SEIZPAT 100 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: patient information
3. Seizpat, 50 mg, coated tablets
4. Seizpat, 100 mg, coated tablets
5. Seizpat, 150 mg, coated tablets
6. Seizpat, 200 mg, coated tablets
   1. Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
7. What is Seizpat and what is it used for
   1. What is Seizpat
   2. What is Seizpat used for
8. Important information before taking Seizpat
   1. When not to take Seizpat
   2. Warnings and precautions
   3. Children
   4. Seizpat and other medicines
   5. Taking Seizpat with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
9. How to take Seizpat
   1. Taking Seizpat
   2. What dose to take
   3. Adults, adolescents, and children weighing at least 50 kg
   4. Children and adolescents weighing less than 50 kg
   5. Taking more Seizpat than prescribed
   6. Missing a dose of Seizpat
   7. Stopping treatment with Seizpat
10. Possible side effects
    1. If you experience any of the following side effects, contact your doctor immediately:
    2. Uncommon: may affect up to 1 in 100 people
    3. Frequency not known: cannot be estimated from the available data
    4. Very common: may affect more than 1 in 10 people
    5. Common: may affect up to 1 in 10 people
    6. Uncommon: may affect up to 1 in 100 people
    7. Additional side effects in children
11. How to store Seizpat
12. Contents of the pack and other information
    1. What Seizpat contains
    2. What Seizpat looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer/Importer
    6. To obtain more detailed information on the medicine and its names in the EEA Member States, contact the representative of the marketing authorization holder:

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Seizpat, 50 mg, coated tablets

Seizpat, 100 mg, coated tablets

Seizpat, 150 mg, coated tablets

Seizpat, 200 mg, coated tablets

lacozamide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Seizpat and what is it used for
• 2. Important information before taking Seizpat
• 3. How to take Seizpat
• 4. Possible side effects
• 5. How to store Seizpat
• 6. Contents of the pack and other information

1. What is Seizpat and what is it used for

What is Seizpat

Seizpat contains lacozamide. It belongs to a group of medicines called antiepileptics. These are medicines used to treat epilepsy.

• This medicine has been prescribed by your doctor to reduce the number of seizures.

What is Seizpat used for

• Seizpat is used:
• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a type of epilepsy characterized by partial seizures and secondary generalized partial seizures. In this type of epilepsy, seizures initially affect only one side of the brain but may then spread to other areas on both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (grand mal seizures involving loss of consciousness) in patients with generalized idiopathic epilepsy (a type of epilepsy believed to have a genetic basis).

2. Important information before taking Seizpat

When not to take Seizpat

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

If any of the above situations apply to you, do not take Seizpat. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Seizpat, consult your doctor if:

• you have thoughts of self-harm or suicide. Some patients taking antiepileptic medicines, such as lacozamide, have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• you have a heart condition that affects the rhythm of your heartbeat - it is often abnormally slow, fast, or irregular (i.e., atrioventricular block, atrial fibrillation, or atrial flutter).
• you have severe heart disease, such as heart failure or have had a heart attack.
• you often experience dizziness or falls. Seizpat may cause dizziness, which may increase the risk of accidental injury or falls. Therefore, be cautious until you are used to the effects of the medicine.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking Seizpat. If you are taking Seizpat and experience any new type of seizure or worsening of existing seizures, tell your doctor. If you are taking Seizpat and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), seek medical attention immediately (see section 4).

Children

Seizpat is not recommended for children under 2 years of age with partial seizures or under 4 years of age with primary generalized tonic-clonic seizures. The efficacy of Seizpat in children in this age group is not yet known, and it is not known whether it is safe for them.

Seizpat and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• medicines for heart conditions;
• medicines that may prolong the PR interval (seen on an electrocardiogram), such as antiepileptic medicines or pain medicines, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

Also, tell your doctor or pharmacist if you are taking any of the following medicines, as they may decrease or increase the effectiveness of Seizpat:

• fluconazole, itraconazole, ketoconazole (medicines used to treat fungal infections).
• ritonavir (a medicine used to treat HIV infection).
• clarithromycin and rifampicin (medicines used to treat bacterial infections).
• St. John's Wort (Hypericum perforatum) - (a herbal medicine used to treat mild anxiety and depression).

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

Taking Seizpat with alcohol

For safety reasons, DO NOT drink alcohol while taking Seizpat.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Seizpat is not recommended during pregnancy, as its effect on pregnancy and the unborn child is unknown. Breastfeeding is not recommended while taking Seizpat, as Seizpat passes into breast milk. If you become pregnant or plan to become pregnant, consult your doctor, who will help you decide whether to take Seizpat. Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures. The severity of the mother's symptoms may also harm the child.

Driving and using machines

Do not drive a car, ride a bike, or use tools or machines until you are sure how the medicine affects you. This is because Seizpat may cause dizziness or blurred vision.

3. How to take Seizpat

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. For children, other formulations of this medicine may be more suitable; consult your doctor or pharmacist.

Taking Seizpat

• Take Seizpat twice a day, approximately every 12 hours.
• Take the medicine at about the same time every day.
• Swallow the tablet with a glass of water.
• Seizpat can be taken with or without food.

Usually, treatment starts with a low daily dose, which your doctor will gradually increase over several weeks. After reaching the dose that is effective for you, called the maintenance dose, you will continue to take it daily. Seizpat is used for long-term treatment. Continue taking Seizpat until your doctor tells you to stop.

What dose to take

The following are the typical recommended doses of Seizpat for patients of different ages and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adults, adolescents, and children weighing at least 50 kg

Taking Seizpat alone

• The usual starting dose of Seizpat is 50 mg twice a day.
• Your doctor may also start treatment with a dose of 100 mg of Seizpat twice a day.
• Your doctor may increase the dose (given twice a day) by 50 mg every week until a maintenance dose of 100 mg to 300 mg twice a day is reached.

Taking Seizpat with other antiepileptic medicines

• The usual starting dose of Seizpat is 50 mg twice a day.
• Your doctor may increase the dose (given twice a day) by 50 mg every week until a maintenance dose of 100 mg to 200 mg twice a day is reached.
• If you weigh at least 50 kg, your doctor may decide to start Seizpat with a single loading dose of 200 mg. Then, 12 hours later, you will start taking the maintenance dose.

Children and adolescents weighing less than 50 kg

• Treatment of partial seizures: remember that Seizpat is not recommended for children under 2 years of age.
• Treatment of primary generalized tonic-clonic seizures: remember that Seizpat is not recommended for children under 4 years of age.
• The dose depends on the child's weight. Treatment usually starts with a syrup formulation, and only then is switched to tablets if the child can swallow them and the correct dose can be achieved using the different strengths of the tablets. Your doctor will prescribe the formulation that is most suitable for the child.

Taking more Seizpat than prescribed

If you take more Seizpat than prescribed, contact your doctor immediately. Do not attempt to drive. You may experience:

• dizziness,
• nausea or vomiting,
• seizures (convulsions),
• abnormal heart rhythms, such as slow, fast, or irregular heartbeat, coma, or low blood pressure with rapid heart rate and sweating.

Missing a dose of Seizpat

• If you miss a dose and it is less than 6 hours since the planned time of administration, take the missed dose as soon as possible.
• If you are more than 6 hours late, do not take the missed dose. Take the next dose of Seizpat at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Seizpat

• Do not stop taking Seizpat without discussing it with your doctor, as your epilepsy symptoms may return or worsen.
• If your doctor decides to stop your treatment with Seizpat, they will tell you how to gradually reduce the dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Seizpat can cause side effects, although not everybody gets them. After taking a single loading dose, side effects from the nervous system, such as dizziness, may worsen.

If you experience any of the following side effects, contact your doctor immediately:

Uncommon: may affect up to 1 in 100 people

• Attempted suicide.
• Thoughts of suicide or self-harm.
• Allergic reactions after taking the medicine, including severe allergic reactions with swelling of the face, throat, hands, feet, ankles, or lower legs (angioedema).
• Hallucinations (seeing or hearing things that are not real).
• Disturbances in thinking or loss of contact with reality.

Frequency not known: cannot be estimated from the available data

• Abnormal fast heart rhythm (ventricular tachycardia);
• Sore throat, high temperature, and increased risk of infection. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis).
• Severe skin reaction, which may be accompanied by high temperature and flu-like symptoms, rash on the face, widespread rash, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increased number of one type of white blood cell (eosinophilia).
• Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and its more severe form, causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Seizures.

Other side effects

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

• Short muscle jerks or muscle groups (myoclonic seizures).
• Difficulty with coordination or walking.
• Balance disturbances, tremors, tingling (paresthesia), or muscle cramps, tendency to fall and bruise.
• Memory disturbances, thinking disturbances, or problems finding words, confusion.
• Rapid, uncontrolled eye movements (nystagmus), blurred vision.
• Feeling of "spinning" (dizziness).
• Vomiting, indigestion, dry mouth.
• Constipation, excessive gas in the stomach or intestines, diarrhea,
• Itching,
• Fatigue, unusual fatigue, and weakness (asthenia), feeling of intoxication.
• Depression
• Sensory disturbances (decreased sensation), speech disturbances (articulation), attention disturbances.
• Ringing in the ears (tinnitus).
• Irritability.
• Rash.
• Sleep disturbances.

Uncommon: may affect up to 1 in 100 people

• Slow heart rate,
• Feeling of heartbeat and (or) fast or irregular heartbeat, or other changes in heart activity (conduction disorders).
• Excessive well-being, seeing and/or hearing things that do not exist.
• Abnormal liver blood test results, liver damage.
• Feeling of anger or agitation.
• Allergic reaction after taking the medicine, hives.
• Fainting.
• Abnormal involuntary movements (dyskinesia).

Additional side effects in children

Additional side effects in children included fever, runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, the child does not behave as usual (abnormal behavior), and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.
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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49 21 301
fax: 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seizpat

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 that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Seizpat contains

The active substance is lacozamide.
Each Seizpat 50 mg coated tablet contains 50 mg of lacozamide.
Each Seizpat 100 mg coated tablet contains 100 mg of lacozamide.
Each Seizpat 150 mg coated tablet contains 150 mg of lacozamide.
Each Seizpat 200 mg coated tablet contains 200 mg of lacozamide.
The other ingredients are:
Microcrystalline cellulose, hypromellose, crospovidone (type A), hypromellose, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E 171), indigo carmine, lake (E 132) (50 mg, 200 mg tablets), iron oxide red (E 172) (50 mg, 150 mg tablets), iron oxide black (E 172) (50 mg, 150 mg tablets), iron oxide yellow (E 172) (100 mg, 150 mg tablets).

What Seizpat looks like and contents of the pack

The 50 mg Seizpat coated tablets are pink, oval with the imprint "I73" on one side and smooth on the other. The average size of the tablet is 10.4 x 4.9 mm.
The 100 mg Seizpat coated tablets are dark yellow, oval with the imprint "I74" on one side and smooth on the other. The average size of the tablet is 13.0 x 6.0 mm.
The 150 mg Seizpat coated tablets are peach, oval with the imprint "I75" on one side and smooth on the other. The average size of the tablet is 15.0 x 7.0 mm.
The 200 mg Seizpat coated tablets are blue, oval with the imprint "I76" on one side and smooth on the other. The average size of the tablet is 16.5 x 7.7 mm.
PVC/PVDC blister pack with an aluminum foil lid in a cardboard box.
Seizpat is available in packs of 14, 28, 56 coated tablets and in multipacks containing 3 packs of 56 coated tablets each.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer/Importer

HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Irlandia
Mylan Germany GmbH
Luetticher Strasse 5,
Troisdorf,
Nordrhein-Westfalen,
53482 Germany
Mylan Hungary Kft.,
Mylan utca 1.,
Komarom,
2900, Hungary

To obtain more detailed information on the medicine and its names in the EEA Member States, contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00
Date of last revision of the leaflet:11/2022