LACOSAMIDE COMBIX 50 mg FILM-COATED TABLETS

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 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Lacosamida Combix

Lacosamida Combix contains lacosamide, 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 are having.

What is it used for

• Lacosamide is used:
• • on its own and with other antiepileptics in adults, adolescents and children from 2 years of age 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, the seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the brain;
  • with other antiepileptics in adults, adolescents and children from 4 years of age to treat primary generalized tonic-clonic seizures (grand mal seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy that is believed to have a genetic origin).

2. What you need to know before you take Lacosamida Combix

Do not take Lacosamida Combix

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure, consult your doctor.
• if you have a heart problem called second or third degree AV block.

Do not take lacosamide if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

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 at any time you have these thoughts, contact your doctor immediately.
• you have a heart problem affecting your heart beat and your pulse is often particularly slow, fast or irregular (such as AV block, atrial fibrillation and atrial flutter).
• you have severe heart disease such as heart failure or have had a heart attack.
• you often feel dizzy or faint. Lacosamide may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be careful until you are used to the effects of this medicine.

If any of the above applies to you (or you are not sure), 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 heart rhythm (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 occurrence of partial-onset seizures or in children under 4 years of age with primary 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 medicines and Lacosamida Combix

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

In particular, tell 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 for heart problems.
• medicines that can increase the “PR interval” in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines 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 not sure) talk to your doctor or pharmacist before taking lacosamide.

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

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazol.
• HIV medicines 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 not sure) talk to 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 potential should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lacosamide is not recommended during pregnancy, as its effects on pregnancy and the fetus are not known.

Lacosamide is not recommended during breastfeeding, as it passes into breast milk.

Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. They will help you decide if you should take this medicine or not.

Do not stop treatment without talking to your doctor first, as this may increase the risk of seizures (fits). 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 medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Lacosamida Combix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Another form of lacosamide may be more suitable for children; consult your doctor or pharmacist.

Taking Lacosamida Combix

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

Normally, you will start by 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 will need to 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 lacosamide 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 lacosamide with other antiepileptic medicines:

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. You will then 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 oral solution and only changed to tablets if the patient is able to take them and to get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lacosamida Combix than you should

If you have taken more lacosamide than you should, talk to 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 rapid heart rate and sweating.

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

If you forget to take Lacosamida Combix

• If you have forgotten to take a dose within the 6 hours following the scheduled dose, take it as soon as you remember.
• If you have forgotten to take a dose after the 6 hours following the scheduled dose, do not take the missed dose. Instead, take lacosamide the next time you would normally take it.
• Do not take a double dose to make up for missed doses.

If you stop taking Lacosamida Combix

• Do not stop taking lacosamide without telling your doctor, as your epilepsy may come back or get worse.
• 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects in the nervous system, such as dizziness, may be greater after a single “loading dose”.

Tell your doctor or pharmacist if you get any of the following side effects:

Very common:may affect more than 1 in 10 people

• headache;
• feeling sick (nausea);
• double vision (diplopia).

Common:may affect up to 1 in 10 people

• brief muscle jerks or twitches (myoclonic seizures);
• difficulty in coordinating movements or walking;
• problems with balance, shakiness (tremor), tingling (paresthesia) or muscle spasms, falling easily and bruising;
• memory problems, difficulty in 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 intestines, diarrhea;
• decreased sensitivity, difficulty in articulating words, altered attention;
• ringing in the ears like buzzing, ringing or whistling;
• irritability, sleep problems, depression;
• sleepiness, tiredness or weakness (asthenia);
• itching, rash.

Uncommon:may affect up to 1 in 100 people

• slow heart rate, palpitations, irregular heartbeat 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 medicine, hives;
• blood tests may show abnormalities in liver function tests, liver damage;
• thoughts of self-harm or suicide or attempted suicide: tell 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 the available data

• abnormally fast heart rhythm (ventricular tachyarrhythmia);
• sore throat, high temperature and infections more often than usual. Blood tests may show a severe decrease in a specific class 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 (lymphadenopathy). Blood tests may show increased levels of liver enzymes 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 causing peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):
• seizures.

Other side effects in children

Additional side effects seen in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, not acting as they normally do (abnormal behavior) and lack of energy (lethargy). Sleepiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Lacosamida Combix

• The active ingredient 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:

Core of the tablet:Microcrystalline cellulose, crospovidone, hydroxypropylcellulose, anhydrous colloidal 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, carmine indigo (E132), red iron oxide (E172), and brilliant blue FCF (E133).

Appearance of the Product and Container Content

Lacosamida Combix 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 approximate dimensions of 10 mm x 5 mm.

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

Lacosamida Combix 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 approximate dimensions of 13 mm x 6 mm.

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

Lacosamida Combix 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 approximate dimensions of 14 mm x 7 mm.

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

Lacosamida Combix 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 approximate 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

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the Last Revision of this Prospectus: July 2022

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