Levetiracetam Aurovitas

Leaflet attached to the packaging: information for the user

Levetiracetam Aurovitas, 250 mg, coated tablets

Levetiracetam Aurovitas, 500 mg, coated tablets

Levetiracetam Aurovitas, 750 mg, coated tablets

Levetiracetam Aurovitas, 1000 mg, coated tablets

Levetiracetam

You should read the contents of the leaflet before taking the medicine or giving it to a child, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Levetiracetam Aurovitas and what is it used for
• 2. Important information before taking Levetiracetam Aurovitas
• 3. How to take Levetiracetam Aurovitas
• 4. Possible side effects
• 5. How to store Levetiracetam Aurovitas
• 6. Contents of the packaging and other information

1. What is Levetiracetam Aurovitas and what is it used for

Levetiracetam Aurovitas, coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Aurovitas is used:

• as monotherapy (as the only medicine) in the treatment of adults and adolescents from 16 years of age with newly diagnosed epilepsy, in the treatment of certain forms of epilepsy. Epilepsy is a condition where patients have recurring seizures (convulsions). Levetiracetam is used to treat this form of epilepsy, where seizures initially occur in one part of the brain, but then may spread to larger areas of both hemispheres of the brain (partial seizures with secondary generalization or without secondary generalization). The doctor has prescribed levetiracetam to reduce the number of seizures;
• as an additional medicine besides another antiepileptic medicine:
• in adults, adolescents, children, and infants from 1 month of age, in the treatment of partial seizures with secondary generalization 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 Levetiracetam Aurovitas

When not to take Levetiracetam Aurovitas

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

Warnings and precautions

Before starting treatment with Levetiracetam Aurovitas, the patient should discuss it with their doctor:

• If kidney disease has been diagnosed in the patient, Levetiracetam Aurovitas 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, the doctor should be contacted.
• In some patients treated with antiepileptic medicines, such as Levetiracetam Aurovitas, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, the doctor should be contacted.
• 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.

The doctor or pharmacist should be informed if any of the following side effects worsen or persist for more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant changes in mood or behavior noticed by the patient or their family and friends.
• 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. In a very rare form of epilepsy with an early onset (epilepsy associated with mutations in the SCN8A gene) 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 appear while taking Levetiracetam Aurovitas, the doctor should be contacted as soon as possible.

Children and adolescents

• Levetiracetam Aurovitas should not be used as monotherapy (only Levetiracetam Aurovitas) in children and adolescents under 16 years of age.

Levetiracetam Aurovitas and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Macrogol (a medicine used for constipation) should not be taken within one hour before and one hour after taking levetiracetam, as it may prevent levetiracetam from working.

Pregnancy, breastfeeding, and fertility

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. Treatment should not be stopped without discussing it with the doctor.
The risk of congenital defects in the fetus cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Aurovitas may impair the ability to drive and operate tools or machines, as it may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. Driving and operating machines are not recommended until the effect of the medicine on the patient's ability to perform these activities is known.
Levetiracetam Aurovitas, 750 mg, coated tablets containorange yellow S (E 110), which may cause allergic reactions.

3. How to take Levetiracetam Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
The number of tablets prescribed by the doctor should be taken.
Levetiracetam Aurovitas 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 (aged 18 and over) and adolescents (aged 12 to 17) with a body weight of 50 kg or less:

Recommended dose: 1000 mg to 3000 mg per day.
If the patient is taking Levetiracetam Aurovitas for the first time, the doctor will initially prescribe a lowerdosefor 2 weeks, and then the lowest daily dose.
For example: if the daily dose is to be 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 (aged 12 to 17) with a body weight of 50 kg or less:

The doctor will prescribe the most suitable pharmaceutical form of Levetiracetam Aurovitas based on the patient's body weight and dose.

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

The doctor will recommend the most suitable form of Levetiracetam Aurovitas, depending on age, body weight, and dose.
Levetiracetam Aurovitas 100 mg/ml oral solution is a more suitable form for infants and children under 6 years of age and for children and adolescents (aged 6 to 17) with a body weight below 50 kg, as well as when it is not possible to administer the appropriate dose in tablets.

Method of administration:

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

Duration of treatment:

• Levetiracetam Aurovitas is used for long-term treatment. Treatment with Levetiracetam Aurovitas should be continued for as long as prescribed by the doctor.
• Treatment should not be stopped without consulting the doctor, as this may cause an increase in the frequency of seizures.

Using a higher dose of Levetiracetam Aurovitas than recommended

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

Missing a dose of Levetiracetam Aurovitas

The doctor should be contacted if one or more doses of the medicine have not been taken.
A double dose should not be taken to make up for a missed tablet.

Stopping treatment with Levetiracetam Aurovitas

If treatment with Levetiracetam Aurovitas is to be stopped, the medicine should be discontinued gradually to avoid an increase in the frequency of epileptic seizures. If the doctor decides to stop treatment with Levetiracetam Aurovitas, they will also inform how to gradually discontinue the medicine Levetiracetam Aurovitas.
If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The doctor or the nearest hospital emergency department (ER) should be informed immediately if the patient experiences:

• 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 a rash on the face and then on the rest of the body, high temperature, increased liver enzyme activity in blood tests, increased number of certain white blood cells (eosinophilia), lymph node enlargement, and involvement of other organs (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;
• 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) (erythema multiforme);
• a widespread rash with blisters and peeling skin, occurring mainly in the area of 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 (loss of memory), 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: nasal congestion, 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 decrease over time.
Very common: may occur in more than 1 in 10 people

• nasal congestion;
• drowsiness, headache.

Common: may occur in up to 1 in 10 people

• loss of appetite;
• depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disturbances, 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 occur in up to 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 lability/mood swings, excitement;
• memory loss (loss of memory), memory disturbances (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disturbances;
• double vision, blurred vision;
• increased/liver enzyme abnormalities;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries.

Rare: may occur in up to 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), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms can be found in the subsection "The doctor or the nearest hospital emergency department (ER) should be informed immediately");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, torso, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• changes 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) (erythema multiforme), a 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;
• occurring simultaneously: fever, muscle stiffness, unstable blood pressure and heart rate, disorientation, low level of consciousness (these may be symptoms of a disorder called malignant neuroleptic syndrome). The incidence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• repetitive unwanted thoughts or feelings, or an internal compulsion to constantly perform the same action (obsessive-compulsive disorder).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Levetiracetam Aurovitas

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storage conditions.
This medicine should not be used after the expiry date stated on the blister, box, and container after: EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Levetiracetam Aurovitas contains

The active substance of the medicine is levetiracetam. Each coated tablet contains 250 mg or 500 mg or 750 mg or 1000 mg of levetiracetam.
In addition, the medicine contains:
Core: cornstarch, colloidal silicon dioxide (E 551), povidone (K-30) (E 1201), talc (E 553b), magnesium stearate (E 470b).
Coating:
250 mg:hypromellose 3cP, hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 4000, indigo carmine lake (E 132).
500 mg:hypromellose 3cP, hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).
750 mg:hypromellose 3cP, hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 4000, red iron oxide (E 172), indigo carmine lake (E 132), orange yellow S (E 110).
1000 mg:hypromellose 5cP (E 464), titanium dioxide (E 171), macrogol 400.

What Levetiracetam Aurovitas looks like and contents of the pack

Coated tablet.
Levetiracetam Aurovitas, 250 mg, coated tablets
Blue oval, biconvex coated tablets, with a dividing line separating the engravings "E" and "10" on one side and smooth on the other side.
The tablet can be divided into equal doses.
Levetiracetam Aurovitas, 500 mg, coated tablets
Yellow oval, biconvex coated tablets, with a dividing line separating the engravings "E" and "11" on one side and smooth on the other side. The tablet can be divided into equal doses.
Levetiracetam Aurovitas, 750 mg, coated tablets
Orange oval, biconvex coated tablets, with a dividing line separating the engravings "E" and "12" on one side and smooth on the other side. The tablet can be divided into equal doses.
Levetiracetam Aurovitas, 1000 mg, coated tablets
White oval, biconvex coated tablets, with a dividing line separating the engravings "E" and "13" on one side and smooth on the other side. The tablet can be divided into equal doses.
Levetiracetam Aurovitas coated tablets are packaged in PVC/PE/PVDC/Aluminum blisters or HDPE containers with PP closures, in a cardboard box.
Packaging:
Blisters: 20, 30, 50, 60, 100, 200, and 500 coated tablets.
HDPE container: 30, 100, 200, and 500 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

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

France:
Levetiracetam Arrow Lab 250 mg/ 500 mg/ 1000 mg, comprimé pelliculé sécable
Germany:
Levetiracetam Aurobindo 250 mg/ 500 mg/ 750 mg/ 1000 mg Filmtabletten
Italy:
Levetiracetam Aurobindo 500 mg/ 1000 mg compresse rivestite con film
Netherlands:
Levetiracetam Aurobindo 250 mg/ 500 mg/ 750 mg/ 1000 mg, filmomhulde tabletten
Poland:
Levetiracetam Aurovitas
Romania:
Levetiracetam Aurobindo 500 mg/ 1000 mg comprimate filmate

Date of last revision of the leaflet: 04/2025