Levetiracetam Aurovitas 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Aurovitas 100 mg/ml oral solution EFG

levetiracetam

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, 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.

Contents of the leaflet

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

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

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

Levetiracetam Aurovitas is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat one form of epilepsy. Epilepsy is a condition in which patients have seizures (fits). 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 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 secondary generalisation 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 12 years of age and older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before starting Levetiracetam Aurovitas

Do not take Levetiracetam Aurovitas

• 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 starting levetiracetam:

• 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 slowing in your child's growth or unexpected development of puberty, 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 any symptoms of depression and/or suicidal thoughts, contact your doctor immediately.
• If you have a personal or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to heart rhythm disturbances 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 normal, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking levetiracetam, seek medical advice as soon as possible.

Children and adolescents

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

Taking Levetiracetam Aurovitas 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 may reduce its effectiveness.

Pregnancy, breastfeeding and fertility

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 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 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 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 operate machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Aurovitas contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

Levetiracetam oral solution, containing methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), may cause allergic reactions (possibly delayed).

Levetiracetam oral solution also contains maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Propylene glycol

This medicine contains 20.27 mg of propylene glycol per ml of oral solution. If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

Levetiracetam Aurovitas 100 mg/ml oral solution EFG contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.

3. How to take Levetiracetam Aurovitas

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

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

Take the oral solution as directed by your doctor.

Monotherapy (from 16 years of age)**

Adults (≥ 18 years) 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.

Recommended dose: Levetiracetam is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you first start taking levetiracetam, your doctor will prescribe a lower dose for two weeks before increasing to the lowest daily dose.

Concomitant therapy

Doses in adults and adolescents (12 to 17 years of age):

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

Recommended dose:

Levetiracetam is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Doses in children from 6 months of age:

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

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.

Recommended dose: Levetiracetam 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 dosing examples in the table below).

Doses in children from 6 months of age:

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

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

Recommended dose: Levetiracetam 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 dosing examples in the table below).

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

Administration method:

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

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew it counterclockwise (Figure 1).

• Separate the syringe adapter (Figure 2). Insert the adapter into the neck of the bottle (Figure 3). Make sure it is securely in place.

• Take the syringe and insert it into the opening of the adapter (Figure 4). Turn the bottle upside down (Figure 5).

• Fill the syringe with a small amount of solution by first pushing the plunger down (Figure 5A), then pulling it up to remove any possible air bubbles (Figure 5B). Pull the plunger down to the graduation mark corresponding to the dose in millilitres (mL) prescribed by your doctor (Figure 5C).

• Place the bottle upright (Figure 6A). Remove the syringe from the adapter (Figure 6B).

• Empty the contents of the syringe into a glass of water or into a baby bottle by pushing the plunger down to the end of the syringe (Figure 7).

• Drink the entire contents of the glass or baby bottle.
• Close the bottle with the plastic screw cap.
• Do not use or apply any solvent when cleaning the syringe; clean it gently with water only after use.

Do not apply force and clean it gently after washing (Figure 8).

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You must continue treatment with levetiracetam for the length of time indicated by your doctor.
• Do not stop your treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam Aurovitas than you should

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

Contact your doctor if you have taken more oral solution than prescribed. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam Aurovitas:

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 Aurovitas:

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

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 can cause adverse effects, although not everyone will experience 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 prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes and involvement of other organs in the body (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 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 behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. Adverse effects such as sleepiness, feeling weak 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 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 (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), 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 behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paraesthesia (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 (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue and throat));
• decrease in blood sodium concentration;
• suicide, personality disorders (behavioural 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;
• uncontrollable 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 lead to blistering and may 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) 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. The 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). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• unwanted and repetitive thoughts 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use more than 7 months after opening the container.

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 are unsure, 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 Aurovitas

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: liquid maltitol (E-965), glycerol (E-422), propylene glycol, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), monohydrate citric acid, sodium citrate, potassium acesulfame (E-950), mafco magnasweet (glycerin, ammonium glycyrrhizinate), grape flavor (flavorings, propylene glycol, ascorbic acid), purified water.

Appearance of the product and contents of the container

Levetiracetam Aurovitas 100 mg/ml oral solution EFG is a clear, colourless liquid with a grape flavour.

The 300 ml glass bottle (type III) of Levetiracetam Aurovitas (for children from 4 years of age, adolescents and adults) with a white child-resistant cap is packaged in a cardboard box with a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle (type III) of Levetiracetam Aurovitas (for infants and young children from 6 months up to less than 4 years of age) with a white child-resistant cap is packaged in a cardboard box with a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml glass bottle (type III) of Levetiracetam Aurovitas (for infants from 1 month up to less than 6 months of age) with a white child-resistant cap is packaged in a cardboard box with a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Levetiracetam Aurovitas 100 mg/ml oral solution EFG

Italy: Levetiracetam Aurobindo Pharma Italia

Malta: Levetiracetam Aurobindo 100 mg/ml oral solution

Portugal: Levetiracetam Aurovitas

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

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