Levetiracetam Aurovitas

Package Leaflet: Information for the Patient

Levetiracetam Aurovitas, 100 mg/ml, Oral Solution

Levetiracetam

Read the package leaflet carefully before taking 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 pack and other information

1.

What is Levetiracetam Aurovitas and what is it used for

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

• as monotherapy (only Levetiracetam Aurovitas) 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 recurring seizures. Levetiracetam is used to treat types 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 has prescribed levetiracetam to reduce the number of seizures;
• as an additional medicine along with 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 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).

2. Important information before taking Levetiracetam Aurovitas

When not to take Levetiracetam Aurovitas

• 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 Levetiracetam Aurovitas, consult your 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, contact your doctor.
• 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, 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:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant mood or behavioral changes 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. If any of these new symptoms occur while taking Levetiracetam Aurovitas, contact your doctor as soon as possible.

Children and adolescents

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

Levetiracetam Aurovitas 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 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. Do not stop treatment without discussing it with your doctor.
The risk of congenital malformations cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Aurovitas may impair 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.

Levetiracetam Aurovitas contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and maltitol

Levetiracetam Aurovitas oral solution contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause an allergic reaction (delayed).
Levetiracetam Aurovitas oral solution contains maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Levetiracetam Aurovitas, 100 mg/ml, oral solution contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per unit volume, i.e., the medicine is considered "sodium-free".

3. How to take Levetiracetam Aurovitas

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Levetiracetam Aurovitas must be taken twice a day, in the morning and evening, at approximately the same time every day.
The oral solution should be taken as directed by your doctor.
Monotherapy (from 16 years of age)

Adults (≥ 18 years) and adolescents (from 16 years of age):

Measure the appropriate dose using the 10 ml syringe provided with the packaging for patients from 4 years of age.
Recommended dose: Levetiracetam Aurovitas is taken twice a day, in two divided doses, each dose is between 5 ml (500 mg) and 15 ml (1500 mg).
If the patient is taking Levetiracetam Aurovitas for the first time, the doctor will initially recommend a lower dose for 2 weeks, and then the lowest daily dose.
Adjunctive therapy

Dose in adults and adolescents (from 12 to 17 years of age):

Measure the appropriate dose using the 10 ml syringe provided with the packaging for patients from 4 years of age.
Recommended dose: Levetiracetam Aurovitas is taken twice a day, in two divided doses, each dose is between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:

The doctor will recommend the most suitable form of Levetiracetam Aurovitas based on the patient's age, weight, and dose.
For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided with the packaging.
For children over 4 years of age, measure the appropriate dose using the 10 ml syringe provided with the packaging.
Recommended dose: Levetiracetam Aurovitas is taken twice a day, in two divided doses, each dose is between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (see the table below for examples of doses).

Dosing in children from 6 months of age and older

Dose in infants (from 1 month to less than 6 months of age):

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 mlsyringe provided with the packaging.
Recommended dose: Levetiracetam Aurovitas is taken twice a day, in two divided doses, each dose is 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 examples of doses).

Dosing in infants (from 1 month to less than 6 months of age):

Method of administration:

After measuring the appropriate dose using the appropriate syringe, Levetiracetam Aurovitas oral solution can be diluted in a glass of water or in a baby bottle. Levetiracetam Aurovitas can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.
Instructions for preparing the medicine for use:

• open the bottle: press the cap and turn it in the opposite direction to the clockwise direction (figure 1)

• separate the connector from the syringe (figure 2). Place the connector in the neck of the bottle (figure 3). Make sure it is well secured.

• push the dosing syringe into the connector (figure 4). Turn the bottle upside down (figure 5)

• draw up a small amount of solution into the syringe by pulling the plunger down (figure 5A), then push the plunger to remove air bubbles from the syringe (figure 5B). Pull the plunger down to the mark on the scale corresponding to the dose prescribed by the doctor in milliliters (ml) (figure 5C).

• turn the bottle over (figure 6A). Remove the syringe from the connector (figure 6B).

• press the contents of the syringe into a glass of water or a baby bottle, by pressing the syringe plunger (figure 7).

• drink the entire contents of the glass/baby bottle.
• close the plastic bottle with the cap.
• rinsing the syringe with water (figure 8).

Duration of treatment:

• Levetiracetam Aurovitas is used for long-term treatment. Continue treatment with Levetiracetam Aurovitas for as long as your doctor recommends.
• Do not stop treatment without consulting your doctor, as this may cause an increase in the frequency of seizures.

Taking 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, consult a doctor or pharmacist immediately. The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Levetiracetam Aurovitas:

Contact your 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 dose.

Stopping treatment with Levetiracetam Aurovitas:

If treatment with Levetiracetam Aurovitas is to be discontinued, the medicine should be gradually discontinued to avoid increasing the frequency of epileptic seizures. If the doctor decides to discontinue treatment, they will also inform you how to gradually discontinue the medicine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Immediately inform your doctor or contact the nearest hospital emergency department 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 rash on the face and then on the whole body, high fever, increased liver enzyme activity in blood tests, increased white blood cell count (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;
• a skin rash 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 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 in the patient signs of disorientation, drowsiness, 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 reported are: rhinitis, 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 decrease over time.
Very common: may affect more than 1 in 10 people

• rhinitis;
• drowsiness, headaches.

Common:may affect up to 1 in 10 people

• loss of appetite;
• depression, feeling hostile or aggressive, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of swaying), lethargy (lack of energy and enthusiasm), tremors (involuntary muscle tremors);
• 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

• 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, mood swings;
• memory loss (loss of memory), memory disorders (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disorders;
• double vision, blurred vision;
• abnormal liver function tests;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries.

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

• infection;
• decreased count of all blood cell types;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome, Quincke's edema);
• 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 "Immediately inform your doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver dysfunction, hepatitis;
• sudden worsening of kidney function;
• skin rash 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 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 non-Japanese patients;
• 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.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
No special precautions for storage of the medicinal product are necessary.
Do not use after 7 months from the first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levetiracetam Aurovitas contains

• The active substance of the medicine is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The medicine also contains: maltitol liquid (E 965), glycerol (E 422), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium citrate, acesulfame potassium (E 950), Mafco Magnasweet contains:

glycerin and ammonium glycyrrhizinate, grape flavor contains: flavors, propylene glycol, ascorbic acid, purified water.

What Levetiracetam Aurovitas looks like and contents of the pack

Levetiracetam Aurovitas, 100 mg/ml, oral solution is a clear, colorless liquid with a grape flavor.
300 ml of Levetiracetam Aurovitas solution in an orange glass bottle (type III) (for children from 4 years of age and older, adolescents, and adults) with a white child-resistant cap, packaged in a cardboard box containing a 10 ml oral syringe (with a scale every 0.25 ml) and a syringe connector.
150 ml of Levetiracetam Aurovitas solution in an orange glass bottle (type III) (for infants and young children from 6 months to less than 4 years of age) with a white child-resistant cap, packaged in a cardboard box containing a 3 ml oral syringe (with a scale every 0.1 ml) and a syringe connector.
150 ml of Levetiracetam Aurovitas solution in an orange glass bottle (type III) (for infants from 1 month to less than 6 months of age) with a white child-resistant cap, packaged in a cardboard box containing a 1 ml oral syringe (with a scale every 0.05 ml) and a syringe connector.
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

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

Italy:
Levetiracetam Aurobindo Pharma Italia
Malta:
Levetiracetam Aurobindo 100 mg/ml oral solution
Poland:
Levetiracetam Aurovitas
Portugal:
Levetiracetam Aurovitas
Spain:
Levetiracetam Aurovitas 100 mg/ml oral solution EFG

Date of last revision of the leaflet: 12/2022