LAMOTRIGINE SANDOZ 25 mg DISPERSIBLE/CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Lamotrigine Sandoz 25 mg Dispersible/Chewable Tablets EFG

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

1. What is Lamotrigine Sandoz and what is it used for

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

Lamotrigine 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 above, lamotrigine can be used on its own or with other medicines, for the treatment of epilepsy.Lamotrigine can also be used with other medicines for the treatment of seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, lamotrigine can be used with other medicines for the treatment of the same conditions.It can also be used on its own for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigine is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic depression) 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 above, lamotrigine 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 lamotrigine works in the brain to have this effect.

2. What you need to know before you take Lamotrigine Sandoz

Do not take Lamotrigine Sandoz:

• if you are allergicto lamotrigine 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 lamotrigine.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Lamotrigine Sandoz:

• if you have any kidney problems,
• if you have ever developed a rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you get a rash or sunburn while taking lamotrigine and being exposed to sunlight or artificial light (such as in a solarium). Your doctor will monitor your treatment and may advise you to avoid sunlight or use a sunscreen and/or protective clothing,
• if you have ever had meningitisafter taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare side effects),
• if you are already taking medicines that contain lamotrigine.

If this applies to you:

? Tell your doctor, who will decide whether to reduce your dose or whether lamotrigine is suitable for you.

Important information about reactions that may affect your liver or blood

A small number of people taking lamotrigine may have allergic reactions or skin reactions that can be life-threatening, which may lead to more serious problems if not treated.These reactions 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 lamotrigine. This risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been detected with this genetic variant (HLA-B*1502), talk to your doctor before taking lamotrigine.

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

Brugada Syndrome

Brugada Syndrome is a genetic disease that causes abnormal electrical activity of the heart.Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heartbeat). Tell your doctor if you have this condition.

Hemophagocytic Lymphohistiocytosis (HLH)

There have been reports of a rare but very serious reaction of the immune system in patients taking lamotrigine.Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., spasms or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Anti-epileptic 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:

• 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 you are taking lamotrigine:

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

It may be helpful for you to tell a family member, carer, or close friend that you are taking lamotrigine 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, such as lamotrigine, have also had thoughts of self-harm or suicide.If you experience these thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigine Sandoz for epilepsy

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

? See a doctor immediately.

Lamotrigine 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 behavior in children and adolescents under 18 years.

Other medicines and Lamotrigine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used to treat epilepsy,
• lithium, olanzapine, or aripiprazoleused to treat mental health conditions,
• bupropionused to treat mental health conditionsor to help you stop smoking.

? Tell your doctorif you are taking any of these medicines.

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

• valproateused to treat epilepsyand mental health conditions,
• carbamazepineused to treat epilepsyand mental health conditions,
• phenytoin, primidone, or phenobarbitalused to treat epilepsy,
• risperidoneused to treat mental health conditions,
• rifampicinwhich is an antibiotic,
• medicines used to treat Human Immunodeficiency Virus (HIV) infection (AIDS)(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 lamotrigine works

Your doctor may recommend that you use a particular hormonal contraceptive, or another method of contraception such as condoms, diaphragm, or intrauterine device (IUD).If you are taking a hormonal contraceptive, such as the pill, your doctor may take blood samples to check the levels of lamotrigine. If you are using a hormonal contraceptive, or if you plan to start using one:

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

Lamotrigine can 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 breakthrough bleeding or spotting:

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

Pregnancy, breast-feeding, and fertility

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 lamotrigine works.You may need to have a blood test and your dose of lamotrigine may be adjusted.
• If lamotrigine is taken during the first 3 months of pregnancy, there may be a small increased risk of birth defects, including cleft lip or cleft palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and during pregnancy.

If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.The active ingredient lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while taking lamotrigine and will perform regular checks on your baby if you decide to breast-feed. Tell your doctor if you notice any of these symptoms in your baby: drowsiness, rash, or poor weight gain.

Driving and using machines

Lamotrigine may cause dizziness and double vision.

Do not drive or use machines unless you are sure that you are not affected by these effects.

If you have epilepsy, ask your doctor about driving or using machines.

Lamotrigine Sandoz contains sorbitol and sodium

This medicine contains 9.725 mg of sorbitol in each dispersible/chewable tablet, equivalent to 2.92 mg of sorbitol.

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

3. How to take Lamotrigine Sandoz

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

What dose of Lamotrigine to take

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

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

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

The usual effective dose of lamotrigine for adults and children aged 13 years and above 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 body weight, up to a maximum maintenance dose of 200 mg per day.

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

How to take your dose of Lamotrigine

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

• Always take the full dose that your doctor has prescribed for you.Never take only part of a tablet.

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

The dispersible/chewable tablets of lamotrigine can be swallowed whole, chewed, or mixed with water to dissolve them.

Chewing the tablet

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

To dissolve the medicine

• put the tablet in a glass that contains enough water to cover the tablet,
• stir to dissolve, or wait until the tablet is completely dissolved,
• drink all the liquid,
• add a little more water to the glass and drink it to make sure you have taken all the medicine.

If you take more Lamotrigine than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount used.

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

Someone who has taken too much lamotrigine 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 Lamotrigine

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

If you forget to take several doses of lamotrigine.

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

Do not stop taking Lamotrigine without your doctor’s advice.

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

If you are taking Lamotrigine Sandoz 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, you may get seizures again or your epilepsy may get worse.

If you are taking Lamotrigine for bipolar disorder

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

4. Possible Adverse Effects

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

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

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

It is more likely that these symptoms will appear during the first few months of treatment with lamotrigine, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking lamotrigine with another medicine called valproate. Some of these symptoms are more frequent in children, so parents should pay special attention to them.

The symptoms of these reactions include:

• skin rashes or redness,which can lead to life-threatening skin reactions, including widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome), peeling over a large area of the skin (more than 30% of the body surface - Toxic Epidermal Necrolysis) or widespread skin rash with liver, blood, and other organ involvement (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS),
• ulcers in the mouth, throat, nose, or genitals,
• pain in the mouth or red or swollen eyes(conjunctivitis),
• high temperature(fever), flu-like symptoms, or drowsiness (somnolence),
• swelling around the faceor inflammation of the lymph nodes in the neck, armpits, or groin,
• bleeding or unexpected bruising, or blue discoloration of the fingers,
• sore throat, or more frequent infections (such as colds),
• increased liver enzyme levels in blood tests,
• increased eosinophils (a type of white blood cell),
• enlarged lymph nodes,
• organ involvement, including the liver and kidneys.

In many cases, these symptoms can be signs of less serious adverse effects. However, you should be aware that they can be life-threatening and can lead to more serious problems,such as organ failure, if left untreated. If you notice any of these symptoms:

? Contact your doctor immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function and may advise you to stop treatment with lamotrigine. 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 Lamotrigina Sandoz).

Very Common Adverse Effects

May affect more than 1 in 10people

• headache,
• skin rash.

Common Adverse Effects

May affect up to 1 in 10people

• aggressiveness or irritability,
• feeling sleepy or drowsy,
• feeling dizzy,
• spasms or tremors,
• difficulty sleeping (insomnia),
• feeling agitated,
• diarrhea,
• dry mouth,
• nausea and vomiting,
• feeling tired,
• back pain, 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 sunlight or artificial light (photosensitivity).

Rare Adverse Effects

May affect up to 1 in 1,000people

• life-threatening skin reaction (Stevens-Johnson Syndrome) (see also 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 that cover the brain and spinal cord (meningitis). These symptoms usually disappear when treatment is discontinued. However, if the symptoms continue or worsen, contact your doctor,
• rapid, uncontrollable eye movements (nystagmus),
• itchy eyes, with discharge and crusts on the eyelids (conjunctivitis).

Very Rare Adverse Effects

May affect up to 1 in 10,000people

• life-threatening skin reaction (Toxic Epidermal Necrolysis: see also 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 inflammation of the lymph nodes in the neck, groin, or armpits (lymphadenopathy) (see also information at the beginning of section 4),
• changes in liver function, which can be observed 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),
• changes that can be observed in blood tests, including low red blood cell count (anemia), low white blood cell count (leukopenia, neutropenia, agranulocytosis), low platelet count (thrombocytopenia), low count of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anemia,
• hallucinations (hearing or seeing things that are not really there),
• confusion,
• feeling unsteady or unstable when moving,
• repetitive body movements and/or sounds or words that are uncontrollable (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,
• lupus-like reaction (symptoms may include: back or joint pain, which may be accompanied by fever and/or generalized illness).

Other Adverse Effects

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

• bone disorders, including osteopenia and osteoporosis (decreased bone thickness) and fractures. Consult your doctor or pharmacist if you have been taking antiepileptics for a long time, if you have a history of osteoporosis, or if you are taking steroids,
• nightmares,
• decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection,
• nodules or red spots on the skin (pseudolymphoma).

Reporting Adverse Effects

If you experience any 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 directly 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 medicine.

5. Storage of Lamotrigina Sandoz

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

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

Do not store above 30°C.

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

6. Package Contents and Additional Information

Composition of Lamotrigina Sandoz 25 mg dispersible/chewable tablets

• The active ingredient is lamotrigine. Each dispersible/chewable tablet contains 25 mg of lamotrigine.
• The other ingredients are: sorbitol, calcium carbonate, microcrystalline cellulose, crospovidone, cornstarch, talc, blackcurrant flavor, sodium saccharin, sodium stearyl fumarate, and anhydrous colloidal silica.

Appearance and Packaging of the Product

Lamotrigina Sandoz 25 mg dispersible/chewable tablets are white or almost white, square-shaped tablets, engraved with an "L" and "25" on one side, and smooth on the other side.

Each package contains 21, 42, or 56 dispersible/chewable tablets, packaged in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Bluepharma Industria Farmaceutica SA

Cimo de Fala, S. Martino do Bispo

Coimbra 3041-801

Portugal

Date of the Last Revision of this Leaflet:October 2023

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