Lackepila

Package Leaflet: Information for the Patient

Lackepila, 50 mg, Film-Coated Tablets

Lackepila, 100 mg, Film-Coated Tablets

Lackepila, 150 mg, Film-Coated Tablets

Lackepila, 200 mg, Film-Coated Tablets

Lacosamide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lackepila and what is it used for
• 2. Important information before taking Lackepila
• 3. How to take Lackepila
• 4. Possible side effects
• 5. How to store Lackepila
• 6. Contents of the pack and other information

1. What is Lackepila and what is it used for

Lackepila is used to treat a certain form of epilepsy (see below) in patients aged 16 and older.
Epilepsy is a condition where the patient experiences recurring seizures. Lackepila is used to treat a form of epilepsy where seizures initially affect only one side of the brain but may then spread to other areas on both sides of the brain (partial and secondary generalized seizures).
Lackepila has been prescribed by a doctor to reduce the number of seizures.
Lackepila can be used alone or with other anti-epileptic medicines.

2. Important information before taking Lackepila

When not to take Lackepila

• if the patient is allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). In case of doubt about the occurrence of an allergy, consult a doctor;
• if the patient has a certain type of heart rhythm disorder (second or third degree atrioventricular block).

Warnings and precautions

In some patients treated with anti-epileptic medicines, such as lacosamide, thoughts of self-harm or suicidal thoughts have occurred. If such thoughts occur, contact a doctor immediately.
Before starting treatment with Lackepila, consult a doctor:

• if the patient has a condition related to heart conduction disorders (atrioventricular block, atrial flutter, and atrial fibrillation) or severe heart disease, such as heart failure or myocardial infarction. Symptoms of atrioventricular block are slow or irregular heartbeat, dizziness, and fainting. In the case of atrial flutter and atrial fibrillation, the patient may experience palpitations, rapid or irregular heartbeat, and shortness of breath.

Lackepila may cause dizziness, which can increase the risk of accidental injury or falls. Therefore, caution should be exercised until it is known how the body reacts to the medicine.

Children and adolescents

Lackepila is not recommended for children and adolescents under 16 years of age. The safety and efficacy of Lackepila have not been established in this age group.

Lackepila and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is especially important when taking medicines for heart disease or if the patient is taking any medicine that may cause ECG abnormalities, such as prolonged PR interval, including carbamazepine, lamotrigine, pregabalin (anti-epileptic medicines), and medicines used to treat certain types of heart rhythm disorders or heart failure. If in doubt about whether the medicines may have such an effect, consult a doctor.
Medicines such as fluconazole, itraconazole, ketoconazole (antifungal medicines), ritonavir (HIV medicine), clarithromycin, rifampicin (antibacterial medicines), and St. John's Wort (Hypericum perforatum) - a medicine used to treat mild anxiety, may affect how the liver breaks down lacosamide.

Taking Lackepila with alcohol

For safety reasons, it is not recommended to drink alcohol while taking Lackepila.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Lackepila is not recommended during pregnancy, as its effect on pregnancy and the unborn child is unknown. If the patient becomes pregnant or plans to become pregnant, she should contact her doctor immediately; the doctor will decide whether to take Lackepila.
Breastfeeding is not recommended while taking Lackepila, as it is unknown whether Lackepila passes into breast milk. If breastfeeding, the patient should consult a doctor immediately; the doctor will decide whether to take Lackepila.
Studies have shown an increased risk of birth defects in children of women who have taken anti-epileptic medicines. However, do not stop effective anti-epileptic treatment, as the severity of the disease symptoms is harmful to the mother and the unborn child.

Driving and using machines

Lackepila may cause dizziness or blurred vision. This may affect the ability to drive vehicles and operate tools or machines. Do not drive vehicles or operate machines until it is known how the medicine affects the patient's ability to perform these activities.

3. How to take Lackepila

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Lackepila has not been studied in patients with epilepsy with a loading dose.
Dosage
Lackepila must be taken twice a day, once in the morning and once in the evening, at approximately the same time every day. Lackepila is used for long-term treatment.
Taking Lackepila alone (monotherapy):
Typically, the initial dose of Lackepila is 100 mg per day, given in two divided doses per day - 50 mg in the morning and 50 mg in the evening.
The doctor may also start treatment with a dose of 200 mg per day, given in two divided doses per day - 100 mg in the morning and 100 mg in the evening.
The doctor may increase the daily dose by 100 mg every week until the so-called maintenance dose is reached, which is between 200 mg and 600 mg per day, given in two divided doses per day. The maintenance dose is used for long-term treatment.
Taking Lackepila with other anti-epileptic medicines (adjunctive therapy):
Typically, the initial dose of Lackepila is 100 mg per day, given in two divided doses per day - 50 mg in the morning and 50 mg in the evening.
The doctor may increase the daily dose by 100 mg every week until the so-called maintenance dose is reached, which is between 200 mg and 400 mg per day, given in two divided doses per day. The maintenance dose is used for long-term treatment.
The doctor may decide to start Lackepila with a single loading dose of 200 mg, and then, after about 12 hours, continue with the maintenance dose. The loading dose should be given under medical supervision.
In case of kidney or liver disorders, the doctor may prescribe a different dose.
How to take Lackepila
Lackepila tablets should be swallowed with a glass of water. Lackepila can be taken with or without food.
How long to take Lackepila
Lackepila is used for long-term treatment. Continue taking Lackepila until the doctor advises you to stop.

Taking a higher dose of Lackepila than recommended

In case of taking a higher dose of Lackepila than recommended, contact a doctor immediately.
The patient may experience dizziness, nausea, vomiting, seizures, heart disorders, coma, low blood pressure with rapid heart rate and sweating.
DO NOT attempt to drive a vehicle.

Missing a dose of Lackepila

If a dose is delayed by a few hours, take the missed dose as soon as possible.
If it is almost time for the next dose (less than 6 hours), DO NOT take the missed dose. Take the next dose of Lackepila at the usual time.
DO NOT take a double dose to make up for the missed dose.

Stopping treatment with Lackepila

DO NOT stop taking Lackepila without consulting a doctor, as the disease symptoms may return or worsen.
If the doctor decides to stop taking Lackepila, the doctor will give instructions on how to gradually reduce the dose.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lackepila can cause side effects, although not everybody gets them.
Side effects from the nervous system, such as dizziness, may occur more frequently after a loading dose.

Very common: may affect more than 1 in 10 people

• Dizziness, headache
• Nausea (morning sickness)
• Double vision

Common: may affect up to 1 in 10 people

• Balance disorders, coordination difficulties, memory disorders, drowsiness, tremors, thinking disorders or word-finding problems, rapid and uncontrollable eye movements (nystagmus), tingling and numbness (paresthesia)
• Blurred vision
• Feeling of spinning (dizziness)
• Vomiting, constipation, excess gas in the stomach or intestines (bloating), diarrhea
• Itching
• Falls, bruises (bruises)
• Fatigue, gait disturbances, fatigue and weakness (asthenia), feeling of intoxication
• Depression
• Confusion
• Sensory disturbances (sensory impairment) or sensitivity, speech disorders (articulation disorders), attention disorders
• Tinnitus (hearing sounds, such as buzzing, ringing, or hissing)
• Indigestion, dry mouth
• Irritability
• Muscle cramps
• Rash
• Difficulty falling asleep

Uncommon: may affect up to 1 in 100 people

• Slow heart rate
• Heart conduction disorders
• Excessive well-being
• Allergic reaction after taking the medicine
• Abnormal liver function test results, liver damage
• Suicide attempt
• Suicidal thoughts or self-harm thoughts
• Palpitations and (or) rapid or irregular heartbeat
• Aggression
• Agitation
• Thinking disorders and (or) loss of contact with reality
• Severe allergic reactions causing facial, throat, hand, foot, ankle, or lower leg swelling

• Hives
• Hallucinations (false sensory perceptions, seeing and (or) hearing and feeling non-existent things)
• Fainting

Frequency not known: cannot be estimated from the available data

• Significant decrease in the number of a certain type of white blood cell (agranulocytosis)
• Severe skin reaction, which may be accompanied by flu-like symptoms, facial rash, spreading rash with high fever, elevated liver enzyme levels in blood tests, increased number of a type of white blood cell (eosinophilia), and swollen lymph nodes
• Widespread rash with blisters and peeling skin, occurring mainly in the area around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides,
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail:
ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lackepila

Keep the 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.
The medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lackepila contains

The active substance is lacosamide.
One film-coated tablet of Lackepila, 50 mg, contains 50 mg of lacosamide.
One film-coated tablet of Lackepila, 100 mg, contains 100 mg of lacosamide.
One film-coated tablet of Lackepila, 150 mg, contains 150 mg of lacosamide.
One film-coated tablet of Lackepila, 200 mg, contains 200 mg of lacosamide.
The other ingredients are:
Core
Microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, colloidal silicon dioxide, anhydrous, crospovidone (Type A), magnesium stearate
Coating
Polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171)
Indigo carmine, lake (E132) (50 mg / 200 mg film-coated tablets)
Iron oxide red (E172) (50 mg / 150 mg film-coated tablets)
Iron oxide black (E172) (50 mg / 150 mg film-coated tablets)
Iron oxide yellow (E172) (100 mg / 150 mg film-coated tablets)

What Lackepila looks like and contents of the pack

Lackepila, 50 mg: pink, oval, film-coated tablets marked "I73" on one side of the tablet. The average size of the tablets is: 10.4 x 4.9 mm.
Lackepila, 100 mg: dark yellow, oval, film-coated tablets marked "I74" on one side of the tablet. The average size of the tablets is: 13.0 x 6.0 mm.
Lackepila, 150 mg: peach, oval, film-coated tablets marked "I75" on one side of the tablet. The average size of the tablets is: 15.0 x 7.0 mm.
Lackepila, 200 mg: blue, oval, film-coated tablets marked "I76" on one side of the tablet. The average size of the tablets is: 16.5 x 7.7 mm.
Lackepila is available in packs containing 7, 14, 28, 56 film-coated tablets, as well as in bulk packs containing 3 packs, each containing 56 film-coated tablets.
The packs contain PVC/PVDC/Aluminum blisters.
Lackepila is available in packs containing 56x1 film-coated tablets in divisible blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Importer

Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany:
Lackepila 50 mg / 100 mg / 150 mg / 200 mg film-coated tablets
Poland:
Lackepila

Date of last revision of the leaflet: