Lydraso 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lydraso 50 mg film-coated tablets EFG

Lydraso 100 mg film-coated tablets EFG

Lydraso 150 mg film-coated tablets EFG

Lydraso 200 mg film-coated tablets EFG

lacosamide

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lydraso is and what it is used for

What Lydraso 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 Lydraso is used for

• It is used:

  • alone and in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by 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 on both sides of the brain.

• in combination with other antiepileptic drugs in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (major seizures, including 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 Lydraso

Do not take Lydraso

• 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 this medicine 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 to use this medicine 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 you experience such thoughts at any time, contact your doctor immediately.
• you have a heart condition that affects your heartbeat and often causes your pulse to be especially 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 (heart attack).
• 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 applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking this medicine, talk to your doctor if you experience a new type of seizure or a worsening of existing seizures.

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

Children

Lacosamide is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, or for 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 Lydraso

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 this medicine.

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 Lydraso with alcohol

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

Pregnancy and breastfeeding

Women of childbearing age 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 lacosamide 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 or not 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

You must not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you. This is because lacosamide may cause dizziness or blurred vision.

3. How to take Lydraso

Follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Another form(s) of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Taking Lydraso

• Take lacosamide twice daily, with an interval of approximately 12 hours.
• Try to take it at about 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. Once you reach the dose that works well for you, known as the “maintenance dose”, you will take the same amount every day. Lacosamide is used as a long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

Dosage

The following are the usual recommended 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 of lacosamide 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 of lacosamide 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 start taking the ongoing 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 appropriate for you.

If you take more lacosamide than you should

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

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures, 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 medicine and the amount ingested.

If you forget to take lacosamide

• 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 lacosamide

• Do not stop taking lacosamide without speaking to 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, lacosamide may cause adverse effects, although not everyone experiences them.

Nervous system effects, 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 seizures);
• Difficulty coordinating movements or walking;
• Problems with balance, tremor, tingling (paraesthesia), or muscle spasms, falling easily and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling intoxicated;
• Dizziness (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 (tinnitus);
• Irritability, trouble 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 the heart's electrical activity (conduction disorder);
• Exaggerated feeling 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;
• Involuntary abnormal movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high temperature, and getting infections more often than usual. 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). Sleepiness (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lydraso

Keep this medicine out of 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 is 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 empty containers and unused medicines at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lydraso

• The active substance is lacosamide. Each film-coated tablet contains 50 mg, 100 mg, 150 mg or 200 mg of lacosamide.

• The other components of the 50 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), low-substituted hydroxypropyl cellulose, colloidal anhydrous silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E533b), indigo carmine aluminium lake (E132), red iron oxide (E172) and black iron oxide (E172) in the coating.

• The other components of the 100 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), low-substituted hydroxypropyl cellulose, colloidal anhydrous silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E533b) and yellow iron oxide (E172) in the coating.

• The other components of the 150 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), low-substituted hydroxypropyl cellulose, colloidal anhydrous silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E533b), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172) in the coating.

• The other components of the 200 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), low-substituted hydroxypropyl cellulose, colloidal anhydrous silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E533b) and indigo carmine aluminium lake (E132) in the coating.

Appearance of the product and contents of the pack

Lydraso 50 mg are film-coated, oval-shaped, biconvex, pale pink tablets, marked with "50" on one side. Tablet dimensions: approximately 11 x 5 mm.

Lydraso 100 mg are film-coated, oval-shaped, biconvex, brownish-yellow tablets, marked with "100" on one side. Tablet dimensions: approximately 13 x 6 mm.

Lydraso 150 mg are film-coated, oval-shaped, biconvex, pale brownish-orange tablets, marked with "150" on one side. Tablet dimensions: approximately 15 x 7 mm.

Lydraso 200 mg are film-coated, oval-shaped, biconvex, blue tablets, marked with "200" on one side. Tablet dimensions: approximately 17 x 8 mm.

All strengths of Lydraso are available in packs containing:

• 14, 28 or 56 film-coated tablets in non-perforated or perforated blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.

C/ Anabel Segura, 10, 28108, Alcobendas (Madrid), Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2023

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/).