Lacosamide Krka

PACKAGE LEAFLET

Package leaflet: information for the patient

Lacosamide Krka 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide
Generic medicine
Please read this leaflet carefully before 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. 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Lacosamide Krka is
Lacosamide Krka 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 to you to reduce the number of seizures (convulsive fits) you experience.

What Lacosamide Krka is used for
It is used:

• alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age onwards, 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 your brain. However, they may then spread to broader areas on both sides of your brain.
• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age onwards, 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 need to know before taking Lacosamide Krka

Do not take Lacosamide Krka

• 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 particular type of heart rhythm problem called second- or third-degree AV block.

Do not take Lacosamide Krka if any of the above apply to you. If you are unsure, speak to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Lacosamide Krka if:

• you have had thoughts of harming or killing yourself. A small number of people taking 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 heartbeat that is particularly slow, fast, or irregular (e.g. 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. Lacosamide Krka may 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 apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Lacosamide Krka.

If you are taking Lacosamide Krka, contact your doctor if you experience seizures of a different type or if your existing seizures worsen.

If you are taking Lacosamide Krka and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded or fainting), contact your doctor immediately (see section 4).

Children

Lacosamide Krka is not recommended for children under 2 years of age with 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 or safe in children within these age groups.

Other medicines and Lacosamide Krka

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 Krka may also affect your heart:

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

If any of the above apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Lacosamide Krka.

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 Krka in your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
• HIV medicines such as ritonavir;
• antibacterial medicines 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 apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Lacosamide Krka.

Lacosamide Krka and alcohol

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

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraceptive measures with their doctor.

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

Lacosamide Krka is not recommended during pregnancy, as the effects of Lacosamide Krka on pregnancy and the unborn baby are unknown. Breastfeeding is not recommended while taking Lacosamide Krka, as lacosamide passes into breast milk.

Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not you should take Lacosamide Krka.

Do not stop treatment without first consulting your doctor, as this could lead to an increase in seizures. Worsening of your condition could also be harmful to your unborn baby.

Driving and using machines

Do not drive, ride a bicycle, or use tools or machinery until you know how this medicine affects you. This is because Lacosamide Krka may cause dizziness or blurred vision.

3. How to take Lacosamide Krka

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
may be more suitable for children: please ask your doctor or pharmacist.
How to take Lacosamide Krka

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

You will usually start with a lower daily dose, and your doctor will gradually increase it
over several weeks. Once you reach the dose appropriate for you, called the "maintenance dose", you will take the same amount every day.
Lacosamide Krka is used as a long-term treatment. You must continue taking Lacosamide Krka until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide Krka 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 Krka alone

• The usual starting dose of Lacosamide Krka is 50 mg twice daily.
• Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Krka 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 Krka with other antiepileptic medicines

• The usual starting dose of Lacosamide Krka 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 Krka using a single "loading dose" of 200 mg. Twelve hours later, you would then start your maintenance dose.

Children and adolescents weighing less than 50 kg

• For the treatment of partial-onset seizures: note that Lacosamide Krka is not recommended in children below 2 years of age.
• For the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Krka is not recommended in children below 4 years of age.
• The dose depends on body weight. Treatment is usually started with the oral syrup, and switched to tablets only if the correct dose can be achieved with the available tablet strengths. Your doctor will prescribe the most appropriate formulation for the patient.

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

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

If you forget to take Lacosamide Krka

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

If you stop taking Lacosamide Krka

• Do not stop treatment with Lacosamide Krka without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue treatment with Lacosamide Krka, they will give you instructions on how to gradually reduce the dose. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
Consult 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 or bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrolled 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 touch sensation or sensitivity, difficulty articulating words, attention disturbance;
• Ringing in the ears such as buzzing, ringing, or whistling sounds;
• 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 sense of well-being, seeing and/or hearing things that are not present;
• Allergic reaction following medicine intake, hives (urticaria);
• Blood tests may show abnormal liver function, liver damage;
• Self-harming thoughts or suicidal thoughts, suicide attempt: inform your doctor immediately;
• Feelings 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).

Not known: frequency cannot be estimated from the available data

• Rapid heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever, and experiencing a higher number of infections than usual. Blood tests may show a severe decrease in the number of a specific type of white blood cells (agranulocytosis);
• Severe skin reaction that 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 a type of white blood cells (eosinophilia);
• Widespread skin rash with blisters and skin peeling, 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.

Additional 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 Krka

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

6. Package contents and other information

What Lacosamide Krka contains

• The active substance is lacosamide. Each film-coated tablet contains 50 mg, 100 mg, 150 mg or 200 mg of lacosamide.
• The other excipients of the 50 mg film-coated tablets are microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), aluminium lake containing indigo carmine (E132), red iron oxide (E172) and black iron oxide (E172) in the film coating.
• The other excipients of the 100 mg film-coated tablets are microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b) and yellow iron oxide (E172) in the film coating.
• The excipients of the 150 mg film-coated tablets are microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172) in the film coating.
• The other excipients of the 200 mg film-coated tablets are microcrystalline cellulose (E460), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type B), magnesium stearate (E470b) in the tablet core; and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b) and aluminium lake containing indigo carmine (E132) in the film coating.

Description of the appearance of Lacosamide Krka and pack contents
Lacosamide Krka 50 mg film-coated tablets are light pink, oval, biconvex film-coated tablets, with "50" engraved on one side. Tablet size: approximately 11 x 5 mm.
Lacosamide Krka 100 mg film-coated tablets: brownish-yellow, oval, biconvex film-coated tablets, with "100" engraved on one side. Tablet size: approximately 13 x 6 mm.
Lacosamide Krka 150 mg film-coated tablets: light brownish-orange, oval, biconvex film-coated tablets, with "150" engraved on one side. Tablet size: approximately 15 x 7 mm.
Lacosamide Krka 200 mg film-coated tablets: blue, oval, biconvex film-coated tablets, with "200" engraved on one side. Tablet size: approximately 17 x 8 mm.
Lacosamide Krka is available in all strengths in packs containing:

• 14 or 56 film-coated tablets in non-perforated or perforated blisters.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto, Slovenia
Local representative in Italy
KRKA Farmaceutici Milano S.r.l. – Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

More detailed information about this medicine is available on the website of the Italian Medicines Agency, https://www.aifa.gov.it