Levetiracetam Viatris 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levetiracetam Viatris 500 mg film-coated tablets EFG

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, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Levetiracetam Viatris contains the active substance levetiracetam, which is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Viatris is used:

• As monotherapy, in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a type of epilepsy. Epilepsy is a condition in which patients have seizures (fits). Levetiracetam is used for the type of epilepsy in which seizures start in one part of the brain only, 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 over 12 years of age with juvenile myoclonic epilepsy.

• Primary generalized tonic-clonic seizures (also known as grand mal seizures, including loss of consciousness) in adults and adolescents aged 12 years 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 Viatris

Do not take Levetiracetam Viatris

• 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 Levetiracetam Viatris:

• If you have kidney problems, follow your doctor's instructions, who will decide whether your dose needs to be adjusted.

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 have thoughts of suicide, consult 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 make you prone to cardiac arrhythmias or imbalances in blood electrolytes.

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 normal, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy.

Rarely, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

You may notice that seizures persist or worsen during treatment in a very rare form of early-onset epilepsy (SCN8A mutation-related epilepsy) that causes multiple seizure types and loss of skills.

Children and adolescents

If you notice any slowing in your child's growth or unexpected development of puberty, consult your doctor.

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

Other medicines and Levetiracetam Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor if you are taking:

• Methotrexate (a medicine used for psoriasis, inflammation, and some cancers).
• Macrogol (a medicine used as a laxative). Do not take macrogol within one hour before or one hour after taking levetiracetam, as it may lose its effect.
• Probenecid (a medicine used for gout).

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.

Pregnancy

Levetiracetam may be used during pregnancy only 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

Breastfeeding is not recommended during treatment, as levetiracetam passes into breast milk.

Driving and using machines

Levetiracetam 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. Do not drive or operate tools or machinery until you are certain that your ability to perform these activities is not affected.

3. How to take Levetiracetam Viatris

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your physician.

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

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

The score line is intended solely to facilitate breaking the tablet if you have difficulty swallowing it whole.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1000 mg and 3000 mg daily.

When you first start taking levetiracetam, your doctor will prescribe a lower starting dose (500 mg per day) for two weeks before increasing to the lowest general dose of 1000 mg.

For example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Adolescents (12 to 17 years) weighing 50 kg or less:

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

Dosing in infants (1 to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) weighing less than 50 kg:

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

An oral solution may be available, as it 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.

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 consulting your doctor, as your seizures may increase.

If you take more Levetiracetam Viatris than you should

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

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

If you forget to take Levetiracetam Viatris

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 Viatris

As with other antiepileptic medicines, discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with this medicine, they will provide instructions for gradual withdrawal.

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

Levetiracetam Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

4. Possible adverse effects

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

The most frequently reported adverse effects are sore nose or throat (nasopharyngitis), drowsiness, headache, fatigue, and dizziness. Some of these adverse effects, such as drowsiness, feeling weak, and dizziness, may be more common when starting treatment or increasing the dose. However, these adverse effects should decrease over time.

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

• Weakness, feeling faint or dizzy, or if you have difficulty breathing, as these could be signs of a serious allergic (anaphylactic) reaction.
• Swelling of the face, lips, tongue, and throat (angioedema).
• Flu-like symptoms and facial rash, followed by a prolonged rash and high fever, high levels of liver enzymes detected in blood tests, an increase in a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs in the body (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 could be signs of sudden decrease in kidney function.
• A skin rash, which may blister and appear as small targets (dark centers surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).
• A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• A more severe rash 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, drowsiness (tendency to sleep), amnesia (memory loss), memory impairment (tendency to forget), abnormal behavior, or other neurological signs, including uncontrolled involuntary movements. These could be symptoms of encephalopathy.
• Suicidal thoughts or suicide attempts.
• Severe abdominal pain spreading to the back, as this may be a sign of inflamed pancreas.

Tell your doctor immediately if you experience any of the following symptoms, as you may require medical attention:

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

• Increased signs of infection, such as fever or mouth ulcers, which could be due to a decrease in white blood cells.

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

• Signs of liver problems, such as abdominal pain, fever, pale stools, dark urine, yellowing of the skin and eyes.
• Rhabdomyolysis (breakdown of muscle tissue) and associated increase in creatine phosphokinase in the blood. The prevalence is considerably higher in Japanese patients compared to non-Japanese patients.
• Combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, low 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.

Other adverse effects include:

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

• Nasopharyngitis (sore nose or throat).
• 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 (weakness/tiredness).

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

• Reduction in the number of platelets, causing you to bruise or bleed more easily or for longer than normal.
• Weight loss, weight gain.
• Mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attacks, 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.
• Abnormal results in liver function tests.
• Hair loss, eczema, itching.
• Muscle weakness, myalgia (muscle pain).
• Injuries.

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

• Decrease in types of blood cells.
• Infection.
• Suicidal behavior or personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating).
• Delirium.
• Encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms).
• Seizures may worsen or occur more frequently.
• Uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity).
• Change in heart rhythm (electrocardiogram).
• Decrease in blood sodium concentration.
• Limping or difficulty walking.

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

• Repeated unwanted 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 Viatris

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

Do not use this medicine after the expiry date stated on the cardboard box, bottle, and blister after CAD or EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Bottles: use within 3 months of first opening. Once opened, keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Viatris

• The active substance is levetiracetam. Each film-coated tablet contains 500 mg of levetiracetam.
• Other components are:
  Tablet core: povidone (E-1201), microcrystalline cellulose (E-460), sodium croscarmellose (E-466), magnesium stearate (E-572), sodium lauryl sulfate (E-487), colloidal anhydrous silica (E-551).
  Coating: titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-464), triacetin (E-1518), macrogol 8000, macrogol 400.

Appearance of the product and contents of the pack

White, oblong, biconvex, film-coated tablet with bevelled edges, marked with an "M" to the left of the score line and "615" to the right of the score line on one side, and blank on the other.

Levetiracetam Viatris tablets are supplied in blisters containing 20, 30, 50, 60, 90, 100, 120 or 200 film-coated tablets, or in single-dose perforated blisters of 30 and 60 film-coated tablets. Levetiracetam Viatris tablets are also packaged in bottles containing 60, 100, 120, 200 or 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Spain: Levetiracetam Viatris 500 mg film-coated tablets EFG
Netherlands: Levetiracetam Viatris 500 mg filmomhulde tabletten
United Kingdom (NI): Levetiracetam Mylan 500 mg Film-coated Tablets

Date of the latest 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) (https://www.aemps.gob.es/).