Levetiracetam PensA: detailed information

PATIENT INFORMATION LEAFLET

Levetiracetam Pensa 500 mg film-coated tablets, 1000 mg film-coated tablets

levetiracetam
Please read this leaflet carefully before you or your child starts 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Pensa is and what it is used for
What you need to know before taking Levetiracetam Pensa
How to take Levetiracetam Pensa
Possible side effects
How to store Levetiracetam Pensa
Contents of the pack and other information

1. WHAT LEVETIRACETAM PENSA IS AND WHAT IT IS USED FOR

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

as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which patients have repeated seizures. Levetiracetam is used for the type of epilepsy in which the initial seizure affects 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). Levetiracetam has been prescribed to you by your doctor to reduce the number of seizures.
as add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without secondary generalization, in adults, adolescents, children, and infants from 1 month of age
- myoclonic seizures (brief, shock-like spasms of a muscle or muscle group) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. WHAT YOU SHOULD KNOW BEFORE TAKING LEVETIRACETAM PENSA

Do not take Levetiracetam Pensa
If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other
ingredients of this medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam Pensa.

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 onset of puberty in the child, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam Pensa have experienced suicidal thoughts or thoughts about harming themselves. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a cardiac arrhythmia (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

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

Unusual thoughts, feeling irritable, or more aggressive reactions 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. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while taking Levetiracetam Pensa, consult a doctor as soon as possible.
Children and adolescents
Levetiracetam Pensa used alone (monotherapy) is not indicated in children and adolescents under 16
years of age.
Other medicines and Levetiracetam Pensa
Inform your doctor or pharmacist if you are taking, or have recently taken, any other
medicines.
Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary. You must not stop your 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 Pensa may reduce your ability to drive or operate tools or machinery, as Levetiracetam Pensa may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE LEVETIRACETAM PENSA

Always take Levetiracetam Pensa exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam Pensa should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive and monotherapy treatment

Adults (≥18 years) and adolescents (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 Pensa, your doctor will prescribe a lower starting dose for 2 weeks before increasing to your usual lowest dose.
Example: if your daily dose is 1,000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1,000 mg per day after 2 weeks.

Adolescents (12 to 17 years) weighing 50 kg or more:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Pensa based on weight and required dose.

Dose for infants (1 to 23 months), children (2 to 11 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Pensa according to age, weight, and required dose.
The oral solution is the most suitable formulation for infants and children under 6 years of age, for children and adolescents (6 to 17 years) weighing less than 50 kg, and when tablets do not allow accurate dosing.

Method of administration:
Swallow Levetiracetam Pensa tablets with a sufficient amount of liquid (e.g., a glass of water). You may take Levetiracetam Pensa with or without food. After oral administration, you may experience a bitter taste of levetiracetam.

Duration of treatment:

Levetiracetam Pensa is used as a chronic treatment. The treatment with Levetiracetam Pensa should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the number of seizures.

If you take more Levetiracetam Pensa than you should:
Possible adverse effects of an overdose of Levetiracetam Pensa include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the best treatment for the overdose.

If you forget to take Levetiracetam Pensa:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed tablet.

If you stop taking Levetiracetam Pensa:
If treatment is to be discontinued, as with any other antiepileptic medicine, Levetiracetam Pensa should be withdrawn gradually to avoid an increase in seizures.
If your doctor decides to discontinue treatment with Levetiracetam Pensa, you will be given instructions on how to gradually stop taking it.

If you have any questions about the use of Levetiracetam Pensa, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Levetiracetam Pensa can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, dizziness or lightheadedness, or difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
swelling of the face, lips, tongue, or throat (Quincke's edema)
flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed 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 skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
widespread skin 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 people around you notice confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported adverse reactions are: nasopharyngitis, somnolence, headache,
fatigue, and dizziness. At the beginning of treatment or when the dose is increased, adverse
reactions such as somnolence, fatigue, and dizziness may be more common. These
reactions should, however, decrease over time.
Very common: may affect more than 1 in 10 people

nasopharyngitis
somnolence, headache

Common: may affect up to 1 in 10 people

anorexia (loss of appetite)
depression, hostility or aggression, anxiety, insomnia, restlessness or irritability
convulsion, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (sensation of spinning)
cough
abdominal pain, diarrhea, 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
suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, affective lability/mood swings, 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/abnormal liver function test results
hair loss, eczema, pruritus (itching)
muscle weakness, myalgia (muscle pain)
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 important allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat])
decreased sodium concentration in the blood
suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate)
delirium
encephalopathy (see the 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)
alteration of heart rhythm (electrocardiogram changes)
pancreatitis
liver failure, hepatitis
sudden worsening of kidney function
skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), widespread skin 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 serum creatine phosphokinase. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients
limping gait 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). 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your
doctor or pharmacist. You may also report adverse reactions directly via the national reporting
system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you
can help provide more information on the safety of this medicine.

5. HOW TO STORE LEVETIRACETAM PENSA

Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton and on the blister after Exp:.
The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer used. This will help protect
the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Levetiracetam Pensa contains
The active substance is called levetiracetam.
Each Levetiracetam Pensa 500 mg tablet contains 500 mg of levetiracetam.
Each Levetiracetam Pensa 1000 mg tablet contains 1000 mg of levetiracetam.
The other ingredients are:
Tablet core: croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, yellow iron oxide (E172).

Description of the appearance of Levetiracetam Pensa and pack contents
Levetiracetam Pensa 500 mg film-coated tablets:
The film-coated tablets are yellow, oval-shaped, and scored on one side.
Carton packs contain 60, 100 or 200 film-coated tablets.
The score line is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.

Levetiracetam Pensa 1000 mg film-coated tablets:
The film-coated tablets are white, oval-shaped, and scored on one side.
Carton packs contain 30, 60, 100 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Towa Pharmaceutical S.p.A. - Via Enrico Tazzoli, 6 - 20154 Milan - Italy
Manufacturer: Noucor Health, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Barcelona - Spain)

This patient information leaflet has been approved in the Member States of the European Economic Area under the following names:
Portugal – Levetiracetam Pensa 250 mg, 500 mg and 1000 mg film-coated tablets
Spain – Levetiracetam Pensa 250 mg, 500 mg and 1000 mg comprimidos recubiertos con película EFG
Italy – Levetiracetam Pensa 500 mg and 1000 mg compresse rivestite con film

This patient information leaflet was last approved in January 2026.