LACOSAMIDE VISO FARMACEUTICA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lacosamide Viso Pharmaceutical 150 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Lacosamide Viso Pharmaceutical and what is it used for
2. What you need to know before taking Lacosamide Viso Pharmaceutical
3. How to take Lacosamide Viso Pharmaceutical
4. Possible side effects
5. Storage of Lacosamide Viso Pharmaceutical
6. Package contents and additional information

1. What is Lacosamide Viso Pharmaceutical and what is it used for

What is Lacosamide Viso Pharmaceutical

Lacosamide Viso Pharmaceutical contains lacosamide, 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.

What is Lacosamide Viso Pharmaceutical used for

• Lacosamide is used:
• • Alone and with other antiepileptics in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by the onset of partial seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the brain;
  • With other antiepileptics in adults, adolescents, and children from 4 years of age 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).

2. What you need to know before taking Lacosamide Viso Pharmaceutical

Do not take lacosamide

• if you are allergic to lacosamide or any of the other components 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 Lacosamide 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 Lacosamide 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 an 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. Lacosamide 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 lacosamide, 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, difficulty breathing, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamide Viso Pharmaceutical is not recommended for children under 2 years of age with epilepsy characterized by the onset of partial 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 Lacosamide Viso Pharmaceutical

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take another medication.

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 lacosamide.

Tell your doctor or pharmacist if you are taking any of the following medications, as they may also increase or decrease the effect of Lacosamide 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 Lacosamide.

Taking Lacosamide Viso Pharmaceutical 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.

Lacosamide is not recommended during pregnancy, as the effects of lacosamide on pregnancy and the fetus are not known.

It is not recommended to breastfeed while taking Lacosamide, as Lacosamide 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 Lacosamide 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 tools or machines until you know if this medication affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Lacosamide Viso Pharmaceutical

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 Lacosamide Viso Pharmaceutical

• Take lacosamide twice a day, with an interval of approximately 12 hours.
• Try to take it at the same time every day.
• Take the lacosamide tablet with a glass of water.
• You can take lacosamide with or without food.

Normally, you will start with 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. 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 usual recommended doses of lacosamide 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 Lacosamide alone:

The recommended 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 Lacosamide 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 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 oral solution and only switched 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 Viso Pharmaceutical 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 package and package leaflet of the medication 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 heart rate and sweating.

If you forget to take Lacosamide Viso Pharmaceutical

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

If you stop taking Lacosamide Viso Pharmaceutical

• Do not stop taking lacosamide without telling your doctor, as your symptoms may return or worsen.
• If your doctor decides to stop your treatment with lacosamide, they will give you instructions on how to gradually decrease 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 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 twitches (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Balance problems, 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 problems;
• 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 can 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 can 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 peeling of the skin 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, 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 effect, consult your doctor or pharmacist, even if it is not listed in this package 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 Lacosamide Viso Pharmaceutical

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 through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lacosamida Viso Farmacéutica

The active ingredient is lacosamida.

Each Lacosamida Viso Farmacéutica 150 mg tablet contains 150 mg of lacosamida.

The other components 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: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the Product and Container Content

Lacosamida Viso Farmacéutica 150 mg are film-coated oval tablets, salmon-colored, marked with “LAC” on one side and “150” on the other.

Lacosamida Viso Farmacéutica is available in packs of 14, 56, 84, and 168 film-coated tablets in PVC/PVDC blisters 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

Further information about this medicinal product can be obtained from 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 about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/