LEVETIRACETAM NORMON 5 mg/ml SOLUTION FOR INFUSION

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

Do not use Levetiracetam NORMON:

• 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

Consult your doctor before starting treatment with Levetiracetam NORMON:

• If you have kidney problems, follow the advice of your doctor who will decide if you need a dose adjustment.
• 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 committing suicide. 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 irregular heartbeats or if you have a condition or are taking a medicine that may affect the heart rhythm or electrolyte balance.

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

• abnormal thoughts, feeling irritable or behaving more aggressively than usual or if you or your family and friends notice significant changes in mood or behaviour.
• worsening of epilepsy

On rare occasions, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after 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 for 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 should only be used during pregnancy if a 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.

Driving and using machines

Levetiracetam NORMON may affect your ability to drive or use tools or machines, as levetiracetam 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 NORMON contains sodium

This medicine contains 368.7 mg of sodium (a major component of cooking/table salt) per bag. This is equivalent to 18.44% of the maximum recommended daily intake of sodium for an adult.

3. How to use Levetiracetam NORMON

Levetiracetam NORMON will be administered to you by a doctor or a nurse through 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 vice versa, directly 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:

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

When you start taking Levetiracetam NORMON, your doctor will prescribe you a lower dose for 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 of body weight and 60 mg per kg of body weight per day.

Method and route of administration:

Levetiracetam NORMON solution for infusion is for intravenous administration.

Levetiracetam NORMON solution for infusion should be 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 the administration of intravenous levetiracetam for a period longer 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 seizures. If your doctor decides to stop your treatment with Levetiracetam NORMON, he/she will give you guidance on how to gradually discontinue Levetiracetam NORMON, if he/she decides to stop your treatment with this medicine.

If you have any further questions on the use of this product, 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 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 enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of the legs, arms or feet, 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 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, drowsiness (somnolence), amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination of movements) 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 may be 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

• decreased number of platelets, decreased number of 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 (memory loss), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling), attention disturbances (lack of concentration);
• double vision, blurred vision;
• elevated liver enzymes;
• 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 hypersensitivity reactions (DRESS, anaphylactic reaction (severe, important and dangerous allergic reaction), Quincke’s oedema (swelling of face, lips, tongue or throat));
• 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 seizures may worsen or occur more frequently;
• involuntary muscle contractions affecting the head, torso and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• 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 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 experience 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 Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Levetiracetam NORMON

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any particles or if the solution is not colourless or slightly yellowish or if you notice any defect in the bag stopper.

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 further information

Composition of Levetiracetam NORMON

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

Appearance and pack contents

Levetiracetam NORMON 5 mg/ml is a clear, colourless or slightly yellowish solution. It is supplied in 100 ml bags of solution for infusion ready for use. It is available in packs containing 50 bags of 100 ml solution.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:April 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78756/P_78756.html

This information is intended only for healthcare professionals:

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

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

This medicine must not be diluted.

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

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

Before administration, the product must be visually inspected for the absence of particles and discolouration as well as for defects in the bag stopper.