Lacosamide Tecnigen 100 mg film-coated tablets EFG

Package leaflet: Information for the user

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

lacosamide

Read the entire leaflet carefully before starting to take 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, 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 Lacosamida TecniGen is and what it is used for
2. What you need to know before taking Lacosamida TecniGen
3. How to take Lacosamida TecniGen
4. Possible adverse effects
5. How to store Lacosamida TecniGen
6. Contents of the pack and other information

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

What Lacosamida TecniGen is

This medicine contains lacosamide, which belongs to a group of medicines called "antiepileptic drugs". These medicines are used to treat epilepsy.

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

What Lacosamida TecniGen is used for

• It is used:
  • alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age onwards, to treat a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures initially affect only one side of the brain. However, they may then spread to larger areas on both sides of the brain;
  • in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age onwards, 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 starting to take Lacosamida TecniGen

Do not take Lacosamida TecniGen

• if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
• if you have a heart rhythm problem called second- or third-degree AV block.

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

Warnings and precautions

Talk to your doctor before starting lacosamide if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If at any time you have such thoughts, contact your doctor immediately.
• you have a heart condition affecting your heartbeat, and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter).
• you have severe heart disease such as heart failure or have had a myocardial infarction.
• you feel dizzy or fall frequently. Lacosamide may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.

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

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

If you are taking lacosamide and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamide is not recommended in children under 2 years of age with epilepsy characterized by partial-onset seizures, or in children under 4 years of age with generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe in children of these age groups.

Other medicines and Lacosamida TecniGen

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamide may also affect the heart:

• medicines used to treat heart problems.
• medicines that may increase the "PR interval" on a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain 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 lacosamide.

Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of lacosamide in your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole.
• an HIV medicine such as ritonavir.
• antibiotics 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 unsure), speak with your doctor or pharmacist before taking lacosamide.

Taking Lacosamida TecniGen with alcohol

As a safety precaution, do not take lacosamide with alcohol.

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraception with their doctor.

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

Lacosamide is not recommended during pregnancy, as the effects of lacosamide on pregnancy and the fetus are not known.

Breastfeeding is not recommended while taking Lacosamida, because lacosamide passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether you should take lacosamide.

Do not stop treatment without first talking to your doctor, as this could increase seizures. Worsening of your condition may also harm the fetus.

Driving and using machines

Lacosamide may cause symptoms such as somnolence, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Lacosamida TecniGen

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Other form(s) of this medicine may be more suitable for children; please consult your doctor or pharmacist.

How to take Lacosamida TecniGen

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

• Try to take it at approximately the same time each day.

• Swallow the lacosamide tablet with a glass of water.

• You may take lacosamide with food or separately.

Normally, you will start with a low daily dose, 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. Lacosamide is used as a long-term treatment. You must continue taking lacosamide until your doctor tells you to stop.

Dosage

Below are the recommended normal doses of lacosamide 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 lacosamide alone:

The usual starting dose is 50 mg twice daily.

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

Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 300 mg twice daily.

When taking lacosamide with other antiepileptic medicines:

The usual starting dose is 50 mg twice daily.

Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 200 mg twice daily.

If you weigh 50 kg or more, your doctor may start lacosamide treatment with a single “loading dose” of 200 mg. You would then begin taking the regular maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

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

The dose depends on body weight. Treatment is usually started with the oral syrup, and only switched to tablets if the patient is able to swallow them and can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form most suitable for you.

If you take more Lacosamida TecniGen than you should

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

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (fits), heart rhythm problems such as slow, fast or irregular pulse, coma, or low blood pressure with tachycardia and sweating.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Lacosamida TecniGen

• If you forget to take a dose within 6 hours of your scheduled dose, take it as soon as you remember.
• If you forget to take a dose more than 6 hours after your scheduled dose, do not take the missed dose; instead, take lacosamide at your next regularly scheduled time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Lacosamida TecniGen

• Do not stop taking lacosamide without telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your lacosamide treatment, you will be given instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Inform 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 jerks of a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremor, tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), sensation of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Decreased sensation, difficulty articulating words, attention disturbance;
• Ringing in the ears such as buzzing, ringing, or hissing;
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• Exaggerated sense of well-being, seeing and/or hearing things that are not real;
• Allergic reaction to the medicine, hives;
• Blood tests may show abnormalities in liver function tests, liver damage;
• Thoughts of self-harm or suicide, or suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts or loss of sense of reality;
• Severe allergic reactions causing 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 heartbeat (ventricular tachyarrhythmia);
• Sore throat, high temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);
• Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increase in a type of white blood cells (eosinophilia);
• 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Other adverse effects in children

Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioural changes, not acting as they normally do (abnormal behaviour), 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 adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly 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 Lacosamide TecniGen

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamide TecniGen

• The active substance is lacosamide.

Each lacosamide 50 mg tablet contains 50 mg of lacosamide.

Each lacosamide 100 mg tablet contains 100 mg of lacosamide.

Each lacosamide 150 mg tablet contains 150 mg of lacosamide.

Each lacosamide 200 mg tablet contains 200 mg of lacosamide.

• The other components are:

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

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

• The colourants 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: indigo carmine (E-132)

Appearance of the product and contents of the pack

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

Lacosamide 50 mg film-coated tablets

Packs containing 14 film-coated tablets in PVC/PE/PVDC blisters sealed with an aluminum foil.

Lacosamide 100 mg film-coated tablets

Packs containing 56 film-coated tablets in PVC/PE/PVDC blisters sealed with an aluminum foil.

Lacosamide 150 mg film-coated tablets

Packs containing 56 film-coated tablets in PVC/PE/PVDC blisters sealed with an aluminum foil.

Lacosamide 200 mg film-coated tablets

Packs containing 56 film-coated tablets in PVC/PE/PVDC blisters 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 the most recent revision of this leaflet: August 2022

Other sources of information

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