Package Insert:Information for the Patient

Kanilad50 mg Film-Coated Tablets

Kanilad 100 mg Film-Coated Tablets

Kanilad 150 mg Film-Coated Tablets

Kanilad200 mg Film-Coated Tablets

Lacosamide

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult yourdoctororpharmacist.
• This medication has been prescribedonlyto you, and you should not give it to others even if they have the same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this package insert. See section 4.

1.What is Kanilad and for what purpose it is used

2.What you need to knowbeforestarting totake Kanilad

3.How to takeKanilad

4.Possible adverse effects

5Storage of Kanilad

6.Contents of the package and additional information

What is Kanilad

Kanilad contains lacosamida, 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 Kanilad used

• Kanilad is used:
• • alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years and older 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, the 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 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 take Kanilad

•if you are allergic to lacosamide or any of the other ingredients in 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 Kanilad 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 Kanilad if:

• You have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines like lacosamide have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• You have a heart problem that affects your heartbeat and your pulse is often very slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• You have a serious heart condition such as heart failure or have had a heart attack.
• You often feel dizzy or fall. Kanilad may cause dizziness, which could increase the risk of accidents 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 unsure), consult your doctor or pharmacist before taking Kanilad.

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

If you are taking lacosamide 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

Kanilad 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 whether it is effective and safe for children in this age group.

Other medicines and Kanilad

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart. The reason is that Kanilad may also affect the heart.

•heart medicines.

•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 Kanilad.

Inform your doctor or pharmacist if you are taking any of the following medicines.

The reason is that they may also increase or decrease the effect of Kanilad on your body.

•antifungal medicines such as fluconazole, itraconazole, or ketoconazole.

•medicines for HIV such as ritonavir.

•antibacterial 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 Kanilad.

Lacosamide 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.

Kanilad is not recommended during pregnancy, as its effects on the fetus are unknown.

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

Ask your doctor for immediate advice if you are pregnant or plan to become pregnant. They will help you decide whether to take Kanilad 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, ride a bike, or use any tools or machines until you know whether this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

Follow exactly the administration instructions of this medication 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.

Kanilad Dosage

• Take this medication 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 Kanilad tablet with a glass of water.
• You can take this medication 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. This medication is used as long-term treatment. You should continue taking this medication until your doctor tells you to stop.

How much to take

The following are the normal recommended doses of this medication 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 Kanilad alone:

The usual starting dose 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 Kanilad with other antiepileptic medications:

The usual starting dose 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 the lacosamide 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:Lacosamide is not recommended for children under 2 years old.

- In the treatment of primary generalized tonic-clonic seizures:Lacosamide is not recommended for children under 4 years old.

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 doses. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Kanilad 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Kanilad

• 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 more than 6 hours after the scheduled dose, do not take the missed dose, instead, take this medication 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 Kanilad

• Do not stop taking this medication 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine 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

• Headache;
• Feeling dizzy or nauseous;
• Diplopia (double vision).

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, difficulty finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling drunk;
• Feeling nauseous (vomiting), 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, beeping or whistling;
• 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 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: 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;
• Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast ventricular heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature and presenting infections more frequently than normal. 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 with 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 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 side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofKanilad

The active ingredient is lacosamide.

Each Kanilad 50 mg tablet contains 50 mg of lacosamide.

Each Kanilad 100 mg tablet contains 100 mg of lacosamide.

Each Kanilad 150 mg tablet contains 150 mg of lacosamide.

Each Kanilad 200 mg tablet contains 200 mg of lacosamide.

• The other components are:

Core of the tablet: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose (low substituted), anhydrous colloidal silica, crospovidone (Type A), magnesium stearate.

Covering:

Poly(vinyl alcohol), macrogol (3350), talc, titanium dioxide (E171).

Indigo carmine aluminium lake (E132) (50 mg and 200 mg film-coated tablets).

Red iron oxide (E172) (50 mg and 150 mg film-coated tablets).

Black iron oxide (E172) (50 mg and 150 mg film-coated tablets).

Yellow iron oxide (E172) (100 mg and 150 mg film-coated tablets).

Appearance of the product and contents of the package

Kanilad 50 mg are oval-shaped, pink film-coated tablets, marked with "I73" on one side and smooth on the other.

The average size of the tablets is 10.4 x 4.9 mm.

Kanilad 100 mg are oval-shaped, dark yellow film-coated tablets, marked with "I74" on one side and smooth on the other.

The average size of the tablets is 13.0 x 6.0 mm.

Kanilad 150 mg are oval-shaped, peach film-coated tablets, marked with "I75" on one side and smooth on the other.

The average size of the tablets is 15.0 x 7.0 mm.

Kanilad 200 mg are oval-shaped, blue film-coated tablets, marked with "I76" on one side and smooth on the other.

The average size of the tablets is 16.5 x 7.7 mm.

PVC/PVDC sealed with an aluminium foil.

Kanilad is available in packages of 7, 14, 28, 56, and 168 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Responsible manufacturer

Medochemie Ltd.Facility A-Z

2 Michael Erakleous street, Agios Athanassios,

Industrial Area, CY-4101 Limassol

Cyprus

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de lasÁguilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

Spain

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

Bulgaria:???????50 mg, 100 mg, 150 mg & 200 mg????????? ????????

Croatia:KANILAD 50 mg, 100 mg, 150 mg & 200 mg filmom obložene tablete

Cyprus:KANILAD 50 mg, 100 mg, 150 mg & 200 mgεπικαλυμμ?ναμελεπτ?υμ?νιοδισκ?α

Czech Republic:KANILAD

Estonia:KANILAD

Germany:KANILAD 50 mg, 100 mg, 150 mg & 200 mg Filmtabletten

Greece:KANILAD 50 mg, 100 mg, 150 mg & 200 mgεπικαλυμμ?ναμελεπτ?υμ?νιοδισκ?α

Latvia:KANILAD 50 mg, 100 mg, 150 mg & 200 mg apvalkotas tabletes

Lithuania:KANILAD 50 mg, 100 mg, 150 mg & 200 mg plevele dengtos tabletes

Malta:KANILAD 50 mg, 100 mg, 150 mg & 200 mg film-coated tablets

Romania:KANILAD 50 mg, 100mg, 150 mg & 200 mg comprimate filmate

Slovakia:KANILAD 50 mg, 100 mg, 150 mg & 200 mg filmom obalené tablety

Last revision date of thisleaflet:September 2022

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