Levetiracetam Desitin 750 mg granules for oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Desitin 750 mg coated granules in sachet

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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Levetiracetam Desitin is used:

• as monotherapy in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a type of epilepsy. Epilepsy is a disease in which patients have attacks (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 Desitin

Do not take Levetiracetam Desitin

• 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 Desitin

• 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 slowed growth 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 about harming themselves or suicide. If you experience symptoms of depression and/or suicidal thoughts, contact your doctor immediately.
• 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 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, mainly during the first month after starting treatment or increasing the dose. In a very rare early-onset form of 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 Desitin, seek medical advice as soon as possible.

Children and adolescents

Levetiracetam Desitin coated granules are not indicated as monotherapy in children and adolescents under 16 years of age, and are not recommended in children under 6 years of age or for initial treatment in children weighing less than 25 kg.

Other medicines and Levetiracetam Desitin

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 laxative medicine) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Taking Levetiracetam Desitin with food, drinks and alcohol

As a safety precaution, do not take Levetiracetam Desitin with alcohol.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you might be pregnant, or plan 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 treatment without consulting your doctor. A risk of birth defects for the unborn child 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.

Driving and using machines

Levetiracetam Desitin 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.

3. How to take Levetiracetam Desitin

Follow exactly the dosing instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Take the number of sachets prescribed by your doctor.

Levetiracetam Desitin should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Standard dose: between 1,000 mg and 3,000 mg per day.

When you start taking Levetiracetam Desitin, your doctor will prescribe a lower dose for the first two weeks before increasing to the lowest standard dose.

For example: for a daily dose of 1,000 mg, your initial reduced dose is 1 sachet of 250 mg in the morning and 1 sachet of 250 mg in the evening, which should be gradually increased to 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on weight and required dose.

• Dosage in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Desitin based on age, weight, and dose.

Levetiracetam oral solution is a more suitable formulation for infants and children under 6 years of age, and for children and adolescents (6 to 17 years) weighing less than 50 kg, especially when sachets do not allow precise dosing.

Method of administration:

2. Hold the sachet above the arrow and shake to move the contents down.

3. Tear along the notch (at the arrow) and cut along the dotted line.

4. Empty the contents directly into the mouth and swallow the granules immediately with a sufficient amount of liquid (e.g. a glass of water). Do not chew the granules, as they may have a slightly bitter taste. You may take levetiracetam with or without food.

The coated granules may also be suspended in at least 10 mL of water by shaking for a minimum of 2 minutes and administered via feeding tube, which should be flushed twice with 10 mL of water immediately after administration. If this method is used, the suspension should be prepared immediately before administration.

Each sachet is for single use only.

Duration of treatment:

• Levetiracetam Desitin is used as a chronic treatment. You must continue treatment with Levetiracetam Desitin for the duration prescribed by your doctor.
• Do not stop treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam Desitin than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Possible adverse effects of an overdose of Levetiracetam Desitin include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma. Contact your doctor if you have taken more sachets than prescribed. Your doctor will determine the best management for the overdose.

If you forget to take Levetiracetam Desitin:

Contact your doctor if you miss one or more doses.

Do not take a double dose to make up for missed doses.

If you stop taking Levetiracetam Desitin:

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

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 Desitin 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 persistent rash with high fever, elevated liver enzymes in blood tests, increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate sudden decrease in kidney function
• 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)
• 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 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. Effects such as drowsiness, 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 (inflammation of the nose or throat)
• somnolence (feeling sleepy), 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 (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (spinning sensation)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), 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 cell count
• weight loss, weight gain
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, 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 liver function test results
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Rare: may affect up to 1 in 1000 people

• infection
• decrease in certain types of white blood cells (neutrophils, granulocytes) or decrease in the number of all types of blood cells
• serious 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 “Contact 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
• 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), 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 increased 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, reduced 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

• Repeated unwanted 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 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 Desitin

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

Do not use this medicine after the expiry date which is stated on the carton and on the sachet after EXP.

The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are 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 Desitin

The active substance is levetiracetam. Each sachet contains 250 mg of levetiracetam.

The other components are:

Povidone k30

Microcrystalline cellulose

Colloidal anhydrous silica

Magnesium stearate

Polyvinyl alcohol

Titanium dioxide (E 171)

Macrogol 3350

Talc

Appearance of the product and contents of the pack

Coated granules in a sachet; the coated granules are white or almost white and spherical (approximately 2 mm in diameter).

Levetiracetam Desitin 250 mg coated granules in a sachet

Pack sizes of 20, 30, 50, 60, 100, and 200 sachets

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Desitin Arzneimittel GmbH,

Weg beim Jäger 214,

22335 Hamburg,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Levetiracetam Desitin 250 mg befilmtes Granulat im Beutel

Portugal: Lovos 250 mg granulado revestido em saqueta

Romania: Levetiracetam Desitin 250 mg granuledrajefiate , în plic

Spain: Levetiracetam Desitin 250 mg granulado recubierto en sobre

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

Detailed and up-to-date 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/