LEVETIRACETAM NORIDEM 100 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Noridem 100mg/ml concentrate for solution for infusion EFG

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levetiracetam Noridem and what is it used for
2. What you need to know before you take Levetiracetam Noridem
3. How to take Levetiracetam Noridem
4. Possible side effects
5. Storage of Levetiracetam Noridem
6. Contents of the pack and other information

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

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

Levetiracetam is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a condition where you have fits (seizures). Levetiracetam is used to treat a form of epilepsy where the seizures initially only affect one side of the brain but may then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of fits.
• with other antiepileptic medicines to treat:
• • partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age.
  • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause).

Levetiracetam concentrate is an alternative for patients when oral administration is temporarily not feasible.

2. What you need to know before you take Levetiracetam Noridem

Do not take Levetiracetam Noridem

• If you are allergic to levetiracetam, to any other pyrrolidone derivative or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you start taking this medicine

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• A small number of people taking antiepileptics such as levetiracetam have had thoughts of harming themselves or suicidal thoughts. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or a family history of abnormal heart rhythms (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Tell your doctor, pharmacist or nurse if any of the following side effects get serious or last more than a few days:

• Abnormal thoughts, feeling irritable or more aggressive than usual or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy:

Rarely, epileptic fits may become worse or more frequent, mainly during the first month after the start of treatment or the increase of the dose.

In a very rare form of epilepsy (early onset epilepsy associated with SCN8A mutations) that causes multiple types of epileptic fits and loss of skills, you may notice that the fits persist or worsen during treatment.

If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (taking only levetiracetam) is not indicated for children and adolescents under 16 years.

Other medicines and Levetiracetam Noridem

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not prescribed by a doctor.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary.

Do not stop your treatment without first discussing it with your doctor.

The risk of birth defects for your baby cannot be completely excluded. Breast-feeding is not recommended during treatment.

Driving and using machines

Levetiracetam may affect your ability to drive or use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Noridem contains sodium

This medicine contains 57 mg (2.5 mmol) of sodium (a major component of cooking/table salt) per maximum single dose. This is equivalent to 2.85% of the maximum recommended daily intake of sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Levetiracetam Noridem

This medicine will be administered to you by a doctor or a nurse through a vein (intravenous infusion). Levetiracetam should be taken twice a day, once in the morning and once in the evening, approximately at the same time each day.

The intravenous formulation is an alternative to oral administration. You can switch from film-coated tablets or oral solution to the intravenous formulation, or vice versa, without dose adjustment. Your total daily dose and frequency of administration should be the same.

Concomitant therapy and monotherapy (from 16 years of age)

Adults(≥18 years)and adolescents (from 12 to 17 years) weighing 50 kg or more:

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

When you first start taking Levetiracetam Noridem, your doctor will prescribe you a lower dosefor two weeks before giving you the lowest daily dose.

Dose in children (from 4 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:

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

Method and route of administration

This medicine is for intravenous use (infusion into a vein).

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

More detailed information for the correct use of levetiracetam is provided in the section for healthcare professionals.

Duration of treatment

There is no experience with the intravenous administration of levetiracetam for a period longer than 4 days.

If you stop taking Levetiracetam Noridem:

As with other antiepileptic medicines, the discontinuation of treatment with this medicine should be done gradually to avoid an increase in fits. If your doctor decides to stop your treatment with levetiracetam, he/she will tell you how to gradually reduce the dose, if he/she decides to stop your treatment with this medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue or throat (Quincke's oedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion and swelling of feet, ankles or hands, as this may be a sign of sudden decrease in kidney function
• a skin rash which may form blisters and may look like targets (central red spot surrounded by a paler area, with a red ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as drowsiness, weakness and dizziness are more frequent at the start of treatment or when the dose is increased. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis
• somnolence (feeling drowsy), headache.

Common: may affect up to 1 in 10 people

• loss of appetite (anorexia)
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)
• vertigo (feeling of spinning);
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash
• asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

• decrease in the number of platelets, decrease in white blood cells
• weight loss, weight gain
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (lack of concentration)
• double vision, blurred vision
• elevated/abnormal liver function tests
• hair loss, eczema, itching
• muscle weakness, muscle pain
• injury.

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

• infection
• decrease in all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema)
• decrease in sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of the symptoms)
• epileptic fits may become worse or more frequent
• 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 failure, hepatitis (inflammation of the liver)
• sudden decrease in kidney function
• skin rash, which may form blisters and may look like targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping or difficulty walking
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased consciousness (may be signs of a disorder called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• unwanted and repeated thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Noridem

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

Do not use this medicine after the expiry date which is stated on the vial/ampoule and on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

The diluted product is physically and chemically stable for 24 hours at 15-25°C and at 2-8°C.

From a microbiological point of view, the product should be used immediately after dilution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Noridem

• The active substance is levetiracetam.

Each ml contains 100 mg of levetiracetam.

• The other ingredients (excipients) are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.

Appearance and contents of the pack

Levetiracetam Noridem is a clear and colourless solution for infusion.

Levetiracetam Noridem is available in two formats:

• 5 ml glass vials containing 500 mg of levetiracetam (10 or 50 vials per box).
• 5 ml polypropylene ampoules containing 500 mg of levetiracetam (1, 10 or 50 ampoules per box).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Noridem Enterprises Limited

Evagorou & Makariou

Mitsi Building 3, Office 115

1065 Nicosia, Cyprus

Manufacturer

DEMO S.A. PHARMACEUTICAL INDUSTRY

21st Km National Road Athens-Lamia.

14568 Greece

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

Date of last revision of this leaflet: July 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Preparation and handling

Instructions for the proper use of Levetiracetam Noridem are provided in section 3.

A vial or ampoule of Levetiracetam Noridem concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Noridem 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 Noridem concentrate

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

The diluted product is physically and chemically stable for 24 hours at 15-25°C and at 2-8°C.

From a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the storage time and conditions before the next use are the responsibility of the user and must not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

It has been found that Levetiracetam Noridem concentrate for solution for infusion is physically compatible and chemically stable when mixed with the following diluents for 24 hours at 15-25°C and at 2-8°C at a concentration of Levetiracetam Noridem 2.5 mg/ml and 15.0 mg/ml.

Diluents:

• Sodium chloride 9 mg/ml (0.9%) injection solution
• Ringer lactate injection solution
• Dextrose 50 mg/ml (5%) injection solution