LAMICTAL 50 mg CHEWABLE/DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

LAMICTAL 50 mg Chewable/Dispersible Tablets

lamotrigine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet.You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only.Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lamictal and what is it used for
2. What you need to know before you take Lamictal
3. How to take Lamictal
4. Possible side effects
5. Storage of Lamictal
6. Contents of the pack and other information

1. What is Lamictal and what is it used for

Lamictal belongs to a group of medicines called antiepileptics. It can be used for the treatment of two conditions: epilepsyand bipolar disorder.

Lamictal is used for the treatment of epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (fits).

• In adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines to treat epilepsy.Lamictal can also be used with other medicines to treat seizures that occur with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamictal can be used with other medicines to treat the same conditions.It can also be used on its own to treat a type of epilepsy called typical absence seizures.

Lamictal is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic-depressive illness) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). In adults aged 18 years and over, Lamictal can be used to prevent the periods of depression that occur in bipolar disorder, either on its own or in combination with other medicines. It is not known how Lamictal works in the brain to have this effect.

2. What you need to know before you take Lamictal

Do not take Lamictal:

If this applies to you:

? Tell your doctorand do not take Lamictal.

Warnings and precautions

Be especially careful with Lamictal

Tell your doctor or pharmacist before you start taking Lamictal:

• . Your doctor will check your treatment and may advise you to avoid sunlight or take other precautions to protect your skin (such as using a sunscreen and/or protective clothing)
• (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 abnormal heart rhythms.

If any of these apply to you:

? Tell your doctor, who will decide whether you should take a lower 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 serious skin reactions, which can be life-threatening. 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 higher in people of Asian descent, particularly Chinese Han and Thai people, who have a genetic variant (HLA-B*1502). If you are of such descent and have been found to have this genetic variant, discuss this with your doctor before taking Lamictal.

? Read the description of these symptoms in section 4 of this leaflet“Reactions that can be life-threatening: see a doctor immediately”.

Hemophagocytic lymphohistiocytosis (HLH)

There have been reports of a rare but 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 (such as fits, tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Anti-epileptic medicines like Lamictal 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, carer 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 anti-epileptics like Lamictal have also had thoughts of self-harm or suicide. If you have any such thoughts at any time, contact your doctor immediately.

If you are taking Lamictal for epilepsy

Seizures in some types of epilepsy may occasionally become worse or more frequent while you are taking Lamictal.Some patients may experience severe seizures, which can cause serious health problems. If your seizures become more frequent or you experience severe seizures while taking Lamictal:

? See a doctor immediately.

Lamictal should 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 Lamictal

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 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 help you stop smoking
• paracetamol, used to treat painand fever.

Tell your doctorif you are taking any of these medicines.

Some medicines interact with Lamictal or may make it more likely that you will get 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, 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, a diaphragm or an intrauterine device (IUD). If you are taking a hormonal contraceptive, such as the pill, your doctor may take blood tests to check the levels of Lamictal in your blood. If you are taking a hormonal contraceptive or plan to start using one:

? Discuss this with your doctor, as they will advise you on the most suitable methods of contraception for you.

Lamictal may also affect how hormonal contraceptives work, although this is unlikely to affect the contraceptive effect. If you are using a hormonal contraceptive and you 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.You may need to have blood tests and your dose of Lamictal may be adjusted.
• If you take Lamictal during the first 3 months of your 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 while you are pregnant.

? 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 can cause dizziness and double vision.

? Do not drive or use machines unless you are sure that you are not affected by these side 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

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

What dose of Lamictal to take

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

• your age
• whether you are taking Lamictal 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 you reach the right dose for you (called the effective dose). Never take more Lamictal than your doctor has told you to.

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

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 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.

Lamictal 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.

Removing a tablet:

These tablets come in a special container to prevent children from taking 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. Peel off the outer layer: starting from a corner, lift and remove the foil that covers the unit.

1. Remove the tablet: press one side of the tablet gently through the foil to remove 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
• 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 no medicine is left in the glass.

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 medication 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 doseto make up for forgotten doses. Takethe next dose at the usual time.

If you forget to take multiple doses of Lamictal

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

Do not stop taking Lamictal without your doctor's advice

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 the treatment of epilepsy

To stop taking Lamictal, it is important that the dose is gradually reducedover about 2 weeks. If you stop taking Lamictal suddenly, you may experience a return of epilepsy symptoms or the disease may worsen.

If you are taking Lamictal for bipolar disorder

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

4. Possible side effects

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

Life-threatening reactions: see your doctor immediately.

A small number of people taking Lamictal have allergic reactions or skin reactions that can 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 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 medication called valproate. Some of these symptoms are more common in children, so parents should pay special attention to them.

The symptoms of these reactions include:

• skin rash or redness, which can lead to serious skin reactions, including a rash with target-like lesions (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling of the skin over a large area (more than 30% of the body surface - toxic epidermal necrolysis) or a skin rash with involvement of the liver, blood, and other organs of the body (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 more infections than usual (such as colds)
• increased liver enzyme levels in blood tests
• increased levels of a type of white blood cell (eosinophils)
• enlarged lymph nodes
• organ damage, including liver and kidney damage.

In many cases, these symptoms can be signs of less serious side effects. But you should be aware that they can 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 have 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 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 sunlight 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 life-threatening skin reaction (Stevens-Johnson syndrome) (see also the information at the beginning of section 4)
• a set of symptoms that include: 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 go away 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 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 Lamictal)
• changes that can be seen in blood tests, including a low number of red blood cells (anemia), a low number of white blood cells (leukopenia, neutropenia, agranulocytosis), a low number of platelets (thrombocytopenia), a low 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 that cannot be controlled (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 be accompanied by fever and/or general 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
• skin nodules or red patches (pseudolymphoma).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they 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 side 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 that appears on the blister pack, 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 through wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, 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 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-substituted hydroxypropylcellulose, aluminum and magnesium silicate, sodium carboxymethyl starch (Type A) potato, povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavor.

Appearance and packaging of Lamictal chewable/dispersible tablets

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

Lamictal 50 mg chewable/dispersible tablets are square with rounded corners. The tablets are marked with "GSCX7" on one side and "50" on the other. Each pack contains blister packs of 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196, or 200 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 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/