Package Leaflet: Information for the Patient

Lacosamida Krka 50 mg Film-Coated Tablets

Lacosamida Krka 100 mg Film-Coated Tablets

Lacosamida Krka 150 mg Film-Coated Tablets

Lacosamida Krka 200 mg Film-Coated Tablets

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 Lacosamida

This medicine contains lacosamida, 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 experience.

What is lacosamida used for

•It is used:

• alone and in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years and above 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 may then spread to larger areas in both sides of the brain;

in combination with other antiepileptic medicines in adults, adolescents, and children aged 4 years and above 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).

Do not takeLacosamida Krka

• if you are allergic to lacosamida or any of the other ingredients of this medicine (listed in section 6). If you are unsure 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 unsure, 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 unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking Lacosamida Krka, 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

Lacosamida 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 Lacosamida Krka

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 heart medicines, as lacosamida may 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 unsure), 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 lacosamida in your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
• • an HIV medicine such as ritonavir;
  • bacterial infection medicines such as clarithromycin or rifampicin;
  • a medicinal herb 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 lacosamida.

Lacosamida Krka 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended to take lacosamida if you are pregnant, as the effects of lacosamida on pregnancy and the fetus are not known.

It is not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.

Seek advice immediately from your doctor if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.

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

Driving and operating machines

You should not drive, cycle, or use any tools or machines until you know if this medicine affects you. The reason is that lacosamida may 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.

Lacosamide Krka 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

The following 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 attempt 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take lacosamida

•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 lacosamida

•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

Uncommon: may affect up to 1 in 100 patients

Frequency not known: cannot be estimated from available data

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 not listed in this prospectus.You can also report directly to the Spanish System for Pharmacovigilance of Medicines 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.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Krka

• The active ingredient is lacosamida. Each film-coated tablet contains 50 mg, 100 mg, 150 mg, or 200 mg of lacosamida.
• The other components of50 mg film-coated tabletsare: microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), hydroxypropyl cellulose, partially substituted, 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, partially substituted, 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, partially substituted, colloidal anhydrous silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core, and polyvinyl 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, partially substituted, 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

Lacosamida Krka 50 mg are oval, biconvex, pale pink film-coated tablets, marked with "50" on one side, with a tablet size of approximately 11 x 5 mm.

Lacosamida Krka 100 mg are oval, biconvex, yellow-brown film-coated tablets, marked with "100" on one side, with a tablet size of approximately 13 x 6 mm.

Lacosamida Krka 150 mg are oval, biconvex, pale orange-brown film-coated tablets, marked with "150" on one side, with a tablet size of approximately 15 x 7 mm.

Lacosamida Krka 200 mg are oval, biconvex, blue film-coated tablets, marked with "200" on one side, with a tablet size of approximately 17 x 8 mm.

All doses of Lacosamida Krka are available in packages containing:

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

Only some package sizes may be marketed.

Holder of the marketing authorization and 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 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 for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).