Levetiracetam Desitin 1000 mg granules in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Desitin 1000 mg coated granules in sachet

Levetiracetam

Read all of this 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, 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Levetiracetam Desitin is and what it is used for
2. What you need to know before you take 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 aged 16 years and older with newly diagnosed epilepsy to treat one type of epilepsy. Epilepsy is a disease 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 muscle group) in adults and adolescents aged 12 years and older with Juvenile Myoclonic Epilepsy

• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years 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 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 your doctor 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 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 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 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 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 Desitin, see a doctor as soon as possible.

Children and adolescents

Levetiracetam Desitin 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 in children weighing less than 25 kg for initial treatment.

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 could reduce its effect.

Use of 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 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 treatment without consulting your doctor. A 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.

Driving and using machines

Levetiracetam Desitin may affect your ability to drive or use 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.

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:

Recommended 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 recommended maintenance 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 body weight and required dose.

• Dosing 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 required 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 downward.

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. The tube should then be flushed twice with 10 mL of water immediately after administration. If this method is used, the suspension must 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 taking Levetiracetam Desitin for the duration prescribed by your doctor.
• Do not stop treatment without consulting your doctor, as this may increase the frequency of your seizures.

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, providing information on the medicine taken and the amount ingested.

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

If you forget to take Levetiracetam Desitin:

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 Desitin:

Discontinuation of Levetiracetam Desitin treatment should be done gradually to avoid an increase in seizure frequency. If your doctor decides to stop your treatment with Levetiracetam Desitin, they will provide instructions for gradually tapering off the medication.

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/Quincke's edema)
• flu-like symptoms and facial rash followed by a prolonged 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 which 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)
• 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 behaviour 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 drowsiness, feeling weak 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 (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 instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (sensation of spinning)
• 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 behaviour, 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 liver function test results
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Rare: may affect up to 1 in 1,000 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/Quincke's edema (swelling of face, lips, tongue and throat))
• decrease in blood sodium concentration
• suicide, personality disorders (behavioural 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 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. 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). 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 effects, consult 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 Desitin

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

Do not use this medicine after the expiry date stated on the carton and on the sachet 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 sachet; the coated granules are white or almost white and spherical (approximately 2 mm in diameter).

Levetiracetam Desitin 250 mg coated granules in sachet

Packs of 20, 30, 50, 60, 100 and 200 sachets

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Desitin Arzneimittel GmbH,
Weg beim Jäger 214,
22335 Hamburg,
Germany

This medicinal product is authorised 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 review of this leaflet: January 2026

Detailed and up-to-date 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/