Prospecto:Information for the Patient

Lacosamida Normon 50 mg Film-Coated Tablets

Lacosamida Normon 100 mg Film-Coated Tablets

Lacosamida Normon 150 mg Film-Coated Tablets

Lacosamida Normon 200 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospectus. See section 4.

1.What is Lacosamida Normon and for what it is used

2.What you need to knowbeforestarting totake Lacosamida Normon

3.How to take Lacosamida Normon

4.Possible adverse effects

5Storage of Lacosamida Normon

6.Contents of the package and additional information

What is lacosamida

This medicine contains lacosamida, which belongs to a group of medicines called

“antiepileptic medicines”. These medicines are used to treat epilepsy.

•You have been prescribed this medicine to reduce the number of seizures you experience.

What is lacosamida used for

•Lacosamida is used:

• alone and in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years and older to treat a certain type of epilepsy characterized by the occurrence of partial onset seizures with or without secondary generalization.In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas in both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents, and children aged 4 years and older to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

Do not take Lacosamida Normon

•if you are allergic to lacosamida or any of the other ingredients of this medicine (listed in section 6). If you are unsure if you are allergic, consult your doctor.

•if you have a heart rhythm problem called second- or third-degree AV block.

Do not take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting to take this medicine if:

•you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamida have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

•you have a heart condition that affects your heartbeat and your pulse is often especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).

•you have a serious heart condition such as heart failure or have had a heart attack.

•you often feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidents or falls. This means you mustbe carefuluntil you are used to the effects of this medicine.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

Consult your doctor if you are taking Lacosamida Normon and experience a new type of seizure or worsening of existing seizures.

Consult your doctor immediately if you are taking Lacosamida Normon and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting) (see section 4).

Children

Lacosamida is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures or for children under 4 years with generalized tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children in this age group.

Other medicines and Lacosamida Normon

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

Inform your doctor or pharmacist in particular if you are taking any of the following medicines that affect the heart, as lacosamida may also affect the heart.

•medicines to treat heart problems.

•medicines that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine, or pregabalin.

•medicines used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking this medicine.

Inform your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of lacosamida in your body.

•medicines for fungal infections such as fluconazole, itraconazole, or ketoconazole.

•medicines for HIV such as ritonavir.

•medicines for bacterial infections such as clarithromycin or rifampicin.

•a medicinal plant used to treat mild anxiety and depression called St. John's Wort.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking lacosamida.

Lacosamida with alcohol

As a precaution, do not take this medicine with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Lacosamida is not recommended during pregnancy, as its effects on the fetus are not known.

It is not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.

Seek advice immediately from your doctor if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.

Do not stop treatment without first talking to your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, ride a bike, or use any tools or machines until you know if this medicine affects you. The reason is that lacosamida may cause dizziness or blurred vision.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Other forms of this medication may be more suitable for children; consult your doctor or pharmacist.

Lacosamide Dosage

•Take lacosamide twice a day, with an interval of approximately 12 hours.

•Try to take it more or less at the same time each day.

•Take the lacosamide tablet with a glass of water.

•You can take lacosamide with meals or separately.

Normally, you will start taking a low dose every day, and your doctor will gradually increase the dose over several weeks. When you reach the dose that works well for you, which is called the "maintenance dose," you will take the same amount every day. Lacosamide is used as long-term treatment. You must continue taking lacosamide until your doctor tells you to stop.

How much to take

The following are the normal recommended doses of lacosamide for different age groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more and adults

When taking lacosamide alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamide twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When taking lacosamide with other antiepileptic medications::

The usual starting dose is 50 mg twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may start lacosamide treatment with a single "loading dose" of 200 mg. Then, you will start taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

- In the treatment of partial seizures:Lacosamide is not recommended for children under 2 years old.

- In the treatment of primary generalized tonic-clonic seizures:Lacosamide is not recommended for children under 4 years old.

Dosage depends on body weight. Normally, treatment is started with other suitable formulations (e.g., syrup) and only switched to tablets if the patient is able to take them and obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more lacosamide than you should

If you have taken more lacosamide than you should, consult your doctor immediately. Do not drive.

You may experience:

•Dizziness;

•Sensation of dizziness (nausea) or dizziness (vomiting);

•Seizures (crises), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with tachycardia and sweating.

If you forget to take lacosamide

•If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.

•If you have forgotten to take a dose more than 6 hours after the scheduled dose, do not take the missed dose. Instead, take lacosamide at the next time you normally take it.

•Do not take a double dose to compensate for the missed doses.

If you stop taking lacosamide

•Do not stop taking lacosamide without telling your doctor, as epilepsy may recur or worsen.

•If your doctor decides to stop your treatment with lacosamide, they will give you instructions on how to gradually reduce the dose.

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

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

The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading" dose.

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

•Headache;

•Feeling dizzy or nauseous;

•Diplopia (double vision).

Common: may affect up to 1 in 10 patients

•Short, involuntary muscle contractions (myoclonic jerks);

•Difficulty coordinating movements or walking;

•Problems maintaining balance, agitation (tremor), paresthesia (tingling), or muscle spasms, easy falling, and bruising;

•Memory problems, difficulty thinking or finding words, confusion;

•Uncontrolled, rapid eye movements (nystagmus), blurred vision;

•Sensation of dizziness (vertigo), feeling drunk;

•Feeling nauseous, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;

•Decreased sensitivity, difficulty articulating words, attention alteration;

•Ringing in the ears like buzzing, ringing, or hissing;

•Irritability, difficulty sleeping, depression;

•Drowsiness, fatigue, or weakness (asthenia);

•Itching, rash.

Uncommon: may affect up to 1 in 100 patients

•Decreased heart rate, palpitations, irregular pulse, or other changes in heart electrical activity (conduction disorder);

•Exaggerated feeling of well-being, seeing and/or hearing things that are not real;

•Allergic reaction to the medication, hives;

•Blood tests may show abnormalities in liver function tests, liver damage;

•Thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;

•Feeling angry or agitated;

•Abnormal thoughts or loss of sense of reality;

•Severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs;

•Loss of consciousness;

•Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

•Abnormally fast heart rate (ventricular tachyarrhythmia);

•Sore throat, elevated temperature, and increased frequency of infections. Blood tests may show severe decrease in a specific type of white blood cells (agranulocytosis);

•Severe skin reaction, which may include elevated temperature and other flu-like symptoms, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in a type of white blood cells (eosinophilia);

•Generalized blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):

•Seizures.

Other side effects in children

The additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (abnormal behavior), and lethargy. Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting 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 directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special conditions for conservation.

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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Normon

• The active ingredient is lacosamida.

Lacosamida Normon 50 mg: Each film-coated tablet contains 50 mg of lacosamida.

Lacosamida Normon 100 mg: Each film-coated tablet contains 100 mg of lacosamida.

Lacosamida Normon 150 mg: Each film-coated tablet contains 150 mg of lacosamida.

Lacosamida Normon 200 mg: Each film-coated tablet contains 200 mg of lacosamida.

• The other components (excipients) are:
• 1. - Core:microcrystalline cellulose, silicified microcrystalline cellulose, hydroxypropyl cellulose, low-substitution hydroxypropyl cellulose, anhydrous colloidal silica, crospovidone, and magnesium stearate.
  2. - Coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide red (this excipient is only found in Lacosamida Normon 50 mg and 150 mg), iron oxide yellow (this excipient is only found in Lacosamida Normon 100 and 150 mg), and indigotin lacquer (this excipient is only found in Lacosamida Normon 200 mg)

Appearance of the product and contents of the package

• Lacosamida Normon 50 mg is presented in the form of film-coated tablets, pink, eliptical, biconvex, and engraved with “L50” on one face. Each package contains 14 tablets.
• Lacosamida Normon 100 mg is presented in the form of film-coated tablets, yellow, eliptical, biconvex, and engraved with “L100” on one face. Each package contains 56 tablets.
• Lacosamida Normon 150 mg is presented in the form of film-coated tablets, salmon-colored, eliptical, biconvex, and engraved with “L150” on one face. Each package contains 56 tablets.
• Lacosamida Normon 200 mg is presented in the form of film-coated tablets, blue, eliptical, biconvex, and engraved with “L200” on one face. Each package contains 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos — Madrid

Spain

Last review date of this prospectus:November 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/.