Lacosamide Combix 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamida Combix 50 mg film-coated tablets EFG

Lacosamida Combix 100 mg film-coated tablets EFG

Lacosamida Combix 150 mg film-coated tablets EFG

Lacosamida Combix 200 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lacosamida Combix is and what it is used for

What Lacosamida Combix is

Lacosamida Combix 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 it is used for

• Lacosamide is used:
  • either alone or in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age, 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, 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 Lacosamida Combix

Do not take Lacosamida Combix

• if you are allergic to lacosamide 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 heart rhythm problem called second- or third-degree AV block.

Do not take lacosamide 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 lacosamide if:

• you have thoughts about self-harm or suicide. A small number of people being treated with antiepileptic medicines such as lacosamide have had thoughts about self-harm or suicide. If at any time you have such thoughts, 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 feel dizzy or fall frequently. Lacosamide may cause dizziness, which could increase the risk of accidental injury or falls. This means 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 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, dyspnea (difficulty breathing), dizziness, or fainting), contact your doctor immediately (see section 4).

Children

Lacosamide 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 it is not yet known whether it is effective and safe in children of these age groups.

Other medicines and Lacosamida Combix

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamide 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 medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin.
• medicines 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 lacosamide.

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

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole.
• medicines for HIV such as ritonavir.
• medicines for bacterial infections such as clarithromycin or rifampicin.
• a herbal medicine 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 taking lacosamide.

Taking Lacosamida Combix with alcohol

As a precaution, do not take lacosamide 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.

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

Breastfeeding is not recommended while taking Lacosamida, because lacosamide 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 this medicine.

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 lacosamide may cause dizziness or blurred vision.

3. How to take Lacosamida Combix

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Other forms of lacosamida may be more suitable for children; please consult your doctor or pharmacist.

How to take Lacosamida Combix

• Take lacosamida twice daily, at approximately 12-hour intervals.
• Try to take it at about the same time each day.
• Take the lacosamida tablet with a glass of water.
• You may take lacosamida with food or separately.

Usually, 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, known as the “maintenance dose”, you will take the same amount every day. Lacosamida is used as a long-term treatment. You should continue taking lacosamida until your doctor tells you to stop.

What dose to take

The following are the normal recommended doses of lacosamida 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 lacosamida alone:

The usual starting dose is 50 mg twice daily.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 lacosamida with other antiepileptic medicines:

The usual 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 lacosamida treatment with a single “loading” dose of 200 mg. You would then start 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 lacosamida is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that lacosamida is not recommended for children under 4 years of age.

The dose depends on body weight. Treatment is usually started with the oral 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 best suited to you.

If you take more Lacosamida Combix than you should

If you have taken more lacosamida than you should, contact your doctor immediately. Do not attempt to drive. You may experience:

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

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

If you forget to take Lacosamida Combix

• 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 your next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Lacosamida Combix

• Do not stop taking lacosamida without telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your lacosamida treatment, you will be given 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 experiences them.

Nervous system effects such as dizziness may be greater after a single "loading" dose.

Tell your doctor or pharmacist if you experience any of the following:

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 jerks of a muscle or group of muscles (myoclonic jerks);
• 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 of dizziness (vertigo), sensation of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Reduced sensation, difficulty articulating words, attention disturbance;
• Ringing in the ears such as buzzing, ringing, or hissing;
• 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);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• Allergic reaction to 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);
• Severe 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 liver enzyme levels and an increase in a type of white blood cells (eosinophilia);
• 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 skin peeling 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 a possible adverse 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 Lacosamida Combix

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 unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamida Combix

• The active substance is lacosamide.

Each Lacosamida Combix 50 mg tablet contains 50 mg of lacosamide.

Each Lacosamida Combix 100 mg tablet contains 100 mg of lacosamide.

Each Lacosamida Combix 150 mg tablet contains 150 mg of lacosamide.

Each Lacosamida Combix 200 mg tablet contains 200 mg of lacosamide.

• The other components are:

Tablet core: Microcrystalline cellulose, crospovidone, hydroxypropylcellulose, colloidal anhydrous silica and magnesium stearate.

Coating:

50 mg: Opadry white 03F58750, composed of: hypromellose, titanium dioxide (E171), macrogol and talc.

100 mg: Opadry yellow 03F520087, composed of: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).

150 mg: Opadry beige 03F570004, composed of: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

200 mg: Opadry blue 03F505020, composed of: hypromellose, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), red iron oxide (E172) and brilliant blue FCF (E133).

Appearance of the product and contents of the pack

Lacosamida Combix 50 mg are oval, film-coated tablets, white or off-white in colour, with bevelled edges, marked with “787” on one side and plain on the other, with approximate dimensions of 10 mm x 5 mm.

The tablets are presented in blister packs contained in cartons of 14 tablets.

Lacosamida Combix 100 mg are oval, film-coated tablets, yellow or yellowish in colour, with bevelled edges, marked with “788” on one side and plain on the other, with approximate dimensions of 13 mm x 6 mm.

The tablets are presented in blister packs contained in cartons of 56 tablets.

Lacosamida Combix 150 mg are oval, film-coated tablets, beige in colour, with bevelled edges, marked with “789” on one side and plain on the other, with approximate dimensions of 14 mm x 7 mm.

The tablets are presented in blister packs contained in cartons of 56 tablets.

Lacosamida Combix 200 mg are oval, film-coated tablets, light blue or blue in colour, with bevelled edges, marked with “790” on one side and plain on the other, with approximate dimensions of 16.2 mm x 7.9 mm.

The tablets are presented in blister packs contained in cartons 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

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the most recent revision of this leaflet: July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/