Product Information for the Patient

Lacosamida TecniGen 50 mg Film-Coated Tablets

Lacosamida TecniGen 100 mg Film-Coated Tablets

Lacosamida TecniGen 150 mg Film-Coated Tablets

Lacosamida TecniGen 200 mg Film-Coated Tablets

Lacosamida

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

What is Lacosamida TecniGen

This medication contains lacosamida, which belongs to a group of medications called “antiepileptic medications”. These medications are used to treat epilepsy.

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

How is Lacosamida TecniGen used

• It is used:
• • alone and in combination with other antiepileptic medications 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 medications 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 TecniGen

• if you are allergic to lacosamida or any of the other ingredients of this medication (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 lacosamida if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before starting to use lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medications 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 heart rhythm and your pulse is often abnormally 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 myocardial infarction.
• you often get dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidents or falls. This means you shouldbe carefuluntil you are accustomed to the effects of this medication.

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

If you are taking lacosamida, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

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

Children

Lacosamida is not recommended for children under 2 years with epilepsy characterized by partial seizure onset 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 medications and Lacosamida TecniGen

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida may also affect the heart:

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

Also inform your doctor or pharmacist if you are taking any of the following medications, as they may increase or decrease the effect of lacosamida on your body:

• medications for fungal infections such as fluconazole, itraconazole, or ketoconazole.
• a medication for HIV such as ritonavir.
• medications 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 TecniGen and alcohol

As a precaution, do not take lacosamida 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 medication.

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

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

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

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

Driving and operating machinery

Lacosamida may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Follow exactly the administration instructions of this medication 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.

Lacosamida TecniGen Dosage

• Take lacosamida 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 lacosamida tablet with a glass of water.
• You can take lacosamida with meals or separately.

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

How much to take

The following are the normal recommended doses of lacosamida 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 lacosamida alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 lacosamida 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 lacosamida 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 onset seizures:Lacosamida is not recommended for children under 2 years old.
• In the treatment of primary generalized tonic-clonic seizures:Lacosamida is not recommended for children under 4 years old.

The dose depends on body weight. Normally, treatment starts with the syrup and only changes to tablets if the patient is able to take them and get the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Lacosamida TecniGen than you should

If you have taken more lacosamida than you should, consult your doctor immediately. Do not try to drive. You may experience:

• dizziness;
• sensation of dizziness (nausea) or dizziness (vomiting);
• seizures (crises), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Lacosamida TecniGen

• If you forgot to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you forgot to take a dose after 6 hours of the scheduled dose, do not take the missed dose, instead, take lacosamida the next time you normally take it.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lacosamida TecniGen

• Do not stop taking lacosamida without telling your doctor, as epilepsy may recur or worsen.
• If your doctor decides to stop your treatment with lacosamida, they will give you instructions on how to gradually reduce the dose.

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

Like all medicines, this medicine 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

• Brief muscle or group of muscles spasms (myoclonic crisis);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, agitation (tremor), paresthesia (tingling) or muscle spasms, easy to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling drunk;
• Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention alteration;
• Ringing in the ears like a 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 taking the medicine, 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;
• Fainting,
• Abnormal involuntary movements (dyskinesia)

Frequency not known: cannot be estimated from available data

• Abnormally fast heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature and presenting infections more frequently than normal. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
• Severe skin reaction, which may include elevated temperature and other pseudogripal 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 cell (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 as they normally do (abnormal behavior) and lack of energy (lethargy). Drowsiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.

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 directly 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 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 at 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 TecniGen

• The active ingredient is lacosamida.

Each lacosamida 50 mg tablet contains 50 mg of lacosamida.

Each lacosamida 100 mg tablet contains 100 mg of lacosamida.

Each lacosamida 150 mg tablet contains 150 mg of lacosamida.

Each lacosamida 200 mg tablet contains 200 mg of lacosamida.

• The other components are:

Tablet core:microcrystalline cellulose, silicon dioxide colloidal anhydrous and microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, hydroxypropyl cellulose (partially substituted) and magnesium stearate.

Covering: poly(vinyl alcohol), macrogol, talc, titanium dioxide (E-171) and colorants*

*The colorants are:

50 mg tablets: iron oxide red (E-172), iron oxide black (E-172), iron oxide yellow (E-172)

100 mg tablets: iron oxide yellow (E-172)

150 mg tablets: iron oxide red (E-172), iron oxide black (E-172), iron oxide yellow (E-172)

200 mg tablets:carminic acid (E-132)

Appearance of the product and contents of the package

• Lacosamida 50 mg are film-coated tablets of pink color, oblong, biconvex, with approximate dimensions of 10.2 mm x 4.2 mm.
• Lacosamida 100 mg are film-coated tablets of yellow color, oblong, biconvex, with approximate dimensions of 12.9 mm x 5.3 mm.
• Lacosamida 150 mg are film-coated tablets of pink color, oblong, biconvex, with approximate dimensions of 14.8 mm x 5.8 mm.
• Lacosamida 200 mg are film-coated tablets of blue color, oblong, biconvex, with approximate dimensions of 17.2 mm x 7.5 mm.

Lacosamida 50 mg film-coated tablets

Packages with 14 film-coated tablets in PVC/PE/PVDC blister sealed with an aluminum foil.

Lacosamida 100 mg film-coated tablets

Packages with 56 film-coated tablets in PVC/PE/PVDC blister sealed with an aluminum foil.

Lacosamida 150 mg film-coated tablets

Packages with 56 film-coated tablets in PVC/PE/PVDC blister sealed with an aluminum foil.

Lacosamida 200 mg film-coated tablets

Packages with 56 film-coated tablets in PVC/PE/PVDC blister sealed with an aluminum foil.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Last review date of this leaflet: August 2022

Other sources of information

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