CEZARIUS 750 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. CEZARIUS 250 mg coated tablets
3. CEZARIUS 500 mg coated tablets
4. CEZARIUS 750 mg coated tablets
5. CEZARIUS 1000 mg coated tablets
   1. Read the package leaflet carefully before taking the medicine or giving it to a child, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
6. What is CEZARIUS and what is it used for
7. Important information before taking CEZARIUS
   1. When not to take CEZARIUS
   2. Warnings and precautions
   3. Children and adolescents
   4. CEZARIUS and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. CEZARIUS 750 mg coated tablets contain the food coloring - orange yellow (E110), which may cause allergic reactions.
8. How to take CEZARIUS
   1. Dosage for adults and adolescents (from 16 years):
   2. Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:
   3. Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:
   4. Dosage for adults and adolescents (from 16 years):
   5. Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:
   6. Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:
   7. Dosage for adults and adolescents (from 16 years):
   8. Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:
   9. Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:
   10. Dosage for adults and adolescents (from 16 years):
   11. Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:
   12. Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:
   13. Method of administration:
   14. Duration of treatment:
   15. Overdose of CEZARIUS
   16. Missed dose of CEZARIUS
   17. Stopping treatment with CEZARIUS
9. Possible side effects
   1. Immediately inform your doctor or contact the nearest hospital emergency department if you experience:
   2. Reporting side effects
10. How to store CEZARIUS
11. Contents of the pack and other information
    1. What CEZARIUS contains
    2. What CEZARIUS looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer 250 mg:

Package Leaflet: Information for the Patient

CEZARIUS 250 mg coated tablets

CEZARIUS 500 mg coated tablets

CEZARIUS 750 mg coated tablets

CEZARIUS 1000 mg coated tablets

Levetiracetam

Read the package leaflet carefully before taking the medicine or giving it to a child, 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is CEZARIUS and what is it used for

Levetiracetam is an antiepileptic medicine (used to treat seizures in epilepsy).
CEZARIUS is used:

• as monotherapy (using only CEZARIUS) in the treatment of certain forms of epilepsy in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Epilepsy is a condition where patients have recurring seizures. Levetiracetam is used to treat this form of epilepsy, where seizures initially occur in one part of the brain but may then spread to larger areas of both hemispheres of the brain (partial seizures with or without secondary generalization). The doctor has prescribed levetiracetam to reduce the number of seizures;
• as an adjunctive therapy (used in combination with other antiepileptic medicines):
• in the treatment of partial seizures or partial seizures with secondary generalization in adults, adolescents, children, and infants from 1 month of age,
• in the treatment of myoclonic seizures (short, shock-like muscle contractions) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy,
• in the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is likely to have a genetic basis).

2. Important information before taking CEZARIUS

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When not to take CEZARIUS

• If the patient is allergic to levetiracetam, pyrrolidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with CEZARIUS, discuss it with your doctor.

• If the patient has kidney disease, this medicine should be used as directed by the doctor. The doctor may decide to adjust the dosage.
• Contact your doctor if your child taking levetiracetam experiences slowed growth or unexpected changes in puberty.
• In some patients treated with antiepileptic medicines, such as CEZARIUS, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

• Monotherapy with levetiracetam (using only CEZARIUS) is not recommended in children and adolescents under 16 years of age.

CEZARIUS and other medicines

Tell your doctor or pharmacist about all medicines your child is taking or has recently taken, as well as any medicines your child plans to take.
Do not take macrogol (a medicine used for constipation) 1 hour before and 1 hour after taking levetiracetam, as it may prevent levetiracetam from working.

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.
CEZARIUS should not be used during pregnancy unless clearly necessary. It is not possible to completely exclude the risk of congenital malformations in the fetus. In animal studies, levetiracetam administered at doses higher than those used to control seizures in humans showed an adverse effect on reproductive function.
Breastfeeding is not recommended during treatment.

Driving and using machines

CEZARIUS may impair your ability to drive and use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or use machines until you know how the medicine affects you.

CEZARIUS 750 mg coated tablets contain the food coloring - orange yellow (E110), which may cause allergic reactions.

Orange(E110), which may cause allergic reactions.

3. How to take CEZARIUS

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The number of tablets to take must be as directed by your doctor.
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CEZARIUS is taken twice a day, in the morning and evening, preferably at the same time each day.
250 mg tablets:

• Monotherapy(treatment using only CEZARIUS 250 mg, coated tablets)

Dosage for adults and adolescents (from 16 years):

Usually, the doctor recommends taking a dose of the medicine between 1000 mg (4 tablets) and 3000 mg (12 tablets) per day.
Treatmentwith CEZARIUS starts with lower dosesfor the first two weeks, and then, depending on the treatment effect, the doctor may increase the dose to achieve the recommended value.
For example, if the recommended daily dose of the medicine is 1000 mg, the lower initial dose is 2 tablets in the morning and 2 tablets in the evening.

• Adjunctive therapy(treatment using CEZARIUS 250 mg, coated tablets and other medicines recommended by the doctor)

Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:

Usually, the doctor recommends taking a dose of the medicine between 1000 mg (4 tablets) and 3000 mg (12 tablets) per day.
For example, if the recommended daily dose of the medicine is 1000 mg, take 2 tablets in the morning and 2 tablets in the evening.

Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:

The doctor will recommend the use of the appropriate form of CEZARIUS most suitable for the child's age, body weight, and recommended dosage.
CEZARIUS 100 mg/ml, oral solution is a more suitable form for use in infants and children under 6 years of age and in children and adolescents (from 6 to 17 years) with a body weight below 50 kg, and when it is not possible to administer the appropriate dose in tablets.
500 mg tablets:

• Monotherapy(treatment using only CEZARIUS 500 mg, coated tablets)

Dosage for adults and adolescents (from 16 years):

Usually, the doctor recommends taking a dose of the medicine between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day.
Treatmentwith CEZARIUS starts with lower dosesfor the first two weeks, and then, depending on the treatment effect, the doctor may increase the dose to achieve the recommended value.
For example, if the recommended daily dose of the medicine is 2000 mg, the lower initial dose is 2 tablets in the morning and 2 tablets in the evening.

• Adjunctive therapy(treatment using CEZARIUS 500 mg, coated tablets and other medicines recommended by the doctor)

Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:

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Usually, the doctor recommends taking a dose of the medicine between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day.
For example, if the recommended daily dose of the medicine is 1000 mg, take 1 tablet in the morning and 1 tablet in the evening.

Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:

The doctor will recommend the use of the appropriate form of CEZARIUS most suitable for the child's age, body weight, and recommended dosage.
CEZARIUS 100 mg/ml, oral solution is a more suitable form for use in infants and children under 6 years of age and in children and adolescents (from 6 to 17 years) with a body weight below 50 kg, and when it is not possible to administer the appropriate dose in tablets.
750 mg tablets:

• Monotherapy(treatment using only CEZARIUS 750 mg, coated tablets)

Dosage for adults and adolescents (from 16 years):

Usually, the doctor recommends taking a dose of the medicine between 1000 mg and 3000 mg per day.
Treatmentwith CEZARIUS starts with lower dosesfor the first two weeks, and then, depending on the treatment effect, the doctor may increase the dose to achieve the recommended value.
For example, if the recommended daily dose of the medicine is 3000 mg, the lower initial dose is 2 tablets in the morning and 2 tablets in the evening.

• Adjunctive therapy(treatment using CEZARIUS 750 mg, coated tablets and other medicines recommended by the doctor)

Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:

Usually, the doctor recommends taking a dose of the medicine between 1000 mg and 3000 mg per day.
For example, if the recommended daily dose of the medicine is 1500 mg, take 1 tablet in the morning and 1 tablet in the evening.

Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:

The doctor will recommend the use of the appropriate form of CEZARIUS most suitable for the child's age, body weight, and recommended dosage.
CEZARIUS 100 mg/ml, oral solution is a more suitable form for use in infants and children under 6 years of age and in children and adolescents (from 6 to 17 years) with a body weight below 50 kg, and when it is not possible to administer the appropriate dose in tablets.
1000 mg tablets:

• Monotherapy(treatment using only CEZARIUS 1000 mg, coated tablets)

Dosage for adults and adolescents (from 16 years):

Usually, the doctor recommends taking a dose of the medicine between 1000 mg and 3000 mg per day.
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Treatmentwith CEZARIUS starts with lower dosesfor the first two weeks, and then, depending on the treatment effect, the doctor may increase the dose to achieve the recommended value.
For example, if the recommended daily dose of the medicine is 2000 mg, the lower initial dose is 1 tablet in the morning and 1 tablet in the evening.

• Adjunctive therapy(treatment using CEZARIUS 1000 mg, coated tablets and other medicines recommended by the doctor)

Dosage for adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:

Usually, the doctor recommends taking a dose of the medicine between 1000 mg and 3000 mg per day.
For example, if the recommended daily dose of the medicine is 2000 mg, take 1 tablet in the morning and 1 tablet in the evening.

Dosage for infants and children (from 1 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a body weight below 50 kg:

The doctor will recommend the use of the appropriate form of CEZARIUS most suitable for the child's age, body weight, and recommended dosage.
CEZARIUS 100 mg/ml, oral solution is a more suitable form for use in infants and children under 6 years of age and in children and adolescents (from 6 to 17 years) with a body weight below 50 kg, and when it is not possible to administer the appropriate dose in tablets.

Method of administration:

CEZARIUS coated tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). CEZARIUS can be taken with or without food.

Duration of treatment:

• CEZARIUS is intended for long-term treatment. Continue treatment with CEZARIUS for as long as your doctor recommends.
• Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

Overdose of CEZARIUS

After an overdose of levetiracetam, somnolence, agitation, aggression, decreased consciousness, respiratory depression, and coma have been reported.
If you have taken more than the recommended dose of CEZARIUS, contact your doctor immediately, who will recommend the most appropriate treatment for the overdose.

Missed dose of CEZARIUS

Contact your doctor if you have missed one or more doses of the medicine.
Do not take a double dose to make up for the missed tablet.

Stopping treatment with CEZARIUS

If treatment with CEZARIUS is to be stopped, the medicine should be discontinued gradually to avoid increasing the frequency of epileptic seizures.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately inform your doctor or contact the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, and throat (Quincke's edema);
• flu-like symptoms and rash on the face and then on the rest of the body, accompanied by high fever, increased liver enzyme activity in blood tests, increased white blood cell count (eosinophilia), and swollen lymph nodes (drug rash with eosinophilia and systemic symptoms - DRESS syndrome);
• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles, or hands, as this may be a sign of sudden kidney function deterioration;
• a skin rash that may cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme);
• widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or signs of disorientation, memory loss (amnesia), memory disorders (forgetfulness), behavioral disorders, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common side effects reported are: nasal congestion, drowsiness, headache, fatigue, and dizziness. At the start of treatment or when increasing the dose, side effects such as drowsiness, fatigue, or dizziness may occur more frequently. The severity of these symptoms usually decreases over time.
Very common:may affect more than 1 in 10 people

• nasal congestion;
• drowsiness, headache.

Common:may affect up to 1 in 10 people

• loss of appetite;
• depression, feelings of hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of spinning), lethargy (lack of energy and enthusiasm), tremors (involuntary trembling);
• dizziness (feeling of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (exhaustion).

Uncommon:may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, mood swings/emotional instability, agitation;

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• memory loss (amnesia), memory disorders (forgetfulness), ataxia (coordination disorders), paresthesia (tingling), attention disorders;
• double vision, blurred vision;
• abnormal liver function test results;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries.

Rare:may affect up to 1 in 1,000 people

• infection;
• decreased blood cell count;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), Quincke's edema (swelling of the face, lips, tongue, and throat);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);
• involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• pancreatitis;
• liver dysfunction, hepatitis;
• sudden kidney function deterioration;
• a skin rash that may cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), widespread rash with blisters and peeling skin, occurring mainly in the area of 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);
• rhabdomyolysis (breakdown of striated muscle) and associated increased creatine phosphokinase activity in the blood. The incidence is significantly higher in Japanese patients compared to other patients (non-Japanese).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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:
Aleje 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 CEZARIUS

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.
The expiry date refers to the last day of the month shown.
This medicine does not require any special storage precautions.
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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 CEZARIUS contains

• The active substance of the medicine is levetiracetam. Depending on the strength, one CEZARIUS coated tablet contains 250 mg, 500 mg, 750 mg, or 1000 mg of levetiracetam.
• The other ingredients (excipients) are: Tablet core: crospovidone (Type B), Povidone K30, colloidal anhydrous silica, magnesium stearate.

Coating of CEZARIUS 250 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc, indigo carmine (E132).
Coating of CEZARIUS 500 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc, yellow iron oxide (E172).
Coating of CEZARIUS 750 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc, orange yellow (E110), red iron oxide (E172).
Coating of CEZARIUS 1000 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc.

What CEZARIUS looks like and contents of the pack

CEZARIUS 250 mg: blue, oval, coated tablets with a dividing line on one side, measuring 12.9 x 6.1 mm, packaged in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 coated tablets.
The tablet can be divided into two equal doses.
CEZARIUS 500 mg: yellow, oval, coated tablets with a dividing line on one side, measuring 16.5 x 7.7 mm, packaged in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 coated tablets.
The tablet can be divided into two equal doses.
CEZARIUS 750 mg: orange, oval, coated tablets with a dividing line on one side, measuring 18.8 x 8.9 mm, packaged in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 coated tablets.
The tablet can be divided into two equal doses.
CEZARIUS 1000 mg: white, oval, coated tablets with a dividing line on one side, measuring 19.2 x 10.2 mm, packaged in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 coated tablets.
The tablet can be divided into two equal doses.

Marketing authorization holder

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“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Phone: +48 (71) 352 95 22
Fax: +48 (71) 352 76 36
Information about the medicine
phone: + 48 (22) 742 00 22
e-mail: [email protected]

Manufacturer 250 mg:

Remedica Ltd
Aharnon str.
Limassol Industrial Estate
CY-3056 Limassol
Cyprus
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
Larisa 41004
Greece
500 mg, 750 mg, 1000 mg:
“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Date of last revision of the leaflet:24.05.2018 r.
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