Package Leaflet: Information for the User

Levetiracetam Aristo 100 mg/ml Oral Solution

Read all of this leaflet carefully before you 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Levetiracetam oral solution is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.

• concurrently with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, children, and infants 1 month of age or older.
• myoclonic seizures (shock-like, brief, muscle or group of muscle seizures) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam Aristo

If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Levetiracetam Aristo.

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications such as levetiracetam have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac irregularities or electrolyte imbalance.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling of irritability, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy:

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

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

Children and adolescents

• Monotherapy with Levetiracetam Aristo is not indicated in children and adolescents under 16 years old.

Other medications and Levetiracetam Aristo

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Levetiracetam can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor first.

The risk of birth defects for the baby cannot be completely ruled out. Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam Aristo may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying disease, may make it difficult for you 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 medication.

Levetiracetam Aristo contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, sodium, maltitol, benzyl alcohol, propylene glycol, and potassium.

It may cause allergic reactions (possibly delayed) due to the presence of parahydroxybenzoic acid methyl ester (E-218) and parahydroxybenzoic acid propyl ester (E-216).

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

This medication contains 2.7 mg of sodium per ml. This is equivalent to 0.1% of the maximum daily sodium intake recommended for an adult.

This medication contains 0.0083 mg per ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe side effects, including respiratory problems (called "breathing difficulty") in your child. Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This medication should not be used for more than a week in children under 3 years old, unless your doctor or pharmacist advises you to do so.

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

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

This medication contains 3.435 mg of propylene glycol per ml. If your baby is under 4 weeks old, consult your doctor or pharmacist, especially if your baby has been given other medications containing propylene glycol or alcohol.

This medication contains 2.9 mg of potassium per ml. Note this in patients with reduced renal function or patients on a low-potassium diet.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Take the oral solution according to your doctor's instructions.

Monotherapy (from 16 years of age)

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

Measure the appropriate dose using the 10 ml syringe included in the package 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 starting to take levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the daily minimum dose.

Concomitant therapy

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

Measure the appropriate dose using the 10 ml syringe included in the package 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 appropriate pharmaceutical form of levetiracetam based on age, weight, and dose.

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

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

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 kg of body weight of the child (see the following table for dose examples).

Dosage in children from 6 months of age:

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 included in the package.

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 kg of body weight of the infant (see the following table for dose examples).

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

Administration form:

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

Usage instructions

• Open the bottle: press the cap and unscrew in the opposite direction to the clock hands (figure 1)

• Separate the syringe adapter from the syringe (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 opening of the adapter (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 dose in milliliters (ml) prescribed 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 bottle by lowering the plunger to the end of the syringe (figure 7).

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

Treatment duration:

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

If you take more Levetiracetam Aristo than you should

The possible adverse effects of a levetiracetam overdoseare drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915620 420, indicating the medication and the amount ingested.

If you forgot to take Levetiracetam Aristo

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

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

If you interrupt treatment with Levetiracetam Aristo:

Like with other antiepileptic medications, the discontinuation of treatment with levetiracetamshould be done gradually to avoid an increase in seizures.

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

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

Inform your doctor immediately, or go to the emergency service 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 a 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 cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS)
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a generalized 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 decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

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

Very common:may affect more than 1 in 10 patients

• nasopharyngitis;
• drowsiness (feeling sleepy), 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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Rare:may affect up to 1 in 100 patients

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS, anaphylaxis (severe allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat);
• decreased sodium concentration in the blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized 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 elevated creatine phosphokinase blood levels associated. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking;
• Combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low level of consciousness (may be signs of a condition calledmalignant neuroleptic syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• unwanted thoughts or feelings and repeated or the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

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

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

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

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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 formate, gamma-butyrolactone, diacetate, delta-dodecalactone, butyl acetate, 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), counter-flavor (acetyl methyl carbinol, benzyl alcohol, butyric acid, cocoa powder extract, delta-decalactone, dihydrocoumarin, delta-dodecalactone, butyl acetate, ethyl maltol, propyl acetate, heliotropin, 60% vol. extract of Holy Herb leaf, triacetin, aniline, propylene glycol-1,2, water).

Appearance of the product and contents of the package

Clear, 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 accompanied by 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 small children from 6 months to less than 4 years of age) is packaged in a cardboard box accompanied by 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 accompanied by a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

150 ml and 300 ml oral solution containers.

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

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication 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 medication is authorized in the EEA member states with the following names:

GermanyLevetiracetam Aristo 100 mg/ml Lösung zum Einnehmen

AustriaLevetiracetam Aristo 100 mg/ml Lösung zum Einnehmen

DenmarkLevetiracetam „Aristo Pharma“

SpainLevetiracetam Aristo 100 mg/ml solución oral EFG

ItalyLevetiracetam Aristo Pharma

NetherlandsLevetiracetam Aristo 100 mg/ml drank

NorwayLevetiracetam Aristo

PortugalLevetiracetam Aristo 100 mg/ml solução oral

SwedenLevetiracetam Aristo Pharma 100 mg/ml oral lösning

United KingdomLevetiracetam Aristo 100 mg/ml oral solution

Last review date of this leaflet:July 2023

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