LEVETIRACETAM ARISTO 100 MG/ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Levetiracetam Aristo 100 mg/ml Oral Solution EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

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

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

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

Levetiracetam is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a disease where patients have seizures (fits). Levetiracetam is used to treat a form of epilepsy where the seizures initially affect only one side of the brain but may subsequently spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you 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 you take Levetiracetam Aristo

Do not take Levetiracetam Aristo

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 before taking Levetiracetam Aristo.

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the 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 have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a family history or medical history of irregular heartbeat (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac irregularities or electrolyte imbalance.

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.
• Worsening of epilepsy:

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after increasing the dose.

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

Children and adolescents

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

Other medicines and Levetiracetam Aristo

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 and breastfeeding

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 can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without consulting your doctor.

The risk of birth defects for your baby cannot be completely excluded. Breastfeeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam Aristo may cause symptoms such as drowsiness, dizziness, or changes in vision, and may affect your ability to react. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Levetiracetam Aristo contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, maltitol, benzyl alcohol, propylene glycol, and potassium.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains liquid maltitol (E-965). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains 2.7 mg of sodium (main component of cooking/table salt) per ml. This is equivalent to 0.1% of the maximum recommended daily intake of sodium for an adult.

This medicine contains 0.0083 mg per ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems (called "gasping syndrome") in infants. Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

This medicine contains 3.435 mg of propylene glycol per ml. If the baby is under 4 weeks of age, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

This medicine contains 2.9 mg of potassium per ml. To be taken into account in patients with reduced kidney function or patients with a low-potassium diet.

3. How to take Levetiracetam Aristo

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

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

Take the oral solution as instructed by your doctor.

Monotherapy (from 16 years of age)

Dosage in adults (≥ 18 years) and adolescents (from 16 years of age):

Measure the correct dose using the 10 ml syringe included in the box for patients over 4 years of age.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

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

Concomitant therapy

Dosage in adults and adolescents (from 12 to 17 years):

Measure the correct dose using the 10 ml syringe included in the box for patients over 4 years of age.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dosage in children from 6 months of age:

Your doctor will prescribe the most suitable pharmaceutical form of levetiracetam according to age, weight, and dose.

For children from 6 months to 4 years of age,measure the correct dose using the 3 ml syringe included in the packaging.

For children over 4 years of age,measure the correct dose using the 10 ml syringe included in the packaging.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (see the following table for examples of doses).

Dosage in children from 6 months of age:

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

For infants from 1 month to less than 6 months of age, measure the correct dose using the 1 ml syringe included in the packaging.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (see the following table for examples of doses).

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

Method of administration:

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

Instructions for use

• Open the bottle: press 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 attached.

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

• Fill the syringe with a small amount of solution by lowering the plunger (figure 5a) and then raising it to eliminate any possible bubbles (figure 5b). Lower the plunger to the graduation mark corresponding to the prescribed dose in milliliters (ml) by your doctor (figure 5c).

• Turn the bottle right side up (figure 6A). Remove the syringe from the adapter (figure 6B).

• Empty the contents of the syringe into a glass of water or a baby bottle, lowering the plunger to the end of the syringe (figure 7).

• Drink the contents of the glass or baby bottle entirely.
• Close the bottle with the plastic screw cap.
• Wash the syringe only with water (figure 8).

Duration of treatment

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

If you take more Levetiracetam Aristo than you should

Possible side effects of an overdose of levetiracetam are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

If you forget to take Levetiracetam Aristo

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for the missed doses.

If you stop treatment with Levetiracetam Aristo:

As with other antiepileptic medicines, stopping treatment with levetiracetam should be done gradually to avoid an increase in seizures.

If you have any other 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 all people suffer from them.

Tell your doctor immediately, or go to the emergency 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 (Quincke's edema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (Drug Hypersensitivity Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may be signs of sudden renal function decrease
• a skin rash that can form blisters and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), 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, drowsiness (feeling of sleep), headache, fatigue, and dizziness. Adverse effects such as drowsiness, weakness, and dizziness may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very common:may affect more than 1 in 10 patients

• nasopharyngitis;
• drowsiness (feeling of sleep), headache.

Common:may affect up to 1 in 10 patients

• anorexia (loss of appetite);
• depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:may affect up to 1 in 100 patients

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function test values;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:may affect up to 1 in 1,000 patients

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (important and severe allergic reaction), Quincke's edema (swelling of face, lips, tongue, and throat));
• decrease in sodium concentration in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, torso, 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 renal function;
• skin rash, which can lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• Combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called malignant neuroleptic 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 or repetitive thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Levetiracetam Aristo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the carton and on the bottle after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package contents and additional information

Composition of Levetiracetam Aristo

The active ingredient is levetiracetam.

Each ml contains 100 mg of levetiracetam.

The other components are: sodium citrate (E331), anhydrous citric acid (E330), purified water, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E420), maltitol (E965), potassium acesulfame (E950), fantasy flavor (anisyl format, gamma-butyrolactone, diacetyl, delta-dodecalactone, ethyl butyrate, 4-(p-hydroxyphenyl)-2-butanone, maltol, menthol, methylcyclopentenolone, propylene glycol E1520, 4-(2,6,6-trimethylcyclohex-1-enyl)but-2-en-4-one, gamma-undecalactone), contramarum flavor (acetyl methyl carbinol, benzyl alcohol, butyric acid, cocoa powder extract, delta-decalactone, dihydrocoumarin, delta-dodecalactone, ethyl butyrate, ethyl maltol, ethyl propionate, heliotropin, 60% vol. Holy Herb leaf extract, triacetin, aniline, propylene glycol-1,2, water).

Appearance of the product and package contents

Transparent, colorless, or slightly brown solution.

The 300 ml glass bottle of Levetiracetam Aristo (for children from 4 years of age, adolescents, and adults) 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 of Levetiracetam Aristo (for infants and young children from 6 months to less than 4 years of age) 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 of Levetiracetam Aristo (for infants from 1 month to less than 6 months of age) is packaged in a cardboard box with a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Packages of 150 ml and 300 ml of oral solution.

Hospital package of 1500 ml (10 x 150 ml or 5 x 300 ml) of oral solution.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorized in the EEA Member States with the following names:

Germany Levetiracetam Aristo 100 mg/ml Lösung zum Einnehmen

Austria Levetiracetam Aristo 100 mg/ml Lösung zum Einnehmen

Denmark Levetiracetam "Aristo Pharma"

Spain Levetiracetam Aristo 100 mg/ml oral solution EFG

Italy Levetiracetam Aristo Pharma

Netherlands Levetiracetam Aristo 100 mg/ml drank

Norway Levetiracetam Aristo

Portugal Levetiracetam Aristo 100 mg/ml oral solution

Sweden Levetiracetam Aristo Pharma 100 mg/ml oral lösning

United Kingdom Levetiracetam Aristo 100 mg/ml oral solution

Date of the last revision of this prospectus:July 2023

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