Vetira

Package Leaflet: Information for the Patient

Vetira, 100 mg/ml, Concentrate for Solution for Infusion

Levetiracetam

Read the package leaflet carefully before using 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.

Contents of the Package Leaflet:
1
What is Vetira and what is it used for
2
Important information before using Vetira
3
How to use Vetira
4
Possible side effects
5
How to store Vetira
6
Contents of the pack and other information
1.

WHAT IS VETIRA AND WHAT IS IT USED FOR

Levetiracetam is an antiepileptic medicine (used to treat seizures in epilepsy).
Vetira is used:
as monotherapy (using only Vetira) in adults and adolescents from 16 years of age with newly diagnosed epilepsy, for the treatment of certain types of epilepsy. Epilepsy is a condition where patients have repeated seizures. Levetiracetam is used to treat a type of epilepsy where seizures first start in one part of the brain and 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 additional medicine alongside another antiepileptic medicine:

• in adults, adolescents, and children from 4 years of age, for the treatment of partial seizures with or without secondary generalization;
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy, for the treatment of myoclonic seizures (short, shock-like muscle contractions),
• 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), for the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness).

Vetira concentrate for solution for infusion is an alternative for patients when oral administration is temporarily not possible.

2. IMPORTANT INFORMATION BEFORE USING VETIRA

When not to use Vetira

In case of hypersensitivity to levetiracetam, pyrrolidine derivatives, or any of the excipients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Vetira, discuss with your doctor:
If kidney disease has been diagnosed in the patient, Vetira should be used in accordance with the doctor's recommendations. The doctor may decide to adjust the dosage.
If any slowing of growth or unexpected premature puberty has been observed in the child, contact your doctor.
In some patients treated with antiepileptic medicines such as Vetira, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and (or) suicidal thoughts, contact your doctor.
If there is a history of irregular heart rhythm (visible on an electrocardiogram) in the patient's family or previously in the patient, or if the patient has a disease and (or) is taking medicines that cause a tendency to irregular heart rhythm or electrolyte imbalance.
Tell your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:
Unusual thoughts, irritability, or a more aggressive reaction than usual, or if the patient or their family and friends notice significant changes in their mood or behavior.
Worsening of epilepsy
In rare cases, seizures may worsen or occur more frequently, especially in the first month after starting treatment or increasing the dose. If any of these new symptoms occur while taking Vetira, contact your doctor as soon as possible.

Children and adolescents

Vetira is not recommended for use as monotherapy (using only Vetira) in children and adolescents under 16 years of age.

Vetira and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as it may reduce the effect of levetiracetam.

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.
Levetiracetam can be used during pregnancy only if the doctor considers it necessary after careful evaluation.
Do not stop treatment without discussing it with the doctor.
The risk of congenital malformations cannot be completely excluded.
Breastfeeding is not recommended during treatment.

Driving and using machines

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

Vetira contains sodium

Vetira contains 59.82 mg of sodium (main component of cooking/table salt) per 15 ml.
This corresponds to 3% of the recommended maximum daily intake of sodium for an adult.

3. HOW TO USE VETIRA

Vetira is administered as an intravenous infusion by a doctor or nurse.
Vetira must be taken twice a day, in the morning and evening, at approximately the same time every day.
The intravenous form is an alternative for patients when oral administration is not possible. Switching from tablets or oral solution to intravenous form or vice versa may be done directly, without gradual dose adjustment. The total daily dose and frequency of administration remain unchanged.
Adjunctive therapy and monotherapy (from 16 years)

Dose in adults and adolescents (12 to 17 years) with a body weight of 50 kg or more:

Usual dose: from 1000 mg to 3000 mg per day.
If the patient is taking the medicine for the first time, the doctor will recommend starting with a lower dosefor 2 weeks, and then the usual dose.

Dosing in children (4 to 11 years) and adolescents (12 to 17 years) with a body weight below 50 kg:

Usual dose: from 20 mg/kg body weight to 60 mg/kg body weight per day

Method and route of administration:

Vetira is administered intravenously.
The recommended dose should be diluted in at least 100 ml of suitable diluent and administered as an infusion over more than 15 minutes.
More detailed information for doctors and nurses on the proper administration of Vetira can be found in section 6.

Duration of treatment:

There are no data on the administration of levetiracetam intravenously for more than 4 days.

Withdrawal of Vetira:

If treatment with Vetira is to be discontinued, the medicine should be gradually withdrawn to avoid increasing the frequency of epileptic seizures. If the doctor decides to discontinue treatment, they will also inform how to gradually withdraw the medicine.
In case of any further doubts about the use of the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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, with high fever, increased liver enzyme activity in blood tests,

increase in the number of certain white blood cells (eosinophilia) and lymph node enlargement (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 worsening of kidney function;
• rash on the skin that can 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);
• signs of serious mental changes, or noticing in the patient signs of disorientation, memory loss (loss of memory), 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 are: inflammation of the nasal passages and throat, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or after increasing the dose, side effects such as drowsiness, fatigue, or dizziness may occur more frequently.
These effects should weaken over time.
Very common:may affect more than 1 in 10 people

• inflammation of the nasal passages and throat;
• drowsiness, headaches.

Common:may affect up to 1 in 10 people

• loss of appetite (loss of appetite); depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability; seizures, balance disorders, dizziness (feeling of swaying), 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
decrease in platelet count, decrease in white blood cell count;
weight loss, weight gain;
suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, emotional instability/mood changes, excitement;
memory loss (loss of memory), memory disorders (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disorders;
double vision, blurred vision;
increased/abnormal liver test results;
hair loss, rash, itching;
muscle weakness, muscle pain;
injuries.
Rare:may affect up to 1 in 1,000 people

• infection; decrease in all types of blood cells; severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), Quincke's edema (swelling of the face, lips, tongue, and throat); decrease in sodium levels in the blood; suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);

delirium;
encephalopathy (detailed description of symptoms, see "Inform your doctor immediately");
seizures may worsen or occur more frequently;
involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
change in heart rhythm (electrocardiogram);
pancreatitis;
liver dysfunction, hepatitis;
sudden worsening of kidney function;
rash on the skin that can 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);
stuttering or difficulty walking.

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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. HOW TO STORE VETIRA

Keep out of the sight and reach of children.
Do not use Vetira after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vetira contains

The active substance is levetiracetam. Each milliliter of concentrate for solution for infusion contains 100 mg of levetiracetam.
The other ingredients are: sodium acetate trihydrate, sodium chloride, glacial acetic acid, water for injections.

What Vetira looks like and contents of the pack

Vetira concentrate for solution for infusion is a clear, colorless, sterile solution.
Vetira concentrate for solution for infusion is packaged in cardboard boxes containing 10 vials of 5 ml each.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Haupt Pharma Wülfing GmbH
Bethelner Landstrasse 18,
31028 Gronau/Leine
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

{Poland}
{Vetira}
Date of revision of the leaflet:12.2023
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The following information is intended for healthcare professionals only:

Instructions for the proper use of Vetira can be found in section 3.
One vial of Vetira concentrate contains 500 mg of levetiracetam (5 ml of concentrate contains 100 mg/ml). Table 1 shows the recommendations for preparing and administering Vetira concentrate to achieve the total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg divided into two doses.
Table 1. Preparation and administration of Vetira concentrate

This medicinal product is intended for single use only, discard any unused solution.
The shelf life of the prepared solution: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the storage time and conditions of the solution are the responsibility of the user and should not exceed 24 hours, at a temperature between 2°C and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.
Vetira concentrate is physically compatible and chemically stable when mixed with the listed diluents for at least 24 hours, when stored in PVC bags at controlled room temperature, i.e., between 15°C and 25°C.
Diluents:

• Sodium chloride (0.9%) for injection
• Ringer's solution for injection with lactate
• Dextrose 5% solution for injection