Leaflet: information for the user

Lamotrigine Stada 25 mg dispersible tablets EFG

Lamotrigine Stada 50 mg dispersible tablets EFG

Lamotrigine Stada 100 mg dispersible tablets EFG

Lamotrigine Stada 200 mg dispersible tablets EFG

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

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What you need to know before you start taking Lamotrigine Stada
2. How to take Lamotrigine Stada

1. Possible side effects
2. Storage of Lamotrigine Stada
3. Contents of the pack and additional information

Lamotrigina belongs to a group of medications calledantiepileptic drugs. It can be used to treat two diseases:epilepsyandbipolar disorder.

Lamotrigina is used to treat epilepsybecause it blocks the signals in thebrain that trigger seizures (convulsions).

• In adults and children 13 years of age and older, lamotrigina can be used alone or in combination with other medications, for the treatment of epilepsy. Lamotrigina can also be used along with other medications for the treatment of seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, lamotrigina can be used in combination with other medications for the treatment of the same diseases. It can also be used without combining with other medications for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigina is also used to treat bipolar disorder.

People with bipolar disorder (formerly known asmanic-depressive disorder) experience extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or desperation). In adults 18 years of age and older, lamotrigina can be used, to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. The way lamotrigina acts in the brain to produce this effect is not known.

Do not take Lamotrigina Stada.

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

If this is the case:

Inform your doctor, and do not take lamotrigine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take lamotrigine.

• If you have any kidney problems
• If you have ever developed any skin rashafter taking lamotrigine or othermedicines for bipolar disorder or epilepsy
• If you experience a rash or sunburn after taking lamotrigine and being exposed to the sun or artificial light (for example, in a solarium). Your doctor will check your treatment and may advise you to avoid the sun or to protect yourself from the sun (for example, by using a sunscreen and/or protective clothing).
• If you have ever had meningitis after taking lamotrigine(see the description of these symptoms in section 4 of this leaflet: “Rare side effects”)

• If you are already taking medicines that contain lamotrigine
• Ifyou have a condition called Brugada Syndrome or other heart problems. Brugada Syndrome is a genetic disease that causes abnormal heart electrical activity. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that may lead to arrhythmias (abnormal heart rhythm)

If this is the case:

• Inform your doctor, who will decide to reduce the dose or determine that lamotrigineis not suitable for you.

Important information about potentially life-threatening reactions

A small number of people who took lamotrigine have had allergic reactions or skin reactions that may be life-threatening, which can lead to more serious problems if not treated. These reactions may include Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS).You need to know the symptoms of these reactions and be aware of themwhile taking lamotrigine.

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

Lymphohistiocytosis hemophagocytic (LHH)

Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine.

?Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., spasms or tremor, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

Antiepileptic drugs are used to treat various conditions, including epilepsy and bipolar disorder. People with bipolar disorder may have had thoughts of self-harm or suicide at somepoint. If you have bipolar disorder, you may be more likely to have these thoughts in the following situations:

• When starting 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 lamotrigine:

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

It may be helpful for you to explain to a family member, carer, or close friend that you may become depressed or have significant mood changes, 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 treated with antiepileptic drugs like lamotrigine have also had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

If you are taking Lamotrigina Stada for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more frequentlywhile taking lamotrigine. 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 lamotrigine:

??See a doctor immediately.

Lamotrigina Stada should not be given to children under 18 years old for the treatment of bipolar disorder. Medicines used to treat depression and other mental health problems increase the risk of thoughts and behaviors of self-harm or suicide in children and adolescents under 18 years old.

Other medicines and Lamotrigina Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Your doctor needs to know if you are taking other medicines for the treatment of epilepsy or mental health problems. This is to ensure that you take the correct dose of lamotrigine. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used for the treatment ofepilepsy
• lithium,olanzapineoraripiprazole, used for the treatment ofmental health problems

• bupropion, used for the treatment ofmental health problemsor tostop smoking
• paracetamol, used to treat pain and fever.

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

Some medicines interact with lamotrigine or make people more likely to have side effects. These include:

• valproate, used for the treatment ofepilepsyandmental health problems
• carbamazepine, used for the treatment ofepilepsyandmental health problems
• phenytoin, primidone, or phenobarbital, used for the treatment ofepilepsy

• risperidone, used for the treatment ofmental health problems

• rifampicin, which is anantibiotic
• medicines used to treat HIV infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such asthe pill(see below).

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

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

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

• Inform your doctor, who will tell you which methods of contraception are most suitable for you.

The administration of lamotrigine may modify the way 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 bleeding between periods:

• Inform your doctor. These may be signs that lamotrigine is affecting the way your contraceptive works.

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 modify the effectiveness of lamotrigine treatment, so you may need to have a blood test and have your dose adjusted.
• If lamotrigine is taken during the first 3 months of pregnancy, there may be a small increase in the risk of birth defects, including cleft lip and/or 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 start breastfeeding, consult your doctor or pharmacist before taking this medicine.Lamotrigine passes into breast milk and may affect yourbaby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine. If you decide to start breastfeeding, your doctor will check your baby from time to time as they may experience drowsiness, rash, or poor weight gain. Inform your doctor if you observe any of these symptoms in your baby.

Driving and using machines

Lamotrigina Stada may 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 containsless than 1 mmol of sodium (23mg) per dispersible tablet; this is, essentially “sodium-free”.

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

Lamotrigina Stada dosage

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

• your age
• whether you are taking lamotrigina with other medications

• whether you have any liver or kidney problems

Your doctor will prescribe a low dose at the beginning of treatment and gradually increase the dose over several weeks to reach the most appropriate dose for you (called theeffective dose).Do not take more 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 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.

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

How to take Lamotrigina Stada

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

• Always take the complete doseprescribed by your doctor. Never take part of thetablet.

Your doctor may advise you to start or stop taking other medications, depending on the condition 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.

Masticate 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 the entire medication.

To dissolve the medication (make a liquid medication):

• Place the tablet in a glass containing at least enough water to cover the entire tablet.
• Shake to dissolve, or wait for a minute, until the tablet is completely dissolved.

• Drink the entire liquid.
• Add a little more water to the glass and drink it, to make sure there is no remaining medication in the glass.

If you take more Lamotrigina Stada than you should

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

If you take morelamotrigina than you should, you may be more prone to severe side effects that can be fatal.

Someone who has taken too much lamotrigina may experience some of the following symptoms:

• rapid and uncontrolled 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 Lamotrigina Stada

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

If you forget to take multiple doses of lamotrigina

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

Do not stop taking lamotrigina without consulting

You must take lamotrigina for as long as your doctor recommends. Do not stop treatment until your doctor tells you to.

If you are taking lamotrigina for epilepsy treatment

To stop taking lamotrigina,it is essential to gradually reduce the doseover approximately 2 weeks. If you stop taking lamotrigina abruptly, you may experience a relapse of epilepsy symptoms or the condition may worsen.

If you are taking lamotrigina for bipolar disorder

Lamotrigina may take time to act, 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, consult your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Reactions that may potentially threaten life: seek immediate medical help.

A small number of people taking lamotrigine develop allergic reactions or skin reactions that may 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 lamotrigine, especially if the initial dose is too high or if the dose is increased too quickly or if lamotrigine is taken with another medicine called valproate. Some of these symptoms are more common in children, so parents should pay special attention.

The symptoms of these reactions include:

• skin eruptions or redness, which can lead to life-threatening skin reactions, including widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis), or extensive skin rash with liver, blood, and other organ involvement (pharmacological reaction with eosinophilia and systemic symptoms also known as drug reaction with eosinophilia and systemic symptoms (DRESS)).

• ulcers in the mouth, throat, nose, or genitals
• eye pain or red, swollen eyes (conjunctivitis)

• high temperature (fever), symptoms similar to the flu or drowsiness (somnolence)
• swelling around the face or inflammation of the lymph nodes in the neck, armpits, or groin

• unexplained bleeding or bruising, or fingers turning blue
• throat pain or experiencing more infections than usual (such as colds)
• increased levels of liver enzymes in blood tests
• increased levels of a type of white blood cell (eosinophils)
• enlarged lymph nodes
• organ damage, including the liver and kidneys.

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

??Contact a doctor immediately.Your doctor will decide if you should undergo tests to assess the function of the liver, kidneys, or blood and may instruct you to stop taking lamotrigine. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will instruct you never to use lamotrigine again.

Lymphohistiocytosis hemophagocytic (LHH)(see section 2. What you need to know before starting to take Lamotrigine Stada).

Very common side effects

May affect more than 1 in 10 people:

• headache

• skin rash

Common side effects

May affect up to 1 in 10 people:

• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy

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

• dry mouth
• nausea or vomiting
• feeling tired

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

Uncommon side effects

May affect up to 1 in 100 people:

• clumsiness and loss of coordination (ataxia)
• double vision or blurred vision
• hair loss (alopecia)
• skin rash or sunburn after exposure to the sun or artificial light (photosensitivity)

Rare side effects

May affect up to 1 in 1,000 people

• life-threatening skin reaction (Stevens-Johnson syndrome)(see also information at the beginning of section 4)
• a group of symptoms that include: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light. This can be caused by inflammation of the membranes that cover the brain and spinal cord (meningitis). These symptoms usually disappear when treatment is stopped. However, if symptoms continue or worsen, contact your doctor
• rapid, uncontrolled eye movements (nystagmus)
• eye itching, with discharge and crusts on the eyelids (conjunctivitis)

Very rare side effects

May affect up to 1 in 10,000 people

• • changes in liver function, which can be seen in blood tests or liver failure (see also information at the beginning of section 4)
• severe blood clotting disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4)
• lymphohistiocytosis hemophagocytic (LHH)(see section 2. What you need to know before starting to take Lamotrigine Stada)
• • changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), a reduced number of all types of blood cells (pancytopenia), and a condition called aplastic anemia
  • hallucinations (hearing or seeing things that are not really there)
  • confusion
  • feeling insecure or unstable when moving
  • uncontrollable body movements (tics), muscle spasms that affect the eyes, head, and torso (coreoatetosis), or other unusual movements such as twitching, spasms, or stiffness
  • more frequent seizures in people with epilepsy
  • worsening of symptoms in people with Parkinson's disease
  • reaction similar to lupus (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or general illness).

Other side effects

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

• bone changes that include osteopenia and osteoporosis (bone thinning) and fractures. Consult your doctor or pharmacist if you have taken antiepileptic medicines for a long time, if you have a history of osteoporosis, or if you take steroids
• inflammation of the kidney (tubulointerstitial nephritis) or inflammation of the kidney and eye (acute tubulointerstitial nephritis and uveitis)
• nightmares
• reduced immunity, due to a reduction in the levels of antibodies called immunoglobulins in the blood that help protect against infection.

Reporting of side effects

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

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

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

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Lamotrigine Stada Composition

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

-The other components are: crospovidone, potassium acesulfame (E 950), orange aroma, mannitol (E 421), anhydrous colloidal silica, sodium stearate fumarate.

Product Appearance and Packaging Content

Lamotrigine Stada 25 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and have the mark “25” on one side.

Lamotrigine Stada 50 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and have the mark “50” on one side.

Lamotrigine Stada 100 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and have the mark “100” on one side.

Lamotrigine Stada 200 mg is presented in the form of dispersible tablets. The tablets are white, round, flat, and have the mark “200” on one side.

Lamotrigine 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 aluminum/PVC/Aclar blisters containing 10, 14, 21, 28, 30, 42, 50, 56, 60, 90, 100, and 200 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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 with the following names:

BE:Lamotrigine EG 25/50/100/200 mg dispergeerbare tabletten

LU:Lamotrigine EG 25/50/100/200 mg comprimés dispersibles

DK:Lamotrigin Stada 5/25/50/100/200 mg dispergible tabletter

HU:LATRIGIL 5/25/50/100/200 mg diszpergálódó tabletta

IT:Lamotrigina EG 5/25/50/100/200 mg compresse dispersibili

ES:Lamotrigina STADA 25/50/100/200 mg comprimidos dispersables EFG

Last review date of this prospectus:December 2023.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”.