LACOSAMIDE VISO FARMACEUTICA 100 mg FILM-COATED TABLETS

2. What you need to know before taking Lacosamida Viso Farmacéutica

Do not take lacosamide

• if you are allergic to lacosamide or any of the other ingredients of this medication (listed in section 6). If you are unsure, consult your doctor.
• if you have a certain type of heart rhythm disorder (second- or third-degree AV block).

Do not take Lacosamida if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before starting to use Lacosamida 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 ever 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 fall. Lacosamida may cause dizziness, which can increase the risk of accidental injuries or falls. Therefore, you should be careful until you are used to the effects of this medication.

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

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 heartbeat (such as slow, fast, or irregular heartbeat, palpitations, difficulty breathing, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamida Viso Farmacéutica is not recommended for children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures, nor for 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 Lacosamida Viso Farmacéutica

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

In particular, tell your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamide may also affect the heart.

• medications for heart problems.
• medications that can 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 you (or you are unsure), consult your doctor or pharmacist before taking lacosamida.

Also, inform your doctor or pharmacist if you are taking any of the following medications, as they may also increase or decrease the effect of Lacosamida in your body.

• medications for fungal infections such as fluconazole, itraconazole, or ketoconazole.
• a medication for HIV 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 you (or you are unsure), consult your doctor or pharmacist before taking Lacosamida.

Taking Lacosamida Viso Farmacéutica 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.

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

It is not recommended to breastfeed while taking Lacosamida, as Lacosamida 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 Lacosamida or not.

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

Driving and using machines

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

3. How to take Lacosamida Viso Farmacéutica

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

• Taking Lacosamida Viso FarmacéuticaTake lacosamida twice a day, with an interval of approximately 12 hours. Try to take it at about the same time every day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida 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 every day. Lacosamida is used as long-term treatment. You should continue taking lacosamida until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of lacosamida 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 Lacosamida alone:

The recommended starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 Lacosamida with other antiepileptic medications:

The recommended 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 lacosamida treatment with a single "loading dose" of 200 mg. Then, you would 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 Lacosamida is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamida is not recommended for children under 4 years of age.

The dose depends on body weight. Normally, treatment is 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 concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Lacosamida Viso Farmacéutica than you should

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 taken.

It is recommended to take the medication packaging and leaflet to the healthcare professional.

Do not attempt to drive.

You may experience:

• dizziness;
• feeling of dizziness (nausea) or vomiting;
• seizures (crises), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Lacosamida Viso Farmacéutica

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

If you stop taking Lacosamida Viso Farmacéutica

• Do not stop taking lacosamida without telling your doctor, as your symptoms may come back or worsen.
• If your doctor decides to stop your treatment with lacosamida, they will give you instructions on how to gradually reduce the dose.

If you have any further 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 gets them.

Side effects in the nervous system, such as dizziness, may be greater after a 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 (tremor), tingling (paresthesia), or muscle spasms, easy falling and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Feeling dizzy (vertigo), feeling drunk;
• Feeling sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention disorder;
• Noise in the ear like ringing, buzzing, or whistling;
• Irritability, sleep problems, depression;
• Somnolence, 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 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 heart rhythm (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 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 over 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, abnormal behavior, and lack of energy (lethargy). 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 effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lacosamida Viso Farmacéutica

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

Do not use this medication after the expiration date stated on the carton and blister 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 via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacosamida Viso Farmacéutica

The active ingredient is lacosamide.

Each Lacosamida Viso Farmacéutica 100 mg tablet contains 100 mg of lacosamide.

The other ingredients are:

Core of the tablet: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), silicified microcrystalline cellulose, crospovidone (type B), magnesium stearate.

Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colorants*

• The colorants are:

100 mg tablets: yellow iron oxide (E172).

Appearance of the Product and Package Contents

Lacosamida Viso Farmacéutica 100 mg are film-coated oval tablets, dark yellow in color, marked with “LAC” on one side and “100” on the other.

Lacosamida Viso Farmacéutica is available in packs of 14, 56, 84, and 168 film-coated tablets in PVC/PVDC blister packs sealed with an aluminum foil.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

Praha 4, 140 78

Czech Republic

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Combino Pharm (Malta) Ltd.

HF60 Hal Far Industriale Estate

BBG3000

SVUS Pharma a.s.

Smetanovo nabrezi 1238/20a

500 02, Hradec Kralove

Czech Republic

Galenica Pharmaceuticals Industry S.A

Asklipiou 4-6, Kryoneri

Attiki, 14568

Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 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:October 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/