Lamotrigine Stada 25 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamotrigina Stada 25 mg dispersible tablets EFG

Lamotrigina Stada 50 mg dispersible tablets EFG

Lamotrigina Stada 100 mg dispersible tablets EFG

Lamotrigina Stada 200 mg dispersible tablets EFG

Read the entire 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 give it to others, even if they have the same symptoms as you, because 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 Lamotrigina Stada is and what it is used for

2. What you need to know before taking Lamotrigina Stada

3. How to take Lamotrigina Stada

4. Possible side effects

5. How to store Lamotrigina Stada

6. Contents of the pack and other information

1. What Lamotrigina Stada is and what it is used for

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

Lamotrigine is used to treat epilepsy because it blocks signals in the brain that trigger seizures (fits).

• In adults and children aged 13 years and older, lamotrigine may be used alone or in combination with other medicines to treat epilepsy. Lamotrigine may also be used together with other medicines to treat seizures caused by a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, lamotrigine may be used in combination with other medicines to treat the same conditions. It may also be used without other medicines to treat a type of epilepsy called typical absence seizures.

Lamotrigine 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, lamotrigine may be used, either alone or in combination with other medicines, to prevent depressive episodes associated with bipolar disorder. It is not known how lamotrigine works in the brain to produce this effect.

2. What you need to know before taking Lamotrigine Stada

DO NOT take Lamotrigine Stada:

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

If this applies to you:

??Inform your doctor, and do not take lamotrigine.

Warnings and precautions

Talk to your doctor or pharmacist before starting lamotrigine.

• 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 experience a rash 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 causing 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 your dose or determine that lamotrigine is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people who took lamotrigine have had allergic or skin reactions that could potentially be life-threatening and 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). You need to be aware of the symptoms of these reactions and monitor for them while taking lamotrigine. This risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai). If you are of one of these ethnicities and have previously been diagnosed with this genetic variant (HLA-B*1502), speak with your doctor before taking Lamotrigine Stada.

• Read the description of these symptoms in section 4 of this leaflet: "Reactions that may potentially be life-threatening: seek immediate medical help".

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., seizures or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat various 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 such thoughts under the following circumstances:

• 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 feel worse or develop new symptoms while being treated with lamotrigine:

??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 inform you if they are concerned about your depression or other changes in your behavior.

A small number of people treated with antiepileptic medicines such as lamotrigine 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 Lamotrigine Stada for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more frequently while taking lamotrigine. Some patients may experience severe seizures, which could cause serious health problems. If seizures occur more frequently or if you experience severe seizures while taking lamotrigine:

??See a doctor immediately.

Lamotrigine should 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 Lamotrigine Stada

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

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 lamotrigine. 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 lamotrigine or make it more likely for people to 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)

• hormonal contraceptives, such as the contraceptive pill (see below).

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

Hormonal contraceptives (such as the contraceptive pill) may affect how Lamotrigine Stada 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 ask you to have a blood test to check lamotrigine levels. If you are using a hormonal contraceptive or are considering starting one:

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

Taking lamotrigine may alter 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:

• Inform your doctor. These may be signs that lamotrigine is affecting how 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 alter the effectiveness of lamotrigine treatment, so you may need a blood test and dose adjustment.

• If lamotrigine 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 during pregnancy.

• If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. The active ingredient in Lamotrigine Stada passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine. If you decide to breastfeed, your doctor will periodically check your baby, as they 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

Lamotrigine Stada 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.

Lamotrigine Stada contains sodium

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

3. How to take Lamotrigina Stada

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

• your age
• whether you are taking lamotrigine together with other medicines
• 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 until reaching the most appropriate dose for you (called the effective dose). Never take more lamotrigine than your doctor has prescribed.

The recommended dose of lamotrigine 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 body weight, up to a maximum maintenance dose of 200 mg per day.

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

How to take the dose of Lamotrigina Stada

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

• Always take the full dose prescribed by your doctor. Never take only 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.

Lamotrigine dispersible tablets may be swallowed whole with a little water, chewed, or mixed with water to dissolve.

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 of the medicine.

To dissolve the medicine (to make a liquid preparation):

• Place the tablet in a glass containing at least enough water to cover the entire tablet.
• Shake to dissolve, or wait for one 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 medicine is left in the glass.

If you take more Lamotrigina Stada than you should

• Contact your doctor or the nearest hospital emergency department immediately, or contact the Toxicology Information Service at telephone: 91 5620420. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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

Someone who has taken too much lamotrigine 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 Lamotrigina Stada

• 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 lamotrigine

• Ask your doctor for advice on how to restart treatment. It is important that you do this.

Do not stop taking lamotrigine without consulting your doctor

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

If you are taking lamotrigine for epilepsy

To stop taking lamotrigine, it is important that the dose is gradually reduced over approximately 2 weeks. If you stop taking lamotrigine suddenly, your epilepsy symptoms may return or your condition may worsen.

If you are taking lamotrigine for bipolar disorder

Lamotrigine may take some time to work, so it is unlikely you will feel better immediately. When stopping lamotrigine, you do not need to gradually reduce the dose. However, even so, you must consult your doctor before stopping treatment with lamotrigine.

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

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: seek medical help immediately.

A small number of people taking lamotrigine develop 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 lamotrigine, especially if the initial dose is too high, if the dose is increased too quickly, or if lamotrigine is taken 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 life-threatening skin reactions, including widespread blistering rash and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis), or widespread rash with involvement of the liver, blood, and other body organs (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 (stupor)

• swelling around the face or swollen lymph nodes in the neck, armpits, or groin

• unexpected 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 body organs 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 problems, such as organ failure, if not treated. If you notice any of these symptoms:

??Contact a doctor immediately. Your doctor will decide whether you need tests to assess the function of your liver, kidneys, or blood, and may advise you to stop treatment with lamotrigine. 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 Lamotrigine Stada).

Very common adverse effects

May affect more than 1 in 10 people:

• headache
• skin rash

Common adverse effects

May affect up to 1 in 10 people:

• aggression or irritability

• feeling sleepy or drowsy

• feeling dizzy

• spasms or tremors

• difficulty sleeping (insomnia)

• feeling restless

• diarrhoea

• dry mouth

• nausea or vomiting

• feeling tired

• back, joint, or other pain.

Uncommon adverse effects

May affect up to 1 in 100 people:

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

Rare adverse effects

May affect up to 1 in 1,000 people:

• 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 crusty eyelids (conjunctivitis)

Very rare adverse effects

May affect up to 1 in 10,000 people:

• skin reaction that may be life-threatening (toxic epidermal necrolysis) (see 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 be seen 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 Lamotrigine Stada)

  • changes that may be seen in blood tests including reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all types of blood cells (pancytopenia), and a disorder of the bone marrow called aplastic anaemia
  • hallucinations (hearing or seeing things that are not really there)
  • confusion
  • feeling unsteady or unstable when moving
  • uncontrollable, repeated body movements and/or 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 occurred in a small number of people, but their exact frequency is not known (frequency cannot be estimated from the available data):

• bone disorders including osteopenia and osteoporosis (decreased bone thickness) and fractures have been reported. 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 are taking steroids
• inflammation of the kidney (tubulointerstitial nephritis) or inflammation of the kidney and eye (acute tubulointerstitial nephritis and uveitis syndrome)
• nightmares
• decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood, which help protect against infection
• red nodules or patches 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamotrigine Stada

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 and outer packaging. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. 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 Lamotrigina Stada

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

• The other components are: crospovidone, acesulfame potassium (E 950), orange flavour, mannitol (E 421), colloidal anhydrous silica, sodium stearyl fumarate.

Appearance of the product and contents of the pack

Lamotrigina Stada 25 mg is presented as dispersible tablets. The tablets are white, round, flat, and marked with “25” on one side.

Lamotrigina Stada 50 mg is presented as dispersible tablets. The tablets are white, round, flat, and marked with “50” on one side.

Lamotrigina Stada 100 mg is presented as dispersible tablets. The tablets are white, round, flat, and marked with “100” on one side.

Lamotrigina Stada 200 mg is presented as dispersible tablets. The tablets are white, round, flat, and marked with “200” on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states under 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 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

Date of the most recent review of this leaflet: January 2024.

Detailed 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/".