Leaflet: information for the user

Levetiracetam Accord 100 mg/ml concentrate for infusion EFG

Read this leaflet carefully before you or your child start to use this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

2. What you need to know before starting to use Levetiracetam Accord

3. How to use Levetiracetam Accord

4. Possible side effects

5. Storage of Levetiracetam Accord

6. Contents of the pack and additional information

Levetiracetam Accord is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Accord is used:

• alone inadults and adolescentsaged 16 years with recently diagnosed epilepsy to treata form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• concurrently with other antiepileptic medications to treat:
• partial onset seizures with or without generalization inadults, adolescents, and childrenfrom 4 years.
• myoclonic seizures(shock-like, short, muscle or group of muscles) in adults and adolescents from12 years with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Levetiracetam Accord concentrated solution for infusion is an alternative for patients in whom oral administration is not temporarily viable..

No use LevetiracetamAccord:

• If you are allergic to levetiracetam, to pyrrolidone derivativesor to any of the other components of this medication (listed in section 6).

Warnings and precautions

• If you have kidney problems, follow your doctor's instructions who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic medications such as Levetiracetam Accord have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling of irritability or reacting more aggressively than normal or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking Keppra, visit a doctor as soon as possible.

Children and adolescents

• Exclusive treatment with Levetiracetam Accord (monotherapy) is not indicated in children and adolescents under 16 years old.

Use of LevetiracetamAccordwith other medications

Inform your doctor or pharmacistif you are using, have used recently or may need to use any other medication.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Levetiracetam Accord can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor first.The risk of birth defects for the baby cannot be completely ruled out.Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam Accordmay affect your ability to drive or operate tools or machinery, as Levetiracetam Accordmay cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not impaired.

LevetiracetamAccordcontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial, that is “essentially sodium-free”

A healthcare professional, such as a doctor or nurse, will administer Levetiracetam Accord through intravenous infusion.

Levetiracetam Accord should be administered twice a day, once in the morning and once at night, approximately at the same time each day.

The intravenous formulation is an alternative to oral administration. You can switch from coated tablets or oral solution to the intravenous formulation, or vice versa, directly without adjusting the dose. Your total daily dose and administration frequency must be identical.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) with a weight below 50 kg:

General dose: between 1,000 mg and 3,000 mg per day.

When starting to take Levetiracetam Accord, your doctor will prescribe a lower dose for two weeks before administering the recommended lowest dose.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) with a weight below 50 kg:

General dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

Method and form of administration

Levetiracetam Accord is for intravenous administration.

The recommended dose must be diluted in at least 100 ml of a compatible diluent and administered through intravenous infusion over 15 minutes.

Further detailed information for the correct use of Levetiracetam Accord is provided in section 6 for doctors and nurses.

Duration of treatment

• No experience is available in the administration of intravenous levetiracetam for a period exceeding 4 days.

If you take more Levetiracetam Accord than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you interrupt treatment with Levetiracetam Accord

Like with other antiepileptic medications, discontinuation of treatment with Levetiracetam Accord should be done gradually to avoid an increase in seizures.If your doctor decides to stop your treatment with Levetiracetam Accord, they will give you instructions for the gradual withdrawal of Levetiracetam Accord.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Levetiracetam Accord may cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• Weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic).
• Swelling of the face, lips, tongue, or throat (Quincke's edema).
• Symptoms of flu and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline.
• A skin rash that may form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).
• A generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• A more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose.However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• Nasopharyngitis.
• Drowsiness (feeling sleepy), headache.

Common:may affect up to 1 in 10 people

• Anorexia (loss of appetite).
• Depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability.
• Seizures, balance disorder, dizziness (feeling unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking).
• Dizziness (feeling of rotation).
• Cough.
• Abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea.
• Skin rash.
• Asthenia/fatigue (feeling weak).

Rare:may affect up to 1 in 100 people

• Decreased platelet count, decreased white blood cell count.
• Weight loss, weight gain.
• Attempted suicide and suicidal thoughts, mental alterations, abnormal behavior.
• Hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation.
• Amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration).
• Diplopia (double vision), blurred vision.
• Elevated or abnormal liver function test values.
• Hair loss, eczema, itching.
• Muscle weakness, myalgia (muscle pain).
• Lesion.

Rare:may affect up to 1 in 1000 people

• Infection.
• Decreased count of all types of blood cells.
• Severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat)).
• Decreased sodium concentration in blood.
• Suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating).
• Delirium;
• Encephalopathy (see the subsection "Inform your doctor immediately" for a detailed description of symptoms);
• Seizures may worsen or occur more frequently
• Involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity).
• Change in heart rhythm (electrocardiogram).
• Pancreatitis (inflammation of the pancreas).
• Liver insufficiency, hepatitis (inflammation of the liver).
• Sudden decline in kidney function.
• Skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• Gait disturbance or difficulty walking
• Combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist where to dispose of the medications you no longer use. By doing so, you will help protect the environment.

Composition of LevetiracetamAccord

• The active ingredient is levetiracetam. Each ml of infusion solution contains 100 mg of levetiracetam.
• The other components are: sodium acetate, glacial acetic acid, sodium chloride, water for injection preparations.

Appearance of the product and contents of the package

Levetiracetam Accord concentrated solution for infusion (Levetiracetam Accord concentrated) is a sterile, transparent, and colorless liquid.

Levetiracetam Accord concentrated solution for infusion is packaged in glass vials of 10 ml that are grouped in cardboard boxes containing 10 vials. Each vial contains 5 ml of Levetiracetam Accord concentrated (500 mg of levetiracetam).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n,

Edifici Est, 6th floor.

08039, Barcelona

Spain

Responsible for manufacturing

Reig Jofré

Gran Capià, 10

08970 Sant Joan Despí

Barcelona (Spain)

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Levetiracetam Accord 100 mg/ml concentrated solution for infusion EFG

Portugal:Levetiracetam Accord 100 mg/ml concentrated solution for infusion MG

Last review of this leaflet was in:May 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

The instructions for the proper use of Levetiracetam Accord are provided in section 3.

One vial of Levetiracetam Accord concentrated contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Accord concentrated to achieve the total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg divided into two doses.

Table 1. Preparation and administration of Levetiracetam Accordconcentratewith

This drug is for single use, so the unused solution must be discarded.

Shelf life in use: from a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the time and storage conditions prior to the next use are the responsibility of the user and should not exceed 24 hours between 2 and8°C, unless the dilution has been made in validated and controlled aseptic conditions.

It was found that Levetiracetam Accord concentrated is physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature between 15-25°C.

Diluents:

• Sodium chloride injection solution (0.9%) 9 mg/ml

• Ringer lactate injection solution

• Dextrose 5% injection solution 50 mg/ml