Levetiracetam Kern Pharma 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Kern Pharma 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 and should not be given to other people, even if they have the same symptoms, as 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:

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

1. What Levetiracetam Kern Pharma is and what it is used for

Levetiracetam Kern Pharma is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Kern Pharma is used:

• as monotherapy in adults and adolescents 16 years of age and older with newly diagnosed epilepsy to treat one 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 (major seizures, including loss of consciousness) 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 taking Levetiracetam Kern Pharma

Do not take Levetiracetam Kern Pharma

• 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 Kern Pharma

• 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 slowing in your child's growth or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Kern Pharma have had thoughts about harming themselves or about suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor immediately.
• If you have a personal or family history of irregular heartbeat (as 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 normal, 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, especially during the first month after starting treatment or after a dose increase.

• 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 Kern Pharma, seek medical advice as soon as possible.

Children and adolescents

• Treatment with Levetiracetam Kern Pharma alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Taking Levetiracetam Kern Pharma with other medicines

Inform 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, breastfeeding, and fertility

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. A 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 Kern Pharma 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 use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Kern Pharma contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), maltitol, and propylene glycol (E1520).

Due to the presence of methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), it may cause allergic reactions (possibly delayed).

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains 0.283 mg of propylene glycol per 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.

3. How to take Levetiracetam Kern Pharma

Follow exactly the instructions for administering Levetiracetam Kern Pharma as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Levetiracetam Kern Pharma 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 according to your doctor's instructions.

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 included in the package.

Recommended dose: Levetiracetam Kern Pharma is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you start taking Levetiracetam Kern Pharma, your doctor will prescribe a lower dose for two weeks before increasing to the lowest general maintenance dose.

Concomitant therapy

Doses 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 included in the package.

Recommended dose: Levetiracetam Kern Pharma is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Doses in children from 6 months of age onwards:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Kern Pharma based on the child's age, weight, and required 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.

General dose: Levetiracetam Kern Pharma is taken twice daily, divided into two equal doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see dosage examples in the table below).

Doses in children from 6 months of age onwards:

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

For infants from 1 month to less than 6 months, measure the appropriate dose using the 1 ml syringe provided in the package.

Recommended dose: Levetiracetam Kern Pharma is taken twice daily, divided into two equal doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see the following table for dose examples).

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

Administration method

After measuring the correct dose with an appropriate syringe, Levetiracetam Kern Pharma oral solution may be diluted in a glass of water or in a baby bottle. Levetiracetam Kern Pharma may be taken with or without food. A bitter taste of levetiracetam may be noticed after oral administration.

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew 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 first 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 baby bottle by pushing the plunger to the end of the syringe (Figure 7).

• Drink the entire contents of the glass.

• Close the bottle with the plastic screw cap.

• Wash the syringe with water (Figure 8).

Duration of treatment

• Levetiracetam Kern Pharma is used as a chronic treatment. You must continue Levetiracetam Kern Pharma 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 Kern Pharma than you should

Possible adverse effects of an overdose of Levetiracetam Kern Pharma include somnolence, 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 most appropriate 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 Kern Pharma

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 Kern Pharma

Discontinuation of treatment with Levetiracetam Kern Pharma should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with this medicine, they will provide you with instructions for the gradual withdrawal of Levetiracetam Kern Pharma.

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

4. Possible adverse effects

Like all medicines, Levetiracetam Kern Pharma can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor 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 facial rash followed by a prolonged rash with high fever, 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 output, fatigue, nausea, vomiting, confusion, and swelling of the 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 blistering rash with 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 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. Drowsiness, feeling of weakness, and dizziness may be more common when treatment is started or when 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, restlessness or irritability;
• seizures, balance disorder, dizziness (sensation of unsteadiness), lethargy, 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 platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), 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 sodium concentration in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Immediately inform your doctor” for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled 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 generalized blistering rash with skin peeling, 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;
• 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 and repetitive thoughts or sensations or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, consult 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Kern Pharma

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

Do not use Levetiracetam Kern Pharma after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Do not use more than 7 months after opening the container.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to 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 Kern Pharma

• The active substance is levetiracetam. Each ml of oral solution contains 100 mg of levetiracetam.
• The other components are: sodium citrate, citric acid monohydrate, methylparaben (E218), propylparaben (E216), ammonium glycyrrhizinate, glycerol (E422), liquid maltitol (E965), acesulfame K (E950), grape flavour (containing propylene glycol (E1520)), purified water.

Appearance of the product and contents of the container

Levetiracetam Kern Pharma is a clear liquid. It is supplied in a 300 ml or 150 ml glass bottle.

The 300 ml glass bottle of Levetiracetam Kern Pharma (for children from 4 years of age, adolescents and adults) is packaged in a cardboard box with a 12 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle of Levetiracetam Kern Pharma (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 Kern Pharma (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.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Zaklady Farmaceutyczne POLPHARMA S.A.

Oddzial Medana w Sieradzu

ul. W. Lokietka 10, 98-200 Sieradz

Poland

Date of the most recent review of this leaflet: January 2026

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