LACOSAMIDE TECNIGEN 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lacosamida TecniGen 50 mg film-coated tablets EFG

Lacosamida TecniGen 100 mg film-coated tablets EFG

Lacosamida TecniGen 150 mg film-coated tablets EFG

Lacosamida TecniGen 200 mg film-coated tablets EFG

lacosamida

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

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

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

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Lacosamida TecniGen and what is it used for
2. What you need to know before taking Lacosamida TecniGen
3. How to take Lacosamida TecniGen
4. Possible side effects
5. Storage of Lacosamida TecniGen
6. Package contents and additional information

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

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.

What is Lacosamida TecniGen used for

• It is used:
• • alone and with other antiepileptic medications in adults, adolescents, and children from 2 years of age 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 can then spread to larger areas on both sides of the brain;
  • with other antiepileptic medications in adults, adolescents, and children from 4 years of age 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).

2. What you need to know before taking Lacosamida TecniGen

Do not take Lacosamida TecniGen

• if you are allergic to lacosamida or any of the other components of this medication (listed in section 6). If you are not sure, 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 not sure, 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 problem that affects your heart rhythm and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• you have severe heart disease 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 accidental injuries or falls. This means you should be careful until you are used to the effects of this medication.

If any of the above applies to you (or you are not sure), 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 in children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures, nor in children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe for children in this age group.

Other medications and Lacosamida TecniGen

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

In particular, tell 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 for 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 not sure), talk to 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 also increase or decrease the effect of lacosamida in 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 herbal remedy used to treat mild anxiety and depression called St. John's Wort.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking lacosamida.

Taking Lacosamida TecniGen with 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 not known.

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 talking to your doctor first, as this could increase the risk of seizures (crises). Worsening of your condition may also harm the fetus.

Driving and using machines

Lacosamida may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction time. These effects, as well as your condition itself, may affect your ability 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.

3. How to take Lacosamida TecniGen

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Another form of this medication may be more suitable for children; consult your doctor or pharmacist.

Taking Lacosamida TecniGen

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

• Try to take it at about the same time every day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida with or without food.

Normally, you will start by 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 every 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 usual recommended doses of lacosamida for different age and weight groups. 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. You will then start taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures:note that lacosamida is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures:note that lacosamida is not recommended for children under 4 years of age.

The dose depends on body weight. Treatment is usually started with the oral solution and only changed 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 Lacosamida TecniGen than you should

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

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (crises), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with rapid heartbeat 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 forget to take Lacosamida TecniGen

• If you have forgotten to take a dose within the next 6 hours, take it as soon as you remember.
• If you have forgotten to take a dose after 6 hours from the scheduled dose, do not take the missed dose. Instead, take lacosamida the next time you normally would.
• Do not take a double dose to make up for missed doses.

If you stop taking Lacosamida TecniGen

• Do not stop taking lacosamida without telling your doctor, as your epilepsy may come back 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Side effects in the nervous system, such as dizziness, may be greater after a single "loading dose".

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

Very common: may affect more than 1 in 10 patients

• headache;
• feeling dizzy or sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 patients

• brief muscle jerks or muscle group jerks (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems maintaining balance, agitation (tremor), tingling (paresthesia), or muscle spasms, falling easily, and bruising;
• memory problems, difficulty thinking or finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), having a dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• decreased sensitivity, difficulty articulating words, attention problems;
• noise in the ear like ringing, buzzing, or whistling;
• irritability, sleep problems, 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 activity (conduction disorder);
• exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• allergic reaction to taking 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;
• fainting,
• abnormal involuntary movements (dyskinesia)

Frequency not known: cannot be estimated from available data

• abnormally fast heart rhythm (ventricular tachyarrhythmia);
• sore throat, elevated temperature, and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased liver enzyme levels and an increase in a type of white blood cell (eosinophilia);
• a widespread rash with blisters 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

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lacosamida TecniGen

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

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Lacosamida TecniGen

• The active ingredient is lacosamide.

Each 50 mg lacosamide tablet contains 50 mg of lacosamide.

Each 100 mg lacosamide tablet contains 100 mg of lacosamide.

Each 150 mg lacosamide tablet contains 150 mg of lacosamide.

Each 200 mg lacosamide tablet contains 200 mg of lacosamide.

• The other components are:

Tablet Core: microcrystalline cellulose, silicified microcrystalline cellulose (colloidal anhydrous silica and microcrystalline cellulose), crospovidone, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and magnesium stearate.

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

• The colorants are:

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

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

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

200 mg tablets: carmine indigo (E-132)

Product Appearance and Package Contents

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

Lacosamide 50 mg film-coated tablets

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

Lacosamide 100 mg film-coated tablets

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

Lacosamide 150 mg film-coated tablets

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

Lacosamide 200 mg film-coated tablets

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

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Date of Last Revision of this Leaflet: August 2022

Other Sources of Information

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