Patient Information Leaflet

Lacosamida Zentiva 50mg Film-Coated Tablets

Lacosamida Zentiva 100mg Film-Coated Tablets

Lacosamida Zentiva 150mg Film-Coated Tablets

Lacosamida Zentiva 200mg 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 similar symptoms, 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.

1. What Lacosamida Zentiva is and what it is used for

2. What you need to know before you start taking Lacosamida Zentiva

3. How to take Lacosamida Zentiva

4. Possible side effects

5. Storage of Lacosamida Zentiva

6. Contents of the pack and additional information

Lacosamida Zentiva contains lacosamida. This belongs to a group of medicines called “anti-epileptic medicines”. These medicines are used to treat epilepsy.

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

This medicine is used:

• on its own and in combination with other anti-epileptic medicines in adults, adolescents, and children aged 2 years and above to treat a certain type of epilepsy characterised by the occurrence of partial onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially 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 anti-epileptic medicines in adults, adolescents, and children aged 4 years and above to treat primary generalised tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalised epilepsy (a type of epilepsy believed to have a genetic origin).

Do not take Lacosamida Zentiva

• 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:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamida 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 the heartbeat and often your pulse is especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• you have a serious heart disease such as heart failure or have had a heart attack.
• you often get dizzy or fall. Lacosamida 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 this medicine.

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

If you are taking lacosamida and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, difficulty breathing, feeling dizzy, fainting), consult your doctor immediately (see section 4).

Children

This medicine is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures and not recommended for children under 4 years 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 Lacosamida Zentiva

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, as this medicine 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.

Also 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:

• 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 anxiety and mild 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 this medicine.

Lacosamida Zentiva and alcohol

As a precaution, do not take lacosamida with alcohol.

Pregnancy and breastfeeding

Fertile women 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.

This medicine is not recommended to be taken if you are pregnant, as the effects of lacosamida on pregnancy and the fetus are not known.

This medicine is not recommended to be breastfed, as lacosamida passes into breast milk.

Ask your doctor immediately if you are pregnant or plan to become pregnant. They will help you decide if you should take this medicine or not.

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

Driving and operating machines

You should not drive, ride a bike, 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.

Take this medication twice a day, approximately every 12 hours.

• Try to take it at roughly 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 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 this medication until your doctor tells you to stop.

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.

Use in adults, adolescents, and children weighing 50 kg or more

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.

Use in 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 old.

In the treatment of primary generalized tonic-clonic seizures: Note that 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 concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Lacosamida Zentiva 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.

If you forgot to take Lacosamida Zentiva

• If you forgot to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you forgot 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 make up for the missed doses.

If you interrupt treatment with Lacosamida Zentiva

• 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 thinking or 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, altered attention;
• Ringing in the ears like a 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 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;
• Fainting.
• Abnormal involuntary movements (dyskinesia).

Frequency not known:cannot be estimated from available data

­Abnormally fast heart rate (ventricular tachyarrhythmia);

• Sore throat, elevated temperature, and presenting infections at a higher frequency 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, facial rash, 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 rash 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

Additional side effects in children were fever (pyrexia), nasal discharge (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 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 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 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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

The active ingredientis lacosamida.

A Lacosamida Zentiva 50mg tablet contains 50mg lacosamida.

A Lacosamida Zentiva 100mg tablet contains 100mg lacosamida.

A Lacosamida Zentiva 150mg tablet contains 150mg lacosamida.

A Lacosamida Zentiva 200mg tablet contains200mg lacosamida.

The other components are:

Tablet core::microcrystalline cellulose, hydroxypropyl cellulose (partially substituted), crospovidone, hydroxypropyl cellulose, anhydrous colloidal silica, and magnesium stearate.

Tablet coating:hypromellose, hydroxypropyl cellulose, macrogol, talc, titanium dioxide (E171), and colorants*.

*The colorants are:

100mg tablet: iron oxide yellow (E172), iron oxide brown (E172), and iron oxide red (E172).

150mg tablet: iron oxide yellow (E172).

200mg tablet: iron oxide red (E172).

Appearance of the product and contents of the package

Lacosamida Zentiva 50mg film-coated tablets:

Film-coated tablet, oblong shape, white to off-white color, approximately 10x5 mm in size.

Lacosamida Zentiva 100mg film-coated tablets:

Film-coated tablet, oblong shape, orange color, approximately 12x6 mm in size.

Lacosamida Zentiva 150mg film-coated tablets:

Film-coated tablet, oblong shape, yellow color, approximately 14×7mm in size.

Lacosamida Zentiva 200mg film-coated tablets:

Film-coated tablet, oblong shape, pink color, approximately 15×8mm in size.

PVC/PVDC/Alu blisters.

Package size: 14,56y168film-coated tablets.

Only some of the package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Zentiva k.s.

U Kabelovny 130
Dolní Mecholupy,

102 37 Praga 10

Republic of Czech

Responsible manufacturer

LABORMED-PHARMA S.A.

Bd.Theodor Pallady nr. 44B, sector 3, Bucure?ti, cod 032266

Romania

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Republic of Czech, Poland, Italy, France, United Kingdom (Northern Ireland), Denmark, Sweden, and Greece: Lacosamide Zentiva

Austria and Germany: Lacosamid Zentiva

Portugal and Spain: Lacosamida Zentiva

Last review date of this leaflet:June 2022

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/