Levetiracetam Sandoz 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Sandoz 100 mg/ml oral solution EFG

levetiracetam

Read the entire leaflet carefully before you or your child 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 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 could 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.

Contents of the leaflet

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

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

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

Levetiracetam is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy to treat a type 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 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 group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy,
  • primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before starting to take Levetiracetam Sandoz

Do not take Levetiracetam Sandoz

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

Warnings and precautions

Talk to your doctor before taking levetiracetam:

• if you have kidney problems, follow your doctor's instructions, as your doctor 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 treated with 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 medical history of irregular heart rhythm (visible 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.

Tell 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 in a more aggressive way than usual, or if you or your family and friends notice significant changes in 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 an increase in 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 levetiracetam, see a doctor as soon as possible.

Children and adolescents

Treatment with levetiracetam alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Sandoz

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 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 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 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 Sandoz contains methyl parahydroxybenzoate, maltitol, benzyl alcohol, and sodium.

This medicine contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

This medicine contains maltitol (E 965). If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 1.6 micrograms of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant, breastfeeding, or 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 should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist. Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically recommended by your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially "sodium-free".

3. How to take Levetiracetam Sandoz

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 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 aged 4 years and older, 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).

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):

For patients aged 4 years and older, 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).

Dosage in children from 6 months of age:

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

For children aged 6 months to 4 years, measure the appropriate dose using the 3 ml syringe provided in the package.

For children older than 4 years, 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 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).

Dosage in children from 6 months of age:

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 supplied 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 the following table for dose examples).

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

Administration method:

After measuring the correct dose with the appropriate syringe, levetiracetam oral solution may be diluted in a glass of water or in a bottle.

You may take levetiracetam with or without food. After oral administration of levetiracetam, you may notice its bitter taste.

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew it counterclockwise (Figure 1),
• Separate the adapter from the syringe (Figure 2). Insert the adapter into the neck of the bottle. Make sure it is securely fixed.
• Take the syringe and insert it into the opening of the adapter. Turn the bottle upside down (Figure 3).
• Fill the syringe with a small amount of solution by pushing the plunger down (Figure 4 a), then pull it up to remove any possible air bubbles (Figure 4 b). Push the plunger down to the graduation mark corresponding to the dose in millilitres (ml) prescribed by your doctor (Figure 4 c).
• Turn the bottle upright. Remove the syringe from the adapter.
• 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 5).
• Drink the entire contents of the glass or bottle.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water only (Figure 6).

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You must continue levetiracetam treatment 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 Sandoz than you should

If you have taken more levetiracetam than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount taken.

Possible adverse effects of a levetiracetam overdose 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.

If you forget to take Levetiracetam Sandoz

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 taking Levetiracetam Sandoz

Stopping treatment with Levetiracetam Sandoz should be done gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with levetiracetam, he/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.

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 fever, elevated liver enzymes in blood tests, and 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 volume, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate 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 affecting more than 30% of the body surface (toxic epidermal necrolysis),
• signs of serious mental changes or if someone around you notices confusion, drowsiness (lethargy), 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 commonly reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling weak, and dizziness may be more frequent 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 discomfort), vomiting, nausea,
• skin rash,
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells,
• weight loss, weight gain,
• suicide attempt and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation,
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paresthesia (tingling), attention disturbances (loss of concentration),
• diplopia (double vision), blurred vision,
• elevated/abnormal results in liver function tests,
• hair loss, eczema, pruritus,
• 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 (behavior problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see subsection “Contact your doctor immediately” for a detailed description of symptoms),
• epileptic seizures that 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,
• liver failure, hepatitis,
• 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 over more than 30% of the body surface (toxic epidermal necrolysis),
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. 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 and repetitive thoughts or the urge to repeat actions (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 may 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 Sandoz

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

Do not use this medicine after the expiry date stated on the bottle and carton following CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 7 months after first opening the bottle.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly 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 Sandoz

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: sodium citrate (for pH adjustment), citric acid (for pH adjustment), methylparaben (E-218), glycerol (E-422), acesulfame potassium (E-950), liquid maltitol (E-965), raspberry flavour (contains benzyl alcohol), purified water.

Nature of the product and contents of the container

Levetiracetam Sandoz oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam Sandoz (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 Sandoz (for infants from 6 months of age and older and children from 2 to 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 Sandoz (for infants from 1 month to less than 6 months of age) is packaged in a cardboard box with an 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

Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Remedica Ltd.
Limassol Industrial Estate,
P.O. Box 51706
CY-3508 Limassol
Cyprus

or

Galenica Pharmaceutical Industry S.A.
3rd Km Old National Road Chalkida Athens,
Chalcis, 341 00
Greece

or

Lek Pharmaceuticals d.d
Trimlini 2D,
9220 Lendava
Slovenia

or

Lek Pharmaceuticals d.d
Verovškova 57,
1526 Ljubljana
Slovenia

or

LEK S.A.
ul. Domaniewska 50 C
02-672 Warszawa
Poland

or

S.C. Sandoz, S.R.L.
Str. Livezeni nr. 7A,
RO-540472 Targu-Mures
Romania

or

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Austria: Levetiracetam Sandoz 100 mg/ml – Lösung zum Einnehmen
Belgium: Levetiracetam Sandoz 100 mg/ml drank
Finland: Levetiracetam 1A farma 100 mg/ml oraaliliuos
France: LEVETIRACETAM SANDOZ 100 mg/ml, solution buvable
United Kingdom: Levetiracetam Sandoz 100 mg / 1 ml, Oral Solution
Netherlands: Levetiracetam Sandoz 100 mg/ml, drank
Sweden: Levetiracetam Sandoz

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

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