VITELAX 100 mg FILM-COATED TABLETS

2. What you need to know before taking Vitelax

Do not take Vitelax

• 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 heart rhythm problem called 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 take 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.
• if 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).
• if you have severe heart disease such as heart failure or have had a heart attack.
• if you often feel dizzy or fall. This medication can cause dizziness, which may 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 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, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamide 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 Vitelax

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

In particular, tell your doctor or pharmacist if you are taking any of the following medications that affect the heart, as this medication 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 this medication in your body:

• medications for fungal infections such as fluconazole, itraconazole, or ketoconazole.
• medications 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 this medication.

Taking Vitelax with alcohol

As a precaution, do not take lacosamide 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 its effects 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 this medication or not.

Do not stop treatment without talking to your doctor first, as this may increase the risk of seizures. 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 can cause dizziness or blurred vision.

3. How to take Vitelax

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Other presentations of lacosamide may be more suitable for children; consult your doctor or pharmacist.

Taking Vitelax

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

Normally, you will start by 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 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 Vitelax 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 Vitelax 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 obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

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

If you forget to take Vitelax

• 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 Vitelax

• 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 twitches (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;
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• decreased sensitivity, difficulty articulating words, attention disorder;
• ringing in the ears like 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 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);
• throat pain, 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);
• 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). 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 effects, consult your doctor or pharmacist, even if they are 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 Vitelax

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and on the 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 the 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. Package Contents and Additional Information

Vitelax Composition

• The active ingredient is lacosamide.

Each 50 mg Vitelax tablet contains 50 mg of lacosamide.

Each 100 mg Vitelax tablet contains 100 mg of lacosamide.

Each 150 mg Vitelax tablet contains 150 mg of lacosamide.

Each 200 mg Vitelax tablet contains 200 mg of lacosamide.

• The other components are:

Tablet Core:microcrystalline cellulose, crospovidone, hydroxypropylcellulose, anhydrous colloidal silica, and magnesium stearate.

Coating Material:

50 mg: white coating agent, composed of: hypromellose, titanium dioxide (E171), macrogol, and talc.

100 mg: yellow coating agent, composed of: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), and red iron oxide (E172).

150 mg: beige coating agent, composed of: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

200 mg: blue coating agent, composed of: hypromellose, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), red iron oxide (E172), and brilliant blue FCF (E133).

Product Appearance and Package Contents

Vitelax 50 mg are film-coated oval tablets, white or off-white in color, with beveled edges, marked with “787” on one side and smooth on the other, with dimensions of 10 mm x 5 mm.

The tablets are presented in blisters packaged in boxes of 14 tablets.

Vitelax 100 mg are film-coated oval tablets, yellow or yellowish in color, with beveled edges, marked with “788” on one side and smooth on the other, with dimensions of 13 mm x 6 mm.

The tablets are presented in blisters packaged in boxes of 56 tablets.

Vitelax 150 mg are film-coated oval tablets, beige in color, with beveled edges, marked with “789” on one side and smooth on the other, with dimensions of 14 mm x 7 mm.

The tablets are presented in blisters packaged in boxes of 56 tablets.

Vitelax 200 mg are film-coated oval tablets, light blue or blue in color, with beveled edges, marked with “790” on one side and smooth on the other, with dimensions of 16.2 mm x 7.9 mm.

The tablets are presented in blisters packaged in boxes of 56 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles,

France

Date of Last Revision of this Leaflet: December 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)