Levetiracetam Vir 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levetiracetam Vir 100 mg/ml oral solution EFG

Read the entire leaflet carefully before you or your child 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

2. What you need to know before taking Levetiracetam Vir

3. How to take Levetiracetam Vir

4. Possible side effects

5. Storage of Levetiracetam Vir

6. Contents of the pack and other information

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

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

Levetiracetam Vir 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 a 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 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 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 starting to take Levetiracetam Vir

Do not take Levetiracetam Vir

• 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

Consult your doctor, pharmacist, or nurse before starting to take Levetiracetam Vir.

• If you have kidney problems, follow your doctor's instructions. He/she 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 Vir have had thoughts about harming themselves or suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

Inform your doctor or pharmacist if any of the following adverse 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.

Children and adolescents

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

Taking Levetiracetam Vir with other medicines

Inform 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 could reduce its effectiveness.

Pregnancy, breastfeeding, and fertility

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

Levetiracetam Vir should not be used during pregnancy unless strictly necessary. 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.

In animal studies, levetiracetam has shown adverse effects on reproduction at doses higher than those needed to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Vir 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 Vir contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, liquid maltitol, and glycerol

Levetiracetam Vir oral solution may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine contains liquid maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. This medicine may cause headache, stomach discomfort, and diarrhoea because it contains glycerol.

3. How to take Levetiracetam Vir

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

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

Take the oral solution according to the instructions given to you by your doctor.

Monotherapy

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

Measure the appropriate dose using the 10 ml syringe supplied in the package for patients from 4 years of age onwards.

General dosage: Levetiracetam Vir is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1500 mg).

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

Concomitant therapy

Dosage in adults and adolescents (from 12 to 17 years of age) with body weight equal to or greater than 50 kg:

Measure the appropriate dose using the 10 ml syringe supplied in the package for patients from 4 years of age onwards.

General dosage: Levetiracetam Vir is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1500 mg).

Dosage in children from 6 months of age onwards:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Vir based on the child's age, weight, and required dosage.

For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe supplied in the package.

For children over 4 years of age, measure the appropriate dose using the 10 ml syringe supplied in the package.

General dosage: Levetiracetam Vir is taken twice daily, divided into two equal doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see dosage examples in the table below).

Dosage in children from 6 months of age onwards:

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

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe provided in the package.

General dose: Levetiracetam Vir is taken twice daily, divided into two equal doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see dosage examples in the table below).

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

Method of administration

After measuring the correct dose with an appropriate syringe, Levetiracetam Vir may be taken by diluting the oral solution in a glass of water or in the baby's bottle. Levetiracetam Vir may be taken with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.

For accurate dosing, the packaging contains an oral dosing syringe graduated in millilitres. Using this syringe, withdraw the prescribed amount of levetiracetam from the bottle.

Insert the syringe into the bottle, pull back the plunger until the liquid reaches the mark in mL, and then remove the syringe.

The syringe should be cleaned and dried after each use.

Duration of treatment

• Levetiracetam Vir is used as a chronic treatment. You must continue treatment with Levetiracetam Vir 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 Vir 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 medication and the amount ingested.

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

Contact your doctor if you have taken more Levetiracetam Vir than you should. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam Vir

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 treatment with Levetiracetam Vir

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

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 experiences them.

Tell your doctor if you experience any of the following adverse effects and are concerned.

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 severe 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 temperature, elevated liver enzymes in blood tests, 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, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate 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 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, 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. Drowsiness, feeling of weakness, and dizziness may be more common when starting treatment or increasing the dose. 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 (sensation of unsteadiness), 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 (forgetfulness), abnormal coordination/ataxia (impaired coordination of movements), 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));
• 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);
• uncontrollable muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which may lead to blistering 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), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• decreased concentration of sodium in the blood;
• 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.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Vir

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

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

Store below 30°C in the original packaging, to protect from light.

Do not use more than 2 months after opening the container.

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

6. Contents of the container and other information

Composition of Levetiracetam Vir

The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.

The other components are: sodium citrate, citric acid monohydrate, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), ammonium glycyrrhizinate, glycerol (E422), liquid maltitol (E965), potassium acesulfame (E950), grape flavour, and purified water.

Appearance of the product and contents of the container

Levetiracetam Vir oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam Vir oral solution is packaged in a cardboard box containing a 10 ml syringe (polyethylene) and a syringe adapter (polyethylene), all contained in a cardboard box.

The 150 ml glass bottle of Levetiracetam Vir oral solution is packaged in a cardboard box containing a 5 ml syringe (polyethylene) and a syringe adapter (polyethylene), all contained in a cardboard box.

The 150 ml glass bottle of Levetiracetam Vir oral solution is packaged in a cardboard box containing a 1 ml syringe (polyethylene) and a syringe adapter (polyethylene), all contained in a cardboard box.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.
28923 - Alcorcón (Madrid), Spain

Manufacturer

Laboratorium Sanitatis, S.L
C/ Leonardo da Vinci, 11
01510 Miñano (Álava) - Spain

Date of the most recent review of this summary: October 2025

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