LAMOTRIGINE STADA 100 mg DISPERSIBLE TABLETS

2. What you need to know before you take Lamotrigina Stada

Do not take Lamotrigina Stada:

• If you are allergic to lamotrigina or any of the other ingredients of this medicine (listed in section 6).

If this applies to you:

Tell your doctor, and do not take lamotrigina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take lamotrigina.

• If you have any kidney problems
• If you have ever developed a skin rashafter taking lamotrigina or other medicines for bipolar disorder or epilepsy
• If you get a rash or sunburn after taking lamotrigina and being exposed to sunlight or artificial light (e.g. in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or use a sunscreen and/or protective clothing.
• If you have ever had meningitis after taking lamotrigina(read the description of these symptoms in section 4 of this leaflet: Rare side effects)

• If you are already taking medicines that contain lamotrigina
• 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. Lamotrigina may 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 reduce the dose or determine that lamotrigina is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people who took lamotrigina have had 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 lamotrigina. This risk may be associated with a genetic variant in people of Asian origin (mainly Chinese Han and Thai). If you are of one of these origins and have been previously diagnosed with this genetic variant (HLA B* 1502), talk to your doctor before taking Lamotrigina Stada.

• Read the description of these symptoms in section 4 of this leaflet“Reactions that can be life-threatening: get medical help immediately”.

Hemophagocytic Lymphohistiocytosis (HLH)

There have been reports of a rare but very serious reaction of the immune system in patients taking lamotrigina.

Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigina: fever, rash, neurological symptoms (e.g. seizures 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 have had thoughts of self-harm or suicide in the past. 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 lamotrigina:

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

It may be useful for you to tell a family member, caregiver, or close friend that you are taking lamotrigina and ask them to read this leaflet.You can ask them to tell you if they are worried about your depression or any changes in your behavior.

A small number of people who were treated with antiepileptics like lamotrigina 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 Lamotrigina Stada for epilepsy

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

Go to a doctor immediately.

Lamotrigina Stada 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 thoughts and behaviors of suicide in children and adolescents under 18 years.

Other medicines and Lamotrigina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 lamotrigina. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used for the treatment of epilepsy
• lithium, olanzapineor 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 pain and fever.

Tell your doctorif you are using any of these medicines.

Some medicines interact with lamotrigina 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 Human Immunodeficiency Virus (HIV) infection(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the contraceptive pill(see below).

• Tell your doctorif you are using any of these medicines, or if you start or stop using them.

Hormonal contraceptives (such as the contraceptive pill) can affect the way Lamotrigina Stada works

Your doctor may recommend that you use a specific hormonal contraceptive, or that you use a different method of contraception, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive like the contraceptive pill, your doctor may ask you to have a blood test to check the levels of lamotrigina. If you are using a hormonal contraceptive or if you are thinking of starting to use one:

• Tell your doctor, as they will advise you on the most suitable contraceptive methods for you.

It is possible that lamotrigina may affect the way hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and you notice changes in your menstrual cycle, such as intermenstrual bleeding or loss between periods:

• Tell your doctor. These may be signs that lamotrigina is affecting the way your contraceptive is working.

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 particularly important if you have epilepsy.
• Pregnancy may affect the effectiveness of treatment with lamotrigina, so you may need to have a blood test and have your dose adjusted.
• If lamotrigina 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 planning to breastfeed, consult your doctor or pharmacist before taking this medicine.The active ingredient of Lamotrigina Stada passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigina. If you decide to breastfeed, your doctor will monitor your baby from time to time, as they may become drowsy, develop a rash, or have a low weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigina Stada 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.

Lamotrigina Stada contains sodium

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

3. How to Take Lamotrigina Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What Dose of Lamotrigina Stada to Take

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

• your age
• if you are taking lamotrigina 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 the effective dose). Never takemore lamotrigina than your doctor has indicated.

The recommended dose of lamotrigina for adults and children 13 years and older 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, normally between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day.

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

How to Take the Dose of Lamotrigina Stada

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

• Always take the complete 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.

Lamotrigina dispersible tablets can be swallowed whole with a little water, chewed, or mixed with water to dissolve them.

Chewing the tablet:

When 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 ensure you have taken all the medication.

To Dissolve the Medication (Make a Liquid Medication):

• Put the tablet in a glass containing enough water to cover the entire tablet.
• Shake to dissolve or wait for about a minute until the tablet is completely dissolved.

• Drink all the liquid.
• Add a little more water to the glass and drink it, to ensure no medication is left in the glass.

If You Take More Lamotrigina Stada Than You Should

• Consult your doctor or the nearest hospital emergency department immediately or the Toxicology Information Service, phone: 91 5620420. It is recommended to take the packaging and the medication leaflet to the healthcare professional.

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

Someone who has taken too much lamotrigina 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 (convulsions), or coma.

If You Missed a Dose of Lamotrigina Stada

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

If You Missed Multiple Doses of Lamotrigina

• Ask your doctor to explain how to start the treatment again. It is important that you do this.

Do Not Stop Taking Lamotrigina Without Consulting

You should take lamotrigina for as long as your doctor recommends. Do not stop treatment until your doctor indicates it.

If You Are Taking Lamotrigina for the Treatment of Epilepsy

To stop taking lamotrigina, it is important to gradually reduce the dose, over about 2 weeks. If you stop taking lamotrigina abruptly, you may experience the return of epilepsy symptoms or the disease may worsen.

If You Are Taking Lamotrigina for Bipolar Disorder

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medications, this medication can have adverse effects, although not everyone will experience them.

Reactions That Can Potentially Threaten Life: Seek Medical Help Immediately.

A small number of people taking lamotrigina develop allergic reactions or skin reactions that can potentially threaten their life, which can lead to more serious problems if not treated.

It is more likely that these symptoms will appear during the first months of treatment with lamotrigina, especially if the initial dose is too high or if the dose is increased too quickly or if lamotrigina is taken 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:

• rash or redness of the skin,which can lead to life-threatening skin reactions, including widespread rash with blisters andpeelingof the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome), extensive skin peeling (more than 30% of 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).

• ulcersin 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 (somnolence)
• 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 levels of a type of white blood cell (eosinophils)
• enlarged lymph nodes
• organ involvement including the liver and kidneys.

In many cases, these symptoms can be signs of less serious adverse effects. However, youshould be aware that they can potentially threaten your life and can lead to more serious problemssuch as organ failure if not treated. If you notice any of these symptoms:

Contact a doctor immediately. Your doctor will decide if you need tests to assess liver, kidney, or blood function and may indicate that you should stop treatment with lamotrigina. If you have developed Stevens-Johnson Syndrome or toxic epidermal necrolysis, your doctor will indicate that you should never take lamotrigina again.

Haemophagocytic Lymphohistiocytosis (HLH)(see section 2. What you need to know before taking Lamotrigina Stada).

Very Common Adverse Effects

May affect more than 1 in 10people:

• headache

• skin rash

Common Adverse Effects

May affect up to 1 in 10people:

• aggression or irritability
• drowsiness or somnolence
• dizziness

• spasms or tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea

• dry mouth
• nausea or vomiting
• feeling tired

• back pain or joint pain, or pain in other areas.

Uncommon Adverse Effects

May 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 Adverse Effects

May affect up to 1 in 1,000people

• 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 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 Adverse Effects

May affectup to 1 in 10,000people

• 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 (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)

• changes that can be observed in blood tests, including decreased red blood cell count (anemia), decreased white blood cell count (leukopenia, neutropenia, agranulocytosis), decreased platelet count (thrombocytopenia), decreased 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
• uncontrollable repetitive body movements and/or sounds or words (tics), uncontrollable 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
• reaction similar to lupus (symptoms may include: back or joint pain, which may be accompanied by fever and/or general illness).

Other Adverse Effects

Other adverse effects have appeared in a small number of people, but their exact frequency is notknown (the frequency cannot be estimated from the available data)

• bone disorders have been reported, including osteopenia and osteoporosis (decrease in bone thickness) and fractures. Consult your doctor or pharmacist if you have taken antiepileptic medications 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
• red nodules or patches on the skin (pseudolymphoma).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lamotrigina Stada

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Medications should not be disposed of in wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. 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 Lamotrigina Stada

-The active ingredient is lamotrigina. Each dispersible tablet contains 25 mg, 50 mg, 100 mg, or 200 mg of lamotrigina.

-The other ingredients are: crospovidone, acesulfame potassium (E 950), orange flavor, mannitol (E 421), colloidal anhydrous silica, sodium stearyl fumarate.

Appearance of the Product and Package Contents

Lamotrigina Stada 25 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and marked with "25" on one side.

Lamotrigina Stada 50 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and marked with "50" on one side.

Lamotrigina Stada 100 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and marked with "100" on one side.

Lamotrigina Stada 200 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and marked with "200" on one side.

Lamotrigina Stada dispersible tablets are packaged in aluminum/aluminum blisters containing 10, 14, 21, 28, 30, 42, 50, 56, 90, 100, and 200 tablets or in polymer blisters (aluminum/PVC/Aclar) containing 10, 14, 21, 28, 30, 42, 50, 56, 60, 90, 100, and 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

SANICO N.V.

Industriezone 4, Veedijk 59

B-2300 - Turnhout

Belgium

or

STADA ARZNEIMITTEL AG

Stadastrasse 2- 18

D-61118 - Bad Vilbel

Germany

This medication is authorized in the member states of the European Economic Area under the following names:

BE: Lamotrigine EG 25/50/100/200 mg dispersible tablets

LU: Lamotrigine EG 25/50/100/200 mg dispersible tablets

DK: Lamotrigin Stada 5/25/50/100/200 mg dispersible tablets

HU: LATRIGIL 25/50/100/200 mg dispersible tablets

IT: Lamotrigina EG 5/25/50/100/200 mg dispersible tablets

ES: Lamotrigina STADA 25/50/100/200 mg dispersible tablets EFG

Date of the Last Revision of this Leaflet:January 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/".