Lacosamide Stada 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamida Stada 50 mg film-coated tablets EFG

Lacosamida Stada 100 mg film-coated tablets EFG

Lacosamida Stada 150 mg film-coated tablets EFG

Lacosamida Stada 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; 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 you should not give it to others, 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 these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

What Lacosamida is

This medicine contains lacosamida, 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 is used for

Lacosamida is used:

• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age, to treat a certain type of epilepsy characterised by "partial-onset seizures with or without secondary generalisation". 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 medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalised tonic-clonic seizures (severe seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Lacosamida Stada

Do not take Lacosamida Stada

• 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 this medicine 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 to use this medicine if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide 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 often have a particularly slow, fast, or irregular pulse (such as AV block, atrial fibrillation, or atrial flutter).
• you have severe heart disease such as heart failure or have had a myocardial infarction (heart attack).
• you frequently feel dizzy or fall. 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 applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

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 Stada

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" in 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 applies to you (or you are unsure), speak with your doctor or pharmacist before taking this medicine.

Also inform your doctor or pharmacist if you are taking any of the following medicines. This is because they may either increase or decrease the effect of lacosamide in your body.

• antifungal medicines, such as fluconazole, itraconazole, or ketoconazole
• an HIV medicine, such as ritonavir
• antibiotics, such as clarithromycin or rifampicin
• a herbal remedy 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 Stada with alcohol

As a 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Lacosamide is not recommended during pregnancy, as the effects of this medicine on pregnancy and the fetus are not known. Breastfeeding is not recommended while taking lacosamide, 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 to take lacosamide.

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 Stada

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

Taking Lacosamida

• 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. When 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 normally 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 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 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 lacosamide treatment with a single “loading dose” of 200 mg. Then you would 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. For doses below 50 mg, an oral syrup may be available. 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 appropriate for you.

If you take more lacosamide than you should

If you have taken more lacosamide than prescribed, 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.

If you forget to take lacosamide

• 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 scheduled time.
• Do not take a double dose to make up for a missed dose.

If you stop taking lacosamide

• Do not stop taking lacosamide without telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your lacosamide 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, lacosamide may 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 effects:

Very common: may affect more than 1 in 10 people

• Headache
• Feeling dizzy or sick (nausea)
• Double vision (diplopia)

Common: may affect up to 1 in 10 people

• Brief jerks of a muscle or group of muscles (myoclonic seizures)
• Difficulty coordinating movements or walking
• Problems with balance, difficulty coordinating movements or walking, trembling (tremor), tingling (paresthesia), or muscle spasms, tendency to fall and bruise easily
• Memory problems, thinking difficulties or trouble finding words, confusion
• Rapid and 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, diarrhea
• Reduced sensation, difficulty speaking, attention disturbance
• Ringing in the ears such as buzzing, ringing, or hissing sounds
• Irritability, sleep problems, depression
• Drowsiness, tiredness or weakness (asthenia)
• Itching, rash

Uncommon: may affect up to 1 in 100 people

• 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 the 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 liver enzyme levels and an increase in a type of white blood cells (eosinophilia)
• Widespread rash with blistering 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), behavioral changes, not acting as usual (abnormal behavior), and lack of energy (lethargy). Sleepiness (drowsiness) 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamide Stada

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

Do not use this medicine after the expiry date 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 empty containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly 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 Stada

• The active substance is lacosamide.

Lacosamida Stada 50 mg: each tablet contains 50 mg of lacosamide.

Lacosamida Stada 100 mg: each tablet contains 100 mg of lacosamide.

Lacosamida Stada 150 mg: each tablet contains 150 mg of lacosamide.

Lacosamida Stada 200 mg: each tablet contains 200 mg of lacosamide.

• The other components are

Tablet core: microcrystalline cellulose (E460), low-substituted hydroxypropyl cellulose, crospovidone (E1202), hydroxypropyl cellulose (E463), anhydrous colloidal silica and magnesium stearate.

Coating: poly(vinyl alcohol) (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553b).

Lacosamida Stada 50 mg: iron oxide red (E172), iron oxide black (E172) and aluminium lake with indigo carmine (E132).

Lacosamida Stada 100 mg: iron oxide yellow (E172) and iron oxide black (E172).

Lacosamida Stada 150 mg: iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172) and aluminium lake with indigo carmine (E132).

Lacosamida Stada 200 mg: aluminium lake with indigo carmine (E132).

Appearance of the product and contents of the pack

Lacosamida Stada 50 mg: pink, film-coated, oblong, biconvex tablets, engraved with '50' on one side, smooth on the other, approximately 10.3 mm in length and 4.8 mm in width.

Lacosamida Stada 100 mg: yellow, film-coated, oblong, biconvex tablets, engraved with '100' on one side, smooth on the other, approximately 13.1 mm in length and 6.1 mm in width.

Lacosamida Stada 150 mg: beige, film-coated, oblong, biconvex tablets, engraved with '150' on one side, smooth on the other, approximately 15.2 mm in length and 7.1 mm in width.

Lacosamida Stada 200 mg: blue, film-coated, oblong, biconvex tablets, engraved with '200' on one side, smooth on the other, approximately 16.6 mm in length and 7.7 mm in width.

Lacosamida Stada is available in packs of 14, 56 and 168 film-coated tablets in transparent PVC/PVDC blisters sealed with an aluminium foil and packaged in cardboard boxes.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Genepharm S.A.

18km Marathonos Avenue

Pallini 15351

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

Wien 1190

Austria

or

Thornton and Ross Ltd,

Manchester Road, Linthwaite,

Huddersfield, West Yorkshire, HD7 5QH

United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Lacosamid AL 50 mg Filmtabletten

Lacosamid AL 100 mg Filmtabletten

Lacosamid AL 150 mg Filmtabletten

Lacosamid AL 200 mg Filmtabletten

Austria: Lacosamid STADA 50 mg Filmtabletten

Lacosamid STADA 100 mg Filmtabletten

Lacosamid STADA 150 mg Filmtabletten

Lacosamid STADA 200 mg Filmtabletten

Belgium: Lacosamide EG 50 mg filmomhulde tabletten

Lacosamide EG 100 mg filmomhulde tabletten

Lacosamide EG 150 mg filmomhulde tabletten

Lacosamide EG 200 mg filmomhulde tabletten

Denmark: Lacosamid STADA

Spain: Lacosamida STADA 50 mg comprimidos recubiertos con película EFG

Lacosamida STADA 100 mg comprimidos recubiertos con película EFG

Lacosamida STADA 150 mg comprimidos recubiertos con película EFG

Lacosamida STADA 200 mg comprimidos recubiertos con película EFG

Finland: Lacosamide STADA 50 mg tabletti, kalvopäällysteinen

Lacosamide STADA 100 mg tabletti, kalvopäällysteinen

Lacosamide STADA 150 mg tabletti, kalvopäällysteinen

Lacosamide STADA 200 mg tabletti, kalvopäällysteinen

France: LACOSAMIDE EG 50 mg, comprimé pelliculé

LACOSAMIDE EG 100 mg, comprimé pelliculé

LACOSAMIDE EG 150 mg, comprimé pelliculé

LACOSAMIDE EG 200 mg, comprimé pelliculé

Netherlands: Lacosamide STADA 50 mg, filmomhulde tabletten

Lacosamide STADA 100 mg, filmomhulde tabletten

Lacosamide STADA 150 mg, filmomhulde tabletten

Lacosamide STADA 200 mg, filmomhulde tabletten

Iceland: Lacosamide STADA 50 mg filmuhúðuð tafla

Lacosamide STADA 100 mg filmuhúðuð tafla

Lacosamide STADA 150 mg filmuhúðuð tafla

Lacosamide STADA 200 mg filmuhúðuð tafla

Italy: LACOSAMIDE EG 50 mg compresse rivestite con film

LACOSAMIDE EG 100 mg compresse rivestite con film

LACOSAMIDE EG 150 mg compresse rivestite con film

LACOSAMIDE EG 200 mg compresse rivestite con film

Luxembourg: Lacosamide EG 50 mg comprimé pelliculé

Lacosamide EG 100 mg comprimé pelliculé

Lacosamide EG 150 mg comprimé pelliculé

Lacosamide EG 200 mg comprimé pelliculé

United Kingdom (Northern Ireland): Lacosamide STADA 50 mg film-coated tablets

Lacosamide STADA 100 mg film-coated tablets

Lacosamide STADA 150 mg film-coated tablets

Lacosamide STADA 200 mg film-coated tablets

Slovak Republic: Lacosamide Stada 50 mg filmom obalené tablety

Lacosamide Stada 100 mg filmom obalené tablety

Lacosamide Stada 150 mg filmom obalené tablety

Lacosamide Stada 200 mg filmom obalené tablety

Sweden: Lacosamide STADA 50 mg filmdragerade tabletter

Lacosamide STADA 100 mg filmdragerade tabletter

Lacosamide STADA 150 mg filmdragerade tabletter

Lacosamide STADA 200 mg filmdragerade tabletter

Date of the most recent revision of this leaflet: June 2023

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