Package Leaflet: Information for the Patient

Levetiracetam Exeltis 250 mg Granules for Oral Suspension

Levetiracetam

Read this leaflet carefully before you 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Levetiracetam Exeltis

3. How to take Levetiracetam Exeltis

4. Possible side effects

5. Storage of Levetiracetam Exeltis

6. Contents of the pack and additional information

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Exeltis is used:

?alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used to treat the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.

?concurrently with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, children, and infants aged 1 month or older
• myoclonic seizures (shock-like, short, muscle or group of muscle seizures) in adults and adolescents aged 12 years or older with Juvenile Myoclonic Epilepsy.

primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years or older with Idiopathic Generalized Epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam Exeltis

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

Warnings and precautions

Consult your doctor before starting to take Levetiracetam Exeltis

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications such as levetiracetam have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling of irritability, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. In a rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) that causes multiple types of seizures 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 Exeltis, see a doctor as soon as possible.

Children and adolescents

Levetiracetam Exeltis granulated coated is not indicated in children and adolescents under 16 years old as monotherapy, and is not recommended in children under 6 years old, as well as in the initial treatment of children under 25 kg.

Other medications and Levetiracetam Exeltis

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Use of Levetiracetam Exeltis with food, drinks, and alcohol

As a precaution, do not take Levetiracetam Exeltis with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Levetiracetam can be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.

Do not interrupt treatment without consulting your doctor. The risk of birth defects for the baby cannot be completely ruled out.

Driving and operating machinery

Levetiracetam Exeltis may affect your ability to drive or use any tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or use machinery until it is confirmed that your ability to perform these activities is not impaired.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Take the number of packets that your doctor has indicated.

Levetiracetam Exeltis should be taken twice a day, once in the morning and once at night, approximately at the same time of day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≤18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:

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

When starting to take Levetiracetam Exeltis, your doctor will prescribe a lower dose for two weeks before administering the general lowest dose.

For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 packet of 250 mg in the morning and 1 packet of 250 mg at night, and the dose should be gradually increased to reach 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) with a weight of less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to weight and dose.

• Dose in infants (1 month to 23 months) and children (2 to 11 years) with a weight of less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Exeltis according to age, weight, and dose.

Levetiracetam oral solution is a more suitable formulation for infants and children under 6 years old and for children and adolescents (6 to 17 years old) with a weight of less than 50 kg and when the packets do not allow for precise dosing.

Administration form:

1. 2. 3.

1.Hold the packet above the arrow and shake to make the contents fall.

2.Tear along the incision (at the arrow) and cut along the dotted line.

3.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 can take levetiracetam with or without food.

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

Each packet is for single use.

Treatment duration:

• Levetiracetam Exeltis is used as a chronic treatment. You should continue treatment with Levetiracetam Exeltis for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures.

If you take more Levetiracetam Exeltis than you should:

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

The possible adverse effects of an overdose of Levetiracetam Exeltis are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma. Contact your doctor if you have taken more packets than you should. Your doctor will establish the best possible treatment for the overdose.

If you forget to take Levetiracetam Exeltis:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levetiracetam Exeltis:

The discontinuation of treatment with Levetiracetam Exeltis should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Exeltis, they will give you instructions for the gradual withdrawal of Levetiracetam Exeltis.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Levetiracetam Exeltis may cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (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 it may be a sign of sudden kidney function decline

a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge)

• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis (inflammation of the nose or throat)
• drowsiness (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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (feeling of rotation)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Rare::may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count
• weight loss, weight gain
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration)
• diplopia (double vision), blurred vision
• 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
• decreased levels of certain types of white blood cells (neutrophils, granulocytes) or decreased total blood cell count
• severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat))
• hyponatremia (low sodium levels in the blood)
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently.
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• electrocardiogram changes
• pancreatitis
• hepatic insufficiency, hepatitis
• sudden decline in kidney function
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase levels associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• gait disturbance or difficulty walking
• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low level of consciousness (may be signs of a condition 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 (Obsessive-Compulsive Disorder).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.

You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the carton and on the overwrap after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Levetiracetam Exeltis

The active ingredient is levetiracetam. Each blister pack contains 250 mg of levetiracetam.

The other components are:

Povidone K30

Microcrystalline cellulose

Anhydrous colloidal silica

Magnesium stearate

Polivinyl alcohol

Titanium dioxide (E 171)

Macrogol 3350

Talc

Appearance of the product and content of the container

Granulated, film-coated; the film-coated granules are white or almost white and round (approximately 2 mm in diameter).

Levetiracetam Exeltis 250 mg granulated, film-coated

Packs of 20, 30, 50, 60, 100, 200 blisters

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Exeltis Healthcare, S.L.

Avda. Miralcampo 7

Polígono Industrial Miralcampo 19200

Azuqueca de Henares (Guadalajara)

Spain

Responsible person for manufacturing

Desitin Arzneimittel GmbH,

Weg beim Jäger 214,

22335 Hamburg,

Germany

This medicinal product is authorized in the member states of the European Economic Area with 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 Exeltis 250 mg granulated, film-coated

Last review date of this leaflet: January 2024

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/