Cezarius

Package leaflet: Information for the patient

CEZARIUS 100 mg/ml oral solution
Levetiracetam
Please read all of this leaflet carefully before taking this medicine or giving it to a child, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What CEZARIUS is and what it is used for
2. What you need to know 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 adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for the treatment of certain types of epilepsy. Epilepsy is a condition in which patients have recurrent seizures. Levetiracetam is used to treat forms of epilepsy where seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (secondarily generalized or without secondary generalization partial seizures). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as an add-on therapy to 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 a muscle or group of muscles),
• 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 ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with CEZARIUS, discuss this with your doctor.
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• 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 early puberty in a child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as CEZARIUS, thoughts about self-harm or suicidal thoughts have occurred. In case of symptoms of depression and (or) suicidal thoughts, contact your doctor.
• If the patient has a family history or previously diagnosed 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 imbalance.

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

• Abnormal thoughts, irritability, 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 form of early-onset 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
CEZARIUS is not recommended for use as monotherapy (CEZARIUS alone) in children and
adolescents under 16 years of age.
CEZARIUS with 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 take.
Do not take macrogol (a medicine used for constipation) within one hour before or 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 your treating doctor.
The risk of congenital malformations in the fetus cannot be completely ruled out. Results of 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 effects of levetiracetam on neurodevelopment in children are limited.
Breastfeeding is not recommended during treatment.
Driving and operating machinery
CEZARIUS may impair the ability to drive and operate tools or machinery, as use of CEZARIUS may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Driving and operating machinery are not recommended until the effect of the medicine on the patient's ability to perform these activities is known.
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CEZARIUS 100 mg/ml oral solution contains liquid maltitol (E 965)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
contact the doctor before taking this medicine.
CEZARIUS 100 mg/ml oral solution contains methyl parahydroxybenzoate (E 218)
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use the medicine CEZARIUS

This medicine should always be taken as directed by the physician. If in doubt, consult
your doctor or pharmacist.
CEZARIUS should be taken twice daily, in the morning and evening, approximately at the
same time each day. The oral solution should be taken as directed by the physician.

Monotherapy (from age 16 onwards)
Adults (aged ≥ 18 years) and adolescents (aged 16 years and older):
Measure the appropriate dose using the 10 ml syringe supplied with the packaging
intended for patients aged 4 years and older.
Recommended dose: CEZARIUS is taken twice daily, in two equal divided doses;
each dose ranging between 5 ml (500 mg) and 15 ml (1500 mg).
If the patient is taking CEZARIUS for the first time, the physician will initially recommend
a lower dose for 2 weeks, followed by the lowest daily dose.

Adjunctive therapy
Dosage in adults and adolescents (aged 12 to 17 years):
Measure the appropriate dose using the 10 ml syringe supplied with the packaging
intended for patients aged 4 years and older.
Recommended dose: CEZARIUS is taken twice daily, in two equal divided doses;
each dose ranging between 5 ml (500 mg) and 15 ml (1500 mg).

Dosage in children from 6 months of age:
The physician will recommend the most appropriate formulation of CEZARIUS depending on
the child's age, body weight, and required dose.
For children aged 6 months to 4 years, measure the appropriate dose using the 3 ml syringe
supplied with the packaging.
For children above 4 years of age, measure the appropriate dose using the 10 ml syringe
supplied with the packaging.
Recommended dose: CEZARIUS is taken twice daily, in two equal divided doses;
each dose ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kilogram of the child's body weight
(see table below for example doses).
Dosage in children from 6 months of age:

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Dosage for infants (from 1 to below 6 months of age):
For infants aged from 1 month to below 6 months, the appropriate dose should be measured using the 1 ml syringe provided in the package.
Recommended dosage: CEZARIUS should be administered twice daily in two equal divided doses; each dose should range between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (see the table below for dose examples).
Dosage for infants (from 1 month to below 6 months of age):

Method of administration
After measuring the appropriate dose using the appropriate syringe, the CEZARIUS oral solution
can be added to a glass of water or to a liquid intended for the child to drink from a bottle. The CEZARIUS medication may be taken with or without food. After oral administration,
levetiracetam may leave a bitter taste.
Instructions for use:

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).
• Place the adapter onto the bottle neck (Figure 2), then insert the dosing syringe into the adapter. Ensure it is securely attached.
• Turn the bottle upside down (Figure 3).
• Fill the dosing syringe with a small amount of solution by pulling the plunger down (Figure 4 a), then press the plunger to expel any air bubbles (Figure 4 b). Next, pull the plunger down until the mark corresponding to the dose of solution in millilitres (ml) prescribed by the doctor is reached (Figure 4 c).
• Turn the bottle right-side up. Remove the dosing syringe from the adapter.
• Pressing the plunger, empty the syringe by pouring the measured dose of solution into a glass of water or into the liquid in a bottle for the child (Figure 5).
• Give the child the medication mixed with water in the glass or bottle to drink.
• Close the bottle with the plastic cap.
• Rinse the dosing syringe with water (Figure 6).

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Duration of treatment:

• CEZARIUS is intended for long-term treatment. Continue treatment with CEZARIUS for as long as directed by the doctor.
• Do not discontinue treatment without consulting your doctor, as this may lead to an increase in seizure frequency.

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

Missed dose of CEZARIUS
Contact your doctor if one or more doses of the medication have been missed. Do not take a double dose to make up for a missed dose.

Discontinuation of CEZARIUS treatment
If treatment with CEZARIUS needs to be discontinued, the medication should be tapered off gradually to avoid an increase in seizure frequency. If the doctor decides to discontinue treatment, they will also provide instructions on how the medication should be gradually withdrawn.

If you have any further questions regarding the use of this medication, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should immediately inform your doctor or contact the nearest hospital emergency department 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 or throat (angioedema);
• flu-like symptoms and facial rash followed by widespread rash, high fever, increased liver enzyme activity observed in blood tests, increase in 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 legs, ankles or feet, which may indicate sudden worsening of kidney function;
• skin rash that may lead to blistering and appear as small target-like lesions (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 more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes, or if the patient shows symptoms of disorientation, drowsiness, amnesia (memory loss), memory disturbances (forgetfulness), behavioral 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 drowsyness, fatigue or dizziness may occur more frequently. These effects should diminish over time.

Very common: may affect more than 1 in 10 patients

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

Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, feeling of anger, disorientation, panic attacks, emotional lability/mood changes, agitation;
• amnesia (memory loss), memory disturbances (forgetfulness), ataxia (impaired coordination of movement), paresthesia (tingling), difficulty concentrating;

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• double vision, blurred vision;
• elevated/abnormal liver function test results;
• hair loss, skin rash, itching;
• muscle weakness, muscle pain;
• injuries.

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

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform 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:
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.
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5. How to store the medicine 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 bottle. The expiry date refers to the last day of the stated month.
Do not use the medicine for longer than 4 months after opening the bottle.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What CEZARIUS contains

• The active substance is levetiracetam. Each millilitre of oral solution contains 100 mg of levetiracetam.
• The other ingredients (excipients) are: sodium citrate (pH regulator), citric acid (pH regulator), methyl parahydroxybenzoate (E 218), glycerol (E 422), potassium acesulfame (E 950), liquid maltitol (E 965), raspberry flavour (mixture of flavouring substances, propylene glycol E 1520), purified water.

What CEZARIUS looks like and contents of the pack
CEZARIUS oral solution 100 mg/ml is a clear liquid.
CEZARIUS oral solution (intended for use in children from 4 years of age, adolescents and adults) is supplied in amber glass bottles containing 300 ml of liquid, placed in a cardboard box together with a 10 ml dosing syringe (graduated in 0.25 ml increments) and a bottle adapter.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicinal product information
tel. + 48 (22) 742 00 22
e-mail: [email protected]
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