KANILAD 100 mg FILM-COATED TABLETS

2. What you need to know before taking Kanilad

Do not take Kanilad

• if you are allergic to lacosamide or any of the other components of this medication

(including those listed in section 6). If you are unsure, 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 your case. If you are unsure, consult your doctor or pharmacist before taking this medication.

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 antiepileptics such as lacosamide have had thoughts of self-harm or suicide. If you have these thoughts at any time, 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 fall. Kanilad may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are used to the effects of this medication.

If any of the above applies to your case (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 heartbeat (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 in children under 2 years of age with epilepsy characterized by the onset of partial seizures or in children under 4 years of age with primary 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 medications and Kanilad

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

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

• medications for heart problems.
• medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, or pregabalin.
• medications used to treat certain types of arrhythmia or heart failure.

If any of the above applies to your case (or you are unsure), talk to your doctor or pharmacist before taking Kanilad.

Also, inform your doctor or pharmacist if you are taking any of the following medications.

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

• medications for fungal infections such as fluconazole, itraconazole, or ketoconazole.
• HIV medications such as ritonavir.
• medications for bacterial infections 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 your case (or you are unsure), talk to your doctor or pharmacist before taking Kanilad.

Taking lacosamide with alcohol

As a precaution, do not take this medication 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 medication.

Kanilad is not recommended if you are pregnant, as the effects of Kanilad on pregnancy and the fetus are not known.

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

Seek immediate advice from your doctor 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 talking to your doctor first, as this may increase the risk of seizures (crises). Worsening of your condition may also harm the fetus.

Driving and using machines

Do not drive, ride a bicycle, or use any tool or machine until you know if this medication affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Kanilad

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Another form of this medication may be more suitable for children; consult your doctor or pharmacist.

Taking Kanilad

• Take this medication twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time every day.
• Take the Kanilad tablet with a glass of water.
• You can take this medication with food or on an empty stomach.

Normally, you will start taking a low dose every 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 every 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 usual recommended doses of this medication 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 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 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 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 syrup and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different doses. The 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 attempt to drive. You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (crises), heart rhythm 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, indicating the medication and the amount ingested.

If you forget to take Kanilad

• 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 this medication the next time you normally would.
• Do not take a double dose to make up for missed doses.

If you stop taking 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Side effects on 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 patients

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

Common: may affect up to 1 in 10 patients

• brief muscle or muscle group jerks (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems maintaining balance, agitation (shaking), numbness or tingling (paresthesia), or muscle spasms, falling easily and bruising;
• memory problems, finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), having a dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• decreased sensitivity, difficulty articulating words, altered attention;
• ringing in the ear like a buzzing, whistling, or hissing;
• irritability, sleep problems, 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 activity (conduction disorder);
• exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• allergic reaction to taking 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;
• fainting;
• abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• abnormally fast heartbeat (ventricular tachyarrhythmia);
• sore throat, elevated temperature, and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show elevated liver enzyme levels and an increase in a type of white blood cell (eosinophilia);
• widespread rash with blisters and skin peeling, 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 observed 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 side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Kanilad

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister pack after "EXP". 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

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, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), anhydrous colloidal silica, crospovidone (Type A), magnesium stearate.

Coating:

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

Aluminum lake indigo carmine (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 container contents

Kanilad 50 mg are oval, 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, 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, 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, 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 aluminum foil.

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

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 las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under 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 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?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 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?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

Date of last revision of thisleaflet:September 2022

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/).