Lacosamide Viso Farmaceutica 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Lacosamida Viso Farmacéutica 50mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Lacosamida Viso Farmacéutica is and what it is used for
2. What you need to know before taking Lacosamida Viso Farmacéutica
3. How to take Lacosamida Viso Farmacéutica
4. Possible side effects
5. How to store Lacosamida Viso Farmacéutica
6. Contents of the pack and other information

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

What Lacosamida Viso Farmacéutica is

Lacosamida Viso Farmacéutica contains lacosamide, which belongs to a group of medicines called "antiepileptic drugs". These medicines are used to treat epilepsy.

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

What Lacosamida Viso Farmacéutica is used for

• Lacosamide is used:
  • Alone or in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age onwards, to treat a certain type of epilepsy characterized by 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 on both sides of the brain;
  • In combination with other antiepileptic drugs in adults, adolescents, and children from 4 years of age onwards, 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 starting to take Lacosamida Viso Farmacéutica

Do not take lacosamida

• if you are allergic to lacosamida or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether 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 either of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before starting Lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people being treated with antiepileptic medicines such as lacosamida have had thoughts of self-harm or suicide. If you experience such thoughts at any time, contact your doctor immediately.
• you have a heart condition affecting your heartbeat, and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter).
• you have severe heart disease such as heart failure or have had a myocardial infarction.
• you frequently feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidental injury or falls. Therefore, you should be cautious until you are accustomed to the effects of this medicine.

If any of the above apply 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 heartbeat (such as slow, fast, or irregular heartbeat, palpitations, difficulty breathing, dizziness, or 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 partial-onset seizures, or for children under 4 years of age with generalized tonic-clonic seizures. This is because its efficacy and safety have not yet been established in children of these age groups.

Other medicines and Lacosamida Viso Farmacéutica

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamida may also affect the heart:

• medicines used to treat heart problems.
• medicines that may increase the "PR interval" on a heart test (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin.
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above apply 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 medicines, as they may increase or decrease the effect of Lacosamida in your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole.
• an HIV medicine such as ritonavir.
• antibiotics used to treat bacterial infections such as clarithromycin or rifampicin.
• a herbal remedy used to treat mild anxiety and depression called St. John’s wort (Hypericum perforatum).

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

Taking Lacosamida Viso Farmacéutica with alcohol

As a safety precaution, do not take this medicine with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding is not recommended while taking Lacosamida, as lacosamida passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether or not you should take Lacosamida.

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

Driving and using machines

You must not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you. This is because lacosamida may cause dizziness or blurred vision.

3. How to take Lacosamida Viso Farmacéutica

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Another (s) form (s) of this medicine may be more suitable (s) for children; consult your doctor or pharmacist.

Taking Lacosamida Viso Farmacéutica

• Take lacosamide twice daily, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Swallow the lacosamide tablet with a glass of water.
• You may take lacosamide with food or separately.

Normally, you will start with a low daily dose, and your doctor will gradually increase the dose over several weeks. Once 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 a long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

What dose to take

Below are the recommended normal 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 daily.

Your doctor may also prescribe a starting dose of 100 mg of lacosamide twice daily.

Your doctor may increase your twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 300 mg twice daily.

When taking Lacosamide with other antiepileptic medicines:

The recommended starting dose is 50 mg twice daily.

Your doctor may increase your twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 200 mg twice daily.

If you weigh 50 kg or more, your doctor may start lacosamide treatment with a single “loading” dose of 200 mg. You would then begin taking the regular 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 switched to tablets if the patient is able to swallow them and can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form most suitable for you.

If you take more Lacosamida Viso Farmacéutica than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

Do not attempt to drive.

You may experience:

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

If you forget to take Lacosamida Viso Farmacéutica

• If you forget to take a dose within 6 hours of your scheduled dose, take it as soon as you remember.
• If you forget to take a dose more than 6 hours after your scheduled dose, do not take the missed dose; instead, take lacosamide at your next regularly scheduled time.
• Do not take a double dose to make up for missed doses.

If you stop taking Lacosamida Viso Farmacéutica

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects affecting 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 jerking of a muscle or group of muscles (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Problems with balance, tremor, tingling (paraesthesia), or muscle spasms, falling easily and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid uncontrolled eye movements (nystagmus), blurred vision;
• Feeling dizzy (vertigo), sensation of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Decreased sensation, difficulty articulating words, attention disturbance;
• Ringing in the ear such as buzzing, ringing, or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• Euphoria (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 suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts or loss of sense of reality;
• Severe allergic reactions causing 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);
• Sore throat, high temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);
• Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in a type of white blood cells (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 causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Other adverse effects in children

Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioural changes, not acting as they normally do (abnormal behaviour), 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 of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamide Viso Farmacéutica

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

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamida Viso Farmacéutica

The active substance is lacosamide.

Each Lacosamida Viso Farmacéutica 50 mg tablet contains 50 mg of lacosamide.

The other components are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, silicified microcrystalline cellulose, crospovidone (type B), magnesium stearate.

Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171),
iron oxide red (E172), iron oxide black (E172), indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Lacosamida Viso Farmacéutica 50 mg are pink, oval, film-coated tablets, marked with “LAC” on one side and “50” on the other.

This medicine is available in packs of 14, 56, 84 and 168 film-coated tablets in PVC/PVDC blisters sealed with an aluminium foil.

Only certain 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 medicine, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: October 2022

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