LAMICTAL 2 mg CHEWABLE/DISPERSIBLE TABLETS

2. What you need to know before you take Lamictal

Do not take Lamictal:

• if you are allergic (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 Lamictal.

Warnings and precautions

Be especially careful with Lamictal

Consult your doctor or pharmacist before taking Lamictal:

• if you have any kidney problems
• if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you get a rash or blisters after taking lamotrigine and being exposed to sunlight or artificial light (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 creams 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 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 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 Lamictal is suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamictal have had allergic reactions or severe 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 watchful for them while taking Lamictal. 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 Lamictal.

? Read the description of these symptoms in section 4 of this leaflet“Life-threatening reactions: see a 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 Lamictal:

? See a 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 Lamictal 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 taking antiepileptics, such as Lamictal, have also had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

If you are taking Lamictal for epilepsy

Seizures in some types of epilepsy may occasionally become worse or happen more often while you are taking Lamictal. Some patients may experience severe seizures that can cause serious health problems. If seizures happen more often or if you experience severe seizures while taking Lamictal:

? See a doctor immediately.

Lamictal 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 behavior in children and adolescents under 18 years.

Other medicines and Lamictal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,including those 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 Lamictal. 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 doctorif you are taking any of these medicines.

Some medicines interact with Lamictal 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, primidoneor 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 doctorif 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 Lamictal 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 do a blood test to check the levels of Lamictal. If you are using a hormonal contraceptive or plan to use one:

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

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

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

Pregnancy and breast-feeding

? 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 particularly important if you have epilepsy.
• Pregnancy may affect how well Lamictal works, so you may need to have a blood test and have your dose adjusted.
• If Lamictal 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 breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.The active ingredient of Lamictal passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while taking Lamictal and will perform regular checks on your baby if you decide to breast-feed.

Driving and using machines

Lamictal may 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 driving or using machines.

Important information about some of the ingredients of Lamictal

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

3. How to take Lamictal

Take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, ask your doctor or pharmacist.

What dose of Lamictal to take

It may take a while to find the best dose of Lamictal for you. The dose you should take will depend on:

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

Your doctor will start you on a low dose and gradually increase the dose over a few weeks until you reach a dose that is suitable for you (called the effective dose). Never take more Lamictal than your doctor has told you to.

For adults and children aged 13 years and over, the effective dose of Lamictal is between 100 mg and 400 mg each day.

For children between 2 and 12 years of age, the effective dose will depend on their body weight, usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.

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

How to take your dose of Lamictal

Take your dose of Lamictal once or twice a day, as your doctor has advised. You can take it with or without food.

• Always take the full dosethat your doctor has prescribed. Never take part of a tablet.

Your doctor may advise you to start or stop taking other medicines, depending on the condition you are being treated for and how you respond to treatment.

The chewable/dispersible tablets of Lamictal can be swallowed whole, chewed, or mixed with water to dissolve them. Never take only part of the liquid.

Chewing the tablet:

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

To dissolve the medicine:

• put the tablet in a glass that contains enough water to cover the whole tablet
• stir 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 you have taken all the medicine.

If you take more Lamictal 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 medicine and the amount taken.

If you take more Lamictal than you should, you may be more likely to have serious side effects that can be life-threatening.

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

• rapid, uncontrollable 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 Lamictal

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

If you forget to take several doses of Lamictal

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

Do not stop taking Lamictal without consulting your doctor

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

If you are taking Lamictal for epilepsy

To stop taking Lamictal, it is important that the dose is gradually reduced over approximately 2 weeks.If you stop taking Lamictal suddenly, you may get your epilepsy symptoms back or your condition may get worse.

If you are taking Lamictal for bipolar disorder

Lamictal may take some time to work, so you may not feel better immediately. If you stop taking Lamictal, you do not need to reduce your dose gradually. However, you should talk to your doctor before stopping treatment with Lamictal.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Reactions that can potentially threaten life: consult your doctor immediately.

A small number of people taking Lamictal have allergic reactions or skin reactions that can potentially threaten their life, which can lead to more serious problems if left untreated.

It is more likely that these symptoms will appear during the first few months of treatment with Lamictal, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Lamictal with another medicine 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 life-threatening, including a rash with target-like lesions (erythema multiforme), a 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 a widespread skin rash with liver, blood, and other organ involvement (drug reaction with eosinophilia and systemic symptoms also known as DRESS syndrome)
• ulcers in the mouth, throat, nose, or genitals
• pain in the mouth or having red or swollen eyes(conjunctivitis)
• high temperature(fever), flu-like symptoms, or drowsiness (sopor)
• swelling around the faceor inflammation of the lymph nodesin the neck, armpits, or groin
• bleeding or unexpected bruising, or turning blue
• sore throator having 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 adverse effects. But you should be aware that they can potentially threaten lifeand can lead to more serious problems, such as organ failure, if left untreated. 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 stop treatment with Lamictal. 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 Lamictal).

Very Common Adverse Effects

These affect more than 1 in 10people:

• headache
• skin rash.

Common Adverse Effects

These affect up to 1 in 10people:

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

Uncommon Adverse 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 sunlight or artificial light (photosensitivity).

Rare Adverse Effects

These affect up to 1 in 1,000people:

• a skin reaction characterized by red, target-like patches on the skin, which can resemble a "bull's eye"; that is, with a dark red center surrounded by lighter 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 crusts on the eyelids (conjunctivitis).

Very Rare Adverse 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, which 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 Lamictal)
• 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 not controllable (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 can include back or joint pain, which can sometimes be accompanied by fever and/or generalized illness).

Other Adverse Effects

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

• bone disorders, including osteopenia and osteoporosis (decreased bone thickness) and fractures, have been reported. 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 Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamictal

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

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

Lamictal does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lamictal 2 mg chewable/dispersible tablets

The active ingredient is lamotrigine. Each chewable/dispersible tablet contains 2 mg of lamotrigine.

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

Appearance and Package Contents of Lamictal chewable/dispersible tablets

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

The Lamictal 2 mg chewable/dispersible tablets are round. The tablets are marked with "LTG" over the number "2"; the other side is marked with two overlapping superellipses. Each bottle contains 30 tablets.

Not all pack sizes may be marketed.

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:April 2024.

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