LACKEPILA 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lackepila, 50 mg, Film-Coated Tablets
3. Lackepila, 100 mg, Film-Coated Tablets
4. Lackepila, 150 mg, Film-Coated Tablets
5. Lackepila, 200 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
6. What is Lackepila and what is it used for
7. Important information before taking Lackepila
   1. When not to take Lackepila
   2. Warnings and precautions
   3. Children and adolescents
   4. Lackepila and other medicines
   5. Taking Lackepila with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
8. How to take Lackepila
   1. Taking a higher dose of Lackepila than recommended
   2. Missing a dose of Lackepila
   3. Stopping treatment with Lackepila
9. Possible side effects
   1. Very common: may affect more than 1 in 10 people
   2. Common: may affect up to 1 in 10 people
   3. Uncommon: may affect up to 1 in 100 people
   4. Frequency not known: cannot be estimated from the available data
   5. Reporting side effects
10. How to store Lackepila
11. Contents of the pack and other information
    1. What Lackepila contains
    2. What Lackepila looks like and contents of the pack
    3. Marketing authorization holder
    4. Importer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet:

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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 leaflet, tell your 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 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 medicines.

2. Important information before taking Lackepila

When not to take Lackepila

Warnings and precautions

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

Lackepila may cause dizziness, which can increase the risk of accidental injury or falls. Therefore, be careful until you know how your 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 in this age group have not yet been established.

Lackepila and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
This is especially important if you are taking medicines for heart conditions or if you are taking any medicine that may cause abnormal electrocardiogram (ECG) readings, known 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 you are unsure whether your medicines may have this effect, consult your doctor.
Medicines 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 medicine used to treat mild anxiety - may affect how the liver breaks down lacosamide.

Taking Lackepila with alcohol

For safety reasons, DO NOT 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 medicine.
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 during treatment with 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 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 your ability to drive or operate tools or machines. Do not drive or operate machinery until you know how the medicine affects your ability to perform these activities .

3. How to take Lackepila

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, 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):
The usual starting dose of Lackepila is 100 mg per day - given in two 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 doses per day - 100 mg in the morning and 100 mg in the evening.
Your 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 doses per day. The maintenance dose is used for long-term treatment.
Taking Lackepila with other anti-epileptic medicines (adjunctive therapy):
The usual starting dose of Lackepila is 100 mg per day - given in two doses per day - 50 mg in the morning and 50 mg in the evening.
Your 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 doses per day. The maintenance dose is used for long-term treatment.
Your 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.
If you have kidney or liver problems, your 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 your doctor tells you to stop.

Taking a higher dose of Lackepila than recommended

If you take more Lackepila than you should, 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 treatment with Lackepila

DO NOT stop taking Lackepila without consulting your doctor, as your symptoms may return or worsen.
If your doctor decides to stop treatment with Lackepila, they will give you instructions on how to gradually reduce the dose.
If you have any further questions about taking this medicine, ask your 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 (sickness)
• Double vision

Common: may affect up to 1 in 10 people

• Balance disorders, coordination difficulties, memory problems, 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, gas in the stomach or intestines (bloating), diarrhea
• Itching
• Falls, bruises
• Fatigue, gait disturbances, fatigue and weakness (asthenia), feeling of intoxication
• Depression
• Confusion
• Sensory disturbances (numbness) 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 spasms
• 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 medicine
• Abnormal liver function test results, liver damage
• Suicide attempt
• Suicidal thoughts or self-harm
• Palpitations and (or) rapid or irregular heartbeat
• Aggression
• Agitation
• Thinking disorders 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 enlarged 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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:
[email protected].
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 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 your 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, 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 with “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 with “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 with “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 with “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 and in multipacks 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 Filmtabletten
Poland:
Lackepila

Date of last revision of the leaflet: