Patient Information Leaflet

Levetiracetam NORMON 5 mg/ml Infusion Solution

Read this leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

Contents of the pack and additional information.

Levetiracetamis an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

LevetiracetamNORMON is used:

• alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy to treat a 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 extend 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 in adults, adolescents, and children aged 4 years or older
  • myoclonic seizures (shock-like, short, muscle or group of muscle seizures) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy(a type of epilepsy thought to have a genetic cause).

Levetiracetam NORMON solution for infusionis an alternative for patients in whom oral administration is not temporarily viable.

Do not use Levetiracetam NORMON:

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

Warnings and precautions

Consult your doctor before starting to useLevetiracetam NORMON:

• 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 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 using Levetiracetam NORMON, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam NORMON is not indicated in children and adolescents under 16 years old.

Other medications and Levetiracetam NORMON

Inform your doctor or pharmacistthat you are taking, have taken recently, or may need to take 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 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 NORMON 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 increasing the dose. Do not drive or use machinery until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam NORMON contains sodium

This medication contains368.7 mg of sodium (main component of table salt/for cooking) in each bag. This is equivalent to 18.44% of the maximum daily sodium intake recommended for an adult.

A doctor or a nurse will administerLevetiracetamNORMON via intravenous infusion.

LevetiracetamNORMON 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 of 50 kg or more:

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

When starting to takeLevetiracetam NORMON, your doctor will prescribe a lower dose for two weeks before administering the general lowest dose.

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 NORMON solution for infusion is for intravenous administration.

LevetiracetamNORMON solution for infusion should be administered by intravenous infusion over 15 minutes.

Further detailed information for the correct use ofLevetiracetam NORMONis 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 interrupt treatment with Levetiracetam NORMON

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

If you have any other questions about the use of thismedication,ask your doctororpharmacist.

Like all medicines, this medicine can 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)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high fever, elevated liver enzyme levels 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 decreased 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 can 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 (drowsiness), headache, fatigue, and dizziness. 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.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness (drowsiness), 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 (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

Rare:may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal attempt 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;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Very rare:may affect up to 1 in 1000 people

• infection;
• decreased count of all types of blood cells;
• severe hypersensitivity 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 "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);
• 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 associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to 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 medicine.

Keepthis medicationout of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe any particles or if the solution is not colorless or slightly yellowish or if you observe any defect in the stopper of the bag.

Medications should not be disposed of through drains or in the trash.Please ask your pharmacist how to dispose of the packaging and medications thatyouno longer need. In this way, you will help protect the environment.

Composition of Levetiracetam NORMON

• The active ingredient is levetiracetam. Each ml of infusion solution contains 5 mg of levetiracetam. Each 100 ml bag contains 500 mg of levetiracetam.
• The other components are sodium chloride, sodium acetate trihydrate, glacial acetic acid, and water for injection preparations.

Appearance of the product and contents of the package

Levetiracetam NORMON 5 mg/ml is a transparent, colorless, or slightly yellowish solution. It is presented in 100 ml ready-to-use infusion bags. It is supplied in packages containing 50 bags of 100 ml solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the last review of this leaflet:April 2021

This information is intended solely for healthcare professionals:

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

A bag of Levetiracetam NORMON 5 mg/ml infusion solution contains 500 mg of levetiracetam (5 mg of levetiracetam per ml).

This medication should not be diluted.

See Table 1 for the recommended administration of Levetiracetam NORMON 5 mg/ml infusion solution 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 NORMON 5 mg/ml infusion solution.

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

Before administration, the product must be visually inspected to check for the absence of particles and discoloration as well as defects in the bag's stopper.