Levetiracetam Aristo 100 mg/ml oral solution EFG
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Levetiracetam Aristo is and what it is used for
- 2. What you need to know before taking Levetiracetam Aristo
- 3. How to take Levetiracetam Aristo
- 4. Possible adverse effects
- 5. Storage of Levetiracetam Aristo
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Levetiracetam Aristo 100 mg/ml oral solution EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, 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 effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Levetiracetam Aristo is and what it is used for
- What you need to know before taking Levetiracetam Aristo
- How to take Levetiracetam Aristo
- Possible side effects
- How to store Levetiracetam Aristo
- Contents of the pack and other information
1. What Levetiracetam Aristo is and what it is used for
Levetiracetam oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam is used:
-
as monotherapy 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 have seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may subsequently 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 secondary 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 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 taking 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
Talk to your doctor before starting Levetiracetam Aristo.
- 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 growth delay in your child 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.
- 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 treatment that may make you prone to heart rhythm disturbances or electrolyte imbalances.
Inform your doctor or pharmacist if any of the following side effects worsen or last for more 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:
Occasionally, 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) causing 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 this medicine, see a doctor as soon as possible.
Children and adolescents
- Monotherapy with Levetiracetam Aristo (treatment with this medicine alone) 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 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 effect.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Levetiracetam may only be used during pregnancy 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 in 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. Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Aristo may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed 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 certain sugars, consult with them before taking this medicine.
This medicine contains 2.3 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 0.1% of the maximum daily recommended sodium intake for an adult.
This medicine contains 0.0083 mg in each ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects, including breathing problems (known as “gasping syndrome”) in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor.
This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.
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 medicine contains 3,435 mg of propylene glycol in each ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.
This medicine contains 2.9 mg of potassium per ml. This should be taken into account in patients with reduced kidney function or those on a potassium-restricted diet.
3. How to take Levetiracetam Aristo
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Levetiracetam 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 as directed 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 provided in the package for patients over 4 years of age.
Recommended dosage: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging between 5 ml (500 mg) and 15 ml (1500 mg).
When you first start taking levetiracetam, your doctor will prescribe a lower dose for two weeks before increasing to the lowest daily maintenance dose.
Concomitant therapy
Dosage in adults and adolescents (12 to 17 years of age):
Measure the correct dose using the 10 ml syringe provided in the package for patients over 4 years of age.
Recommended dosage: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging 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, body weight, and required dose.
For children from 6 months to 4 years of age, measure the correct dose using the 3 ml syringe provided in the package.
For children over 4 years of age, measure the correct dose using the 10 ml syringe provided in the package.
Recommended dosage: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of the child's body weight (see examples of dosing in the following table).
Dosage in children from 6 months of age:
Weight | Initial dose: 0.1 ml/kg twice daily | Maximum dose: 0.3 ml/kg twice daily |
6 kg | 0.6 ml twice daily | 1.8 ml twice daily |
8 kg | 0.8 ml twice daily | 2.4 ml twice daily |
10 kg | 1 ml twice daily | 3 ml twice daily |
15 kg | 1.5 ml twice daily | 4.5 ml twice daily |
20 kg | 2 ml twice daily | 6 ml twice daily |
25 kg | 2.5 ml twice daily | 7.5 ml twice daily |
From 50 kg | 5 ml twice daily | 15 ml twice daily |
Dosage in infants (from 1 month to less than 6 months of age):
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.
Recommended dose: levetiracetam is taken twice daily, in two equal doses, with each individual dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight (see dose examples in the table below).
Dosing in infants (from 1 month to less than 6 months of age):
Weight | Starting dose: 0.07 mL/kg twice daily | Maximum dose: 0.21 mL/kg twice daily |
4 kg | 0.3 mL twice daily | 0.85 mL twice daily |
5 kg | 0.35 mL twice daily | 1.05 mL twice daily |
6 kg | 0.45 mL twice daily | 1.25 mL twice daily |
7 kg | 0.5 mL twice daily | 1.5 mL twice daily |
Administration method:
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. You may take levetiracetam with or without food. A bitter taste may be noticed after oral administration of levetiracetam.
Instructions on how to use the syringe:
- Open the bottle: press down on the cap and unscrew counterclockwise (Figure 1)
- Follow these steps the first time you take this medicine:
- Remove the oral dosing syringe adapter (Figure 2)
- Place the adapter onto the top of the bottle (Figure 3). Make sure it is securely fixed in place. There is no need to remove the adapter after use.
- Follow these steps each time you take this medicine:
- Attach the oral dosing syringe to the opening of the adapter (Figure 4)
- Turn the bottle upside down (Figure 5).
- Hold the bottle upside down with one hand and use the other hand to fill the oral dosing syringe.
- Pull the plunger down to fill the oral dosing syringe with a small amount of solution (Figure 5A).
- Then, push the plunger up to expel any possible air bubbles (Figure 5B).
- Lower the plunger to the graduation mark on the oral dosing syringe corresponding to the dose in millilitres (mL) prescribed by your doctor (Figure 5C). The plunger may rise slightly within the barrel during the first dose. Therefore, make sure to keep the plunger in position until the dosing syringe is disconnected from the bottle.
- 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 bottle by pushing the plunger down to the end of the syringe (Figure 7).
- Drink the entire contents of the glass or bottle.
- Close the bottle with the plastic screw cap (there is no need to remove the adapter).
- To clean the syringe, rinse it with cold water only, moving the plunger up and down several times, and expel the water without separating the two components (Figure 8).
- Keep the bottle, syringe, and package leaflet in the carton.
Duration of treatment
- Levetiracetam is used as a chronic treatment. You must continue levetiracetam treatment for the duration indicated by your doctor.
- Do not stop your treatment without consulting your doctor, as your seizures may increase.
If you take more Levetiracetam Aristo than you should
Possible adverse effects of an overdose of levetiracetam include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915620 420, indicating the medication and the amount ingested.
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 forgotten doses.
If you stop treatment with Levetiracetam Aristo:
As with other antiepileptic medicines, discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures.
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 will experience them.
Tell 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 rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, increase in a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
- symptoms such as low urine volume, 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 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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
- a more severe form causing skin peeling affecting 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. Adverse effects such as drowsiness, feeling of weakness, and dizziness may be more common when treatment is started or 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, 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, burning and acid sensation), 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 behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
- amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (impaired coordination of movement), 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 (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue, and throat);
- decreased concentration of sodium 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;
- 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 blisters appearing 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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
- rhabdomyolysis (breakdown of muscle tissue) and elevated blood creatine phosphokinase levels. 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, and decreased 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, repeated thoughts or sensations, or the urge to do something over and over again (obsessive-compulsive disorder).
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 Aristo
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Levetiracetam Aristo
The active substance 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 glycyrrhizinate, glycerol (E420), maltitol (E965), acesulfame potassium (E950), "fantasie" flavour (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" flavour (acetyl methyl carbinol, benzyl alcohol, butyric acid, cocoa powder extract, delta decalactone, dihydrocoumarin, delta dodecalactone, ethyl butyrate, ethyl maltol, ethyl propionate, heliotropin, 60% v/v Holy Herb leaf extract, triacetin, aniline, propylene glycol-1,2, water).
Nature of the product and contents of the container
Clear, colourless 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 up 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 up 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.
Pack sizes of 150 ml and 300 ml of oral solution.
Hospital pack of 1500 ml (10 x 150 ml or 5 x 300 ml) of oral solution.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain
This medicinal product is authorised in EEA Member States under 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 solução oral
Sweden Levetiracetam Aristo Pharma 100 mg/ml oral lösning
United Kingdom Levetiracetam Aristo 100 mg/ml oral solution
Date of the most recent revision of the 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/