Levetiracetam Hospira

Do not take it if

From the package leaflet in EMA’s product information, p. 27.

How to take it

These directions are for this exact strength and form. Another one is different.

• A doctor or a nurse will administer you Levetiracetam Hospira as an intravenous infusion.
• Levetiracetam Hospira must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
• The intravenous formulation is an alternative to your oral administration. You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical.
• Adjunctive therapy and monotherapy (from 16 years of age)
• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
• Recommended dose: between 1,000 mg and 3,000 mg each day.
• When you first start taking Levetiracetam Hospira, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest daily dose.
• Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
• Recommended dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
• Method and route of administration:
• Levetiracetam Hospira is for intravenous use.
• The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
• For doctors and nurses, more detailed direction for the proper use of Levetiracetam Hospira is provided in section 6.
• Duration of treatment:
•  There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.
• If you stop using Levetiracetam Hospira:
• If stopping treatment, as with other antiepileptic medicines, Levetiracetam Hospira should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Hospira treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Hospira.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 29.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 28.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 28.

Other medicines

From the package leaflet in EMA’s product information, p. 28.

Driving and using machines

• Levetiracetam Hospira may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose.
• You should not drive or use machines until it is established that your ability to perform such activities is not affected.
• Levetiracetam Hospira contains sodium One maximum single dose of Levetiracetam Hospira concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This is equivalent to 2.85% of the recommended maximum daily dietary intake of sodium for an adult. This should be taken into consideration if you are on a controlled sodium diet.

From the package leaflet in EMA’s product information, p. 28–29.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Tell your doctor immediately, or go to your nearest emergency department, if you experience:
•  weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction  swelling of the face, lips, tongue and throat (Quincke’s oedema)
•  flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia), enlarged lymph nodes and the involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
•  symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function  a skin rash which may form blisters and look like small 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)
•  a more severe form of rash 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, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.
• The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.
• Very common: may affect more than 1 in 10 people  nasopharyngitis;
•  somnolence (sleepiness), headache.
• Common: may affect up to 1 in 10 people  anorexia (loss of appetite);
•  depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
•  convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
•  vertigo (sensation of rotation);
•  cough;
•  abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
•  rash;
•  asthenia/fatigue (tiredness).
• Uncommon: may affect up to 1 in 100 people  decreased number of blood platelets, decreased number of white blood cells;
•  weight decrease, weight increase;
•  suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
•  amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
•  diplopia (double vision), vision blurred;
•  elevated/abnormal values in a liver function test;
•  hair loss, eczema, pruritus;
•  muscle weakness, myalgia (muscle pain);
•  injury.
• Rare: may affect up to 1 in 1,000 people  infection;
•  decreased number of all blood cell types;
•  severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);
•  decreased blood sodium concentration;
•  suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
•  delirium;
•  encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
•  seizures may become worse or happen more often;
•  uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
•  change of the heart rhythm (Electrocardiogram);
•  pancreatitis;
•  liver failure, hepatitis;
•  sudden decrease in kidney function;
•  skin rash, which may form blisters and looks like small 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 associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
•  limp or difficulty walking;
•  combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome).
• Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
• Very rare: may affect up to 1 in 10,000 people  repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).
• Reporting of side effects If you get 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 29–31.

How to store it

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the vial and carton box after EXP:
• The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.

From the package leaflet in EMA’s product information, p. 31.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

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