Leaflet: information for the user

LevetiracetamAristogen250 mg film-coated tablets

Read this 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 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 leaflet. See section 4.

6. Contents of the pack and additional information

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

Levetiracetam is used:

• alone in adults and adolescents aged 16 years and older with recently diagnosed epilepsy, to treata form of epilepsy. Epilepsy is a disease where patients have seizures (attacks). 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 one month and older;
• myoclonic seizures(shock-like, brief, muscle or group of muscle spasms)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).

Do not take Levetiracetam Aristogen

• 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:

• if you have kidney problems, follow your doctor's instructions. Your doctor may decide 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 like 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 disease or are taking a 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. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Other medications and Levetiracetam Aristogen

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 and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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.

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)

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 night, and 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 your weight and dose.

• Dose in infants (1 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 your age, weight, and dose.

Levetiracetam 100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years old andfor 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 this may increase your seizures..

If you take more Levetiracetam Aristogen 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 Aristogen

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 Aristogen

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 the medication.

If you have any other questionsabout 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 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 temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes (hypersensitivity 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) (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 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
• 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 unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (feeling of rotation)
• cough
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea
• skin rash

• asthenia/fatigue (feeling weak)

Rare:may affect up to 1 in 100 people

• decreased platelets, decreased white blood cells
• 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 (difficulty with coordinated movements)
• paresthesia (tingling), attention problems (loss of concentration)
• diplopia (double vision), blurred vision
• elevated/abnormal liver function test results
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Very rare:may affect up to 1 in 1,000 people

• infection;
• decreased levels of all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• 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 and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• change in heart rhythm (electrocardiogram)
• pancreatitis (inflammation of the pancreas)
• hepatic insufficiency, hepatitis (inflammation of the liver)
• 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 more 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.

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 Medicinal Products for Human Use 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levetiracetam Aristogen

• The active ingredient is levetiracetam.

Each film-coated tablet contains 250 mg of levetiracetam.

• The other components are:

Core of the tablets:

Maize starch, anhydrous colloidal silica (E551), povidone (K-30) (E1201), talc (E553b), magnesium stearate (E470b).

Coating of the tablets:

Hypromellose 3cp & 6cp (E464), titanium dioxide (E171), macrogol 4000, aluminium lake of indigo carmine (E132).

Appearance of the product and contents of the package

Blue, biconvex, oval-shaped film-coated tablets with a deep groove on one face and a smooth face on the other.The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

LevetiracetamAristogenfilm-coated tablets are packaged in blister packs of PVC/PE/PVdC–Aluminium or in HDPE bottles with a polypropylene cap.

Package size:

Blister pack: 10, 20, 30, 50, 60, 100 and 200 film-coated tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain