LACOSAMIDE STADA 200 mg FILM-COATED TABLETS

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

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

What is Lacosamida

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 are having.

What is Lacosamida used for

Lacosamida is used:

• alone and in combination with other antiepileptic medicines 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, seizures affect only one side of your brain. However, they can then spread to larger areas on both sides of your brain.
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (severe seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause).

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

Do not take Lacosamida Stada

• if you are allergic to lacosamida 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 this medicine 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 use this medicine if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamida 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 that affects your heartbeat 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. Lacosamida 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 this medicine.

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

Children

Lacosamida is not recommended in children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures, nor in children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe for children in this age group.

Other medicines and Lacosamida Stada

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 lacosamida may 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 this medicine.

Tell your doctor or pharmacist if you are taking any of the following medicines. The reason is that they may also increase or decrease the effect of lacosamida in your body.

• medicines for fungal infections, such as fluconazole, itraconazole, or ketoconazole
• a medicine 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 not sure), talk to your doctor or pharmacist before taking lacosamida.

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 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 medicine.

Lacosamida is not recommended during pregnancy, as the effects of this medicine on pregnancy and the fetus are not known. It is not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk. Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. They will help you decide whether to take lacosamida 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 lacosamida may cause dizziness or blurred vision.

3. How to take Lacosamida Stada

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Another form of lacosamida may be more suitable for children; consult your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time each day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida 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. Lacosamida is used as long-term treatment. You will need to continue taking lacosamida until your doctor tells you to stop.

How much to take

The following are the usual 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 a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 lacosamida 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 lacosamida 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 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. For doses below 50 mg, a syrup may be available. Treatment is usually started with the syrup and only switched to tablets if the patient is able to take them and get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lacosamida Stada than you should

If you have taken more lacosamida 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 heartbeat and sweating.

If you forget to take Lacosamida Stada

• 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 lacosamida 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 Stada

• Do not stop taking lacosamida without telling your doctor, as your epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with lacosamida, 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, lacosamida can cause side effects, although not everybody gets them.

Side effects on 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 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 muscle jerks or twitching (myoclonic seizures)
• difficulty coordinating movements or walking
• problems with balance, difficulty coordinating movements or walking, shaking (tremor), tingling (paresthesia), 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), feeling drunk
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea
• decreased sensitivity, difficulty articulating words, attention problems
• 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)
• feeling extremely happy, 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 type of white blood cell (agranulocytosis)
• severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased liver enzyme levels 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 that causes 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), eating less than usual (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 website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Stada

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 on the blister after EXP. The expiry date is the last day of the month stated.

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. Package Contents and Additional Information

Composition of Lacosamida Stada

• The active ingredient is lacosamide.

Lacosamida Stada 50 mg: each film-coated tablet contains 50 mg of lacosamide.

Lacosamida Stada 100 mg: each film-coated tablet contains 100 mg of lacosamide.

Lacosamida Stada 150 mg: each film-coated tablet contains 150 mg of lacosamide.

Lacosamida Stada 200 mg: each film-coated tablet contains 200 mg of lacosamide.

• The other components are

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

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

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

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

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

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

Product Appearance and Package Contents

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

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

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

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

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 authorized 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 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

Finland: 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

France: LACOSAMIDE EG 50 mg, film-coated tablet

LACOSAMIDE EG 100 mg, film-coated tablet

LACOSAMIDE EG 150 mg, film-coated tablet

LACOSAMIDE EG 200 mg, film-coated tablet

Netherlands: 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

Iceland: 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

Italy: LACOSAMIDE EG 50 mg film-coated tablets

LACOSAMIDE EG 100 mg film-coated tablets

LACOSAMIDE EG 150 mg film-coated tablets

LACOSAMIDE EG 200 mg film-coated tablets

Luxembourg: Lacosamide EG 50 mg film-coated tablets

Lacosamide EG 100 mg film-coated tablets

Lacosamide EG 150 mg film-coated tablets

Lacosamide EG 200 mg film-coated tablets

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 film-coated tablets

Lacosamide Stada 100 mg film-coated tablets

Lacosamide Stada 150 mg film-coated tablets

Lacosamide Stada 200 mg film-coated tablets

Sweden: 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

Date of the last revision of this leaflet:June 2023

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