Levetiracetam Accord

Leaflet accompanying the packaging: patient information

Levetiracetam Accord, 100 mg/ml, oral solution

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, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• -This medicine has been prescribed specifically for you. 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 any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1.

What is Levetiracetam Accord and what is it used for

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

• as monotherapy (using only one medicine) 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 (convulsions). Levetiracetam is used to treat types of epilepsy where seizures initially occur in one part of the brain, but may then 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 alongside 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 groups of muscles)
• in adults and adolescents from 12 years of age with idiopathic 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 Accord

When not to take Levetiracetam Accord

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

Warnings and precautions

Before starting treatment with Levetiracetam Accord, consult your doctor:

• If kidney disease has been diagnosed in the patient, Levetiracetam Accord should be used as directed by the doctor. The doctor may decide to adjust the dosage.
• If any slowing of growth or unexpected premature puberty has been observed in the child, contact the doctor.
• In some patients treated with antiepileptic medicines, such as Levetiracetam Accord, suicidal thoughts or behaviors have occurred. In case of symptoms of depression and/or suicidal thoughts, contact the 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 get worse or last more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant mood or behavior 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 Accord, contact the doctor as soon as possible. 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.

Children and adolescents

Levetiracetam Accord should not be used as monotherapy in children and adolescents under 16 years of age.

Levetiracetam Accord and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
Do not take macrogol (a medicine used for constipation) 1 hour before and 1 hour after taking levetiracetam, as it may limit the effect of levetiracetam.

Levetiracetam Accord with food, drink, and alcohol

Levetiracetam Accord can be taken with or without food. For safety reasons, do not drink alcohol while taking this medicine.

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 before taking this medicine.
Levetiracetam Accord should only be used during pregnancy if the doctor considers it necessary after careful evaluation.
Do not stop treatment 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 Accord may impair the ability to drive and operate tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or after increasing the dose. 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.

Levetiracetam Accord contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and maltitol

Levetiracetam Accord oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause an allergic reaction (possible late reactions).
Levetiracetam Accord also contains maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Levetiracetam Accord

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the number of tablets as directed by your doctor.
Levetiracetam Accord 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 the doctor.
Monotherapy (from 16 years)

Adults (from 18 years) and adolescents (from 16 years):

To measure the correct dose, use the 10 ml syringe provided in the packaging for children from 4 years of age and older patients.
Recommended dose:
Levetiracetam Accord should be taken twice a day, in two equal divided doses, each dose between 5 ml (500 mg) and 15 ml (1500 mg).
If the patient is taking Levetiracetam Accord for the first time, the doctor will initially prescribe a smaller dose for 2 weeks, and then the smallest daily dose.
Adjunctive therapy

Dose for adults and adolescents (from 12 to 17 years):

To measure the correct dose, use the 10 ml syringe provided in the packaging for children from 4 years of age and older patients.
Recommended dose:
Levetiracetam Accord should be taken twice a day, in two equal divided doses, each dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dose for children from 6 months of age and older

The doctor will prescribe the most suitable form of Levetiracetam Accord depending on the age, weight, and dose.
For children from 6 months to 4 years of age, measure the correct dose using the 3 ml syringe provided in the packaging.
For children over 4 years of age, measure the correct dose using the 10 ml syringe provided in the packaging.
Recommended dose:
Levetiracetam Accord should be taken twice a day, in two equal divided doses, each dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (example dosing in the table below).

Dose for children from 6 months of age and older

Dose for 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 correct dose using the 1 ml syringe provided in the packaging.
Recommended dose:
Levetiracetam Accord should be taken twice a day, in two equal divided doses, each dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (example dosing in the table below).

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

Method of administration:

After measuring the correct dose using the appropriate syringe, the Levetiracetam Accord oral solution can be diluted in a glass of water or a baby bottle.
Levetiracetam Accord 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 of the arrow (figure 1)

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

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

• Draw a small amount of solution into the syringe by pulling the plunger down (figure 5A), then, by pressing the plunger, 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 syringe plunger to expel the contents into a glass of water or a baby bottle, pressing the syringe plunger (figure 7).

• Drink the entire contents of the glass/baby bottle.
• Close the plastic bottle with the cap.
• Rinse the syringe with water (figure 8 ).

Duration of treatment:

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

Taking a higher dose of Levetiracetam Accord than recommended

Possible side effects of overdosing on Levetiracetam Accord include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If a higher dose of the medicine than recommended is taken, seek medical attention immediately. The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Levetiracetam Accord

Contact the 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 Accord

If treatment with Levetiracetam Accord 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, 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Levetiracetam Accord 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 a rash on the face, then on the rest of the body, with a high fever, increased liver enzyme activity in blood tests, increased white blood cell count (eosinophilia), and lymph node enlargement, as well as 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 (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 mouth, eyes, nose, and genital areas ( 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 common side effects are: rhinitis, drowsiness, headache, fatigue, and dizziness. At the start 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 occur in more than 1 in 10 patients

• rhinitis;
• drowsiness, headache.

Common:may occur in less than 1 in 10 patients

• loss of appetite;
• depression, feelings of hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disturbances, dizziness (feeling of swaying), lethargy (lack of energy and enthusiasm), tremors (involuntary shaking);
• dizziness (feeling of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (exhaustion).

Uncommon:may occur in less than 1 in 100 patients

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and behaviors, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, mood swings, and excitement;
• memory loss (loss of memory), 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 less than 1 in 1000 patients

• infections;
• decreased blood cell count;
• 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);
• seizures may worsen or occur more frequently;
• delirium;
• encephalopathy (detailed description of symptoms can be found in the subsection "Immediately inform your doctor");
• 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;
• 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), a widespread rash with blisters and peeling skin, occurring mainly in the mouth, eyes, nose, and genital areas ( 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 (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 patients

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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
phone: +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 Accord

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Expiry date" and (or) "EXP". The expiry date refers to the last day of the month stated.
Do not use after 4 months from the first opening of the bottle.
No special storage temperature instructions for the medicine
Store in the original bottle to protect from light
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 Accord contains:

The active substance is levetiracetam. Each milliliter contains 100 mg of levetiracetam.
In addition, the medicine contains: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizinate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavor containing propylene glycol (E1520) and flavoring substances, purified water.

What Levetiracetam Accord looks like and contents of the pack

Levetiracetam Accord is a colorless liquid with a grape flavor, pH 5.0-7.0.
A 300 ml bottle of dark type III glass with a PP closure, child-resistant (for children from 4 years of age, adolescents, and adults) is placed in a cardboard box containing a 10 ml oral syringe with PE/PS, with a scale every 0.25 ml and a connector with PE.
A 150 ml bottle of dark type III glass with a PP closure, child-resistant (for infants and young children from 6 months to less than 4 years of age) is placed in a cardboard box containing a 3 ml oral syringe with PE/PS, with a scale every 0.1 ml and a connector with PE.
A 150 ml bottle of dark type III glass with a PP closure, child-resistant (for infants from 1 month to less than 6 months of age) is placed in a cardboard box containing a 1 ml oral syringe with PE/PS, with a scale every 0.05 ml and a connector with PE.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: June 2025