Patient Information Leaflet

Lydraso 50 mg Film-Coated Tablets

Lydraso 100 mg Film-Coated Tablets

Lydraso 150 mg Film-Coated Tablets

Lydraso 200 mg Film-Coated Tablets

Lacosamide

Read this 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Lydraso

This medication contains lacosamide, 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 Lydraso used

•It is used:

• alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years and olderto 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, including loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

Do not takeLydraso

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting to use this medicine if:

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

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

If you are taking this medicine 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

Lacosamide 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 of this age group.

Other medicines and Lydraso

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

Particularly, inform your doctor or pharmacist if you are taking any of the following:

medicines that affect the heart, as lacosamide can 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 not sure), 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 lacosamide in your body:

• medicines for fungal infections such as fluconazole, itraconazole, or ketoconazole;
• • a medicine 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 not sure), speak with your doctor or pharmacist before taking lacosamide.

Lydraso and 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended for use during pregnancy, as the effects of lacosamide on the pregnancy and fetus are not known.

This medicine is not recommended for breastfeeding, as lacosamide passes into breast milk.

Immediately ask your doctor for advice if you are pregnant or planning to become pregnant. They will help you decide if you should take lacosamide 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, cycle, or use any tools or machines until you know if this medicine affects you. The reason is that lacosamide can 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.

Lydrazo 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 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. Lacosamide is used as long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

How much to take

Below 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 of lacosamide 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 of lacosamide 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 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: 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. Normally, treatment starts with the syrup and only changes 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 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 after 6 hours of 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 interrupt treatment with 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 medications, 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

Common: may affect up to 1 in 10 patients

• Brief muscle or muscle group 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, thinking problems, or difficulty finding words, confusion;
• Rapid, involuntary 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 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;
• Involuntary abnormal 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 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), nasal congestion (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (abnormal behavior), and lack of energy (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 prospectus. You can also report directly to the Spanish System for the Vigilance of Medicinal Products for Human Use: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 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 Lydraso

• The active ingredient is lacosamide. Each film-coated tablet contains 50 mg, 100 mg, 150 mg or 200 mg of lacosamide.
• The other components of50 mg film-coated tabletsare: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), 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), aluminium lake of indigo carmine (E132), iron oxide red (E172) and iron oxide black (E172) in the coating.

• The other components of100 mg film-coated tabletsare: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), 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 iron oxide yellow (E172) in the coating.
• The other components of150 mg film-coated tabletsare: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), hydroxypropyl cellulose, colloidal anhydrous silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core andpolyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E533b), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172) in the coating.
• The other components of200 mg film-coated tabletsare: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), 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 aluminium lake of indigo carmine (E132) in the coating.

Appearance of the product and contents of the package

Lydraso 50 mg are oval, biconvex, pale pink film-coated tablets, marked with "50" on one face, tablet size: approximately 11 x 5 mm.

Lydraso 100 mg are oval, biconvex, yellowish-brown film-coated tablets, marked with "100" on one face, tablet size: approximately 13 x 6 mm.

Lydraso 150 mg are oval, biconvex, pale orange-brown film-coated tablets, marked with "150" on one face, tablet size: approximately 15 x 7 mm.

Lydraso 200 mg are oval, biconvex, blue film-coated tablets, marked with "200" on one face, tablet size: approximately 17 x 8 mm.

All doses of Lydraso are available in packs containing:

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

Only some package sizes may be marketed.

Marketing authorisation holder

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

Manufacturer

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 authorisation holder:

KRKA Farmacéutica, S.L.

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

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:January 2023

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