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 Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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 years and older.
Epilepsy is a condition where the patient has repeated seizures (fits). Lackepila is used to treat a form of epilepsy where the seizures initially only affect one side of the brain but may then spread to other areas on both sides of the brain (partial seizures and secondary generalized seizures).
Lackepila has been prescribed by your doctor to reduce the number of seizures.
Lackepila can be taken alone or with other anti-epileptic medications.

2. Important information before taking Lackepila

When Not to Take Lackepila

• if you are allergic to lacosamide or any of the other ingredients of this medication (listed in section 6). If you are unsure whether you are allergic, consult your doctor;
• if you have a certain type of heart rhythm disorder (second or third degree atrioventricular block).

Warnings and Precautions

In some patients treated with anti-epileptic medications, such as lacosamide, thoughts of self-harm or suicide have occurred. If you ever have such thoughts, contact your doctor immediately.
Before starting treatment with Lackepila, consult your doctor:

• if you have a condition related to heart conduction disorders (atrioventricular block, atrial flutter, or atrial fibrillation) or severe heart disease, such as heart failure or myocardial infarction. Symptoms of atrioventricular block include slow or irregular heartbeat, dizziness, and fainting. In the case of atrial flutter or 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, be cautious until you are sure how your body reacts to the medication.

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 Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
This is especially important if you are taking medications for heart conditions or if you are taking any medication that may cause abnormal electrocardiogram (ECG) readings, such as carbamazepine, lamotrigine, pregabalin (anti-epileptic medications), or medications used to treat certain types of heart rhythm disorders or heart failure. If you are unsure whether your medications may have this effect, consult your doctor.
Medications such as fluconazole, itraconazole, ketoconazole (used to treat fungal infections), ritonavir (used to treat HIV infection), clarithromycin, rifampicin (used to treat bacterial infections), and St. John's Wort (Hypericum perforatum) - a medication 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Lackepila should not be taken during pregnancy, as its effect on pregnancy and the unborn child is not known. If you become pregnant or plan to become pregnant, contact your doctor immediately; your doctor will decide whether you should take Lackepila.
Breastfeeding is not recommended while taking Lackepila, as it is not known whether Lackepila passes into breast milk. If you are breastfeeding, consult your doctor immediately; your doctor will decide whether you should take Lackepila.
Studies have shown an increased risk of birth defects in children of women who have taken anti-epileptic medications. However, do not stop taking effective anti-epileptic treatment, as the severity of the disease symptoms can harm the mother and the unborn child.

Driving and Using Machines

Lackepila may cause dizziness or blurred vision. This may affect your ability to drive or operate tools or machines. Do not drive or operate machines until you are sure how the medication affects your ability to perform these activities.

3. How to Take Lackepila

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. The administration of a loading dose has not been studied in patients with epilepsy.
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):
The usual starting 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.
Your 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.
Your doctor may increase the daily dose by 100 mg per 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 medications (adjunctive therapy):
The usual starting 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.
Your doctor may increase the daily dose by 100 mg per 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.
Your doctor may decide to start treatment with a single loading dose of 200 mg, followed by a maintenance dose after approximately 12 hours. The loading dose should be given under medical supervision.
If you have kidney or liver problems, your doctor may prescribe a different dose.
How to Take Lackepila
Swallow the tablets 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 your doctor tells you to stop.

Taking More Lackepila Than Prescribed

If you take more Lackepila than prescribed, contact your doctor immediately.
You may experience dizziness, nausea, vomiting, seizures, heart problems, coma, low blood pressure with rapid heart rate and sweating.
DO NOT attempt to drive.

Missing a Dose of Lackepila

If you are late taking a dose 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 Lackepila Treatment

DO NOT stop taking Lackepila without consulting your doctor, as your disease symptoms may return or worsen.
If your doctor decides to stop Lackepila treatment, they will give you instructions on how to gradually reduce the dose.
If you have any further questions about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 (sickness)
• Double vision

Common: May Affect Up to 1 in 10 People

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

Uncommon: May Affect Up to 1 in 100 People

• Slow heart rate
• Heart conduction disorders
• Excessive well-being
• Allergic reaction after taking the medication
• 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 problems and (or) loss of contact with reality
• Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or

lower legs

• Hives
• Hallucinations (false sensory perceptions, seeing and (or) hearing and (or) 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, rash on the face, spreading rash with high fever, increased 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, mainly on 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 you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
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 this medication.

5. How to Store Lackepila

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
The medication does not require special storage conditions.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications 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:
Tablet core
Microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, colloidal silica, anhydrous, crospovidone (Type A), magnesium stearate
Tablet 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 multipacks containing 3 packs, each with 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 Filmtabletten
Poland:
Lackepila

Date of Last Revision of the Package Leaflet: