Package Insert: Information for the User

Levetiracetam Aurovitas 750mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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 must 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 package insert. See section 4.

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

Levetiracetam is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later extend 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 1 month of age or older;
• myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy;
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take levetiracetam:

• 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 family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a condition and/or treatment that makes you prone to irregular heartbeats 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 irritable, 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 very 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, seek medical attention as soon as possible.

Children and adolescents

Levetiracetam monotherapy is not indicated in children and adolescents under 16 years old.

Use of Levetiracetam Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Levetiracetam can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary. Do not stop your treatment without discussing it with your doctor first.The risk of birth defects for the baby cannot be completely ruled out.

It is not recommended to breastfeed during treatment.

Driving and operating machinery

Levetiracetam may impair your ability to drive or operate 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 operate machinery until it is confirmed that your ability to perform these activities is not affected.

Levetiracetam Aurovitas 750 mgcontainsYellow Orange S (E110):

This medication contains Yellow Orange S (E110), which may cause allergic reactions.

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

Take the number of tablets prescribed by your doctor.

Levetiracetam should be taken twice a day, once in the morning and once at night, 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)with a weight of 50 kg or more:

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

When starting to take levetiracetam, your doctor will prescribe alower dosefor two weeks before administering the daily dose.

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

Adolescents (12 to 17 years) with a weight equal to or 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 less than 50 kg:

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

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years old and for children and adolescents (6 to 17 years) with a weight less than 50 kg and when tablets do not allow for precise dosing.

Administration form

Swallow the levetiracetam tablets with a sufficient amount of liquid (e.g. a glass of water). You can take levetiracetam with or without food. After oral administration of levetiracetam, its bitter taste may be perceived.

Treatment duration

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

If you take more Levetiracetam Aurovitas than you should

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

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

If you forgot to take Levetiracetam Aurovitas

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 Aurovitas

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

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

Like all medicines, this medicine can 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 lightheadedness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis);
• 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 fever, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia), enlarged lymph nodes, and the involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms (DRESS));
• symptoms such as decreased 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) (erythema multiforme);
• 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 deterioration (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 (drowsiness), headache, fatigue, and dizziness. The side effects of drowsiness, weakness, 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;
• drowsiness (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 instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, indigestion, vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

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 deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention disturbances (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 1,000 people

• infection;
• decreased levels of all types of blood cells;
• severe allergic reactions (DRESS, anaphylaxis, Quincke's edema);
• decreased 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);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver 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, and 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

• unwanted thoughts or sensations that are repeated 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 leaflet. You can also report them directly through the Spanish System for the Vigilance 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 medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications if you are unsure. By doing so, you will help protect the environment.

Composition of Levetiracetam Aurovitas

The active ingredient is levetiracetam.

Each film-coated tablet contains 750 mg of levetiracetam.

• The other components (excipients) are:

Core of the tablet:cornstarch, anhydrous colloidal silica, povidone (K-30), talc, magnesium stearate.

Coating material:hypromellose 3 cp and 6 cp (E-464), titanium dioxide (E-171), macrogol 4000, indigo carmine (E-132), yellow-orange S (E110), iron oxide red (E-172).

Appearance of the product and contents of the package

Film-coated tablet.

Levetiracetam Aurovitas 750mg film-coated tablets EFG

Film-coated tablets, orange in color, biconvex, oval, and marked with a deep groove separating “E” and “12” on one face of the tablet and flat on the other face. The tablet can be divided into equal doses.

Levetiracetam Aurovitas film-coated tablets are available in blister packs.

Pack sizes:

Blister pack: 20, 30, 50, 60, 100, and 120 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, n.o 19,

Venda Nova, 2700-487 Amadora, Lisboa

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2025

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).