PATIENT INFORMATION LEAFLET

LEVETIRACETAM SUN 500 mg FILM-COATED TABLETS

(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 pass it on to others even if they have the same symptoms as you. It may harm them.

− If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

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

3. How to take Levetiracetam SUN

4. Possible side effects

5. Storage of Levetiracetam SUN

6. Contents of the pack and additional information

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

Levetiracetam SUN is used:

• alone inadults 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 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 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 medications to treat:

• partial onset seizures with or without secondary generalization inadults, adolescents, children, and infants from 1 month of age

• 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 takeLevetiracetam SUN

• 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 SUN

• 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 SUN, 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 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, it is possible that seizures will continue or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam SUN, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam SUN is not indicated in children and adolescents under 16 years old.

Use of Levetiracetam SUN with other medications

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

If you are being treated with Metotrexato and Levetiracetam at the same time, serum concentrations of these medications should be closely monitored.

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

Pregnancy and breastfeeding

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

Levetiracetam SUN can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop treatment without discussing it with your doctor first.

The risk of birth defects for the baby cannot be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam SUN 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. Consult your doctor or pharmacist if you have any doubts.

Take the number of tablets that your doctor has prescribed.

Levetiracetam SUN 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 SUN, your doctor will prescribe alower dosefor two weeks before administeringthe lowest 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 SUN 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 SUN according to age, weight, and dose.

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years 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 Levetiracetam SUN tablets with a sufficient amount of liquid (e.g. a glass of water).Levetiracetam SUN can be taken with or without food.After oral administration of levetiracetam, its bitter taste may be perceived.

Treatment duration:

• Levetiracetam SUN is used as a chronic treatment. Continue treatment with Levetiracetam SUN 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 moreLevetiracetam SUNthan 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 a Levetiracetam SUN 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.

If you forgot to takeLevetiracetam SUN:

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 the treatment withLevetiracetam SUN:

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

If you have any other doubts about the use of this product, 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 (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) (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. Side effects such as 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;

• convulsions, balance disorder, dizziness (sensation of instability)lethargy;

(lack of energy and enthusiasm);shakiness (involuntary tremor);

• vertigo (sensation of rotation);

• cough;

• abdominal pain, diarrhea, indigestion, vomiting, nausea;

• skin rash,;

• asthenia/fatigue (sensation 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;

• 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 alterations (loss of concentration);

• diplopia (double vision), blurred vision;

• elevated/abnormal liver function test values; ;• hair loss, eczema, itching;

• muscle weakness, myalgia (muscle pain);

• injury.

Rare:may affect up to 1 in 1,000 people

• infection;

• decrease in 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 concentration in blood

• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);

• seizures may worsen or occur more frequently;

• delirium;

• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);

• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);

• change in heart rhythm (electrocardiogram);

• pancreatitis (inflammation of the pancreas);

• liver 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 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).

•myoglobinuria (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated.

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

• unwanted or repeated thoughts or sensations or the urge to do something over and over again (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 out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton and in the blister 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 medications you no longer need at your local SIGRE collection point. 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 SUN

The active ingredient is levetiracetam. Each tablet contains 500 mg of levetiracetam.

The other components are: Maize starch, Povidone (K-30), Microcrystalline cellulose, Anhydrous colloidal silica, Crospovidone (Type B), Talc, Magnesium stearate,Opadry Yellow,(Hypromellose 6cP,Titanium dioxide (E171), Macrogol 400, Talc, Macrogol 4000, Yellow iron oxide (E172), Aluminium lake of indigo carmine (E132)).

Appearance of the product and contents of the package

The film-coated tablets are yellow, oval, 18.5 x 9 mm, with “RB” and “19” engraved on each side of the groove on one face and smooth on the other face. The tablets can be divided into equal doses.

The packages contain 10, 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.:+3493 342 78 90

This medicine is authorized in the following member states, with the following names:

Last reviewed date of the text:September 2023

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