take a dose of Crisomet

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

If you forget to take multiple doses of Crisomet

?Ask your doctor for advice on how to restart treatment. 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 do so.

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, your epilepsy symptoms may return or your condition may worsen.

If you are taking Crisomet for bipolar disorder

Crisomet may take some time to work, so you are unlikely to feel better immediately. When stopping Crisomet, you do not need to gradually reduce your dose. However, you should still consult your doctor before stopping treatment with Crisomet.

4. Possible adverse effects

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

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

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

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

Symptoms of these reactions include:

• Skin rash or redness, which may lead to skin reactions that can be serious or, occasionally, potentially fatal, including rash with target-like lesions (erythema multiforme), widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling over a large area of skin (more than 30% of body surface – toxic epidermal necrolysis), or widespread skin rash associated with liver involvement, blood abnormalities, and other organ damage (drug reaction with eosinophilia and systemic symptoms, also known as hypersensitivity syndrome (DRESS))
• Ulcers in the mouth, throat, nose, or genitals
• Pain in the mouth or red, swollen eyes (conjunctivitis)
• High temperature (fever), flu-like symptoms, or drowsiness (sopor)
• Swelling around the face, or swollen lymph nodes in the neck, armpits, or groin
• Unexplained bleeding or bruising, or fingers turning blue
• Sore throat or experiencing more infections than usual (such as colds)
• Increased levels of liver enzymes in blood tests
• Increase in a type of white blood cells (eosinophils)
• Enlarged lymph nodes
• Involvement of organs in the body, including the liver and kidneys.

In many cases, these symptoms may be signs of less serious adverse effects. However, you should be aware that they may potentially be life-threatening and could lead to more serious complications, such as organ failure, if left untreated. If you notice any of these symptoms:

?Contact a doctor immediately. Your doctor will decide whether you need tests to assess liver, kidney, or blood function and may instruct you to stop treatment with Crisomet. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you never to take lamotrigine again.

Haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Crisomet).

Very common adverse effects

These affect more than 1 in 10 people:

• Headache
• Skin rash.

Common adverse effects

These affect up to 1 in 10 people:

• Aggression or irritability
• Feeling sleepy or drowsy
• Dizziness
• Spasms or tremors
• Difficulty sleeping (insomnia)
• Feeling restless
• Diarrhea
• Dry mouth
• Nausea or vomiting
• Feeling tired
• Back, joint, or other pain.

Uncommon adverse effects

These may affect up to 1 in 100 people:

• Clumsiness and loss of coordination (ataxia)
• Double vision or blurred vision
• Decreased hair mass or unusual hair loss (alopecia)
• Skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity).

Rare adverse effects

These affect up to 1 in 1,000 people:

• Skin reaction characterized by concentric red spots on the skin, which may look like a "target"; that is, a dark red center surrounded by paler red rings (erythema multiforme)
• Skin reaction that may be life-threatening (Stevens-Johnson syndrome) (see also information at the beginning of section 4)
• A group of symptoms including: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light.

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

• Rapid, uncontrolled eye movements (nystagmus)
• Itchy eyes, with discharge and crusting of the eyelids (conjunctivitis).

Very rare adverse effects

These affect up to 1 in 10,000 people:

• A skin reaction that may be life-threatening (toxic epidermal necrolysis) (see also information at the beginning of section 4)
• Drug reaction with eosinophilia and systemic symptoms (DRESS) (see also information at the beginning of section 4)
• High temperature (fever) (see also information at the beginning of section 4)
• Swelling around the face (edema) or swollen glands in the neck, groin, or armpits (lymphadenopathy) (see also information at the beginning of section 4)
• Changes in liver function, which may show up in blood tests, or liver failure (see also information at the beginning of section 4)
• Serious blood clotting disorder, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4)
• Haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Crisomet)
• Changes detectable in blood tests, including reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), 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 uncontrollable sounds or words (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness
• In people with epilepsy, more frequent seizures
• In people with Parkinson's disease, worsening of symptoms
• Lupus-like reaction (symptoms may include back or joint pain, sometimes accompanied by fever and/or general illness).

Other adverse effects

Other adverse effects have been reported in a small number of people, but their exact frequency is unknown:

• Bone disorders have been reported, including osteopenia and osteoporosis (reduced bone density) and fractures. Consult your doctor or pharmacist if you have taken antiepileptic medicines for a long time, have a history of osteoporosis, or are taking steroids
• Inflammation of the kidney (tubulointerstitial nephritis) or inflammation of the kidney and eye (acute tubulointerstitial nephritis and uveitis syndrome)
• Nightmares
• Reduced immunity due to decreased levels of antibodies called immunoglobulins in the blood, which help protect against infection
• Red nodules or spots on the skin (pseudolymphoma).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse 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 Crisomet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack, carton, or bottle. The expiry date refers to the last day of the month indicated.

Crisomet does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Crisomet 100 mg chewable/dispersible tablets

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

The other components are: calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminium silicate, sodium carboxymethyl potato starch (Type A), povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavouring.

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

Crisomet chewable/dispersible tablets are white to off-white in colour and may be slightly mottled. The tablets have a blackcurrant odour.

Crisomet 100 mg chewable/dispersible tablets are square with rounded corners. The tablets are marked with the code “GSCL7” on one side and “100” on the other. Each pack contains 56 tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of the summary of product characteristics: June 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/