Package Insert: Information for the Patient

Lacosamide Cinfa 50 mg Film-Coated Tablets

Lacosamide Cinfa 100 mg Film-Coated Tablets

Lacosamide Cinfa 150 mg Film-Coated Tablets

Lacosamide Cinfa 200 mg Film-Coated Tablets

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

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

What is lacosamida cinfa

This medicine contains lacosamida, which belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

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

What is lacosamida cinfa used for

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

Do not takeLacosamida Cinfa

• if you are allergic to lacosamida or any of the other ingredients of this medication (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 takelacosamidaif 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 uselacosamidaif:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic drugs 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 condition that affects heart rhythm and often your pulse is especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• you have a serious heart condition such as heart failure or have had a myocardial infarction.
• you often get dizzy or fall.Lacosamidamay cause dizziness, which could increase the risk of accidental injuries or falls. This means you shouldbe carefuluntil 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 takinglacosamida.

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

If you are takinglacosamidaand experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamidais 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 of this age group.

Other medications andLacosamida Cinfa

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, aslacosamidamay 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 takinglacosamida.

Also inform your doctor or pharmacist if you are taking any of the following medications, as they may increase or decrease the effect oflacosamidain your body:

• antifungal medications such as fluconazole, itraconazole, or ketoconazole.
• medications for HIV 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), speak with your doctor or pharmacist before takinglacosamida.

Use ofLacosamida Cinfawith alcohol

As a precaution, do not takelacosamidawith 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.

Lacosamidais not recommended if you are pregnant, as its effects on pregnancy and the fetus are unknown.

It is not recommended to breastfeed while takinglacosamida, aslacosamidapasses into breast milk.

Seek advice immediately from your doctor if you are pregnant or plan to become pregnant. They will help you decide if you should takelacosamidaor not.

Do not stop treatment without first speaking with 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, cycle, or use any tools or machines until you know if this medication affects you. The reason is thatlacosamidamay 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 presentations of this medication may be more suitable for children; consult your doctor or pharmacist.

Lacosamida Cinfa Dosage

• Takelacosamidatwice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time each day.
• Take thelacosamidatablet with a glass of water.
• You can takelacosamidawith 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.Lacosamidais used as long-term treatment. You will need to continue takinglacosamidauntil your doctor tells you to stop.

How much to take

The following are the usual recommended doses oflacosamidafor 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 adultsWhen takinglacosamidaalone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg oflacosamidatwice 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 takinglacosamidawith 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 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 thatlacosamidais not recommended for children under 2 years.
• In the treatment of primary generalized tonic-clonic seizures:note that

lacosamidais not recommended for children under 4 years.

The dose depends on body weight. Treatment usually starts with the syrup and only changes 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 moreLacosamida Cinfa than you should

If you have taken morelacosamidathan 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.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeLacosamida Cinfa

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

If you interrupt treatment withLacosamida Cinfa

• Do not stop takinglacosamidawithout telling your doctor, as epilepsy may recur or worsen.
• If your doctor decides to stop your treatment withlacosamida, 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.

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 people

• Headache;
• Feeling dizzy or nauseous;
• Diplopia (double vision).

Common:may affect up to 1 in 10 people

• Short, involuntary muscle contractions or 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, involuntary eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling intoxicated;
• Feeling nauseous, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty articulating words, altered attention;
• Ringing in the ears like buzzing, beeping, or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue, or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 people

• 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;
• Loss of consciousness;
• 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 more frequently 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 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

The additional side effects observed in children were fever (pyrexia), nasal congestion (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 (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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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.

Composition of lacosamida cinfa

• The active ingredient is lacosamida.

Each lacosamida cinfa 50 mg tablet contains 50 mg of lacosamida.

Each lacosamida cinfa 100 mg tablet contains 100 mg of lacosamida.

Each lacosamida cinfa 150 mg tablet contains 150 mg of lacosamida.

Each lacosamida cinfa 200 mg tablet contains 200 mg of lacosamida.

• The other components are:

Core of the tablet: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose with low degree of substitution, anhydrous colloidal silica, microcrystalline cellulose silicified (formed by microcrystalline cellulose and anhydrous colloidal silica), crospovidone and magnesium stearate.

Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E-171) and colorants*

*The colorants are:

50 mg tablets: iron oxide red (E-172).

100 mg tablets: iron oxide yellow (E-172).

150 mg tablets: iron oxide red (E-172), iron oxide yellow (E-172).

200 mg tablets: carmine of indigo (E-132).

Appearance of the product and contents of the package

• Lacosamida cinfa 50 mg are oval-shaped, pink, biconvex tablets marked with “L1” on one face.
• Lacosamida cinfa 100 mg are oval-shaped, dark yellow, biconvex tablets marked with “L2” on one face.
• Lacosamida cinfa 150 mg are oval-shaped, salmon-colored, biconvex tablets marked with “L3” on one face.
• Lacosamida cinfa 200 mg are oval-shaped, blue, biconvex tablets marked with “L4” on one face.

Lacosamida cinfa is available in packages with 14, 28 and 56 film-coated tablets in PVC/PVDC-Aluminum blister packaging.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:May 2025

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/

Lacosamida cinfa 50 mg film-coated tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/86515/P_86515.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86515/P_86515.html

Lacosamida cinfa 100 mg film-coated tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/86512/P_86512.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86512/P_86512.html

Lacosamida cinfa 150 mg film-coated tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/86513/P_86513.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86513/P_86513.html

Lacosamida cinfa 200 mg film-coated tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86514/P_86514.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86514/P_86514.html