Leaflet: information for the patient

Lacosamida Stada 50 mg film-coated tablets

Lacosamida Stada 100 mg film-coated tablets

Lacosamida Stada 150 mg film-coated tablets

Lacosamida Stada 200 mg film-coated tablets

Read this 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 you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Lacosamida Stada

4.Possible side effects

5.Storage of Lacosamida Stada

6.Contents of the pack and additional information

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 experience.

What is lacosamida used for

Lacosamida is used:

• alone or in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years and above, to treat a certain type of epilepsy characterised by the occurrence of “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 aged 4 years and above for the treatment of primary generalised tonic-clonic seizures (seizures that are severe, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is believed to have a genetic cause).

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 unsure if 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 any of the above applies to you. If you are unsure, 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 antiepileptic medicines such as lacosamida have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

•you have a heart problem that affects your heartbeat and your pulse is often very slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).

•you have a serious heart disease such as heart failure or have had a heart attack.

•you often feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidents 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 unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking lacosamida 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

Lacosamida is not recommended for children under 2 years with epilepsy characterised by the onset of partial seizures or for children under 4 years with generalised 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 Stada

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamida may affect the heart.

•medicines to treat heart problems.

•medicines that may 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 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. The reason is that they may also increase or decrease the effect of lacosamida in your body.

•antifungal medicines, such as fluconazole, itraconazole, or ketoconazole

•an HIV medicine, such as ritonavir

•antibacterial medicines, such as clarithromycin or rifampicin

•a medicinal herb 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 lacosamida.

Lacosamida Stada and 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 its effects on the pregnancy and the fetus are not known. Lacosamida is not recommended to be breastfed as it passes into breast milk. Ask your doctor immediately if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.

Do not stop treatment without talking to your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, cycle, 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.Other forms of lacosamide may be more suitable for children; consult your doctor or pharmacist.

Lacosamide Dosage

•Take lacosamide 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 lacosamide tablet with a glass of water.

•You can take lacosamide with meals or separately.

Normally, you will start 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, which is called the "maintenance dose," you will take the same amount each day. Lacosamide is used as long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

How much to take

Below are the normal recommended doses of lacosamide for different age groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children who weigh 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 medications::

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. Then you will start taking the continuous maintenance dose 12 hours later.

Children and adolescents who weigh less than 50 kg

-In the treatment of partial onset seizures:note that lacosamide is not recommended for children under 2 years.

-In the treatment of primary generalized tonic-clonic seizures:note that lacosamide is not recommended for children under 4 years.

The dose depends on body weight. For doses below 50 mg, a syrup may be available. Normally, treatment starts with the syrup and only changes to tablets if the patient is able to take them and obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more lacosamide than you should

If you have taken more lacosamide than you should, consult your doctor immediately. Do not attempt to drive.

You may experience:

•dizziness;

•sensation of dizziness (nausea) or dizziness (vomiting);

•seizures (crises), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.

If you forget to take lacosamide

•If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.

•If you have forgotten to take a dose more than 6 hours after the scheduled dose, do not take the missed dose, instead, take lacosamide at the next time you normally take it.

•Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with lacosamide

•Do not stop taking lacosamide without telling your doctor, as epilepsy may recur or worsen.

•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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, lacosamide may cause side effects, although not everyone will experience them.

The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading dose".

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 people

•Headache

•Feeling dizzy or nauseous

•Diplopia (double vision)

Common: may affect up to 1 in 10 people

•Short, involuntary muscle contractions (myoclonic jerks)

•Difficulty coordinating movements or walking

•Problems maintaining balance, difficulty coordinating movements or walking, agitation (tremor), paresthesia (tingling) or muscle spasms, easy falling and bruising

•Memory problems, difficulty thinking or finding words, confusion

•Rapid, involuntary eye movements (nystagmus), blurred vision

•Sensation of dizziness (vertigo), feeling intoxicated

•Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea

•Decreased sensitivity, difficulty articulating words, attention alteration

•Ringing in the ears like buzzing, beeping or whistling

•Irritability, difficulty sleeping, depression

•Drowsiness, fatigue or weakness (asthenia)

•Itching, rash

Uncommon: may affect up to 1 in 100 people

•Decreased heart rate, palpitations, irregular heartbeat or other changes in heart electrical activity (conduction disorder)

•Exaggerated feeling of well-being, seeing and/or hearing things that are not real

•Allergic reaction to the medication, hives

•Lab tests may show abnormalities in liver function tests, liver damage

•Thoughts of self-harm or suicide or attempted suicide: inform 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

•Loss of consciousness.

•Abnormal involuntary movements (dyskinesia)

Unknown frequency: cannot be estimated from available data

•Abnormally fast heart rate (ventricular tachyarrhythmia)

•Sore throat, elevated temperature and presenting infections more frequently than normal. Lab tests may show a severe decrease in a specific type of white blood cell (agranulocytosis)

•Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, facial rash, generalized rash with lymph node inflammation (enlarged lymph nodes). Lab tests may show increased levels of liver enzymes and an increase in a type of white blood cell (eosinophilia)

•Generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)

•Seizures

Other side effects in children

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

Reporting side effects

Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety ofthis medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Stada

• The active ingredient 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 tabletcontains 150 mg of lacosamide.

Lacosamida Stada 200 mg: each tabletcontains 200 mg of lacosamide.

• The other components are

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

Covering: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 Stada150 mg: iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172) and aluminium lake with indigo carmine (E132).

Lacosamida Stada200 mg: aluminium lake with indigo carmine (E132).

Appearance of the product and contents of the package

Lacosamida Stada 50 mg: film-coated tablets with a pink film coating, oblong, biconvex, 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:film-coated tablets with a yellow film coating, oblong, biconvex, 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:film-coated tablets with a beige film coating, oblong, biconvex, 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:film-coated tablets with a blue film coating, oblong, biconvex, 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 blister packs of 14, 56 and 168 film-coated tablets in transparent PVC/PVDC blisters sealed with an aluminium foil and packed in cardboard boxes.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Genepharm S.A.

18km Marathonos Avenue

Pallini 15351

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

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) with 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 KingdomLacosamide STADA 50 mg film-coated tablets

(Northern Ireland):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

Last review date of this leaflet:June 2023

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