Levetiracetam Tarbis Farma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Tarbis Farma 250 mg film-coated tablets EFG

Levetiracetam Tarbis Farma 500 mg film-coated tablets EFG

Levetiracetam Tarbis Farma 750 mg film-coated tablets EFG

Levetiracetam Tarbis Farma 1,000 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 should 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 Tarbis Farma is and what it is used for
2. What you need to know before taking Levetiracetam Tarbis Farma
3. How to take Levetiracetam Tarbis Farma
4. Possible side effects
5. How to store Levetiracetam Tarbis Farma
6. Contents of the pack and other information

1. What Levetiracetam Tarbis Farma is and what it is used for

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

Levetiracetam Tarbis Farma is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a specific form 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 (short, 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 (grand mal 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 Tarbis Farma

Do not take Levetiracetam Tarbis Farma

• 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 taking this medicine

• If you have kidney problems, follow your doctor's instructions, as your dose may need to be adjusted.
• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Tarbis Farma have had thoughts of harming themselves or of suicide. If you experience 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 treatment(s) 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, especially during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam Tarbis Farma (treatment used alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Tarbis Farma

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 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, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor 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 Tarbis Farma 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.

Levetiracetam Tarbis Farma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Levetiracetam Tarbis Farma

Follow exactly the dosing instructions for this medicine as 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.

Concomitant 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 per day.

When you first start taking levetiracetam, your doctor will prescribe a lower dose for the first 2 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) weighing 50 kg or less:

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

• Dosing in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and 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) weighing less than 50 kg, especially when tablets do not allow for precise dosing.

Method of administration

Levetiracetam is administered orally. Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water). You may take levetiracetam with or without food. A bitter taste may be noticed after oral administration of levetiracetam.

Duration of treatment

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

If you take more Levetiracetam Tarbis Farma than you should

Possible adverse effects of a levetiracetam overdose include somnolence, 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, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and amount taken.

If you forget to take Levetiracetam Tarbis Farma

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 taking Levetiracetam Tarbis Farma

Discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your levetiracetam treatment, they will provide you with instructions for gradually withdrawing this medicine.

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

4. Possible adverse effects

Like all medicines, levetiracetam 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 facial rash followed by a widespread rash with high fever, elevated liver enzymes in blood tests, 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 lesions (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 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.

The most frequently reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue and dizziness. Adverse effects such as drowsiness, 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 unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (spinning sensation);
• 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

• decrease in platelet count, decrease in 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 coordination of movement), 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 (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue and throat));
• decrease in blood sodium concentration;
• 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, 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 blister and may appear as small target-like lesions (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 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, 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.

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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Tarbis Farma

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

Do not use this medicine after the expiry date stated on the carton 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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Tarbis Farma

The active substance is levetiracetam.

Each film-coated tablet contains 250 mg of levetiracetam.

Each film-coated tablet contains 500 mg of levetiracetam.

Each film-coated tablet contains 750 mg of levetiracetam.

Each film-coated tablet contains 1,000 mg of levetiracetam.

The other components are:

Tablet core:

Corn starch, sodium croscarmellose, povidone (K 30), anhydrous colloidal silica, talc, magnesium stearate.

Film coating:

250 mg

Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, indigo carmine aluminium lake (E132).

500 mg

Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

750 mg

Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

1,000 mg

Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the medicinal product and contents of the pack

Film-coated tablet.

Levetiracetam Tarbis Farma 250 mg film-coated tablets EFG

Film-coated, scored, oblong, blue tablets engraved with an 'H' on one side and the number '87' on the other. The score is intended only to facilitate breaking the tablet for ease of swallowing and not to divide the tablet into equal doses.

Levetiracetam Tarbis Farma 500 mg film-coated tablets EFG

Film-coated, oblong, yellow, scored tablets engraved with an 'H' on one side and the number '88' on the other. The score is intended only to facilitate breaking the tablet for ease of swallowing and not to divide the tablet into equal doses.

Levetiracetam Tarbis Farma 750 mg film-coated tablets EFG

Film-coated, scored, oblong tablets, beige to light orange in colour, engraved with an 'H' on one side and the number '90' on the other. The score is intended only to facilitate breaking the tablet for ease of swallowing and not to divide the tablet into equal doses.

Levetiracetam Tarbis Farma 1000 mg film-coated tablets EFG

Film-coated, oblong, white, scored tablets engraved with an 'H' on one side and the number '91' on the other. The score is intended only to facilitate breaking the tablet for ease of swallowing and not to divide the tablet into equal doses.

Levetiracetam Tarbis Farma film-coated tablets are packaged in blisters.

Packs containing 1, 30, 50, 60, 100 and 200 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:

Germany: Levetiracetam Amarox 250 mg/500 mg/750 mg/1000 mg Filmtabletten

Spain: Levetiracetam Tarbis Farma 250 mg/500 mg/750 mg/1.000 mg film-coated tablets EFG

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

Detailed 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/