LEVETIRACETAM NORMON 100 MG/ML CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Levetiracetam NORMON 100 mg/ml Concentrate for Solution for Infusion EFG

Read all of this leaflet carefully before you start using 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Levetiracetam Normon and what is it used for.
2. What you need to know before you use Levetiracetam Normon.
3. How to use Levetiracetam Normon.
4. Possible side effects.
5. Storage of Levetiracetam Normon.

Contents of the pack and further information.

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

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

Levetiracetam Normon 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 for a form of epilepsy where the seizures first affect only one side of the brain but may then spread to other parts 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 secondary 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 Normon concentrate is an alternative for patients when oral administration is temporarily not feasible.

2. What you need to know before you use Levetiracetam Normon

Do not use Levetiracetam Normon:

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

Warnings and precautions

Consult your doctor before you start taking Levetiracetam Normon:

• If you have kidney problems, follow your doctor’s instructions, as they 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 disturbances.

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

• Abnormal thoughts, feeling irritable or behaving aggressively or if you, your family or friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

On rare occasions, epileptic fits may become worse or more frequent, mainly during the first month after the start of treatment or the increase of the dose. If you experience any of these new symptoms while taking Levetiracetam Normon, contact a doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam Normon (use on its own) is not indicated in children and adolescents below 16 years.

Other medicines and Levetiracetam Normon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 your doctor considers it essential.

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

The risk of birth defects for your baby cannot be completely excluded.

Breast-feeding is not recommended during treatment with Levetiracetam Normon.

Driving and using machines

Levetiracetam Normon may affect your ability to drive or use tools or machines, as it may cause somnolence (sleepiness). 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 Normon contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per vial, i.e., essentially “sodium-free”.

3. How to use Levetiracetam Normon

A doctor or nurse will administer Levetiracetam Normon to you by intravenous infusion.

Levetiracetam Normon should be administered twice daily, once in the morning and once in the evening, approximately at the same time every 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 from the intravenous formulation to film-coated tablets or oral solution, without dose adjustment. Your total daily dose and frequency of administration should be the same.

Concomitant therapyand monotherapy (from 16 years of age)

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

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

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

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

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

Method and route of administration:

Levetiracetam Normon is for intravenous use.

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 Normon is provided in section 6 for doctors and nurses.

Duration of treatment:

There is no experience with intravenous administration of levetiracetam for more than 4 days.

If you stop treatment with Levetiracetam Normon

As with other antiepileptic medicines, stopping treatment with Levetiracetam Normon should be done gradually to avoid an increase in fits. If your doctor decides to stop your treatment with Levetiracetam Normon, he/she will tell you how to reduce the dose gradually.

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

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, 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 low urine output, tiredness, nausea, vomiting, confusion and swelling of the 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 small targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (memory loss), 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 somnolence, fatigue and dizziness are more likely to occur when you first start treatment or when the dose is increased. However, these 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;
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acid regurgitation), 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 (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling), attention disturbances (lack of concentration);
• double vision, blurred vision;
• elevated/abnormal liver enzymes in blood tests;
• hair loss, eczema, itching;
• muscle weakness, muscle pain;
• injury.

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

• infection;
• decrease in all blood cell types;
• severe hypersensitivity reactions (DRESS, anaphylactic reaction, Quincke’s oedema);
• decrease in blood sodium levels;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see 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 small targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling over 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.

Reporting of side effects

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

5. Storage of Levetiracetam Normon

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 and carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

6. Container Contents and Additional Information

Composition of Levetiracetam Normon

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

Appearance of the Product and Container Contents

Levetiracetam Normon concentrated solution for infusion (Levetiracetam Normon concentrated) is a sterile, transparent, and colorless or slightly yellowish liquid.

Levetiracetam Normon is packaged in cardboard boxes containing 10 vials. Each vial contains 5 ml of Levetiracetam Normon concentrated solution.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Other Presentations

Levetiracetam Normon 250 mg film-coated tablets EFG.

Levetiracetam Normon 500 mg film-coated tablets EFG.

Levetiracetam Normon 1000 mg film-coated tablets EFG.

Levetiracetam Normon 100 mg/ml oral solution EFG.

Levetiracetam Normon 5 mg/ml solution for infusion.

Date of the Last Revision of this Leaflet: April 2021

Detailed and updated 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/.

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76285/P_76285.html

This Information is Intended Only for Healthcare Professionals:

Instructions for the proper use of Levetiracetam Normon concentrated solution are provided in section 3.

A vial of Levetiracetam Normon concentrated solution contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Normon concentrated solution to achieve a 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 Concentrated Solution

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

In-use Shelf-life: 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 at 2-8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

It was found that Levetiracetam Normon concentrated solution was physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in plastic bags at a controlled temperature of 2-8°C and 25°C.

Diluents:

• Sodium chloride injection (0.9%).
• Lactated Ringer's injection.
• Dextrose 5% injection.