Levetiracetam CINFA 100 mg/ml oral solution EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Levetiracetam cinfa 100 mg/ml oral solution EFG
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 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 cinfa is and what it is used for
- What you need to know before taking Levetiracetam cinfa
- How to take Levetiracetam cinfa
- Possible side effects
- How to store Levetiracetam cinfa
- Contents of the pack and other information
1. What Levetiracetam cinfa is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam cinfa is used:
- as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a specific form of epilepsy. Epilepsy is a condition in which patients experience 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 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 muscle group) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
- primary generalized tonic-clonic seizures (generalized convulsive seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).
2. What you need to know before taking Levetiracetam cinfa
Do not take Levetiracetam cinfa
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 to take Levetiracetam cinfa.
- If you have kidney problems, follow your doctor's instructions, as your dose may need to be adjusted.
- If you notice any delay in your child's growth or unexpected onset of puberty, contact your doctor.
- A small number of people taking antiepileptic medicines such as Levetiracetam cinfa have had thoughts of harming themselves or of suicide. If you experience symptoms of depression and/or suicidal thoughts, contact your doctor immediately.
- If you have a personal or family history of irregular heartbeat (seen on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias 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 usual, or if you or your family and friends notice significant changes in mood or behavior.
- Worsening of epilepsy:
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 Levetiracetam cinfa, 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.
Other medicines and Levetiracetam cinfa
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 laxative medicine) within one hour before or one hour after taking levetiracetam, as it may reduce its effect.
Taking Levetiracetam cinfa with food, drinks and alcohol
You may take levetiracetam with or without food. As a precaution, do not take levetiracetam with alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 for 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 may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the underlying 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 cinfa contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).
Levetiracetam cinfa contains liquid maltitol.
This medicine contains liquid maltitol (E 965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Levetiracetam cinfa contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per ml; hence, it is essentially “sodium-free”.
3. How to take Levetiracetam cinfa
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Levetiracetam cinfa 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)
Adults (≥ 18 years) and adolescents (from 16 years of age):
For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.
Recommended dose: Levetiracetam cinfa 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 start taking levetiracetam, your doctor will prescribe a lower dose for the first two weeks before increasing to the lowest daily dose.
Concomitant therapy
Doses in adults and adolescents (12 to 17 years of age):
For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.
Recommended dose: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging between 5 ml (500 mg) and 15 ml (1500 mg).
Doses in children from 6 months of age:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam depending on age, weight, and dose.
For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided in the package.
For children over 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.
Recommended dose: Levetiracetam cinfa 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 the following table for dose examples).
Doses 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 cinfa 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 examples of dosing in the table below).
Dosing in infants (from 1 month to less than 6 months of age):
Weight | Initial 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 the appropriate syringe, Levetiracetam cinfa may be diluted in a glass of water or in a bottle. This medicine can be taken with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.
Instructions for correct administration:
- Open the bottle: press down on the cap and unscrew it counterclockwise (figure 1)
Insert the adapter into the neck of the bottle (figure 2). Make sure it is securely fixed.
Take the syringe and insert it into the opening of the adapter (figure 3). Turn the bottle upside down (figure 4)
Fill the syringe with a small amount of solution by pushing the plunger down (figure 5A), then pulling it up to remove any possible air bubbles (figure 5B). Push the plunger down to the graduation mark corresponding to the dose in millilitres (ml) prescribed by your doctor (figure 5C).
Turn 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 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.
- Wash the syringe with water only (figure 8).
Duration of treatment:
- Levetiracetam is used as a chronic treatment. You must continue treatment with this medicine for the length of 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 cinfa than you should:
Possible adverse effects of an overdose of Levetiracetam cinfa include drowsiness, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.
Contact your doctor if you have taken more oral solution than you should. Your doctor will determine the best treatment for the overdose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Levetiracetam cinfa:
Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for missed doses.
If you stop taking Levetiracetam cinfa:
Discontinuation of treatment with Levetiracetam cinfa should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam cinfa, he or she will give you 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, 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 severe 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, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
- symptoms such as low urine volume, tiredness, nausea, vomiting, confusion, and swelling of the 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)
- 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 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 (numbness), 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 (feeling sleepy), headache, fatigue, and dizziness. Adverse effects such as feeling sleepy, feeling weak, 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 (feeling sleepy), 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 of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
- vertigo (spinning sensation);
- cough;
- abdominal pain, diarrhea, dyspepsia (indigestion, burning and acid reflux), vomiting, nausea;
- skin rash;
- asthenia/fatigue (feeling of weakness).
Uncommon: may affect up to 1 in 100 people
- decreased number of platelets, decreased 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 (memory problems), abnormal coordination/ataxia (impaired movement coordination), 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 (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
- decreased concentration of sodium in the 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, 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 kidney function;
- skin rash, which may 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 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 elevated blood creatine phosphokinase levels. 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). 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 urges to perform an action repeatedly (obsessive-compulsive disorder)
Reporting of adverse effects
If you experience any kind of 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 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 cinfa
Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.
Do not use levetiracetam cinfa 100 mg/ml oral solution 2 months after opening the container.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. 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 cinfa
- The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
- The other components are: sodium citrate dihydrate, citric acid monohydrate, methyl 4-hydroxybenzoate (E 218), propyl 4-hydroxybenzoate (E 216), ammonium glycyrrhizinate, glycerol (E 422), liquid maltitol (E 965), acesulfame K (E 950), grape flavour, and purified water.
Nature of the product and pack contents
Levetiracetam cinfa 100 mg/ml oral solution is a clear liquid.
The 300 ml glass bottle (for children from 4 years of age, adolescents and adults) is packaged in a cardboard box and supplied with a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.
The 150 ml glass bottle (for infants and young children from 6 months up to but less than 4 years of age) is packaged in a cardboard box and supplied with a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.
The 150 ml glass bottle (for infants from 1 month up to but less than 6 months of age) is packaged in a cardboard box and supplied with a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer:
Laboratorium Sanitatis, S.L.
P.T. Alava – C/ Leonardo Da Vinci, 11 01510 Miñano (Álava) - Spain
Date of the most recent revision of this leaflet: November 2025
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).
You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76440/P_76440.html
QR code to: https://cima.aemps.es/cima/dochtml/p/76440/P_76440.html