Cezarius

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
Please read this leaflet carefully before taking the medicine or giving it to a child, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What CEZARIUS is and what it is 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 CEZARIUS is and what it is used for

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

• as monotherapy (using CEZARIUS alone) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of epilepsy. Epilepsy is a condition in which patients have recurrent seizures. Levetiracetam is used to treat a type of epilepsy where seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (partial seizures with secondary generalization or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as an additional medicine alongside another antiepileptic medicine:
• in adults, adolescents, children, and infants from 1 month of age, for the treatment of partial seizures with or without secondary generalization,
• in adults and adolescents aged 12 years and older, for the treatment of juvenile myoclonic epilepsy, specifically myoclonic seizures (brief, shock-like jerks of single muscles or muscle groups),
• in adults and adolescents aged 12 years and older, for the treatment of idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis), specifically for primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

2. Important information before using the medicine CEZARIUS

When not to use CEZARIUS

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

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Warnings and precautions
Before starting treatment with CEZARIUS, discuss this with your doctor.

• If the patient has a kidney disease, this medicine should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any growth retardation or unexpected premature development is observed in a child taking levetiracetam, contact the doctor.
• In some patients treated with antiepileptic medicines such as CEZARIUS, suicidal thoughts or thoughts about self-harm have occurred. If symptoms of depression and (or) suicidal thoughts occur, contact your doctor.
• If the patient has a family history or personal history of irregular heart rhythm (seen on electrocardiogram), or if the patient has a disease and (or) is taking medicines that predispose to irregular heart rhythm or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse reactions
become more severe or persist for longer than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.
• Worsening of epilepsy: In rare cases, seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A gene mutations) causing various types of seizures and loss of skills, the patient may notice that seizures continue or worsen during treatment.

If any of these new symptoms occur while taking CEZARIUS, contact your doctor as soon as possible.
Children and adolescents
The use of levetiracetam as monotherapy (using CEZARIUS alone) is not recommended in children and
adolescents under 16 years of age.
CEZARIUS and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as this may reduce the effectiveness of levetiracetam.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary. Do not discontinue treatment without discussing it with the treating doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out. Results from two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the effect of levetiracetam on neurodevelopment in children are limited.
Breastfeeding is not recommended during treatment.
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CEZARIUS 750 mg film-coated tablets contain sunset yellow FCF (E110)
This medicine may cause allergic reactions.

3. How to use CEZARIUS

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Take the number of tablets as directed by your doctor. CEZARIUS must be taken twice daily, in the morning and evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from 16 years of age)

• Adults (aged ≥18 years) and adolescents (aged 12 to 17 years) with body weight of 50 kg or more: The recommended dose is 1000 mg to 3000 mg per day. If the patient is taking CEZARIUS for the first time, the doctor will initially prescribe a lower dose for 2 weeks, before increasing to the minimum daily dose. For example, if the recommended daily dose is 1000 mg, the initial lower dose would be 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased so that after 2 weeks the daily dose of 1000 mg is reached.
• Adolescents (aged 12 to 17 years) with body weight less than or equal to 50 kg: The doctor will prescribe the most appropriate pharmaceutical form of CEZARIUS based on body weight and required dose.
• Dosage for infants and children (aged 1 to 23 months) and children (aged 2 to 11 years) with body weight below 50 kg: The doctor will recommend the most appropriate form of CEZARIUS depending on age, body weight, and required dose.

CEZARIUS 100 mg/ml oral solution is the more suitable formulation for use in infants and children under 6 years of age, and in children and adolescents (aged 6 to 17 years) with body weight below 50 kg, as well as when the required dose cannot be accurately administered using tablets.

Administration method
CEZARIUS coated tablets should be swallowed whole with sufficient liquid (e.g. a glass of water). CEZARIUS may be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Duration of treatment

• CEZARIUS is intended for long-term treatment. Continue taking CEZARIUS for as long as your doctor recommends.
• Do not stop treatment without consulting your doctor, as this may lead to an increase in seizure frequency.

Overdose of CEZARIUS
Possible adverse effects following levetiracetam overdose include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If an overdose of CEZARIUS has been taken, seek immediate medical advice. The doctor will recommend the most appropriate treatment for overdose.

Missed dose of CEZARIUS
If one or more doses have been missed, contact your doctor. Do not take a double dose to make up for a missed tablet.

Stopping CEZARIUS
If treatment with CEZARIUS needs to be discontinued, the medicine should be gradually withdrawn to avoid an increase in frequency of epileptic seizures. If your doctor decides to stop treatment, they will also advise you on how to taper the dose gradually.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should immediately inform your doctor or contact the nearest hospital emergency department (A&E) if the patient experiences:

• weakness, dizziness or breathing difficulties, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue and throat (angioedema);
• flu-like symptoms and facial rash followed by a rash spreading over the entire body, accompanied by high fever, increased liver enzyme activity observed in blood tests, increased count of certain white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms - DRESS syndrome);
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles or legs, as these may indicate sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment affecting over 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances or observation of disorientation, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), behavioural disturbances, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse reactions are: inflammation of the mucous membranes of the nose and throat, drowsiness,
headache, fatigue and dizziness. At the beginning of treatment or when the dose is increased, adverse reactions such as: drowsiness, fatigue or dizziness may occur more frequently. These effects should diminish over time.
Very common: may affect more than 1 in 10 people

• inflammation of the mucous membranes of the nose and throat;
• drowsiness, headache.

Common: may affect up to 1 in 10 people

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, loss of balance, dizziness (feeling of unsteadiness), lethargy (lack of energy and motivation), tremors (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness). 4/7

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight decrease, weight increase;
• suicidal thoughts and suicide attempts, mental disturbances, abnormal behaviour, hallucinations, feeling of anger, disorientation, panic attacks, emotional lability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), ataxia (impaired coordination of movement), paraesthesia (tingling), difficulty concentrating;
• double vision, blurred vision;
• elevated/abnormal liver function test results;
• hair loss, skin eruption, itching;
• muscle weakness, muscle pain;
• injuries.

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

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), angioedema (swelling of the face, lips, tongue and throat);
• decreased sodium levels in blood;
• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms is provided in the section "You should immediately inform your doctor");
• seizures may worsen or occur more frequently;
• involuntary contractions of head, trunk and limb muscles, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiographic examination);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment affecting over 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine phosphokinase activity in blood. Occurrence is significantly more frequent in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• occurrence of fever, muscle rigidity, unstable blood pressure and heart rate, disorientation, reduced level of consciousness (these may be symptoms of a disorder known as neuroleptic malignant syndrome). The frequency of occurrence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• recurrent intrusive thoughts or feelings, or an inner compulsion to repeatedly perform the same action (obsessive-compulsive disorder).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
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Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine CEZARIUS

Keep this 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 stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Cezarius contains

• The active substance is levetiracetam. Depending on the strength, one film-coated tablet of Cezarius contains 250 mg, 500 mg, 750 mg or 1000 mg of levetiracetam, respectively.
• Other ingredients (excipients) are:
  Tablet core: Crospovidone (Type B), Povidone K30, anhydrous colloidal silicon dioxide, magnesium stearate.

Coating of film-coated Cezarius 250 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc, indigo carmine (E132).
Coating of film-coated Cezarius 500 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc, iron oxide yellow (E172).
Coating of film-coated Cezarius 750 mg tablets:
Hypromellose, Macrogol / PEG 400, titanium dioxide (E171), purified talc, sunset yellow (E110), iron oxide red (E172).
Coating of film-coated 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 film-coated tablets with a dividing score line on one side, measuring 12.9 x 6.1 mm, packed in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 film-coated tablets.
The tablet can be divided into two equal doses.
Cezarius 500 mg: yellow, oval film-coated tablets with a dividing score line on one side, measuring 16.5 x 7.7 mm, packed in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 film-coated tablets.
The tablet can be divided into two equal doses.
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Cezarius 750 mg: orange, oval film-coated tablets with a dividing score line on one side, measuring 18.8 x 8.9 mm, packed in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 film-coated tablets.
The tablet can be divided into two equal doses.
Cezarius 1000 mg: white, oval film-coated tablets with a dividing score line on one side, measuring 19.2 x 10.2 mm, packed in aluminum/PVC-PE-PVDC blisters, placed in a cardboard box containing 50 film-coated tablets.
The tablet can be divided into two equal doses.

Marketing Authorisation Holder and Manufacturer
"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

Medicines Information
Tel.: (22) 742 00 22
e-mail: [email protected]
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