Cezarius

Leaflet accompanying the packaging: patient information

CEZARIUS 250 mg coated tablets

CEZARIUS 500 mg coated tablets

CEZARIUS 750 mg coated tablets

CEZARIUS 1000 mg coated tablets

Levetiracetam

Read the 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents 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 brain hemispheres (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 recommended by the doctor. The doctor may decide to adjust the dosage.
• Contact the doctor if the 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 the 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 the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as it may prevent levetiracetam from working.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
CEZARIUS should not be used during pregnancy unless it is absolutely necessary. It is not possible to completely rule out the risk of birth defects in the fetus. In animal studies, levetiracetam administered in doses higher than those used to control seizures in humans showed an adverse effect on fertility.
During treatment, breastfeeding is not recommended.

Driving and using machines

CEZARIUS may impair the ability to drive and use tools or machines, as taking CEZARIUS may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. It is not recommended to drive or use machines until the effect of the medicine on the patient's ability to perform these activities is known.

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

Orange(E110) may cause allergic reactions.

3. How to take CEZARIUS

Take this medicine always as recommended by your doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The number of tablets taken must be as recommended by the doctor.
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CEZARIUS is taken twice a day, in the morning and evening, preferably at the same time of 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 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, best suited to 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 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, best suited to 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 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, best suited to 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 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, best suited to 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, washed down 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. Treatment with CEZARIUS should be continued for as long as recommended by the doctor.
• Do not stop treatment without consulting a doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of CEZARIUS than recommended

After an overdose of levetiracetam, drowsiness, agitation, aggression, decreased consciousness, slowed breathing, and coma have been reported.
In case of taking a higher dose of CEZARIUS than recommended, consult a doctor immediately, who will recommend the most appropriate treatment for the overdose.

Missing a dose of CEZARIUS

Consult a doctor if one or more doses of the medicine have not been taken.
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 an increase in the frequency of epileptic seizures.
In case of any further doubts about the use of the medicine, consult a 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.

Inform your doctor or contact the nearest hospital emergency department immediately 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 whole 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 legs, as this may be a sign of sudden kidney function deterioration;
• a skin rash that can cause blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• a 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 noticing signs of disorientation, memory loss (amnesia), memory disturbances (forgetfulness), behavioral disturbances, 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 beginning 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 occur in more than 1 in 10 patients

• nasal congestion;
• drowsiness, headaches.

Common:may occur in 1 to 10 in 100 patients

• loss of appetite (anorexia);
• depression, feelings of hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disturbances, 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 occur in 1 to 10 in 1000 patients

• 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, excitement;

Rare:may occur in 1 to 10 in 10,000 patients

• 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 disturbances), thinking disturbances (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 can cause blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme), a 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 side effects occur, including any side effects 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:
Aleje 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 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. Package contents 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
Tel. +48 (71) 352 95 22
Fax +48 (71) 352 76 36
Medicine information
tel. + 48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

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
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