Prospect: Information for the Patient

Lacosamida Viso Pharmaceutical 100mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Lacosamida Viso Pharmaceutical

3.How to take Lacosamida Viso Pharmaceutical

4.Possible adverse effects

5.Storage of Lacosamida Viso Pharmaceutical

6.Contents of the package and additional information

What is Lacosamida Viso Farmacéutica

Lacosamida Viso Farmacéutica contains lacosamida, 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 Lacosamida Viso Farmacéutica used forLacosamida Viso Farmacéutica

• Lacosamida is used:
• • Alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years and older to treat a certain type of epilepsy characterized by the occurrence of partial onset seizures with or without secondary generalization. In this type of epilepsy, seizures 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 antiepileptic medications in adults, adolescents, and children aged 4 years and older 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).

Do not take lacosamida

•if you are allergic to lacosamida or any of the other ingredients in this medication (listed in section 6). If you are unsure if you are allergic, 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 antiepileptic medications such as lacosamida have had thoughts of self-harm or suicide. If you ever have this type of thought, contact your doctor immediately.
• you have a heart problem that affects your 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 myocardial infarction.
• you often get dizzy or fall.Lacosamida may cause dizziness, which may increase the risk of accidental injuries or falls. Therefore, you shouldbe carefuluntil you are accustomed 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 lacosamida.

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, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamida Viso Farmacéutica is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures or for children under 4 years with 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 medications and Lacosamida Viso Farmacéutica

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida may also affect the heart.

• medications to treat 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 you (or you are unsure), speak with 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 on your body.

• antifungal medications such as fluconazole, itraconazole, or ketoconazole.
• an HIV medication such as ritonavir.
• antibacterial medications such as clarithromycin or rifampicin.
• a medicinal plant 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.

Lacosamida Viso Farmacéutica and 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.

Do not takeLacosamidaif you are pregnant, as the effects of lacosamida on pregnancy and the fetus are not known.

Do not breastfeed a baby 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 if you should take Lacosamida or not

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

Driving and operating machinery

You should not drive, ride a bike, 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.

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. Another (other) form of this medication may be more suitable for children; consult your doctor or pharmacist.

• Lacosamide Tablet AdministrationTake lacosamide twice a day, with an interval of approximately 12 hours. Try to take it more or less at the same time each day.
• Take the lacosamide tablet with a glass of water.
• You can take lacosamide with meals or separately.

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 lacosamide until your doctor tells you to stop.

How much to take

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.

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 seizures:Lacosamide is not recommended for children under 2 years old.

- In the treatment of primary generalized tonic-clonic seizures: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 Lacosamide 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 ingested.

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

Do not attempt 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 Lacosamide Viso Farmacéutica

• 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 after 6 hours of the scheduled dose, do not take the missed dose, instead, take lacosamide at the next time you normally take it.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lacosamide Viso Farmacéutica

• Do not stop taking lacosamide without telling your doctor, as your symptoms may appear again or worsen.
• If your doctor decides to stop your treatment with lacosamide, he 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 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 (nausea);

•Dual vision (diplopia)

Common: may affect up to 1 in 10 patients

• Brief muscle or muscle group spasms (myoclonic crisis);
• Difficulty coordinating movements or walking;
• Balance problems, agitation (tremor), numbness (paresthesia) or muscle spasms, easy to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Uncontrolled rapid 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 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 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, 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 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

The additional side effects observed in children were fever (pyrexia), runny nose (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 side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly throughthe 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 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 drain or in the trash. Dispose of the containers 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Viso Pharmaceutical

The active ingredient is lacosamida.

Each Lacosamida Viso Pharmaceutical 100 mg tablet contains 100 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.

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

* The colorants are:

100 mg tablets: iron oxide yellow (E172).

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

Praha 4, 140 78,

Republic of Czech

Responsible for manufacturing:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143,

Vysoké Mýto 566 17

Republic of Czech

Ó

Combino Pharm (Malta) Ltd.

HF60 Hal Far Industriale Estate

BBG3000

ó

SVUS Pharma a.s.

Smetanovo nabrezi 1238/20a

500 02, Hradec Kralove

Czech Republic

Ó

Galenica Pharmaceuticals Industry S.A

Asklipiou 4-6, Kryoneri,

Attiki, 14568

Greece

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U.

C/Retama 7, 7th floor

28045 Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: October 2022

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/