Vetira

Package leaflet: Information for the patient

Vetira, 100 mg/ml, concentrate for solution for infusion
Levetiracetam
Please read this leaflet carefully before using the medicine or administering 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 pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:
1 What Vetira is and what it is 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 VETIRA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Vetira is used:
as monotherapy (treatment with Vetira alone) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of seizures. Epilepsy is a condition in which patients have recurrent seizures (fits). Levetiracetam is used to treat a type of epilepsy in which seizures start in one part of the brain but may then spread to larger areas of both brain hemispheres (secondarily generalized partial seizures or partial seizures without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
as an add-on therapy to another antiepileptic medicine:

• in adults, adolescents and children aged 4 years and older, for the treatment of secondarily generalized partial seizures or partial seizures without secondary generalization;
• in adults and adolescents aged 12 years and older, for the treatment of myoclonic seizures in juvenile myoclonic epilepsy (brief, shock-like jerks of a muscle or group of muscles);
• in adults and adolescents aged 12 years and older, for the treatment of primary generalized tonic-clonic seizures in idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis), characterized by major 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
Do not use Vetira if you are allergic to levetiracetam, to pyrrolidone derivatives, or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Vetira, discuss the following with your doctor:
If you have kidney disease, Vetira should be used according to your doctor's recommendations. Your doctor may decide to adjust the dosage.
If you notice any slowing of growth or unexpected early puberty in a child, contact your doctor.
Some patients treated with antiepileptic medicines such as Vetira have had thoughts about self-harm or suicide. If symptoms of depression and/or suicidal thoughts occur, contact your doctor immediately.
If you or a family member has a history of irregular heart rhythm (seen on electrocardiogram), or if you have a heart condition and/or are taking medicines that may predispose to irregular heart rhythm or electrolyte imbalance.

Inform your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:
Unusual thoughts, irritability, or more aggressive reactions than usual, or if you or your family and friends notice significant changes in mood or behaviour.

Worsening of epilepsy
In rare cases, seizures may worsen or occur more frequently, especially during the first month of treatment or after an increase in dose. If any of these new symptoms appear while taking Vetira, contact your doctor as soon as possible.

Children and adolescents
Vetira is not indicated for use as monotherapy (Vetira alone) in children and adolescents under 16 years of age.

Vetira and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as it may reduce the effectiveness of levetiracetam.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
Do not stop treatment without discussing it with your doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and operating machinery
Vetira may impair the ability to drive or operate tools or machinery, as this medicine may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

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

3. HOW TO USE VETIRA

Vetira is administered as an intravenous infusion by a doctor or nurse.
Vetira must be given twice daily, in the morning and evening, approximately at the same time each day.
The intravenous formulation of Vetira is an alternative to oral administration. Switching from tablets or oral solution to the intravenous formulation, 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 of age)
Dosage in adults and adolescents (aged 12 to 17 years) with body weight of 50 kg or more:
The usual dosage range is 1000 mg to 3000 mg per day.
If the patient is starting Vetira for the first time, the doctor will initially recommend a lower dose for 2 weeks, followed by the lowest usually recommended dose.
Dosage in children (aged 4 to 11 years) and adolescents (aged 12 to 17 years) with body weight below 50 kg:
The usual dosage range is 20 mg/kg to 60 mg/kg per day.
Method and route of administration:
Vetira is administered intravenously.
The recommended dose should be diluted in at least 100 ml of a suitable diluent and administered as an infusion over more than 15 minutes.
Further 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 intravenous administration of levetiracetam for periods longer than 4 days.
Discontinuation of Vetira:
If treatment with Vetira is to be discontinued, the drug should be withdrawn gradually to avoid increased frequency of epileptic seizures. If the doctor decides to discontinue treatment, they will also advise on how to taper the medication gradually.
If you have any further questions regarding 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 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, Quincke's oedema);
• flu-like symptoms and rash on the face followed by a rash spreading over the entire body, accompanied by high fever, increased liver enzyme activity detected in blood tests, increased number of certain white blood cells (eosinophilia), and enlarged lymph nodes (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, 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 spot 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);
• a more severe form of rash causing skin detachment affecting more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances, or if you notice symptoms of disorientation, amnesia (memory loss), memory impairment (forgetfulness), behavioural disorders or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse reactions are: inflammation of the mucous membranes of the nose and throat, drowsiness, headache, fatigue and dizziness. During the initial treatment period or after dose increase, 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, feelings of hostility or aggression, anxiety, insomnia, nervousness or irritability; seizures, balance disorders, dizziness (feeling of swaying), somnolence (lack of energy and motivation), tremors (involuntary shaking); vertigo (spinning sensation); cough; abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea; rash; asthenia/fatigue.

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and suicide attempts, mental disturbances, abnormal behaviour, hallucinations, feeling angry, disorientation, panic attacks, emotional lability/mood swings, agitation;
• amnesia (memory loss), memory disorders (forgetfulness), ataxia (impaired coordination of movements), paraesthesia (tingling sensations), difficulty concentrating;
• double vision, blurred vision;
• elevated/abnormal liver function test results;
• hair loss, skin rash, pruritus (itching);
• muscle weakness, muscle pain;
• injuries.

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

• infection; decreased number of all types of blood cells; severe hypersensitivity reactions (drug rash with eosinophilia and systemic symptoms – DRESS syndrome), Quincke's oedema (swelling of the face, lips, tongue and throat); decreased sodium levels in blood; suicide, personality disorders (behavioural disturbances), disturbances in thinking (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms, see 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 (excessive activity);
• change in heart rhythm (electrocardiographic findings);
• 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 spot 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 skeletal muscles) and associated increase in serum creatine phosphokinase activity. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients;
• limping or difficulty walking.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl . Reporting adverse reactions helps provide more information on the safety of this medicine.

Adverse reactions can also be reported to the Marketing Authorisation 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,
which refers to the last day of the stated month: Expiry date (EXP).
This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Vetira contains
The active substance is levetiracetam. Each millilitre 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, colourless, sterile liquid.
Vetira concentrate for solution for infusion is packed in cardboard boxes containing 10 vials of 5 ml each.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

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

This medicinal product is authorised for sale in the European Economic Area under the following names:
{Poland} {Vetira}

The following information is intended for healthcare professionals only:

Instructions for the proper use of Vetira are provided in section 3.
One vial of Vetira concentrate contains 500 mg of levetiracetam (5 ml of concentrate contains 100 mg/ml).
Table 1 provides recommendations for the preparation and administration of Vetira concentrate to achieve a 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; any unused solution should be discarded.
Shelf life of the prepared solution: from a microbiological point of view, the medicinal product should be used immediately after dilution. If not used immediately, the duration and storage conditions of the solution for use are the responsibility of the user and should not exceed 24 hours at a temperature of 2°C to 8°C, unless the solution was prepared under controlled and validated aseptic conditions.
Vetira concentrate is physically compatible and chemically stable when mixed with the diluents listed below for at least 24 hours when stored in PVC bags at controlled room temperature, i.e., 15°C to 25°C.
Diluents:

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