Levetiracetam Teva Italia

Package leaflet: Information for the patient

Levetiracetam Teva Italia 100 mg/ml concentrate for solution for infusion

levetiracetam
Generic medicine
Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Levetiracetam Teva Italia is and what it is used for
2. What you need to know before taking Levetiracetam Teva Italia
3. How to use Levetiracetam Teva Italia
4. Possible side effects
5. How to store Levetiracetam Teva Italia
6. Contents of the pack and other information

1. What Levetiracetam Teva Italia is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Teva Italia is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part of the brain, but may subsequently spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed Levetiracetam to reduce the number of your seizures.
• as add-on therapy to other antiepileptic medicines to treat: partial-onset seizures with or without generalization in adults, adolescents, and children from 4 years of age; myoclonic seizures (brief, "shock-like" jerks of a muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

Levetiracetam Teva Italia concentrate for solution for infusion is an alternative for patients when oral administration of the antiepileptic medicine is temporarily not possible.

2. What you need to know before taking Levetiracetam Teva Italia

Do NOT take Levetiracetam Teva Italia

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

Warnings and precautions
Talk to your doctor before taking Levetiracetam Teva Italia

• If you have kidney problems, follow your doctor’s instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you notice slowed growth or unexpected development of puberty in your child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Teva Italia have had thoughts of harming themselves or thoughts about suicide. If you experience any symptoms of depression and/or have thoughts about suicide, contact your doctor.
• If you or a family member has or has had a heart rhythm disorder (visible on electrocardiogram), or if you have a disease and/or are taking medicines that can cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last for more than a
few days:

• Unusual 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
  Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking Levetiracetam Teva Italia, consult a doctor as soon as possible. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of existing abilities, you may notice that seizures persist or worsen during treatment.

Children and adolescents
Levetiracetam Teva Italia used alone (monotherapy) is not indicated in children and adolescents under 16
years of age.
Other medicines and Levetiracetam Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines without a prescription.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, consult your doctor before taking this medicine.
Levetiracetam may be used during pregnancy only if your doctor considers it necessary after careful evaluation. Do not stop treatment without discussing it with your doctor. A risk of birth defects for the unborn child cannot be completely ruled out. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Teva Italia may impair your ability to drive or use tools or machinery, as Levetiracetam Teva Italia may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. You must not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.
Levetiracetam Teva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”.

3. How to use Levetiracetam Teva Italia

A doctor or nurse will administer Levetiracetam Teva Italia to you as an intravenous infusion.
Levetiracetam Teva Italia must be administered twice daily, 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 may switch directly from film-coated tablets or oral solution to the intravenous formulation, or vice versa, without dose adjustment. The total daily dose and frequency of administration remain unchanged.
Adjunctive and monotherapy (from age 16 onwards)
Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
Recommended dose: between 1000 mg and 3000 mg per day.
When starting Levetiracetam Teva Italia for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.
Dose for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Recommended dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.
Method of administration:
Levetiracetam Teva Italia is for intravenous use. The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
More detailed instructions for appropriate use of Levetiracetam Teva Italia are provided for doctors and nurses in section 6.
Duration of treatment:

• There is no experience regarding intravenous administration of levetiracetam for periods longer than 4 days.

If you interrupt treatment with Levetiracetam Teva Italia:
As with any other antiepileptic medicinal product, Levetiracetam Teva Italia should be discontinued gradually to avoid an increase in seizures. If your doctor decides to stop treatment with Levetiracetam Teva Italia, they will give you specific instructions on how to taper off the medication gradually.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately, or go to the nearest emergency room, if you experience:

• weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema)
• flu-like symptoms and rash on the face, followed by widespread rash with high fever, increased liver enzyme levels in blood tests, increase in a type of white blood cells (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may indicate sudden worsening of kidney function
• a rash which may appear as blistering lesions resembling small targets (a dark central spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour or other neurological signs, including involuntary or uncontrollable movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness, headache, fatigue and dizziness. At the beginning of treatment, or when the dose is increased, side effects such as drowsiness, fatigue and dizziness may be more common. However, these effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• 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 disorders, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells in the blood;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated or abnormal liver function test results;
• hair loss, eczema, pruritus (itching);
• muscle weakness, myalgia (muscle pain);
• injury (trauma).

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

• infection;
• decreased number of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], angioedema [swelling of face, lips, tongue and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate);
• delirium;
• encephalopathy (see sub-section “Contact your doctor immediately” for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• changes in heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden worsening of kidney function;
• rash which may form blisters and appear as small targets (a dark central spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, reduced level of consciousness (may be signs of a disorder called neuroleptic malignant 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

• repetitive unwanted thoughts or urges to perform actions repeatedly (obsessive-compulsive disorder)

Reporting of side effects
If you experience any of the side effects, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Use during treatment: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the storage time during use and the conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
Do not use Levetiracetam Teva Italia if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Teva Italia contains

• The active substance is levetiracetam.
• Each ml of concentrate for solution for infusion contains 100 mg of levetiracetam.
• The excipients are: sodium acetate trihydrate, sodium chloride, glacial acetic acid, water for injections.

Description of the appearance of Levetiracetam Teva Italia and contents of the pack
Levetiracetam Teva Italia 100 mg/ml concentrate for solution for infusion is a sterile, clear and colourless liquid.
The 5 ml vial of Levetiracetam Teva Italia 100 mg/ml concentrate for solution for infusion is
packaged in a cardboard box containing 1 vial or 10 vials.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturer responsible for batch release
Haupt Pharma Wülfing GmbH Bethelner Landstrasse 18, 31028 Gronau/Leine, Germany.
Rafarm S.A, Thesi Pousi Xatzi, Agiou Louka str., 19002, Paiania, Attiki, Greece.

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Levetiracetam-ratiopharm 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Italy: Levetiracetam Teva Italia 100 mg/ml concentrato per soluzione per infusione
Netherlands: Levetiracetam 100 mg/ml Teva, concentraat voor oplossing voor infusie

This Patient Information Leaflet was last revised in March 2026

The following information is intended exclusively for healthcare professionals:

Instructions for the correct use of Levetiracetam Teva Italia are provided in section 3.
A vial of Levetiracetam Teva Italia 100 mg/ml concentrate for solution for infusion contains 500 mg of levetiracetam (5 ml of concentrate at 100 mg/ml). See Table 1 for the recommended preparation and administration of Levetiracetam Teva Italia 100 mg/ml concentrate for 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 Teva Italia 100 mg/ml concentrate for solution for infusion

This medicinal product is intended for single use and any unused solution must be discarded.
In-use stability: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Levetiracetam Teva Italia 100 mg/ml concentrate for solution for infusion has been shown to be physically compatible and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature of 15-25°C.
Diluents:

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