Vetira

Leaflet accompanying the packaging: patient information

Vetira, 250 mg, film-coated tablets

Vetira, 500 mg, film-coated tablets

Vetira, 750 mg, film-coated tablets

Vetira, 1000 mg, film-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, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:
1
What is Vetira and what is it used for
2
Important information before taking Vetira
3
How to take 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

Vetira film-coated tablets are an antiepileptic medicine (used to treat seizures in epilepsy).
Vetira is used:
as monotherapy (using only Vetira) in the treatment of adults and adolescents from 16 years of age with newly diagnosed epilepsy, in the treatment of certain types of epilepsy. Epilepsy is a condition where patients have recurring seizures. Levetiracetam is used to treat a type of epilepsy where seizures initially occur in one part of the brain, but can then spread to larger areas of both hemispheres of the brain (partial seizures with or without secondary generalization). The doctor 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 in the treatment of partial seizures with or without secondary generalization,
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy in the treatment of myoclonic seizures (short, shock-like contractions of single muscles or muscle groups),
• 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) in the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness).

2. IMPORTANT INFORMATION BEFORE TAKING VETIRA

When not to take Vetira

• if the patient is allergic to levetiracetam, pyrrolidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

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 if the patient has previously had an irregular heart rhythm, 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 should not be used 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 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) 1 hour before and 1 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. Levetiracetam can be used during pregnancy only if the treating doctor considers it necessary after careful evaluation.
Do not stop treatment without discussing it with the treating doctor.
It is not possible to completely exclude the risk of congenital defects in the fetus. During treatment, breastfeeding is not recommended.

Driving and using machines

Vetira may impair the ability to drive and operate any tools or machines, as taking Vetira can cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose of the medicine. It is not recommended to drive or operate machines until the effect of the medicine on the patient's ability to perform these activities is known.
Vetira 750 mg film-coated tablets contain orange yellow FCF lake (E110).
The dye orange yellow FCF lake (E110) may cause allergic reactions.

3. HOW TO TAKE VETIRA

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the number of tablets as recommended by your doctor.
Vetira must be taken twice a day, in the morning and evening, at approximately the same time every day.

Additional treatment and monotherapy (from 16 years of age)

Adults (18 years and older) and adolescents (12 to 17 years) with a body weight of 50 kg or more:

Usual dose: 1000 mg to 3000 mg per day.
If the patient is taking the medicine for the first time, the doctor will initially recommend a lower dosefor 2 weeks, and then the usual dose.
For example, if the daily dose is 1000 mg, the initial lower dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.

Adolescents (12 to 17 years) with a body weight of 50 kg or less:

The doctor will prescribe the most suitable pharmaceutical form of Vetira for the patient based on their body weight and dose.

Dose in infants and children (1 to 23 months), children (2 to 11 years) with a body weight below 50 kg:

The doctor will recommend the most suitable form of Vetira based on the patient's age, body weight, and dose.
Vetira 100 mg/ml oral solution is a more suitable form for infants and children under 6 years of age and for children and adolescents (6 to 17 years) with a body weight below 50 kg, and when it is not possible to administer the correct dose in tablets.

Method of administration:

Tablets should be swallowed, washed down with a sufficient amount of liquid (e.g., a glass of water). Vetira can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Duration of treatment:

Vetira is used for long-term treatment. Treatment with Vetira should be continued for as long as recommended by the treating doctor.
Do not stop treatment without consulting the treating doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of Vetira than recommended

Possible side effects of overdosing on Vetira include: drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma. If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately. The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Vetira

Consult the treating doctor if one or more doses of the medicine have not been taken.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Vetira

If treatment with Vetira is to be stopped, the medicine should be discontinued gradually to avoid increasing the frequency of epileptic seizures. If the doctor decides to stop treatment, they will also inform you how to gradually discontinue the medicine.
If you have any doubts about taking the medicine, consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Vetira can cause side effects, although not everybody gets them.

Immediately inform your doctor or contact the nearest hospital emergency department 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, then on the rest of the body, with high fever, increased liver enzyme activity in blood tests, increased 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 hands, as this may be a sign of sudden worsening of kidney function;
• 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, mainly on 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, drowsiness, 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 commonly reported side effects are: inflammation of the nasal passages and throat, 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. These effects should weaken over time.
Very common:may occur in more than 1 in 10 people

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

Common:may occur in no more than 1 in 10 people
loss of appetite (anorexia);
depression, feeling hostile or aggressive, 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 no more than 1 in 100 people
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, emotional instability/mood swings, excitement;
memory loss (amnesia), memory disturbances (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disturbances;
double vision, blurred vision;
abnormal liver function tests;
hair loss, rash, itching;
muscle weakness, muscle pain;
injuries.
Rare:may occur in no more than 1 in 1,000 people

• infection;
• decreased number of 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);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms, see "Immediately inform your doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, torso, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver dysfunction, hepatitis;
• sudden worsening of kidney function;
• 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, mainly on 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, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of 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 .
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 the medicine out of the sight and reach of children.
Do not use Vetira after the expiry date stated on the carton and blister after:
Expiry date (EXP).
The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vetira contains

The active substance is levetiracetam.
Each film-coated tablet of Vetira 250 mg contains 250 mg of levetiracetam.
Each film-coated tablet of Vetira 500 mg contains 500 mg of levetiracetam.
Each film-coated tablet of Vetira 750 mg contains 750 mg of levetiracetam.
Each film-coated tablet of Vetira 1000 mg contains 1000 mg of levetiracetam.
The other ingredients are:
Core:
Crospovidone (type B)
Povidone K 30
Colloidal anhydrous silica
Magnesium stearate
Coating:
Vetira 250 mg film-coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc
Indigo carmine lake (E132)
Vetira 500 mg film-coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc
Yellow iron oxide (E172)
Vetira 750 mg film-coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc
Orange yellow FCF lake (E110)
Red iron oxide (E172)
Vetira 1000 mg film-coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc

What Vetira looks like and contents of the pack

Vetira 250 mg film-coated tablets: blue, oval, film-coated tablets with a dividing line on one side, measuring 12.9 x 6.1 mm, packaged in PVC/PE/PVDC/Aluminum blisters, placed in cardboard boxes, containing 20, 30, 50, 60, 100, and 200 film-coated tablets.
Vetira 500 mg film-coated tablets: yellow, oval, film-coated tablets with a dividing line on one side, measuring 16.5 x 7.7 mm, packaged in PVC/PE/PVDC/Aluminum blisters, placed in cardboard boxes, containing 10, 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.
Vetira 750 mg film-coated tablets: orange, oval, film-coated tablets with a dividing line on one side, measuring 18.8 x 8.9 mm, packaged in PVC/PE/PVDC/Aluminum blisters, placed in cardboard boxes, containing 20, 30, 50, 60, 80, 100, and 200 film-coated tablets.
Vetira 1000 mg film-coated tablets: white, oval, film-coated tablets with a dividing line on one side, measuring 19.2 x 10.2 mm, packaged in PVC/PE/PVDC/Aluminum blisters, placed in cardboard boxes, containing 10, 20, 30, 50, 60, 100, and 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Remedica Ltd
Limassol Industrial Estate,
P.O. Box 51706,
CY-3508 Limassol,
Cyprus
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area,
Larisa, 41004,
Greece
PharOs MT Ltd.
HF 62X, Hal Far Industrial Estate,
Birzebbugia, BBG 3000, Malta

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

{Poland}
{Vetira}
Date of leaflet approval:08.2022