Lacosamide EG

Package leaflet: Information for the patient

LACOSAMIDE EG 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you take 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lacosamide EG is and what it is used for

What Lacosamide EG is
Lacosamide EG contains the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.

• This medicine has been prescribed for you to reduce the number of seizures (epileptic fits) you experience.

What Lacosamide EG is used for

• Lacosamide EG is used
• alone and in combination with other antiepileptic medicines in adults, adolescents and children from the age of 2 years to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain, but may then spread to broader areas on both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents and children from the age of 4 years to treat primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you should know before taking Lacosamide EG

Do not take Lacosamide EG

• 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 specific type of heart rhythm problem called second- or third-degree AV block. Do not take Lacosamide EG if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor before taking Lacosamide EG if:

• you have had thoughts of harming or killing yourself. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts about harming or killing themselves. If you have any such thoughts at any time, inform your doctor immediately;
• you have a heart condition affecting your heartbeat and often experience a particularly slow, fast, or irregular heartbeat (AV block, atrial fibrillation or atrial flutter);
• you have a serious heart condition, such as heart failure or have had a heart attack;
• you often feel dizzy or fall frequently. Lacosamide EG can cause dizziness – this may 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 situations apply to you (or you are unsure), consult your doctor or pharmacist before taking Lacosamide EG.

If you are taking Lacosamide EG, contact your doctor immediately if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide EG and develop symptoms of abnormal heartbeat (such as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children
Lacosamide EG is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, and is not recommended for 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 in children within these age groups.

Other medicines and Lacosamide EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because lacosamide may also affect your heart:

• medicines used to treat heart diseases;
• medicines that can prolong the "P-R interval" on an electrocardiogram (ECG), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

If any of the above situations apply to you (or you are unsure), consult your doctor or pharmacist before taking Lacosamide EG.

Also inform your doctor or pharmacist if you are taking any of the following medicines: because they may increase or decrease the effect of Lacosamide EG in your body:

• antifungal medicines, such as fluconazole, itraconazole, or ketoconazole;
• HIV medicines such as ritonavir;
• medicines used to treat 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 situations apply to you (or you are unsure), consult your doctor or pharmacist before taking Lacosamide EG.

Lacosamide EG and alcohol
As a precautionary safety measure, do not take Lacosamide EG with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is recommended not to take Lacosamide EG during pregnancy, as the effects of lacosamide on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Lacosamide EG, as lacosamide passes into breast milk. Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to take Lacosamide EG.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (episodes). Worsening of your condition may also be harmful to your unborn child.

Driving and using machines
Do not drive, ride a bicycle, or operate 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 Lacosamide EG

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. Other forms of this medicine might be
more suitable for children: please ask your doctor or pharmacist.
Instructions for taking Lacosamide EG

• Take Lacosamide EG twice daily – approximately 12 hours apart.
• Try to take it at approximately the same time each day.
• Swallow the Lacosamide EG tablet with a glass of water.
• You may take Lacosamide EG with or without food.

You will usually start with a lower daily dose, and your doctor will gradually increase it over a
number of weeks. Once the appropriate dose for you has been reached, this is called the "maintenance dose". Take the same amount every day. Lacosamide EG is used as a long-term treatment. You must continue taking Lacosamide EG until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide EG for different age groups and body weights. 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 EG alone
The usual starting dose of Lacosamide EG is 50 mg twice daily.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide EG twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose between 100 mg and 300 mg twice daily.
When taking Lacosamide EG with other antiepileptic medicines
The usual starting dose of Lacosamide EG is 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose between 100 mg and 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide EG using a single "loading dose" of 200 mg, followed 12 hours later by the initiation of a maintenance dosing regimen.
Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that Lacosamide EG is not recommended in children below 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide EG is not recommended in children below 4 years of age. The dose depends on body weight. For doses below 50 mg, an oral syrup formulation is available. Treatment usually starts with the syrup, and patients may switch to tablets only if they are able to swallow them and can receive the correct dose with the available tablet strengths. Your doctor will prescribe the most appropriate formulation for you.

If you take more Lacosamide EG than you should
Contact your doctor immediately if you have taken more Lacosamide EG than prescribed.
Do not attempt to drive.
You may experience:

• dizziness;
• feeling unwell (nausea) or being unwell (vomiting);
• seizures, heart problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Lacosamide EG

• If you forget a dose and less than 6 hours have passed since your usual time, take it as soon as you remember.
• If you forget a dose and more than 6 hours have passed since your usual time, do not take the missed tablet. Instead, take your next dose of Lacosamide EG at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Lacosamide EG
Do not stop treatment with Lacosamide EG without consulting your doctor, as symptoms may return or worsen.
If your doctor decides to discontinue your treatment with Lacosamide EG, they will provide instructions on how to gradually reduce the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single loading dose.
Contact your doctor or pharmacist if you experience any of the following symptoms:

Very common: may affect more than 1 in 10 people

• Headache
• Dizziness or feeling unwell (nausea)
• Double vision (diplopia)

Common: may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks)
• Difficulty coordinating movements or walking
• Problems maintaining balance, tremors, tingling (paraesthesia) or muscle spasms, increased tendency to fall and bruise
• Memory problems, difficulty thinking or finding words, confusion
• Rapid and uncontrollable eye movements (nystagmus), blurred vision
• Sensation of spinning (vertigo), feeling of drunkenness
• Feeling unwell (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea
• Reduced sense of touch or sensitivity, difficulty articulating words, attention disturbance
• Ringing or other noises in the ears such as buzzing or whistling
• Irritability, difficulty sleeping, depression
• Drowsiness, tiredness or weakness (asthenia)
• Itching, irritation

Uncommon: may affect up to 1 in 100 people

• Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder)
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present
• Allergic reaction following medicine intake, hives
• Blood tests may show abnormal liver function, liver damage
• Self-harming or suicidal thoughts, suicide attempt: inform your doctor immediately
• Feeling of anger or agitation
• Abnormal thoughts or loss of contact with reality
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs
• Fainting
• Abnormal involuntary movements (dyskinesia)

Frequency not known: frequency cannot be estimated from the available data

• Accelerated heartbeat (ventricular tachyarrhythmia)
• Sore throat, high fever, and experiencing more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific class of white blood cells (agranulocytosis)
• Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia)
• Widespread rash with blisters and peeling of the skin, particularly 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)
• Seizure

Other side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), and lack of energy (lethargy). Drowsiness 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacosamide EG contains

• The active substance is lacosamide.

Each tablet of Lacosamide EG 50 mg contains 50 mg of lacosamide.
Each tablet of Lacosamide EG 100 mg contains 100 mg of lacosamide.
Each tablet of Lacosamide EG 150 mg contains 150 mg of lacosamide.
Each tablet of Lacosamide EG 200 mg contains 200 mg of lacosamide.

• The other components are:
  Tablet core
  Microcrystalline cellulose (E 460)
  Low-substituted hydroxypropyl cellulose
  Crospovidone (E1202)
  Hydroxypropyl cellulose (E463)
  Anhydrous colloidal silica
  Magnesium stearate

Coating
Poly(vinyl alcohol) (E1203)
Macrogol 3350 (E1521)
Titanium dioxide (E171)
Talc (E553b)

50 mg film-coated tablets
Red iron oxide (E172)
Black iron oxide (E172)
Indigo carmine aluminium lake (E132)

100 mg film-coated tablets
Yellow iron oxide (E172)
Black iron oxide (E172)

150 mg film-coated tablets
Red iron oxide (E172)
Yellow iron oxide (E172)
Black iron oxide (E172)
Indigo carmine aluminium lake (E132)

200 mg film-coated tablets
Indigo carmine aluminium lake (E132)

Description of the appearance of Lacosamide EG and contents of the pack

Lacosamide EG is available as film-coated tablets.
Lacosamide EG 50 mg is a pink, oblong, biconvex film-coated tablet, with "50" engraved on one side and smooth on the other, approximately 10.3 mm in length and 4.8 mm thick.
Lacosamide EG 100 mg is a yellow, oblong, biconvex film-coated tablet, with "100" engraved on one side and smooth on the other, approximately 13.1 mm in length and 6.1 mm thick.
Lacosamide EG 150 mg is a beige, oblong, biconvex film-coated tablet, with "150" engraved on one side and smooth on the other, approximately 15.2 mm in length and 7.1 mm thick.
Lacosamide EG 200 mg is a blue, oblong, biconvex film-coated tablet, with "200" engraved on one side and smooth on the other, approximately 16.6 mm in length and 7.7 mm thick.

Lacosamide EG is available in packs of 14, 56 and 168 film-coated tablets, contained in transparent PVC/PVDC blisters sealed with an aluminium foil and placed in cardboard cartons. Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturer
Genepharm S.A., 18 km Marathon Avenue 15351 Pallini Attikis – Greece
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Wien – Austria
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel – Germany

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
AT Lacosamid STADA 50 mg Filmtabletten
Lacosamid STADA 100 mg Filmtabletten
Lacosamid STADA 150 mg Filmtabletten
Lacosamid STADA 200 mg Filmtabletten

BE Lacosamide STADA 50 mg filmomhulde tabletten
Lacosamide STADA 100 mg filmomhulde tabletten
Lacosamide STADA 150 mg filmomhulde tabletten
Lacosamide STADA 200 mg filmomhulde tabletten

DE Lacosamid AL 50 mg Filmtabletten
Lacosamid AL 100 mg Filmtabletten
Lacosamid AL 150 mg Filmtabletten
Lacosamid AL 200 mg Filmtabletten

DK Lacosamide STADA
Lacosamide STADA
Lacosamide STADA
Lacosamide STADA

ES 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

FI Lacosamide STADA 50 mg tabletti, kalvopäällysteinen
Lacosamide STADA 100 mg tabletti, kalvopäällysteinen
Lacosamide STADA 150 mg tabletti, kalvopäällysteinen
Lacosamide STADA 200 mg tabletti, kalvopäällysteinen

FR LACOSAMIDE EG 50 mg, comprimé pelliculé
LACOSAMIDE EG 100 mg, comprimé pelliculé
LACOSAMIDE EG 150 mg, comprimé pelliculé
LACOSAMIDE EG 200 mg, comprimé pelliculé

IS Lacosamide STADA 50 mg filmuhúðuð tafla
Lacosamide STADA 100 mg filmuhúðuð tafla
Lacosamide STADA 150 mg filmuhúðuð tafla
Lacosamide STADA 200 mg filmuhúðuð tafla

IT 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

LU Lacosamide EG 50 mg, comprimé pelliculé
Lacosamide EG 100 mg, comprimé pelliculé
Lacosamide EG 150 mg, comprimé pelliculé
Lacosamide EG 200 mg, comprimé pelliculé

NL Lacosamide STADA 50 mg, filmomhulde tabletten
Lacosamide STADA 100 mg, filmomhulde tabletten
Lacosamide STADA 150 mg, filmomhulde tabletten
Lacosamide STADA 200 mg, filmomhulde tabletten

SE Lacosamide STADA 50 mg filmdragerade tabletter
Lacosamide STADA 100 mg filmdragerade tabletter
Lacosamide STADA 150 mg filmdragerade tabletter
Lacosamide STADA 200 mg filmdragerade tabletter

SK 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

UK 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