LYDRASO 50 mg FILM-COATED TABLETS

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 package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Lydraso and what is it used for

What is Lydraso

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

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

What Lydraso is used for

• It is used:
  • alone and with other antiepileptics 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 your brain. However, they can then spread to larger areas on both sides of your brain.

• with other antiepileptics in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (grand mal 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 you take Lydraso

Do not take Lydraso

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure, consult your doctor.
• if you have a heart rhythm problem called second- or third-degree atrioventricular (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:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamide have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.
• you have a heart problem that affects your heartbeat 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 faint. Lacosamide may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be careful until you are used to the effects of this medicine.

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 heartbeat (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 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 if it is effective and safe for children in this age group.

Other medicines and Lydraso

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

In particular, tell 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 for 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), talk to your doctor or pharmacist before taking this medicine.

Also, tell 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 called ritonavir;
  • medicines for bacterial infections such as clarithromycin or rifampicin;
  • a herbal medicine 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 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 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 medicine.

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

Lacosamide passes into breast milk. It is not recommended to breastfeed while taking lacosamide.

Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. They will help you decide whether to take lacosamide or not.

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

Driving and using machines

Do not drive, cycle, or use any tools or machines until you know if this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Lydraso

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

Taking Lydraso

• Take lacosamide twice a day, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Take the lacosamide tablet with a glass of water.
• You can take lacosamide 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 each day. Lacosamide is used as long-term treatment. You will need to keep taking lacosamide until your doctor tells you to stop.

How much to take

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 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 medicines:

• 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 lacosamide 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 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 solution and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lydraso than you should

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

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (fits), heartbeat 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, stating the medicine and the amount taken.

If you forget to take Lydraso

• If you have forgotten to take a dose within the next 6 hours after the scheduled dose, take it as soon as you remember.

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

If you stop taking lacosamide

• Do not stop taking lacosamide without telling your doctor, as epilepsy may come back or get worse.
• 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, lacosamide can cause side effects, although not everybody 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 people

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

Common: may affect up to 1 in 10 people

• brief muscle jerks or twitching (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems with balance, shakiness (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), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• decreased sensitivity, difficulty articulating words, attention problems;
• ringing in the ears like buzzing, ringing, or whistling;
• irritability, sleep problems, depression;
• drowsiness, tiredness, or weakness (asthenia);
• itching, rash.

Uncommon: may affect up to 1 in 100 people

• slow heart rate, palpitations, irregular heartbeat, 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 medicine, hives;
• blood tests may show abnormalities in liver function tests, liver damage;
• thoughts of self-harm or suicide or attempted suicide: tell 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 the available data

• abnormally fast heartbeat (ventricular tachyarrhythmia);
• sore throat, high temperature, and infections more often than usual. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
• severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread 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 skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• seizures.

Other side effects in children

Additional side effects seen in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lydraso

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

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

• The other components of 100 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal 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 150 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal 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 200 mg film-coated tablets are: microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E533b), and aluminum lake indigo carmine (E132) in the coating.

Product Appearance and Packaging Content

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

Lydraso 100 mg are oval, biconvex, film-coated tablets, yellow-brown in color, marked with 100 on one side, tablet dimensions: approximately 13 x 6 mm.

Lydraso 150 mg are oval, biconvex, film-coated tablets, pale orange-brown in color, marked with 150 on one side, tablet dimensions: approximately 15 x 7 mm.

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

All doses of Lydraso are available in boxes containing:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

You can request more information about this medicinal product by contacting 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 last revision 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/).