Summary of Product Characteristics: information for theuser

Levetiracetam Kern Pharma 100 mg/ml concentrated solution for infusion EFG

Read this summary of product characteristics carefully before you start touse this medicine, because it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other peoplealthough they may 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 summary of product characteristics.

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

Levetiracetam is used:

• alone (without the need for another antiepileptic medication) in patients aged 16 years or older with recently diagnosed epilepsy to treat partial onset seizures with or without secondary generalization,
• in combination with other antiepileptic medications to treat:
• • partial onset seizures with or without secondary generalization in patients aged 4 years or older,
  • myoclonic seizures in patients 12 years of age or older with juvenile myoclonic epilepsy,
  • primary generalized tonic-clonic seizures in patients aged 12 years or older with idiopathic generalized epilepsy.

Levetiracetam concentrate is an alternative for patients in whom oral administration is not temporarily viable.

No use Levetiracetam Kern Pharma

• if you are allergic to levetiracetam or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to use levetiracetam

• 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
• if you notice an increase in the severity of seizures (e.g. increased frequency), contact your doctor
• a small number of people taking antiepileptic medications such as levetiracetam have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor

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.

Use of Levetiracetam Kern Pharma with other medications

Inform your doctor or pharmacistif you are using or have recently used other medications, including those purchased without a prescription.

Use of Levetiracetam Kern Pharma with food, drinks, and alcohol

You can use levetiracetam with or without food. As a precaution, do not use levetiracetam with alcohol.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, inform your doctor.

Levetiracetam should not be used during pregnancy unless strictly necessary. The risk to the baby during pregnancy is unknown. In animal studies, levetiracetam has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures.

It is not recommended to breastfeed during treatment.

Driving and operating machinery

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

Levetiracetam Kern Pharma contains sodium

Other components are sodium acetate, glacial acetic acid, sodium chloride, water for injection preparations.

This medication contains less than 1 mmol of sodium (23 mg) per vial, i.e. "essentially sodium-free".

A healthcare professional will administer Levetiracetam Kern Pharma to you via intravenous infusion.

Levetiracetam 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.

Monotherapy

Dose in adults and adolescents (16 years of age and older):

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

When starting to take levetiracetam, your doctor will prescribe alower dosefor two weeks before administering the general lowest dose.

Concomitant therapy

Dose in adults and adolescents (12 to 17 years) with a weight of 50 kg or more:

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

Dose in children (4 to 11 years) and adolescents (12 to 17 years) with a weight less than 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 must be diluted in at least 100 ml of a compatible diluent and administered via intravenous infusion over 15 minutes.

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

Treatment duration:

• Levetiracetam is used as a chronic treatment. You should continue treatment with Levetiracetam for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures. If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for the gradual withdrawal of levetiracetam, if they decide to discontinue your treatment with this medication.
• No experience is available with the intravenous administration of levetiracetam for a period exceeding 4 days.

If you interrupt treatment with Levetiracetam Kern Pharma

Like other antiepileptic medications, the discontinuation of treatment with levetiracetam should be done gradually to avoid an increase in seizures.

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

Like all medications, levetiracetam may cause side effects, although not everyone will experience them.

Some side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

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

Very common:may affect more than 1 in 10 patients

• nasopharyngitis;
• drowsiness (drowsiness), headache.

Common:may affect up to 1 in 10 patients

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (sensation of instability), lethargy, tremor (involuntary shaking);
• dizziness (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/weakness (sensation of weakness).

Rare:may affect up to 1 in 100 patients

• decrease in the number of platelets, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental alterations, abnormal behavior, hallucinations, anger, confusion, 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;
• abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:may affect up to 1 in 1000 patients

• infection;
• decrease in all types of blood cells;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• hepatic insufficiency, hepatitis (inflammation of the liver);
• 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)
• decrease in sodium concentration in the blood;
• sudden decline in kidney function;
• rhabdomyolysis (muscle tissue breakdown) and associated elevated creatine phosphokinase in the blood.

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 or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus.

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

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need..By doing so, you will help protect the environment.

Composition of Levetiracetam Kern Pharma

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 injectable preparations.

Appearance of the product and contents of the package

Levetiracetam Kern Pharma concentrated solution for infusion is a sterile, transparent, and colorless liquid.

The 5 ml vials of Levetiracetam Kern Pharma concentrated are packaged in carton boxes of 10 vials.

Holder of the marketing authorization and Responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II,

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: October 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for doctors and healthcare professionals:

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

One vial of Levetiracetam concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of levetiracetam concentrate 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 Kern Pharma concentrate

This medication is for single use only, 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 and 8°C, unless the dilution has been made in validated and controlled aseptic conditions.

It was found that levetiracetam concentrate 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 of 15-25°C.

Diluents:

• Sodium chloride injection (0.9%)

• Ringer lactate injection

• Dextrose 5% injection