Levetiracetam Combix 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Combix 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Levetiracetam Combix is and what it is used for
2. What you need to know before taking Levetiracetam Combix
3. How to take Levetiracetam Combix
4. Possible side effects
5. How to store Levetiracetam Combix

Pack contents and additional information

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

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

Levetiracetam Combix is used:

• as monotherapy (without the need for another antiepileptic medicine) in adults and adolescents 16 years of age or older with newly diagnosed epilepsy, to treat partial-onset seizures with or without secondary generalization.
• 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 in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
  • primary generalized tonic-clonic seizures in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy.

2. What you need to know before starting to take Levetiracetam Combix

Do not take Levetiracetam Combix

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levetiracetam Combix.

• 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.
• If you notice an increase in the severity of seizures (e.g., increased frequency), 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 symptoms of depression and/or suicidal thoughts, contact your doctor.

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

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

Taking Levetiracetam Combix with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking Levetiracetam Combix with food, drinks and alcohol

You may take Levetiracetam Combix with or without food. As a precaution, do not take Levetiracetam Combix with alcohol.

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 should only be used during pregnancy if, after careful evaluation, your doctor considers it strictly necessary. Do not stop your treatment without first discussing it with your doctor. A 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 ability. These effects, as well as the condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Levetiracetam Combix

Follow exactly the instructions for using Levetiracetam Combix as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Take the number of tablets prescribed by your doctor.

Monotherapy

Dosage in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.

When you start taking Levetiracetam Combix, your doctor will prescribe a lower dose for two weeks before increasing to the lowest general dose.

For example: for a daily dose of 2,000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.

Concomitant therapy

Dosage in adults and adolescents (from 12 to 17 years of age) weighing 50 kg or more:

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.

For example, for a daily dose of 1,000 mg, you should take one tablet in the morning and one tablet in the evening.

Dosage in infants (from 6 to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to age, weight, and dose.

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years of age.

General dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

Dosage in infants (from 1 month to less than 6 months):

The oral solution is a more suitable formulation for infants under 6 months of age.

Method of administration

Swallow the Levetiracetam Combix tablets with a sufficient amount of liquid (e.g. a glass of water).

Duration of treatment

• Levetiracetam Combix is used as a chronic treatment. You should continue treatment with Levetiracetam Combix for the duration specified by your doctor.
• Do not discontinue treatment without your doctor's recommendation, as your seizures may increase. If your doctor decides to stop treatment with Levetiracetam Combix, they will provide instructions for gradually withdrawing the medication.

If you take more Levetiracetam Combix than you should

Possible adverse effects of an overdose of Levetiracetam include drowsiness, agitation, aggression, decreased alertness, 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.

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

If you forget to take Levetiracetam Combix

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for missed doses.

If you stop treatment with Levetiracetam Combix

As with other antiepileptic medicines, discontinuation of treatment with Levetiracetam Combix should be done gradually to avoid an increase in seizures.

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

4. Possible adverse effects

Like all medicines, Levetiracetam Combix may cause adverse effects, although not everyone experiences 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 rash on the face followed by a persistent rash with high fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as these may indicate sudden decrease in kidney function
• a skin rash that may blister and appear as small targets (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 signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

Some adverse effects such as drowsiness, weakness, and dizziness may be more common when treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 patients

• nasopharyngitis
• somnolence (drowsiness), headache

Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• decreased platelet count, decreased white blood cell count
• 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 (lack of memory), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration)
• diplopia (double vision), blurred vision
• abnormal results in liver function tests
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Rare: may affect up to 1 in 1000 patients

• infection
• decrease in all types of blood cells
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating)
• uncontrolled muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• skin rash, which may lead to blisters appearing as small targets (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)
• decreased concentration of sodium in blood
• sudden decrease in kidney function
• 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.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Combix

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

This medicine does not require any special storage conditions.

Do not use Levetiracetam after the expiry date which is 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 drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, 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 Combix 500 mg film-coated tablets

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other components are pregelatinized corn starch, sodium starch glycolate (type A) from potato, povidone K-30, corn starch, colloidal anhydrous silica, magnesium stearate, coating agent Instacoat Universal ICG-U-10276 Yellow (hypromellose-E464-, macrogol, talc-E553b-, titanium dioxide -E171-, iron oxide yellow -E172-).

Appearance of the product and contents of the pack

Levetiracetam Combix 500 mg film-coated tablets are yellow, oval-shaped, biconvex, with the number “500” engraved on one side and scored on the other.

Blister packs made of OPA/Al/PVC/Al and blister packs made of PVC/PVDC/Al.

Packs containing 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent revision of this leaflet: February 2026.

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