LEVETIRACETAM VIR 100 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Levetiracetam Vir 100 mg/ml Oral Solution EFG

Read the entire package leaflet carefully before you or your child start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Levetiracetam Vir and what is it 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

1. Contents of the pack and further information

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

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

Levetiracetam Vir is used:

• on its own (without the need for another antiepileptic medicine) in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a type of epilepsy. Epilepsy is a condition where patients have seizures (fits). Levetiracetam is used for the type of epilepsy where the seizures initially affect only one side of the brain but can then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). 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 generalisation in adults, adolescents, children, and infants from 1 month of age.
  • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause).

2. What you need to know before taking 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

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

• If you have kidney problems, follow your doctor's instructions. He/She will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• A small number of people taking antiepileptics, such as Levetiracetam Vir, have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

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

Children and adolescents

• Monotherapy with Levetiracetam Vir (single treatment) is not indicated in children and adolescents under 16 years.

Using Levetiracetam Vir with other medicines

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

Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam Vir should not be used during pregnancy unless clearly necessary. It is not possible to exclude a risk of birth defects for the baby. In animal studies, levetiracetam has shown undesirable effects on reproduction at doses higher than you may need to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Vir may affect your ability to drive or use tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

Levetiracetam Vir contains methylparahydroxybenzoate, propylparahydroxybenzoate, liquid maltitol, and glycerol

Levetiracetam Vir oral solution may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine. This medicine may cause headache, stomach upset, and diarrhoea because it contains glycerol.

3. How to take Levetiracetam Vir

Follow exactly the instructions given to you by your doctor or pharmacist. In case of 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 following the instructions given to you by your doctor.

Monotherapy

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

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

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

When starting Levetiracetam Vir, your doctor will prescribe a lower dosefor two weeks before giving you the lowest general dose.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years) with a weight of 50 kg or more:

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

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

Dose in children from 6 months of age onwards:

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

For children from 6 months to 4 years,measure the appropriate dose using the 3 ml syringe included in the pack.

For children over 4 years,measure the appropriate dose using the 10 ml syringe included in the pack.

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

Dose in children from 6 months of age onwards:

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

For infants from 1 month to less than 6 months,measure the appropriate dose using the 1 mlsyringe included in the pack.

General dose: Levetiracetam Vir is taken twice daily, divided into two equal doses, each of 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see examples of doses 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 can be taken by diluting the oral solution in a glass of water or in the baby's bottle. You can take Levetiracetam Vir with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.

For exact dosing, the packs contain a graduated oral syringe. Using this syringe, extract the prescribed amount of levetiracetam from the bottle.

The syringe is inserted into the bottle, the plunger is pulled up until the liquid reaches the mark in ml, and the syringe is removed.

The syringe should be cleaned and dried after each use.

Duration of treatment

• Levetiracetam Vir is used as a chronic treatment. You should continue treatment with Levetiracetam Vir for the time indicated by your doctor.
• Do not stop your treatment without your doctor's advice, as your seizures may increase.

If you take more Levetiracetam Vir than you should

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

The possible side effects of an overdose of Levetiracetam Vir are drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more Levetiracetam Vir than you should. Your doctor will establish the best possible 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

Stopping 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 give you instructions for the gradual withdrawal of Levetiracetam Vir.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you have any of the following side effects and they worry you.

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)

swelling of the face, lips, tongue, or throat (angioedema)

• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature

and elevated liver enzymes in blood tests and an increase in a type of white blood cell (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 this may be a sign of sudden decrease in kidney function

a skin rash that may form blisters and may look like targets (central dark spot 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)

• signs of serious mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);

these may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or when the dose is increased. However, these side effects should decrease over time.

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

• nasopharyngitis;
• somnolence (feeling drowsy), 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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:may affect up to 1 in 100 people:

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• double vision, blurred vision;
• elevated liver enzymes;
• hair loss, eczema, itching;
• muscle weakness, muscle pain;
• injury.

Rare:may affect up to 1 in 1000 people:

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction, angioedema);
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms);
• muscle spasms that cannot be controlled, 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 that may form blisters and may look like targets (central dark spot 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);
• decrease in blood sodium levels;
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 expiration date that appears on the packaging and on the bottle after CAD.:. The expiration date is the last day of the month indicated.

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

Do not use after 2 months of opening the package.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Levetiracetam Vir

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

The other components are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), liquid maltitol (E965), potassium acesulfame (E950), grape flavor, and purified water.

Appearance of the product and package contents

Levetiracetam Vir oral solution is a transparent 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 package sizes may be marketed.

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 last revision of this prospectus:May 2020

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