Levetiracetam Sun 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LEVETIRACETAM SUN 1,000 mg FILM-COATED TABLETS EFG

(Levetiracetam)

Read the entire leaflet carefully before you or your child starts 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 must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

Levetiracetam SUN is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a condition in which patients have 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 muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam SUN

Do not take Levetiracetam SUN

• 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 before starting Levetiracetam SUN

• 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 pubertal development, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam SUN 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 (seen on electrocardiogram), or if you have a disease and/or are taking a treatment that may make you prone to cardiac arrhythmias or electrolyte imbalances.

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

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

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after a dose increase.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) causing multiple seizure types and loss of skills, you may observe that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam SUN, see a doctor as soon as possible.

Children and adolescents

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

Taking Levetiracetam SUN with other medicines

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

If you are being treated with methotrexate and levetiracetam at the same time, serum concentrations of these medicines should be carefully monitored.

Do not take macrogol (a medicine used as a laxative) 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 plan to become pregnant, consult your doctor before using this medicine.

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

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

A risk of birth defects in 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 SUN may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

3. How to take Levetiracetam SUN

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Take the number of tablets prescribed by your physician.

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

Concomitant 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 and 3,000 mg per day.

When you start taking Levetiracetam SUN, 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 per day 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 SUN based on body 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 SUN based on age, body weight, and required dose.

Levetiracetam 10 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, and when tablets do not allow precise dosing.

Method of administration:

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

Duration of treatment:

• Levetiracetam SUN is used as a chronic treatment. You must continue Levetiracetam SUN treatment for the duration indicated by your doctor.

• Do not discontinue treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam SUN 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 the amount ingested.

Possible adverse effects of a Levetiracetam SUN 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 management for the overdose.

If you forget to take Levetiracetam SUN:

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 SUN:

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

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

4. Possible adverse effects

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

Tell 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, and 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 output, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, 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);
• 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 skin peeling 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 weak, 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, nervousness, or irritability;
• seizures, balance disorder, dizziness (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), 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 swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/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);
• epileptic seizures may worsen or occur more frequently;
• delirium;
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms);
• uncontrollable muscle spasms affecting the head, trunk, 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), 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 skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. 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). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 SUN

Keep out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam SUN

The active substance is levetiracetam. Each tablet contains 1,000 mg of levetiracetam.

The other components are: Corn starch, Povidone (K30), Microcrystalline cellulose, Colloidal anhydrous silica, Crospovidone (Type B), Talc, Magnesium stearate, Opadry white (Hypromellose 5cP, Titanium dioxide (E171), Macrogol 400, Talc).

Appearance of the product and contents of the pack

The film-coated tablets are white, oval-shaped, 19.1 x 10.2 mm, with "LT" and "4" engraved on either side of the score line on one side and smooth on the other. The tablets can be divided into equal doses.

The packs contain 30, 50, 60, 100 and 200 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

This medicinal product is authorized in the following member states under the following names:

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

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