Levetiracetam CINFA 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam cinfa 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Levetiracetam is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat one type of epilepsy. Epilepsy is a condition in which patients experience seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may then 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 seizures.
• in combination with 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 jerks of a muscle or group of muscles) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam cinfa

Do not take Levetiracetam cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Levetiracetam cinfa.

• If you have kidney problems, follow your doctor's instructions, as they will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a personal or family history of irregular heartbeat (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may predispose you to cardiac arrhythmias or electrolyte imbalances.

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

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

Rarely, epileptic seizures may worsen or occur more frequently, particularly during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (SCN8A mutation-related epilepsy) causing multiple seizure types and loss of skills, seizures may persist or worsen during treatment.

If you experience any of these new symptoms while taking levetiracetam, seek medical advice as soon as possible.

Children and adolescents

Treatment with levetiracetam alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam cinfa

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

Do not take macrogol (a laxative medicine) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

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

The risk of birth defects for the baby 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 infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction capability. These effects, as well as the underlying disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special alertness until your doctor has assessed your response to this medicine.

3. How to take Levetiracetam cinfa

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

Levetiracetam should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more:

Recommended dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) daily. When you first start taking levetiracetam, your doctor will prescribe a lower dose for two weeks before increasing to the lowest daily dose.

For example: for a daily dose of 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 should be gradually increased to reach 1,000 mg daily after 2 weeks of treatment.

• Adolescents (12 to 17 years) with body weight equal to or less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on weight and required dose.

• Dosage in infants (1 month to 23 months) and children (2 to 11 years) with body weight below 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and required dose.

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years of age, and for children and adolescents (6 to 17 years) with body weight below 50 kg, or when tablets do not allow precise dosing.

Method of administration

Swallow the levetiracetam tablets with a sufficient amount of liquid (e.g. a glass of water). Levetiracetam may be taken with or without food. A bitter taste of the medicine may be noticed after oral administration.

Duration of treatment

• Levetiracetam is used as a chronic treatment. You must continue taking levetiracetam for the duration indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

The tablet may be divided into equal doses.

If you take more Levetiracetam cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and amount ingested.

Possible adverse effects of a levetiracetam overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam cinfa

Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for forgotten doses.

If you stop taking Levetiracetam cinfa

Discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your levetiracetam treatment, he or she will provide instructions for the gradual withdrawal of levetiracetam.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• weakness, dizziness, or difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
• swelling of the face, lips, tongue, or throat (angioedema);
• flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS));
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may be signs of sudden decrease in kidney function;
• a skin rash that may blister and may appear as small target-like spots (dark central spots surrounded by a paler 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 causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or if someone around you notices confusion, drowsiness (numbness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling of weakness, and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common (may affect more than 1 in 10 people):

• nasopharyngitis;
• somnolence (drowsiness);
• headache.

Common (may affect up to 1 in 10 people):

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, heartburn, and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon (may affect up to 1 in 100 people):

• decreased platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated or abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
• decreased concentration of sodium in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Contact your doctor immediately” for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• 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 lead to blisters appearing as small target-like spots (dark central spots surrounded by a paler 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), and a more severe form causing peeling of the skin over 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, and 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):

• Unwanted, repeated thoughts or sensations, or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam cinfa

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other components are:

Tablet core: povidone, hydrogenated castor oil, colloidal anhydrous silica, and magnesium stearate.

Coating: hypromellose, titanium dioxide (E-171), macrogol 400, and yellow iron oxide (E-172).

Appearance of the medicinal product and contents of the pack

Levetiracetam cinfa 500 mg are film-coated, oblong, biconvex, yellow tablets, scored on one side and marked with the code “LV2” on the other.

They are packaged in PVC-PVDC/Aluminum blisters and available in pack sizes of 60, 100 or 500 (Hospital Pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: November 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75003/P_75003.html

QR code link: https://cima.aemps.es/cima/dochtml/p/75003/P_75003.html